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Relu Creator

Relu BV • Radiology • 06/13/2024

510(k)IEC 62304 Class B
FDA Summary PDF

Device Purpose

Relu Creator is a specialized software designed for 3D anatomical modeling of dental and craniomaxillofacial structures through advanced image segmentation and multimodel registration of medical scans like CBCT, 1OS, and FS. Its purpose is to provide precise design input for a range of dental solutions, supporting preoperative planning and enhancing diagnostic capabilities for dental specialists by processing and analyzing image data.

Summary

Relu Creator is a software program designed for dental specialists to manage, transfer, and analyze dental and craniomaxillofacial image information as part of the preoperative planning digital workflow. Its primary function is to facilitate 3D modeling of patient anatomy through image segmentation and multimodel registration, using medical images such as Cone Beam Computed Tomography (CBCT), 1OS (image data), and FS (image data). The software displays and enhances these digital images to support diagnostic processes and treatment planning, providing outputs in formats like STL, DICOM, PLY, and OBJ, which serve as design input for various dental solutions. Relu Creator does not acquire image data itself but processes imported images and can store and share them within a system or across different computer locations. The core technology of Relu Creator revolves around 3D modeling, specifically image segmentation (including an automatic segmentation algorithm powered by Relu Engine) and multimodel registration of dental and craniomaxillofacial structures. This enables the creation of detailed anatomical models from various imaging sources, which can then be used for simulations in preoperative and pretreatment planning across diverse dental disciplines, including orthodontics, implantology, and maxillofacial surgery. While it offers general image processing features, it does not perform volume or surface area measurements. Performance testing and software validation have demonstrated that Relu Creator functions as intended and is appropriate for its specified uses, being available in both web-application and local application formats.

AI Regulatory Concerns

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Keywords

3D ModelingImage SegmentationDental SoftwareCraniomaxillofacial ImagingPreoperative PlanningCBCT1OS (Medical Image)FS (Medical Image)Multimodel RegistrationRelu Engine

Device Metadata

Submission Number
K233925
Company
Relu BV
Panel
Radiology
Product Code
N/A
Data Type
Images
Clinical Function
Intervention
AI Function
Analysis
AI Subclass
quantification/feature localization

Relevant Clinical Questions

  • Q1. How does the 'Relu Engine' automatic segmentation algorithm compare in accuracy and efficiency to other commercially available or research-grade segmentation tools for diverse dental and craniomaxillofacial anatomies and pathologies?; What specific validation studies were conducted to assess the precision of the 3D models generated by Relu Creator, particularly when using combined image modalities like CBCT, 1OS, and FS for multimodel registration?; Given that Relu Creator provides design input for dental solutions but does not include treatment planning itself, what are the typical downstream software or workflows it integrates with, and how seamless is this integration?; What is the range of 'dental solutions' for which Relu Creator can provide design input, and are there specific complex cases (e.g., severe asymmetries, reconstructive surgery planning) where its capabilities are particularly advantageous or limited?; Since Relu Creator is available as both a web-application and local application, what are the differences in performance, data security protocols, and feature sets between these two deployment models?

Risk Classification

ESL Analysis
FDA Device ClassII

FDA Class II via 510(k) pathway; IEC 62304 Class B (software safety classification); Post-§524B but no clear network capability detected

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Cybersecurity Evidence

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Based on AI-generated device summaries, not the full FDA submission. Items not detected here may still be present in the complete submission package.

Cyber Score30/100
SBOM Evidence⚠ Not in summary - likely in full submission per §524B
Cyber Risk Assessment✓ Detected in Summary
Postmarket Plan⚠ Not in summary - likely in full submission per §524B
§524B ApplicableYes

Supply Chain BOM Evidence

Based on the CycloneDX / OWASP ECMA-424 xBOM ecosystem. Detection is from the AI-generated summary.

SBOMSoftware Bill of Materials
- Not detected
ML-BOMMachine Learning Bill of Materials(algorithm)
✓ Detected
SaaSBOMSoftware-as-a-Service Bill of Materials
- Not detected
HBOMHardware Bill of Materials
- Not detected
CBOMCryptography Bill of Materials
- Not detected
VDR/VEXVulnerability Disclosure Report / Vulnerability Exploitability eXchange
- Not detected
OBOMOperations Bill of Materials(deployment)
✓ Detected

Analysis:

• Analysis is based on the AI-generated device summary, not the full FDA submission package. Click "Analyze Full FDA PDF" below to scan the actual submission document.

• Evidence of ML-BOM, OBOM detected in AI-generated device summary.

• SBOM not mentioned in AI-generated device summary. Under §524B (effective Oct 2023), cyber devices must provide a SBOM.

• Postmarket cybersecurity monitoring plan not clearly documented in AI-generated device summary.

• Not detected in AI-generated device summary: SBOM, SaaSBOM, HBOM, CBOM, VDR/VEX. These may be present in the full FDA submission.

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Relu Creator - Relu BV | ESL FDA AI Device Intelligence