The PeriCoach® OTC is a perineometer designed to treat stress, mild-moderate urge and mixed urinary incontinence in women, by strengthening of the pelvic floor muscles through exercise. This device provides biofeedback via smart phone technology.

Device Description

The PeriCoach® OTC device consists of a rigid probe covered in a silicone sheath that is temporarily inserted into the vagina. Sensors located under the sheath measure the strength of contraction of the user's pelvic floor muscles. This information is then transmitted wirelessly to a smartphone application in order to provide real-time feedback to the user. It is a single patient, reusable device to be supplied over-the-counter.

AI/ML Overview

The provided document describes the PeriCoach® OTC device. While it mentions the device meets acceptance criteria, it does not explicitly provide a table of acceptance criteria and reported device performance in the typical quantitative format for algorithmic performance metrics (e.g., sensitivity, specificity, AUC). Instead, the "acceptance criteria" are implied by the standards and bench tests it passed, and the "performance" is qualitative or relates to the device's physical and functional properties.

The document focuses on demonstrating substantial equivalence to a predicate device (PeriCoach® K143580) for a change from prescription use to over-the-counter (OTC) use, and software/firmware upgrades. Therefore, the "study" described is primarily focused on safety and equivalence, rather than a clinical trial proving specific diagnostic or treatment efficacy metrics typically found with AI/ML device submissions.

Here's an attempt to answer your questions based on the provided text, while acknowledging its limitations for an AI/ML context:

1. Table of Acceptance Criteria and Reported Device Performance

As noted, the document doesn't provide a typical quantitative performance table for an AI/ML diagnostic. Instead, the acceptance criteria are met by demonstrating compliance with standards and successful bench testing. The "performance" is stated qualitatively in terms of safety, usability, and functional equivalence.

Acceptance Criteria Category	Specific Criteria (Implied)	Reported Device Performance
Biocompatibility	Compliance with ISO 10993 standards for patient-contacting materials	Tested in accordance with ISO 10993; found safe for intended purpose.
Software	Evaluation per FDA guidance (May 11, 2005)	Evaluated in accordance with FDA guidance for software.
Electrical Safety & EMC	Compliance with IEC 60601-1, -1-2, -1-11, and IEC 62133	Meets respective standards for electrical safety and EMC.
Bench Testing (Mechanical)	Pass Drop test, Durability test, Immersion/long term cleaning exposure, Sensor behavior test	Met all acceptance criteria for these tests.
Usability/OTC Suitability	General user understanding and ease of use without supervision; no safety concerns for OTC use	Post market user survey demonstrated general understanding and ease of use; raised no concerns with OTC use.
Substantial Equivalence	Similar intended use, mode of use, target population, principle of operation, sensing method, parameters monitored, user feedback, anatomical sites, energy use, environmental compatibility, sterility, body materials, chemical safety, and construction as predicate.	All parameters listed as "Same" as predicate (K143580).

2. Sample Size Used for the Test Set and Data Provenance

Test Set Description: The document refers to a "post-market user survey." This survey appears to be the primary "test set" for assessing suitability for OTC use and general user experience.
Sample Size: The exact sample size for the post-market user survey is not specified in the provided text. It is only referred to as "a post market user survey."
Data Provenance: The document does not specify the country of origin for the survey data. It states the submission is from Australia ("Analytica Pty Ltd," "St Leonards, NSW Australia"), which might imply the survey was conducted there, but this is not explicitly stated. The survey is characterized as "post market," indicating it's retrospective relative to the device's initial market release (as a prescription device).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not Applicable in this context. The "ground truth" for this device's performance isn't established by expert review of medical images or data requiring clinical expertise (like radiologists for AI). Instead, the "ground truth" for the post-market user survey would be the users' direct self-reported experience and feedback, and for the bench testing, it was engineering measurements against pre-defined specifications. Health professionals might have been involved in designing the survey or interpreting aggregated results, but they were not "experts establishing ground truth" in the diagnostic AI sense.

