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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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The Consult Station TS is intended to be used by the general public to perform a health check including the measurement of certain vital signs (weight, BMI, temperature, blood pressure and pulse rate). The lay user autonomously self-performs all the measurements listed above.

Using an audio-video conferencing feature incorporated in the Consult Station TS to connect with a healthcare professional remotely. it is possible to perform additional examinations: ENT (Ear. Nose. Throat) and skin examinations. auscultations sounds and blood oxygen level. The lay user and the healthcare professional are able to see and to interact each other.

The Consult Station TS is not intended for diagnostic use. Lay users should consult their personal physician if they have concerns regarding the results of their health check.

The Consult Station TS is intended for lay users of fourteen (14) years old or older. The Consult Station TS is not intended for children under the age of fourteen.

The Consult Station can be deployed in indoor public areas, such as: pharmacies, senior living communities, shopping centers, corporations, etc.

The Consult Station TS is an automated non-invasive screening device intended to be used by the general public (lay users). Equipped with sensors and instruments, the Consult Station TS presents itself in the shape of a health booth and allows to perform health check-ups in order to collect reliable medical data.

The Consult Station TS is not a diagnostic device and only provides data in order for lay users to consult with their personal physician. Lay users should consult with their physician if they have concerns regarding the results of their health check-up.

Two scenarios for the use of the Consult Station TS are available:

1. A scenario where the lay user will autonomously self-perform the measurements of his/her vital signs ("Unsupervised Mode");
   This use does not require assistance of a healthcare professional. The lay user autonomously self-performs a health check allowing him/her to collect a number of his/her vital signs: weight and BMI, systolic and diastolic blood pressure, pulse rate and temperature. An user interface guides the lay user with video tutorials, a series of interactive screens and voice instructions through the various steps of the health check cycle.

2. An alternative scenario where, at first, the lay user will autonomously self-perform measurements of his/her vital signs ("Unsupervised Mode"), and then be remotely connected with a healthcare professional through the audio-video conferencing feature to perform additional examinations ("Supervised Mode").
   This use that requires assistance of a healthcare professional to ensure that data is appropriately collected and interpreted. After performing a health check (see scenario above), the lay user is connected through the audio-video conferencing feature with a healthcare professional, the lay user and the healthcare professional being able to see and to interact with each other.

The healthcare professional can then remotely guide the lay user to use as needed:

• · an otoscope for ENT examinations (inspection of the external ear canal),
• · a dermatoscope for skin surface examinations,
• · a stethoscope for auscultation of sounds associated with the heart and lungs,
• · a pulse oximeter for the measurement of the blood oxygen level.

The otoscope (ENT examination), the dermatoscope (skin examination), the stethoscope (auscultations sounds) and the pulse oximeter (blood oxygen level) are only used in the Supervised Mode. The use of the pulse oximeter, dermatoscope, otoscope and the stethoscope are restricted on the order of a licensed practitioner.

In both scenarios, at the end of cycle, a ticket is printed inside the booth which summarizes the results of the measurement as well as user access codes for subsequent online access.

Lay users may manually enter blood glucose level measurements. The Consult Station TS may accept loaded data from an external blood glucometer (if such device is FDA cleared).

Consult Station is intended for users of 14 years old or older. The Consult Station TS is not intended for children under the age of fourteen (14).

Consult Station TS system consists of:

• A health booth,
• A software embedded in the health booth,
• . A Consult Access software containing an audio-video conferencing feature,
• . A web application which provides secure access by patients and health professionals to their anonymized data.

The health booth is an enclosed space, accessible through a door and containing a seat, sensors and instruments as well as communication tools (i.e. screens, camera, speakers, printer).

The software embedded in the health booth is responsible for the management of the man-machine interface (MMI) used to provide instructions to the patient, to collect patient data and to print them via the printer on a ticket. The software is also responsible for starting, stopping and repeating measurements. These functionalities are implemented by communicating via the serial or USB interfaces of the connected devices involved (sending commands followed by receiving of results).

The Consult Access is a software that allows through an audio-video conferencing connecting a healthcare professional with a patient seated inside the Consult Station. The patient and the healthcare professional will be able to see and to interact with each other. The healthcare professional can remotely guide the patient throughout all the measurements and examinations performed. The otoscope, the dermatoscope and the oximeter are only available while the video conferencing feature is in use.

The web application provides secure access by patients and healthcare professionals (only with the patient's agreement) to the measurements performed via the Consult Station TS.

Here's a breakdown of the acceptance criteria and supporting studies for the Consult Station TS, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document primarily focuses on demonstrating substantial equivalence to predicate devices and adherence to recognized standards. Direct "acceptance criteria" for metrics like sensitivity, specificity, or accuracy (beyond standard adherence) are not explicitly stated for the overall device, but rather for its individual components in relation to their respective standards.

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