HealthPPT
Zebra Medical Vision Ltd.HealthPPT is an AI-powered software tool that helps radiologists by automatically detecting signs of pneumoperitoneum in adult frontal chest X-rays. It prioritizes urgent cases by notifying the radiology workstation with a low-resolution preview image, enabling faster review of potentially critical findings. The device works alongside standard workflows without altering original images and does not itself diagnose the condition, but aids clinical assessment by highlighting suspicious cases for prompt review.
Intended Use
The HealthPPT device is a software workflow tool designed to aid the clinical assessment of adult frontal Chest X-Ray cases with features suggestive of pneumoperitoneum in the medical care environment. It analyzes cases using an AI algorithm to identify suspected findings and makes case-level output available to a PACS/workstation for worklist prioritization or triage. It is not intended for diagnostic use or to replace clinical decision-making.
Technology
HealthPPT automatically retrieves and analyzes frontal chest X-rays using an artificial intelligence algorithm to detect signs suggestive of pneumoperitoneum. It validates input data, generates case-level findings, and sends notifications including compressed preview images to PACS or a standalone application for prioritization. The software operates in parallel with standard care workflows and does not alter the original images.
Performance
The device's performance was validated on a retrospective cohort of 216 anonymized chest X-rays (107 positive, 109 negative for pneumoperitoneum) evaluated by three board-certified radiologists. The AI demonstrated an AUC of 96.75%, with sensitivity and specificity exceeding performance goals at two operating points. The mean processing time was 4.78 seconds, faster than the predicate device's 20.3 seconds.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
6/11/2021
6 months - 2
FDA Approval
12/15/2021
Other devices from Zebra Medical Vision Ltd.
- HealthCCSng2021 • 510K
- HealthJOINT2020 • 510K
- HealthMammo2020 • 510K
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