4. Adjudication Method for the Test Set

Not Applicable. Since the "test set" is a user survey and bench testing, there's no diagnostic decision or interpretation of complex medical data requiring an adjudication method like 2+1 or 3+1.

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

No such study was performed or is relevant. This device is a biofeedback perineometer, not an AI-powered diagnostic imaging tool that assists human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable to this submission.

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

Partially Applicable. The "sensor behavior test" and the overall bench testing could be considered "standalone" technical performance assessments of the device's core functionality (measuring pelvic floor muscle strength). However, the primary "performance" assessment mentioned for the OTC transition is the user survey, which inherently involves human interaction with the device. There isn't an "algorithm only" performance measured in the sense of an AI model making a diagnosis/prediction without human input.

7. The Type of Ground Truth Used

Engineering Specifications / User Experience Data.
- For bench testing: The ground truth was defined by engineering specifications and relevant industry standards (e.g., specific thresholds for drop tests, durability cycles, immersion resistance, and sensor accuracy within tolerances).
- For the user survey: The "ground truth" was derived from self-reported user feedback and experience data regarding ease of use, understanding, and safety concerns. There was no clinical outcome data (e.g., pathology or long-term therapeutic outcomes) presented to substantiate the device's efficacy, as its purpose is to aid in exercise, not diagnose a condition. The claim is for "strengthening of the pelvic floor muscles through exercise" with biofeedback, implying efficacy via adherence to exercise, not a direct treatment within the device itself.

8. The Sample Size for the Training Set

Not applicable / Not specified for an AI model. The document describes a medical device, not an AI/ML algorithm that undergoes a training phase with a specific dataset. The device's "performance" is based on its physical and software design validation, and user experience.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As above, this is not an AI/ML algorithm with a traditional "training set." The device's design and functionality would be based on engineering principles and potentially prior clinical knowledge about pelvic floor muscle training, not a machine learning training process.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 11, 2016

Analytica Ltd. % Tammy Ahmadzada Senior Consultant Brandwood Biomedical Suite 5, Level 9, 1 Chandos Street St. Leonards, NSW 2065 Australia

Re: K160758

Trade/Device Name: PeriCoach OTC Regulation Number: 21 CFR§ 884.1425 Regulation Name: Perineometer Regulatory Class: II Product Code: HIR Dated: March 29, 2016 Received: April 12, 2016

Dear Tammy Ahmadzada:

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. 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.

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You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Joyce M. Whang -S

for

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K160758

Device Name PeriCoach OTC

Indications for Use (Describe)

Prescription Use (Part 21 CFR 801 Subpart D)

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

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Date Prepared:	29 February 2016
510(k) Owner:	Analytica Pty Ltd320 Adelaide Street,Brisbane, QLD 4000,AustraliaTel: +61 (0) 732781950
Application Contact:	Tammy AhmadzadaSuite 5, 1 Chandos StSt Leonards NSW 2065AustraliaTel: +61(0) 299062984Fax: +61(0) 285804613tammy@brandwoodbiomedical.com
Trade Name:	PeriCoach® OTC
Common Name:	Perineometer
Classification Name:	(21CFR 884.1425) Perineometer
Product Code:	HIR
Predicate:	PeriCoach® (K143580)
Intended Use:	The PeriCoach® OTC is a perineometer designed to treat stress, mild-moderate urge and mixed urinary incontinence in women, bystrengthening of the pelvic floor muscles through exercise. This deviceprovides biofeedback via smart phone technology.
Device Description:	The PeriCoach® OTC device consists of a rigid probe covered in asilicone sheath that is temporarily inserted into the vagina. Sensorslocated under the sheath measure the strength of contraction of theuser's pelvic floor muscles. This information is then transmittedwirelessly to a smartphone application in order to provide real-timefeedback to the user. It is a single patient, reusable device to besupplied over-the-counter.
Non-clinical Testing:	BiocompatibilityThe patient contacting material in the PeriCoach® OTC have beentested in accordance with ISO 10993 standards and found to be safefor the intended purpose. Biocompatibility testing included

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Cytotoxicity, Sensitization, Vaginal Irritation, and Systemic Toxicity.

