The PeriCoach 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® 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 under prescription only.

AI/ML Overview

The provided text appears to be a 510(k) summary for the PeriCoach device, which is a perineometer. This document is primarily focused on demonstrating "substantial equivalence" to a predicate device (Neen Healthcare Periform K002617) to obtain FDA clearance, rather than detailing a study that establishes explicit acceptance criteria and corresponding device performance in clinical use. Thus, much of the requested information regarding "acceptance criteria," "study that proves the device meets the acceptance criteria," "sample sizes," "expert ground truth," "adjudication methods," and "MRMC comparative effectiveness studies" is not explicitly present.

However, based on the information provided, we can infer some aspects related to non-clinical testing and the basis for substantial equivalence.

Here's an attempt to answer your questions based on the provided text, with many fields being marked as "Not explicit in text" where the information is absent:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission, the "acceptance criteria" are implicitly met by demonstrating "substantial equivalence" to a legally marketed predicate device. The document summarizes the non-clinical testing performed to establish this. Explicit acceptance criteria with quantitative thresholds for performance metrics (e.g., sensitivity, specificity, accuracy) are not provided in this summary.

Acceptance Criteria (Implied/Inferred for Substantial Equivalence)	Reported Device Performance (Non-Clinical Test Results)
Biocompatibility (ISO 10993 compliance)	Pass: Tested for Cytotoxicity (ISO 10993-5), Sensitization (ISO 10993-10), Vaginal Irritation (ISO 10993-10), and Systemic Toxicity (ISO 10993-11). Found to be safe for the intended purpose.
Electrical Safety (IEC 60601-1 compliance)	Pass: Conducted in accordance with IEC 60601-1:2005.
Electromagnetic Compatibility (IEC 60601-1-2 compliance)	Pass: Conducted in accordance with IEC 60601-1-2:2007.
Home Healthcare Environment Electrical Safety (IEC 60601-1-11)	Pass: Conducted in accordance with IEC 60601-1-11:2010.
Software Verification & Validation (IEC 62304 compliance)	Pass: Conducted in accordance with IEC 62304:2006.
Mechanical Durability	Pass: Various mechanical tests conducted, including drop testing, durability testing, immersion/long term cleaning exposure, and sensor behavior testing. Results indicate device is effective for intended use. (Specific values or thresholds not provided).
Chemical Safety	Pass: Probe outer surface constructed of chemically inert materials and tested in accordance with ISO10993 standards.
Functional Equivalence (Principle of Operation)	Substantially Equivalent: Both devices use a probe inserted into the vagina to determine strength of pelvic floor muscles and encourage/assist with Kegel exercises via feedback. PeriCoach uses force sensing resistors (wireless) vs. predicate's sEMG biofeedback (wired). Changes are not new safety/efficacy concerns.
Anatomical Sites & Target Population	Substantially Equivalent: Female Pubococcygeus muscle area; Adult female urinary incontinence.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not explicit in the text. The document refers to non-clinical testing (biocompatibility, electrical safety, mechanical tests, software V&V) of the device itself, rather than a clinical human subject test set.
Data Provenance: Not explicit in the text. The company is based in Australia. The non-clinical tests were conducted according to international standards (ISO, IEC).
Retrospective or Prospective: Not applicable as no clinical study on human subjects is described for proving performance against acceptance criteria in the context of efficacy for the indication. The tests were primarily device characterization.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable/Not explicit in the text. This document does not describe a clinical study where expert ground truth was established for a test set. The non-clinical tests rely on compliance with standards.

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

Not applicable/Not explicit in the text. No clinical test set requiring adjudication is described.

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 MRMC comparative effectiveness study is mentioned. This device is a biofeedback perineometer, not an AI-assisted diagnostic tool for human readers.

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

This is not an "algorithm only" device in the typical AI sense. Its primary function is a measurement and biofeedback device. The non-clinical testing establishes the standalone performance of the device's components (sensors, software, electrical safety, etc.) as detailed in Q1. The device itself (the probe and its communication to the smartphone app) constitutes the "standalone" element being tested for safety and basic function.

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

For Non-Clinical Testing: The "ground truth" for the non-clinical tests referred to here is compliance with established international standards (ISO 10993, IEC 60601 series, IEC 62304) and manufacturer specifications for mechanical performance. There isn't a "clinical ground truth" like pathology or outcomes data presented in this summary for the purpose of demonstrating efficacy.

8. The sample size for the training set

Not applicable/Not explicit in the text. This document does not pertain to an AI model that would require a "training set." The software verification and validation are for the device's operational software, not for training a predictive model.

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

Not applicable/Not explicit in the text. Not relevant for this type of device and submission.

Summary Interpretation:

The provided document, a 510(k) summary, is intended to demonstrate that the PeriCoach device is "substantially equivalent" to a previously cleared predicate device. This is achieved by showing that:

It has the same intended use.
It has similar technological characteristics (or that any differences do not raise new questions of safety and efficacy).
Non-clinical testing (biocompatibility, electrical safety, mechanical durability, software V&V) confirms its safety and performance in alignment with relevant standards, thereby addressing any potential new safety or efficacy concerns arising from the differences (e.g., wireless feedback, different materials).

The document does not present results from a clinical trial or study designed to establish quantitative efficacy or performance metrics for the device's ability to "treat stress, mild-moderate urge and mixed urinary incontinence" in human subjects. The approval is based on the idea that if it's substantially equivalent in terms of safety and how it works, and the predicate device is already cleared for that indication, then this device can also be cleared.

