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The Tyto Stethoscope is an electronic stethoscope that enables transmission of auscultation sound data, whereby a clinician at one location on an IP network can listen to the auscultation sounds of a patient on site or at a different location on the IP network with the signal carried on an IP connection between the two locations. The Tyto Stethoscope is intended to be used by professional users in a clinical environment or by lay users in a nonclinical environment. The device is for medical diagnostics purposes only. The device is not intended for self-diagnosis.

The Tyto Stethoscope (OTC) is designed for use by professional as well as lay users in clinical or non-clinical environments. It enables four types of stethoscope exams: Heart, Lungs, Heart Rate and Audio (Audio is for clinician only). The operation process of the Tyto Stethoscope uses four (4) primary functional elements: (1) The Tyto Stethoscope (composed of a Stethoscope Tip and a Base Unit – Tyto Device and supported with proprietary software). (2) A mobile device (e.g., a smartphone, not part of the Tyto Stethoscope device, not supplied by TytoCare, on which the proprietary TytoCare App is running), (3) The Tyto Server platform (composed of server hardware not part of the Tyto Stethoscope device, not supplied by TytoCare, on which the proprietary server software is running). (4) A clinician receiving platform located in a clinical environment (e.g., a PC at the clinic, not part of the Tyto Stethoscope device, not supplied by TytoCare, on which the proprietary Clinician App is running).

The provided text is a 510(k) summary for the Tyto Stethoscope (OTC). It mostly focuses on establishing substantial equivalence to predicate devices and does not contain detailed information about specific acceptance criteria or a study that rigorously proves the device meets those criteria in a quantitative sense as typically seen for AI/ML devices.

However, based on the general information provided about performance testing, we can infer some "acceptance criteria" through the lens of device specifications and the types of tests mentioned.

Here's an attempt to answer the questions based on the available text, acknowledging that much of the detailed study information is not present in this summary.

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

Based on the provided text, the "acceptance criteria" are broad and relate to meeting specifications and demonstrating similar performance and safety to predicate devices. The text doesn't provide specific quantitative "reported device performance" metrics against numeric acceptance thresholds, as it relies on the device being technologically identical to a previously cleared device.

2. Sample size used for the test set and the data provenance

The document states, "A testing plan was developed and performed in order to verify that the Tyto Stethoscope (K160401) meets its specifications and demonstrates, based on comparable characteristics, similar performance and safety as compared to its predicate devices". It then lists categories of performance testing.

• Sample Size for Test Set: Specific sample sizes for any of the listed tests (e.g., stethoscope performance, pseudo clinical, heart rate measurement) are not provided in this summary.
• Data Provenance: Not explicitly stated. Given the device is an electronic stethoscope and the context is regulatory, it's highly likely that the performance testing involved simulated scenarios, physical measurements, and potentially human subjects for usability or sound perception. The original clearance (K160401) would contain more details.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the 510(k) summary. The summary refers to "pseudo clinical" and "stethoscope performance" testing, which would typically involve expert assessment, but no details are given.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the 510(k) summary.

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 Tyto Stethoscope (OTC) is described as an electronic stethoscope for transmitting auscultation sounds to a clinician. It enables the transmission of raw sound data for human clinicians to interpret. There is no indication in this summary that it incorporates AI for interpretation or diagnosis, nor is there any mention of an MRMC comparative effectiveness study involving AI assistance.

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

Since there is no mention of an AI algorithm performing diagnosis or interpretation, this question is not applicable. The device's function is to transmit data for a human clinician.

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

Given the device's function (electronic stethoscope for sound transmission and heart rate), the "ground truth" for performance testing would likely involve:

• For Stethoscope Performance: Comparison to established acoustic standards, reference stethoscopes, or expert audiologist/physician assessments of sound quality.
• For Heart Rate Measurement: Comparison to ECG, manual palpation, or other validated heart rate measurement devices.
• For Pseudo Clinical: Likely comparison to expert clinical assessment of scenarios or validated simulated patient sounds.

However, the specific type of ground truth used for each test is not detailed in this summary.

8. The sample size for the training set

The provided text describes performance testing for an electronic stethoscope, not an AI/ML algorithm that requires training data in the traditional sense. Therefore, the concept of a "training set" as it relates to AI models is not applicable here. The device's functionality is based on hardware and software for sound acquisition and transmission, not data-driven learning.

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

As explained in point 8, the concept of a "training set" for an AI/ML algorithm is not applicable to this device as described.

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