Software

The software used in the PeriCoach OTC was evaluated in accordance with the FDA guidance document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," dated May 11, 2005.

Electrical Safety and EMC

The PeriCoach OTC was evaluated in accordance with the following standards IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, and IEC 62133. The PeriCoach OTC meets the respective standards for electrical safety and EMC to establish the safety of the device.

Bench testing

Various mechanical tests have also been conducted to establish the safety of the device. The following bench tests were completed:

Drop test
Durability test
Immersion/long term cleaning exposure
Sensor behavior test

The bench testing established that the PeriCoach OTC met all of the acceptance criteria needed to demonstrate substantial equivalence.

Clinical Testing: A post market user survey to substantiate the safety and effectiveness of the subject device for OTC use was provided. Although this type of information is not typically required for the review of OTC perineometer devices, the survey information was reviewed to further substantiate the substantial equivalence determination. The post market user survey demonstrated that the subject device is generally well understood and easy to use without supervision. The survey does not raise any concerns with OTC use of the device.

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Summary of Basis for Substantial Equivalence:

Parameters	Predicate: PeriCoach®(K143580)	PeriCoach® OTC(Proposed device)
Mode of Use	Reusable for singlepatient	Same
Target Population	Adult female urinaryincontinence patients	Same
Principle ofOperation	A probe inserted into thevagina to determine thestrength of the pelvicfloor muscles. Probesends signals to externaldevice to indicate musclecontraction strength toencourage and assistuser with voluntary kegelexercises.	Same
Sensing method	Output from forcesensing resistors.	Same
Parametermonitored	Analogue to digital outputof uncalibrated forceexerted against externalwalls of device bypubococcygeus andpuborectalismuscles.	Same
User Feedback	Provides real-timefeedback, via anapplication on the user'sAndroid or iOSsmartphone. Thesmartphone applicationdisplays the relativemagnitudes of pelvicmuscle contraction orgraphically displays thenormalized analogue todigital sensor outputdepending on whichoption is selected.	Same
Anatomical Sites	FemalePubococcygeusmusclearea	Same
Over the Counter	No, prescription only	Yes
Energy usedand/or delivered	The device is notintended to deliverenergy to the patient.Energy is used to operatethe device andcommunicate the results.	Same
Compatibility withenvironment andother devices	Probe is not known toconflict with other devicesor cause environmentalhazards and tested inaccordance withIEC60601-1-2 (2007)	Same
Sterility	Non-sterile device	Same
Body Materials	Medical grade silicone	Same
Biocompatibility ofbody material	Biocompatible inaccordance withISO10993	Same
Electrical Safety	Tested in accordancewithIEC60601-1-2 (2007)andIEC60601-1(2005)	Same
Chemical Safety	Probe outer surfaceconstructed of chemicallyinert materials and testedin accordance withISO10993	Same
Construction	Rigid polymer structureenclosed within a medicalgrade silicone outer layer	Same

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Conclusion: The predicate and proposed devices share indications for use, usage environments, outer construction materials and general principle of operation. The devices are all single patient, reusable and non-sterile.
The primary differences between the predicate device and the proposed device are:
. the original PeriCoach® predicate device was prescription use only and the new PeriCoach® OTC device will be available as an over the counter device;
. Software and firmware upgrades have been made to improve functionality

A Post Market Surveillance Report supports the decision to change the availability of the PeriCoach® device from prescription to over-the-counter. Non-clinical testing demonstrates that the PeriCoach® OTC device raises no

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new safety or efficacy concerns and is therefore substantially equivalent to the legally marketed predicate devices.

Regulation Number and Section

§ 884.1425 Perineometer.

(a)
Identification. A perineometer is a device consisting of a fluid-filled sack for intravaginal use that is attached to an external manometer. The devices measure the strength of the perineal muscles by offering resistence to a patient's voluntary contractions of these muscles and is used to diagnose and to correct, through exercise, uninary incontinence or sexual dysfunction.(b)
Classification. Class II (performance standards).