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.

Device Description

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).

AI/ML Overview

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.

Acceptance Criteria Category	Reported Device Performance (Summary from Text)
Electrical Safety	Meets IEC 60601-1, IEC 60601-1-11 standards
EMC (Electromagnetic Compatibility)	Meets IEC 60601-1-2 standard
Biocompatibility	Assessment performed (assumed to meet relevant standards)
Stethoscope Performance	Demonstrated "stethoscope performance" (e.g., sound quality, frequency response for heart/lung sounds); considered comparable to predicate devices. Specific metrics are not provided.
Pseudo Clinical Performance	Demonstrated "pseudo clinical" performance, implying functionality in simulated clinical scenarios. Specific metrics are not provided.
Heart Rate Measurement Accuracy	Demonstrated accuracy in heart rate measurement. Specific metrics are not provided.
Wireless Coexistence	Verified wireless coexistence performance. Specific metrics are not provided.
Software Validation	Software validation testing performed.
Usability	Usability study performed.

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.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Tyto Care Ltd. % Dave Yungvirt Official Third Party Correspondent Third Party Review Group, LLC The Old Station House 24 Lackawanna Place Millburn, New Jersey 07041

December 17, 2018

Re: K181612

Trade/Device Name: Tyto Stethoscope (OTC) Regulation Number: 21 CFR 870.1875 Regulation Name: Stethoscope Regulatory Class: Class II Product Code: DQD Dated: December 4, 2018 Received: December 6, 2018

Dear Dave Yungvirt:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

{1}------------------------------------------------

requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Stephen C. Browning -S5

for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K181612

Device Name Tyto Stethoscope (OTC)

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)| | Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for TytoCare. The logo features a stylized owl icon on the left, followed by the word "tytocare" in a sans-serif font. Below "tytocare" is the tagline "Health is in your hands" in a smaller, lighter font. The owl icon and the word "tytocare" are in a dark blue color.

510(k) Summary

This 510(k) summary is being submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 CFR 807.92.

Submitter Nameand Address:	Tyto Care Ltd.12 Haomanut StreetNetanya, Israel, 4250445
Contact Person:	Stella Raizelman PerryRA DirectorEmail: stellar@tytocare.comPhone Number: +972 72-2210750Fax Number: +972 72-2210752
EstablishmentRegistrationNumber:	3012678246
Date Prepared:	November 28, 2018
Device TradeName(s):	Tyto Stethoscope (OTC)
Device CommonName:	Electronic Stethoscope
Classification:	Name: Electronic StethoscopeProduct code: DQDRegulation No: 21 CFR 870.1875Class: IIPanel: Cardiovascular
PredicateDevice(s):
Primary:
Device nameTyto Stethoscope	510(k) No.K160401	Date of ClearanceOctober 19, 2016
Secondary:Device name	510(k) No.	Date of Clearance
CliniCloud Stethoscope	K173448	January 25, 2018

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image is a logo for TytoCare. The logo features a stylized owl face on the left, followed by the word "tytocare" in a sans-serif font. Below the word "tytocare" is the tagline "Health is in your hands" in a smaller font.

The OTC use of an electronic stethoscope is supported by a second predicate, the CliniCloud Stethoscope (K173448) which is similarly cleared for over the counter use in periodic recording of lung and heart sounds.

Intended use / indication for use statement

Device description

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).

{5}------------------------------------------------

Image /page/5/Picture/1 description: The image shows the logo for TytoCare. The logo features a stylized owl head on the left, followed by the word "tytocare" in a sans-serif font. Below the word "tytocare" is the tagline "Health is in your hands" in a smaller font. The logo is a dark blue color.

Two operational flows are optional for using the Tyto Stethoscope: store-andforward 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 storeand-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.

Substantial Equivalence to Predicate Devices:

The Tyto Stethoscope (OTC) has the same intended use, and substantially similar indications for use, and fundamental technological characteristics as its primary and secondary predicate devices, the Tyto Stethoscope and the CliniCloud Stethoscope.

The Tyto Stethoscope (OTC) is the same device as the primary predicate Tyto Stethoscope (K160401) with a modification to the indications for use for OTC use of the device. This OTC indication is consistent with the secondary predicate, the CliniCloud Stethoscope.

Any minor differences in indications or technology between the Tyto Stethoscope (OTC) and its predicates do not raise different questions of safety or effectiveness. Furthermore, testing demonstrates that the performance of the Tyto Stethoscope (OTC) is comparable to its predicate devices as the device is technologically the same as the primary predicate Tyto Stethoscope. Consequently, it is concluded that the Tyto Stethoscope can be considered substantially equivalent to its primary and secondary predicate devices.

Performance Testing:

The Tyto Stethoscope (OTC) has the same technological characteristics as the primary predicate Tyto Stethoscope device (K160401), and accordingly, the

{6}------------------------------------------------

Image /page/6/Picture/1 description: The image shows the logo for Tytocare. The logo features a stylized owl icon to the left of the word "tytocare" in a dark blue sans-serif font. Below the word "tytocare" is the tagline "Health is in your hands" in a smaller, lighter font.

performance data collected to evaluate the safety and efficacy of the cleared version of the device is still applicable.

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 (K102893 and K083903). The main aspects of the testing plan are presented below:

· Electrical safety and electromagnetic compatibility testing (according to IEC 60601-
1, IEC 60601-1-11 and IEC 60601-1-2)
· Biocompatibility assessment
· Performance testing (e.g., stethoscope performance, pseudo clinical, heart rate measurement, wireless coexistence)
SW validation testing and
A usability study

Conclusion

Based on the technological characteristics of the devices and the intended use, Tyto Care believes that the Tyto Stethoscope (OTC) and its predicate devices are substantially equivalent. The differences do not raise any new issues of safety or effectiveness.

Regulation Number and Section

§ 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.