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HD Steth is an electronic stethoscope meant to assist a qualified clinician to capture, record and replay heart sounds and electrocardiogram (ECG or EKG) rhythm. It is intended to be used on one patient at a time. Heart sounds (PCG) and 1-lead EKG rhythm are acquired and displayed simultaneously on an accompanying mobile application on a hand-held smart device like a phone or tablet. The waveforms can be recorded and saved on the smart device on which the app is running.

The device has 3 auscultation modes – Bell, Diaphragm and Lung (Wide). These modes and volume levels can be changed by the press of a button. The EKG rhythm recording assists in getting an indicative Heart Rate (HR) that gets displayed on a display panel on the device.

The device must be used in a clinical setting by trained and qualified personnel only. HD Steth is not intended to be used as a diagnostic device. It does not supersede the judgement of a qualified clinician. The device is intended to aid the physician in the evaluation of PCG and EKG rhythm. The clinicians are completely responsible for reviewing and interpreting the results, along with all other relevant information, when making a referral decision.

Caution: The sale of this device is restricted to licensed clinicians or entities referred to by a licensed clinician. It is intended for use by a licensed clinician only.

HD Steth is an electronic audio-visual stethoscope with integrated electrodes for electrocardiogram (ECG or EKG) rhythm. HD Steth is designed to acquire heart sounds through a diaphragm and 1-lead EKG rhythm through three fixed electrodes integrated around the diaphragm. The device has 3 auscultation modes – Bell, Diaphragmand Lung (Wide). The EK G rhythm recording assists in getting an indicative Heart Rate (HR) that gets displayed on a display panel on the device. Both the heart sounds or phonocardiogram (PCG) and the EKG rhythm are acquired simultaneously and can be visualized, recorded and replayed using an accompanying mobile application. HD Steth provides high fidelity audio in addition to visually observing a PCG and ECG Rhythm signal.

The HD Steth device, an electronic stethoscope, was submitted for 510(k) clearance. The provided document focuses primarily on establishing substantial equivalence to the predicate device, Cardiosleeve (K131287), rather than presenting a standalone study with detailed acceptance criteria and performance against those criteria.

However, based on the documented performance testing, some information can be inferred.

1. A table of acceptance criteria and the reported device performance

The provided document describes general "Performance Data" rather than specific acceptance criteria thresholds. The performance is reported as "Pass" for all tested items.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify a separate "test set" in the context of clinical or performance data from human subjects. The performance data primarily refers to engineering and software verification and validation tests. Therefore, information about sample size, country of origin, or retrospective/prospective nature of a clinical test set is not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. The performance data is largely technical validation, not clinical ground truth established by experts.

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, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

The document does not describe a multi-reader multi-case (MRMC) comparative effectiveness study. The device is described as an "electronic stethoscope meant to assist a qualified clinician" and "not intended to be used as a diagnostic device" nor does it "supersede the judgement of a qualified clinician." The focus is on providing high fidelity audio and visual display of PCG and EKG rhythm.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The document describes "ECG (EKG) and PCG Simulation Testing" as part of the performance data, which suggests some standalone algorithmic or system testing. However, detailed results or specific performance metrics from this simulation are not provided beyond a "Successful Assessment." The device's primary function is described as acquiring and displaying waveforms for clinician review, implying it's not a fully autonomous diagnostic algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the technical performance tests mentioned (EMC, Bluetooth, Software, Hardware, Firmware, ECG/PCG Simulation), the "ground truth" would be established by verifying adherence to the referenced technical standards (e.g., ANSI/AAMI/IEC 60601-1-2:2014, ANSI C63.27:2017, FCC15.247:2020), rather than clinical ground truth from expert consensus or pathology. The document does not indicate the use of clinical ground truth for validation of the device's basic function.

8. The sample size for the training set

The document does not describe any machine learning components with a "training set." The device is presented as an electronic stethoscope for capturing, recording, and replaying heart sounds and EKG rhythm, not as a device with a feature that requires a training set (e.g., an AI diagnostic algorithm).

9. How the ground truth for the training set was established

As there is no mention of a "training set" for a machine learning component, this information is not applicable and not provided.

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