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CINA CHEST

Avicenna.AI • Radiology • 05/19/2021

510(k)IEC 62304 Class B
FDA Summary PDF

Device Purpose

CINA CHEST is an AI-powered software designed to expedite the triage of critical findings by analyzing chest and thoraco-abdominal CT angiograms for suspected Pulmonary Embolism and Aortic Dissection. It employs distinct algorithms for PE and AD detection, providing non-diagnostic notifications and preview images to radiologists via a web application, aiming to improve workflow efficiency and prioritize urgent patient care.

Summary

CINA CHEST, developed by Avicenna.AI, is a radiological computer-aided triage and notification software designed to assist radiologists in managing workflow for urgent findings. It analyzes Chest and Thoraco-abdominal CT angiography (CTA) scans to detect suspected cases of Pulmonary Embolism (PE) and Aortic Dissection (AD). The system employs an artificial intelligence algorithm to process DICOM images, identifying potential PE or AD. These findings are then communicated through a standalone web application that operates in parallel with standard image interpretation workflows. The software provides active pop-up notifications and passive iconic flags on a worklist, along with compressed, non-diagnostic preview images, to alert clinicians to high-priority cases, thereby facilitating earlier review. Technologically, CINA CHEST runs on standard server hardware and consists of separate image processing applications for PE and AD detection, which can integrate with compatible medical image communication platforms like the CINA Platform. These applications verify DICOM properties, execute their respective algorithms, and generate notification results. Performance was evaluated in a retrospective, multicenter study using 396 cases for PE and 298 for AD. For PE detection, sensitivity was 91.1% and specificity was 91.8%. For AD detection, sensitivity was 96.4% and specificity was 97.5%. The mean time-to-notification was approximately 63 seconds for PE and 36.5 seconds for AD, demonstrating its potential to expedite the identification of critical cases.

AI Regulatory Concerns

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Keywords

Pulmonary Embolism (PE)Aortic Dissection (AD)CT Angiography (CTA)Artificial Intelligence (AI)Triage SoftwareWorkflow PrioritizationRadiologyDICOMImage AnalysisNotification System

Device Metadata

Submission Number
K210237
Company
Avicenna.AI
Panel
Radiology
Product Code
N/A
Data Type
Images
Clinical Function
Assessment
AI Function
Analysis
AI Subclass
triage

Relevant Clinical Questions

  • Q1. How does the AI algorithm differentiate between subtle PE/AD findings and mimics or artifacts in CT angiography, and what is its performance in these challenging scenarios?; What impact does the implementation of CINA CHEST have on overall patient outcomes and departmental efficiency metrics, such as report turnaround time or length of stay for PE/AD patients?; Are there specific patient populations or CT scanner parameters where the CINA CHEST algorithm's performance (sensitivity/specificity) is notably higher or lower?; How does the CINA CHEST system handle variations in image quality or contrast opacification across different institutions or scanners, and what are the minimum image quality requirements?; What is the learning curve for radiologists integrating CINA CHEST notifications into their existing workflow, and what strategies are effective for optimizing its use without inducing notification fatigue?

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 Score15/100
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(server, platform)
✓ Detected
HBOMHardware Bill of Materials(hardware)
✓ 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, HBOM 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, CBOM, VDR/VEX, OBOM. These may be present in the full FDA submission.

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CINA CHEST - Avicenna.AI | ESL FDA AI Device Intelligence