Summary

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

March 18, 2015

Analytica Ltd % Tracey Bullivant Consultant Brandwood Biomedical 408, 460 Pacific Highway St Leonards, NSW 2065 AU

Re: K143580

Trade/Device Name: PeriCoach Regulation Number: 21 CFR 884.1425 Regulation Name: Perineometer Regulatory Class: Class II Product Code: HIR Dated: December 12, 2014 Received: December 18, 2014

Dear Tracey Bullivant,

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. 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

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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 yours,

Joyce M. Whang -S

for Benjamin Fisher 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) K143580

Device Name PeriCoach

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary

Date Prepared:	13 December, 2014
510(k) Owner:	Analytica Pty Ltd320 Adelaide Street,Brisbane, QLD 4000,AustraliaTel: +61 (0) 732781950
Official Contact:	Tracey Bullivant408, 460 Pacific HighwaySt Leonards NSW 2065AustraliaTel: +61(0) 299062984Fax: +61(0) 285804613tracey@brandwoodbiomedical.com
Trade Name:	PeriCoach®
Common Name:	Perineometer
Classification Name:	(21CFR 884.1425) Perineometer
Product Code:	HIR
Predicate:	Neen Healthcare Periform (K002617)
Intended Use:	The PeriCoach® 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® device consists of a rigid probe covered in a siliconesheath that is temporarily inserted into the vagina. Sensors locatedunder the sheath measure the strength of contraction of the user's pelvicfloor muscles. This information is then transmitted wirelessly to asmartphone application in order to provide real-time feedback to theuser. It is a single patient, reusable device to be supplied underprescription only.
Non-clinical Testing:	The patient contacting materials in the PeriCoach have been tested inaccordance with ISO 10993 standards and found to be safe for the

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intended purpose. Biocompatibility testing includes Cytotoxicity (ISO 10993-5, 2009), Sensitization (ISO 10993-10, 2010), Vaginal Irritation (ISO 10993-10, 2010), and Systemic Toxicity (ISO 10993-11, 2006).

Electrical safety and electromagnetic compatibility testing have been conducted in accordance with IEC 60601-1:2005, IEC 60601-1-2:2007, and IEC 60601-1-11:2010 to establish the safety of the device. Software verification and validation testing has also been conducted in accordance with IEC 62304:2006.

In addition, various mechanical tests have been conducted to establish substantial equivalence including mechanical drop testing, durability testing, immersion/long term cleaning exposure, and sensor behavior testing. The results of these tests indicate that the device is effective for the intended use.

Predicate: Periform PeriCoach Parameters (K002617) (New device) Mode of Use Reusable for single patient Same Target Population Adult female urinary incontinence Same patients Principle of A probe inserted into the vagina to Same Operation determine the strength of the pelvic floor muscles. Probe sends signals to external device to indicate muscle contraction strength to encourage and assist user with voluntary kegel exercises. Electrode/sensor Longitudinal Same orientation Sensing method sEMG biofeedback recording (wired Output from force sensing electrode). resistors (wireless). Parameter Aqqreqate surface electromyogram Analoque to digital output of monitored (sEMG). uncalibrated force exerted against external walls of device by pubococcyqeus and puborectalis muscles.

Summary of Basis for Substantial Equivalence:

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Parameters	Predicate: Periform(K002617)	PeriCoach(New device)
User Feedback	The Periform does not provide feedbackdirectly to the user; a separate externalfeedback device is required.	The PeriCoach is designed toprovide real-time feedback, via anapplication on the user'sSmartphone. The Smartphoneapplication displays the relativemagnitudes of pelvic musclecontraction or graphically displaysthe normalized analogue to digitalsensor output depending onwhich option is selected.
Anatomical Sites	Female Pubococcygeus muscle area	Same
Where used	Hospitals, Clinics, Doctors' offices orhome use under Clinician supervision	Same
Energy usedand/or delivered	No energy used or delivered, onlytransported1	The device is not intended todeliver energy to the patient.Energy is used to operate thedevice and communicate with theSmartphone Application.
Compatibility withenvironment andother devices	Probe is not known to conflict with otherdevices or cause environmentalhazards	Same - the PeriCoach device hasbeen tested in accordance withIEC60601-1-2 (2007)
Sterility	Probe does not need to be sterile.Appropriate cleaning procedureincluded in instructions for use.	Same
Body Materials	BP Empera Impact Polystyrene Type514	Medical grade silicone
Biocompatibility ofbody material	Biocompatible	Same - tested in accordance withISO10993 standards
Electrical Safety	Unknown	Tested in accordance withIEC60601-1-2 (2007) andIEC60601-1(2005)
Chemical Safety	Body and electrodes constructed ofchemically inert materials	Probe outer surface constructedof chemically inert materials andtested in accordance withISO10993 standards.
Construction	Two mouldings enclosing twoelectrodes, ultrasonically weldedtogether	Rigid polymer structure enclosedwithin a medical grade siliconeouter layer
Shaft length	76 mm	Same
Parameters	Predicate: Periform(K002617)	PeriCoach(New device)
Width acrosselectrodes/sensors	34 mm	30-35 mm, across regioncontaining sensor
Maximum flangedimension	28.2 mm	30-35 mm
Electrode surfacearea	4.9cm2 x 2	Sensor surface area is 11.8cm2
Prescription onlydevice	Yes	Same

¹ Wording taken directly from 510(k) summary for Periform, K002617

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Conclusion: Both devices share common indications for use, usage environments and general principle of operation. The devices are both single patient reusable, nonsterile and are available by prescription only.
The main differences between the devices are the way the pelvic floor muscle activity is determined, the materials used and the method of feedback to the user. Non-clinical testing demonstrates that the PeriCoach device raises no new safety or efficacy concerns and is therefore substantially equivalent to the legally marketed predicate device.

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).