BriefCase

Aidoc Medical, Ltd. • Radiology • 04/26/2022

510(k)IEC 62304 Class B

Device Purpose

BriefCase is a radiological computer-aided triage and notification software employing an artificial intelligence algorithm to analyze contrast-enhanced chest CTs (excluding CTPA protocols) for suspected incidental Pulmonary Embolism (iPE) in adults. The system aims to improve clinical workflow by flagging these cases for medical specialists via desktop notifications and preview images, thereby facilitating earlier review and prioritization without altering original images or the standard diagnostic process.

Summary

The BriefCase device is a radiological computer-aided triage and notification software designed to analyze contrast-enhanced chest CT scans (excluding dedicated CTPA protocols) in adults and transitional adolescents aged 18 and older. Its primary purpose is to assist hospital networks and trained medical specialists in workflow triage by flagging and communicating suspected cases of incidental Pulmonary Embolism (iPE). The system utilizes an artificial intelligence algorithm to analyze images and sends notifications for suspect cases to a standalone desktop application, operating in parallel with standard image interpretation. These notifications include compressed preview images for informational purposes only, not for diagnostic use, and the device does not alter the original medical images. The goal is to prompt earlier review of potential iPE cases by drawing clinicians' attention to them. The system architecture includes an Aidoc Hospital Server (AHS) for image acquisition, an Aidoc Cloud Server (ACS) for image processing, and an Aidoc Worklist Application for user interface and notifications. DICOM images are filtered, de-identified, and processed chronologically. Users can filter notifications by pathology or medical center. The device was evaluated in a retrospective, multicenter study involving 159 cases (78 positive, 81 negative for iPE) from Philips and Toshiba CT scanners, demonstrating a sensitivity of 89.7% and specificity of 90.1%. It has also been shown to significantly reduce the time to exam review for suspected positive cases compared to standard care. The software is compatible with GE, Siemens, Philips, and Toshiba CT scanners.

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

BriefCasePulmonary EmbolismiPECTcontrast-enhancedtriagenotification softwareartificial intelligenceDICOMworkflow

Device Metadata

Submission Number

K213886

Company

Aidoc Medical, Ltd.

Panel

Radiology

Product Code

N/A

Data Type

Images

Clinical Function

Assessment

AI Function

Analysis

AI Subclass

triage

Relevant Clinical Questions

Q1. What is the specific performance (sensitivity, specificity, PPV, NPV) of the BriefCase algorithm when analyzing CT scans from Philips and Toshiba scanners individually, as compared to the pooled data presented?; How does the AI algorithm differentiate between true incidental Pulmonary Embolism and other lung pathologies or artifacts that might mimic iPE on contrast-enhanced chest CTs?; What are the computational requirements and processing time per study for the BriefCase software, particularly for the Aidoc Cloud Server (ACS) module?; How does the system's performance vary with different levels or qualities of contrast enhancement in the chest CT examinations?; Are there plans to expand the BriefCase software's capabilities to detect other incidental findings beyond Pulmonary Embolism in chest CTs or other anatomical regions?

Risk Classification

ESL Analysis

IEC 62304 ClassB

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

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 mentioned 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

- Not detected

ML-BOMMachine Learning Bill of Materials(algorithm)

✓ Detected

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

✓ 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.

• 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: SBOM, HBOM, CBOM, VDR/VEX, OBOM. These may be present in the full FDA submission.

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