Better Diagnostics Caries Assist (BDCA) Version 1.0

Better Diagnostics AI Corp • Radiology • 03/11/2025

510(k)IEC 62304 Class B§524B Cyber Device

Device Purpose

The Better Diagnostics Caries Assist (BDCA) Version 1.0 is an automated software tool designed to aid board-licensed dentists in identifying and localizing carious lesions on bitewing and periapical radiographs. This device leverages cloud-hosted computer vision models to enhance diagnostic accuracy, as demonstrated by improved sensitivity and maintained specificity in clinical evaluations.

Summary

Better Diagnostics AI Corp. has developed the Better Diagnostics Caries Assist (BDCA) Version 1.0, an automated software tool designed to assist dentists in identifying and localizing carious lesions (cavities) on bitewing and periapical radiographs. This software is classified as a Class II medical image analyzer and is intended for use by board-licensed dentists as a supplementary aid. It is not meant to replace a comprehensive clinical evaluation, as a dentist's final judgment should always incorporate additional patient history and in-vivo assessment. This device has been determined to be substantially equivalent to a legally marketed device. The BDCA Version 1.0 integrates a user interface, an Application Programming Interface (API), a business layer, and cloud-hosted computer vision models to process dental images and highlight suspected carious areas with bounding boxes. The software is specifically for radiographs acquired from patients aged 18 years or older. Performance testing, including standalone and multi-reader clinical evaluations, demonstrated that the device significantly enhances diagnostic accuracy. Studies indicated improved sensitivity and maintained specificity for dentists utilizing the software's assistance compared to those without it, confirming its robust performance across diverse clinical scenarios and patient demographics.

AI Regulatory Concerns

Jev reads the full FDA letter and returns calibrated concern probabilities per regulatory category. These are AI estimates, not regulatory advice.

Keywords

Caries AssistAutomated softwareDental radiographsCarious lesionsDiagnostic accuracyComputer visionMedical image analyzerSensitivitySpecificityDentists

Device Metadata

Submission Number

K241725

Company

Better Diagnostics AI Corp

Panel

Radiology

Product Code

N/A

Data Type

N/A

Clinical Function

N/A

AI Function

N/A

AI Subclass

N/A

Relevant Clinical Questions

Q1. What is the false positive rate of the BDCA Version 1.0 and how does it compare to unassisted diagnoses?; Were the clinical evaluations conducted across different types of imaging equipment and dental practice settings to assess generalizability?; How does the software's performance vary for different stages or severities of carious lesions (e.g., incipient vs. advanced)?; What is the training data set size and composition used for the cloud-hosted computer vision models?; Are there plans for future versions of BDCA to include support for pediatric patients or other types of dental imaging (e.g., CBCT)?

Risk Classification

ESL Analysis

IEC 62304 ClassB

FDA Device ClassII

FDA Class II via 510(k) pathway; IEC 62304 Class B (software safety classification); Qualifies as a cyber device under §524B (post-Dec 2023, networked)

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Cybersecurity Evidence

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 Score10/100

SBOM Evidence⚠ Not in summary - likely in full submission per §524B

Cyber Risk Assessment⚠ Not in summary - likely in full submission per §524B

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(training data, data set)

✓ Detected

SaaSBOMSoftware-as-a-Service Bill of Materials(cloud, hosted)

✓ 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 ML-BOM, SaaSBOM 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.

• Cybersecurity risk assessment not referenced in AI-generated device summary. FDA cybersecurity guidance (2023) expects this for cyber devices.

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

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

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