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SIS Software Version 3.6.0

Surgical Information Sciences, Inc. • Radiology • 09/13/2019

510(k)IEC 62304 Class B
FDA Summary PDF

Device Purpose

SIS Software Version 3.6.0 is an advanced medical imaging application designed to aid neurosurgical planning by providing enhanced 3D visualization of brain structures, particularly the subthalamic nuclei. It utilizes machine learning, sophisticated image processing for MRI and CT scans, and improved image fusion and registration methodologies, including handling for CT gantry tilt, to generate patient-specific anatomical models for stereotactic procedures.

Summary

SIS Software Version 3.6.0 is a medical imaging application designed for medical professionals, including surgeons, neurologists, and radiologists, to assist in neurosurgical procedures. Its core capabilities encompass the viewing, presentation, and documentation of medical images, featuring modules for image processing, image fusion, and intraoperative functional planning. The software generates 3D outputs that are compatible with stereotactic image-guided surgery systems and other visualization tools, with a specific indication to aid in the visualization of the subthalamic nuclei (STN), thereby supplementing standard clinical methods by offering enhanced visual information. The technology underpinning SIS Software leverages machine learning and advanced image processing algorithms to create patient-specific 3D anatomical models of brain structures from MRI and CT scans. Version 3.6.0 introduces significant enhancements, including a more comprehensive MR to post-operation CT registration methodology that utilizes tools like ANTS and ELASTIX for both linear and non-linear registration. It also features improved image processing techniques to handle CT images acquired with gantry tilt. Performance validation confirmed these modifications maintain accurate image registration and object segmentation, with results comparable to its predecessor. Additionally, this version includes an updated web user interface with more administrative options and audit logging functionalities.

AI Regulatory Concerns

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Keywords

Medical ImagingImage ProcessingMachine Learning3D ModelingNeurosurgerySubthalamic Nuclei (STN)Image FusionStereotactic SurgeryMR-CT RegistrationGantry Tilt

Device Metadata

Submission Number
K192304
Company
Surgical Information Sciences, Inc.
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 machine learning algorithm specifically improve the segmentation accuracy of the subthalamic nuclei compared to traditional image processing techniques?; What are the quantitative metrics for the 'more comprehensive MR to post-operation CT registration methodology,' and how do ANTS and ELASTIX tools contribute to its improved performance over previous methods?; Can the SIS Software be integrated with real-time intraoperative imaging modalities, and if so, what is the latency in updating the 3D model?; What specific challenges do 'CT images acquired with gantry tilt' pose for image processing, and how does Version 3.6.0's methodology address these to maintain segmentation accuracy?; Beyond STN visualization, what is the potential for this software's image processing and 3D modeling capabilities in planning other types of neurosurgical interventions or for other anatomical regions?

Risk Classification

ESL Analysis
FDA Device ClassII

FDA Class II via 510(k) pathway; IEC 62304 Class B (software safety classification); Authorized before §524B enforcement

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Cybersecurity Evidence

Powered by SBOMator™

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✓ Detected in Summary
Cyber Risk Assessment⚠ Not mentioned in summary
Postmarket Plan⚠ Not mentioned in summary
§524B ApplicableNo

Supply Chain BOM Evidence

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

SBOMSoftware Bill of Materials(software version)
✓ Detected
ML-BOMMachine Learning Bill of Materials(machine learning, 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
- Not 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 SBOM, ML-BOM detected in AI-generated device summary.

• This device was authorized before §524B took effect. Cybersecurity evidence requirements were less prescriptive at the time.

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

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

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SIS Software Version 3.6.0 - Surgical Information Sciences, Inc. | ESL FDA AI Device Intelligence