(250 days)
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 for use by professional users in a clinical environment or in conjunction with patients or lay users in a non-clinical environment.
The Tyto Stethoscope is designed for use by professional as well as lay users in clinical or nonclinical 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 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).
Two operational flows are optional for using the Tyto Stethoscope: store-and-forward flow and on-line exam flow. Both flows are essentially similar and share the same fundamental steps: performing one or more measurements using the Tyto Stethoscope, recording the data and sending to a clinician, review of the recorded measurements by the clinician, and user receiving a written summary from the clinician presenting his/her assessment and/or recommendations. While in the store-and-forward flow the user can perform the measurements and send the recorded data to the clinician whenever convenient for him/her, an on-line flow may be executed only when also the clinician is available on-line.
This document provides information about the Tyto Stethoscope, for which a 510(k) premarket notification was reviewed by the FDA. The document summarizes the device's intended use, description, and performance testing, but it does not explicitly state specific acceptance criteria or provide a detailed study that proves the device meets those criteria in the format requested.
Therefore, many of the requested fields cannot be directly extracted from the provided text. However, based on the information given, here's what can be inferred or stated:
Missing Information:
The provided document details the FDA's clearance for the Tyto Stethoscope but does not include:
- A table of specific acceptance criteria and detailed reported device performance.
- Sample size used for the test set or its provenance.
- Number of experts, their qualifications, or adjudication methods for establishing ground truth.
- Whether an MRMC comparative effectiveness study was done or effect size.
- Whether a standalone algorithm-only performance study was done.
- The sample size for the training set or how its ground truth was established.
Information Extracted from the Document:
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A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated in a tabular format. The document generally implies that the device should function as expected and be as safe and effective as predicate devices. The performance testing section lists categories of tests performed.
- Reported Device Performance: The document states, "Test results indicated that the Tyto Stethoscope functions as expected and is as safe and effective as its predicate devices for its intended use." No specific quantitative performance metrics are provided.
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Sample size used for the test set and the data provenance: Not mentioned in the provided text.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned in the provided text.
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Adjudication method for the test set: Not mentioned in the provided text.
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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 mentioned in the provided text. The device is a "Stethoscope," not an AI diagnostic tool in the sense of image interpretation assistance.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The Tyto Stethoscope is an electronic stethoscope that records and transmits audio. Its "performance testing" likely refers to the fidelity of audio capture, heart rate measurement, and wireless transmission, as opposed to an AI algorithm making a diagnosis. The document does not describe a standalone algorithm-only performance as might be applicable to an AI diagnostic device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned in the provided text. The testing seems to focus on functional performance (e.g., stethoscope performance, heart rate measurement) and safety rather than diagnostic accuracy against a disease ground truth.
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The sample size for the training set: Not mentioned in the provided text.
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How the ground truth for the training set was established: Not mentioned in the provided text.
§ 870.1875 Stethoscope.
(a)
Manual stethoscope —(1)Identification. A manual stethoscope is a mechanical device used to project the sounds associated with the heart, arteries, and veins and other internal organs.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.(b)
Electronic stethoscope —(1)Identification. An electronic stethoscope is an electrically amplified device used to project the sounds associated with the heart, arteries, and veins and other internal organs.(2)
Classification. Class II (special controls). The device, when it is a lung sound monitor, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.