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510(k) Data Aggregation
(377 days)
The Zargis Acoustic Cardioscan, (ZAC), is an electronic auscultatory device, intended to provide support to the physician in the evaluation of heart sounds in patients.
The product will acquire and record the acoustic signals of the heart and analyze these signals. The analysis procedure will identify specific heart sounds that may be present. Identified sounds include S1, S2, and suspected murmurs.
The device is indicated for use in a clinical setting, by a physician or by trained personnel who are acting on the orders of a licensed physician. It is not intended as a sole means of diagnosis.
The interpretations of heart sounds offered by the Zargis Acoustic Cardioscan are only significant when used in conjunction with physician over-read as well as consideration of all other relevant patient data.
The ZAC is an electronic auscultatory device intended to acquire, record, and analyze heart sounds. Heart sounds identified are S1, S2 and suspected murmurs.
The complete system is comprised of an electronic stethoscope, a notebook computer, software, a printer and an isolation transformer.
The provided text describes the Zargis Acoustic Cardioscan (ZAC) and its 510(k) summary, but it does not contain the specific details required to answer all parts of your request comprehensively. The document focuses on showing substantial equivalence to predicate devices and general validation, rather than an in-depth clinical study with detailed performance metrics and ground truth establishment.
However, based on the available information, here's what can be extracted and what remains unknown:
Acceptance Criteria and Study Details for Zargis Acoustic Cardioscan (ZAC)
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state numerical acceptance criteria for specific performance metrics (e.g., sensitivity, specificity for murmur detection) or report precise numerical device performance results against such criteria. It generally states that "non-clinical performance testing has been conducted to demonstrate the performance of the ZAC device and that it meets its intended use" and that "A clinical software validation was performed to insure the performance of the heart sound detection algorithm."
| Metric / Aspect | Acceptance Criterion (Not explicitly stated in document) | Reported Device Performance (Not explicitly stated in document) |
|---|---|---|
| Heart Sound Detection | Sufficient accuracy and reliability in identifying S1, S2, and suspected murmurs to support a physician in evaluation, without being a sole means of diagnosis. (Inferred) | "A clinical software validation was performed to insure the performance of the heart sound detection algorithm." (No specific numerical performance, e.g., sensitivity/specificity, is reported). |
| Intended Use | Consistently fulfills intended use and user needs. (Stated) | "Validation of the ZAC was performed to ensure that the ZAC device consistently fulfills its intended use and the needs of the user." |
| Safety | Safe for clinical use. (Inferred) | "Safety and Performance: A comprehensive list of verification and validation testing was performed..." (No specific safety metrics reported). |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. The document mentions "A clinical software validation was performed," but does not specify the number of cases or the origin (country, retrospective/prospective) of the data used for this validation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. While the device's output "is only significant when used in conjunction with physician over-read," the number and qualifications of experts involved in establishing ground truth for the validation set are not detailed.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
This information is not provided in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
This information is not provided in the document. The document states the device "is intended to provide support to the physician" and "is not intended as a sole means of diagnosis," implying a human-in-the-loop scenario. However, a formal MRMC study demonstrating improvement with AI assistance is not mentioned.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The document states, "A clinical software validation was performed to insure the performance of the heart sound detection algorithm." This implies a standalone evaluation of the algorithm's performance in identifying heart sounds (S1, S2, suspected murmurs). However, no specific performance metrics from this standalone evaluation are reported.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The document does not explicitly state the type of ground truth used for its "clinical software validation." Given the nature of heart sound analysis, it is highly likely that ground truth would have been established by a panel of expert cardiologists or auscultation specialists, potentially using a combination of clinical assessment, echocardiography, or other diagnostic information, but this is an inference, not directly stated.
8. The Sample Size for the Training Set
This information is not provided in the document. The document mentions "software verification was performed," but does not detail the size or nature of any training data used for the algorithm's development.
9. How the Ground Truth for the Training Set Was Established
This information is not provided in the document.
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