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510(k) Data Aggregation
(187 days)
HealthPPT
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. HealthPPT analyzes cases using an artificial intelligence algorithm to identify suspected findings. It makes case-level output available to a PACS/workstation for worklist prioritization or triage. HealthPPT is not intended to direct attention to anomalies other than pneumoperitoneum. Notifications include compressed preview images that are meant for informational purposes only and not intended for diagnostic use beyond notification. The device does not alter the original medical image and is not intended to be used as a diagnostic device. Its results are not intended to be used on a stand-alone basis for clinical decision-making nor is it intended to rule out pneumoperitoneum or otherwise preclude clinical assessment of X-Ray cases.
The HealthPPT solution is a software product that automatically identifies suspected findings on chest x-rays (e.g. pneumoperitoneum) and notifies PACS/workstation of the presence of this critical finding in the scan. This notification allows for prioritization of the identified scan and assists clinicians in viewing the prioritized scan before others. The device aim is to aid in prioritization and triage of radiological medical images only.
The software is automatic and is capable of analyzing PA or AP chest x-rays. If a suspected finding is found in a scan, the alert is automatically sent to the PACS/workstation used by the radiologist or to a standalone desktop application in parallel with the ongoing standard of care. The PACS/workstation prioritizes and displays the study through its worklist interface. The ZebrAInsight standalone application includes a compressed preview image meant for informational purposes only and is not intended for diagnostic use.
The HealthPPT device works in parallel to and in conjunction with the standard care of workflow. After a chest x-ray has been performed, a copy of the study is automatically retrieved and processed by the HealthPPT device performs the analysis of the study and returns a notification about the relevant pathology to the PACS/workstation for prioritization. The clinician is then able to review the study earlier than in standard of care workflow.
The software does not recommend treatment or provide a diagnosis. It is meant as a tool to assist in improved workload prioritization of critical cases. The final diagnosis is provided by a radiologist after reviewing the scan itself.
The following modules compose the HealthPPT software for Pneumoperitoneum:
Data input and validation: Following retrieval of a study, the validation feature assessed the input data (i.e. age, modality, view) to ensure compatibility for processing by the algorithm.
Pneumoperitoneum algorithm: Once a study has been validated, the algorithm analyzes the frontal chest x-ray for detection of suspected finding suggestive of pneumoperitoneum.
IMA Integration feature: The study analysis and the results of a successful study analysis is provided to IMA, to then be sent to the PACS/workstation for prioritization.
Error codes feature: In the case of a study failure during data validation or the analysis by the algorithm, an error is provided to the system.
Here's a breakdown of the acceptance criteria and study details for the HealthPPT device, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Metric | Acceptance Criterion (implicitly met if "reached performance goal") | Reported Device Performance |
|---|---|---|
| Overall Accuracy | Comparable to predicate device & exceeds technical method | AUC: 96.75% (95% CI: [94.28%, 99.21%]) |
| Operating Point 1 (Balanced Sensitivity & Specificity) | Reached performance goal | Sensitivity: 92.52% (95% CI: [85.94%;96.16%]), Specificity: 92.66% (95% CI: [86.18%;96.23%]) |
| Operating Point 2 (High Specificity) | Reached performance goal | Sensitivity: 80.37% (95% CL: [71.85%;86.79%]), Specificity: 97.25% (95% CI: [92.22%;99.06%]) |
| Processing Time | Lower than predicate device | Average performance time: 4.78 seconds |
2. Sample Size and Data Provenance for Test Set
- Sample Size: 216 anonymized Chest X-ray cases.
- Data Provenance: Retrospective cohort from the USA and OUS (Outside the US).
- 107 cases positive for Pneumoperitoneum.
- 109 cases negative for Pneumoperitoneum, including confounding imaging factors.
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts: Three.
- Qualifications: US Board-Certified Radiologists.
4. Adjudication Method
The document states the validation data set was "trued (ground truth) by three US Board-Certified Radiologists." It does not explicitly mention an adjudication method like 2+1 or 3+1, but implies consensus among the three radiologists to establish the ground truth.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly mentioned or presented in the document. The study focused on the standalone performance of the HealthPPT device.
6. Standalone Performance Study
Yes, a standalone (algorithm only without human-in-the-loop performance) study was done. The document explicitly states: "The stand-alone detection accuracy was measured on this cohort respective to the ground truth."
7. Type of Ground Truth Used
Expert consensus. The ground truth was established by "three US Board-Certified Radiologists."
8. Sample Size for the Training Set
The document does not specify the sample size used for the training set. It only details the test/validation set.
9. How the Ground Truth for the Training Set Was Established
The document does not specify how the ground truth for the training set was established. It only details the establishment of ground truth for the validation data set.
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