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The HeartBuds Stethoscope is an electronic stethoscope that enables transmission of auscultation sound data, whereby a clinician at one location via the HeartBuds mobile application can listen to the auscultation sounds of a patient at a different location. The HeartBuds Stethoscope is intended to be used by professional users in a clinical environment or by non medical professional adult users in a non clinical environment. The device is for medical diagnostics purposes only. The device is not intended for self-diagnosis.

HeartBuds is an electronic stethoscope intended to auscultate heart and lung sounds. HeartBuds Stethoscope can be used on any patient undergoing a physical assessment. This stethoscope consists of a hand-held device with integral plastic sound diaphragm, that must be used together with a smartphone equipped with the HeartBuds application software. HeartBuds Stethoscope allows users to digitally record heart and lung internal auscultation and transmit the sound data to a medical professional in another location. The HeartBuds system includes two (2) main components: The HeartBuds Electronic Stethoscope and the HeartBuds mobile app.

The HeartBuds Electronic Stethoscope connects to mobile devices (Apple and Android) by means of an audio cable. The HeartBuds app with the integrated HeartBuds software provides users a platform to listen, display, and record sounds simultaneously using an external microphone. The users can share their recordings with their healthcare provider within the HeartBuds app for remote examination.

The provided text describes the HeartBuds Electronic Stethoscope, which is an electronic stethoscope enabling the transmission of auscultation sound data. It specifically states that "Clinical data was not required for this type of device" (page 11), indicating that no clinical study was conducted to prove the device meets acceptance criteria related to its diagnostic performance.

Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (Tyto Stethoscope K181612) through verification and validation activities against recognized standards. These activities are designed to ensure the device's safety and effectiveness in its stated use, rather than clinical diagnostic accuracy.

Therefore, the following information cannot be extracted from the provided text as it pertains to clinical studies that were not performed:

• A table of acceptance criteria and the reported device performance regarding diagnostic accuracy.
• Sample size used for the test set and data provenance (e.g., country of origin of the data, retrospective or prospective).
• Number of experts used to establish the ground truth for the test set and their qualifications.
• Adjudication method for the test set.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of how much human readers improve with AI vs. without AI assistance.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done (as this device transmits sound data for a clinician to interpret, it's inherently human-in-the-loop).
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for diagnostic performance.
• The sample size for the training set (as no AI algorithm for diagnostic inference is mentioned).
• How the ground truth for the training set was established.

However, the document does provide information on performance testing related to safety and usability. These are not diagnostic performance metrics, but rather engineering and operational validations.

Here's a summary of the acceptance criteria and performance as described for the device's overall design verification and validation:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance: Not applicable as no clinical diagnostic performance study was conducted.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no clinical diagnostic performance study was conducted.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable as no clinical diagnostic performance study was conducted.

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: Not applicable. The device transmits raw sound data; it does not include AI for diagnostic assistance. No MRMC study was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device's function is to transmit sound data for human interpretation; it does not perform standalone diagnostic analysis.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the verification and validation listed (e.g., electrical safety, usability), the "ground truth" would be compliance with the respective standards and design requirements, as demonstrated by successful test results. For instance, for usability, the ground truth was that users could effectively operate the device in a simulated environment. For biocompatibility, the ground truth was meeting ISO 10993 requirements.

8. The sample size for the training set: Not applicable as there is no mention of a machine learning algorithm or AI model requiring a training set for diagnostic classification.

9. How the ground truth for the training set was established: Not applicable for the same reason as above.

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