The Feminine Personal Trainer (FPT) is indicated for the strengthening of the perineal pelvic floor muscles by providing resistance to an individual's voluntary contractions of these muscles. It seeks to correct, through exercise, urinary incontinence in women.

Device Description

The FPT is designed specifically for women for their use in strengthening the pelvic floor musculature. It is a single, reusable, home-use device that comes into contact with the vaginal mucosal membrane for a limited (< 24 hours) duration per each use. The FPT is an hourglass-shaped device made from surgical stainless steel. The FPT is available in three sizes: standard, small and petite. The FPT is inserted into the vagina and is held in place by contracting the pelvic floor muscles. The hourglass shape ensures automatic positioning so that the appropriate muscles are targeted. The weight of the FPT provides resistance as it is gently lifted with each contraction of the pelvic floor muscles. When utilized correctly, the device will move upward and inward when the user contracts her pelvic floor muscles. The body's angle while exercising controls the level of resistance.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called the "Feminine Personal Trainer (FPT)." This document is a regulatory submission for premarket clearance and does not contain the level of detail typically found in reports of clinical studies, especially those involving AI/ML components or human reader performance.

Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment cannot be found in this document.

Here's an analysis based on the information available in the text:

The FPT is a physical device (hourglass-shaped surgical stainless steel) used for strengthening pelvic floor muscles, similar to a perineometer. It does not appear to involve any AI/ML components, image analysis, or complex algorithms that would require the types of studies outlined in your request (e.g., MRMC studies, standalone algorithm performance).

The "study" referenced in the document is "Non-clinical Performance Testing," which focuses on biocompatibility and material safety rather than clinical efficacy through comparative trials or complex performance metrics.

Information that CANNOT be extracted from the document:

A table of acceptance criteria and the reported device performance: The document states the device is "as safe and effective as the predicate" based on "performance testing" and "same intended use." Specific performance metrics with acceptance criteria are not provided. The non-clinical tests were for biocompatibility (cytotoxicity, irritation, sensitization), not efficacy metrics.
Sample sizes used for the test set and the data provenance: Not applicable. The "testing" was biocompatibility testing, not a clinical trial with a test set of patient data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for clinical endpoints or image interpretation is not relevant for this device's testing.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 applicable. The device is a physical, non-AI product.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as there's no diagnostic or interpretative function. The ground truth for biocompatibility is whether the materials exhibit toxic, irritating, or sensitizing effects as per ISO standards.
The sample size for the training set: Not applicable, as there is no AI/ML model for training.
How the ground truth for the training set was established: Not applicable, as there is no AI/ML model for training.

Information that can be extracted or inferred from the document:

Device Type: Feminine Personal Trainer (FPT), a physical device (perineometer) for strengthening pelvic floor muscles. It is not an AI/ML device.
Purpose of "Study": Non-clinical performance testing focused on biocompatibility of the device materials.
Acceptance Criteria (Implied for Biocompatibility): The materials must not be cytotoxic, irritating, or sensitizing.
Reported Device Performance (for Biocompatibility): "Test results from the tests listed above supported that the device is not cytotoxic, not irritating, and not sensitizing. The FPT device has been demonstrated to be biocompatible."
Testing Standards: ISO 10993-5:2009 (Tests for In Vitro Cytotoxicity) and ISO 10993-10:2010 (Tests for Irritation and Skin Sensitization, Vaginal Irritation and Guinea Pig Maximization Sensitization).

Conclusion:

This document is a 510(k) summary for a physical medical device. The "study" mentioned is non-clinical biocompatibility testing to demonstrate material safety, not a clinical efficacy trial or a study assessing the performance of an AI/ML system. Therefore, the vast majority of your detailed questions regarding acceptance criteria, sample sizes, expert involvement, and ground truth for AI/ML or clinical performance studies are not relevant to this specific device or the information provided in this regulatory submission.

Summary

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

August 29, 2017

Ralston Group % Jennifer Tillman Business Coordinator Intertek Surveying Services 16441 Space Center Blvd, Suite D-100 Houston, TX 77058

Re: K171896 Trade/Device Name: Feminine Personal Trainer (FPT) Regulation Number: 21 CFR§ 884.1425 Regulation Name: Perineometer Regulatory Class: II Product Code: HIR Dated: June 7, 2017 Received: June 26, 2017

Dear Jennifer Tillman:

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.

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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 devicerelated 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 (DICE) 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 (DICE) 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,

Benjamin R. Fisher -S

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) K171896

Device Name

Feminine Personal Trainer (FPT)

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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Registration Use (Part 21 CFR 201.2 Subpart D)
Over-The-Counter Use (21 CFR 201.2 Subpart C)

_ | Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary

I. SUBMITTER

Ralston Group 656 Lake Lanier Rd. Selma, AL 36701

Phone: 334-875-2298

Contact Person: Russell Ralston Date Prepared: August 16, 2017

II. DEVICE

Name of Device:	Feminine Personal Trainer (FPT)
Common or Usual Name:	Kegel Exercise and Pelvic Floor Workout Device
Classification Number:	21 CFR § 884.1425
Classification Name:	Perineometer
Regulatory Class:	II
Product Code:	HIR (Perineometer)
Classification Panel:	Obstetrics/Gynecology

III. PREDICATE DEVICE

	510(k) Number Trade or Proprietary or Model Name
K121902	NatraTone®	Orelle Corporation Ltd

This predicate has not been subject to a design-related recall.

IV. DEVICE DESCRIPTION

The FPT is an hourglass-shaped device made from surgical stainless steel. The FPT is available in three sizes: standard, small and petite.

The FPT is inserted into the vagina and is held in place by contracting the pelvic floor muscles. The hourglass shape ensures automatic positioning so that the appropriate muscles are targeted. The weight of the FPT provides resistance as it is gently lifted with each contraction of

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the pelvic floor muscles. When utilized correctly, the device will move upward and inward when the user contracts her pelvic floor muscles. The body's angle while exercising controls the level of resistance.

V. INDICATIONS FOR USE

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

Device Name	Feminine Personal Trainer (FPT)	NatraTone®	DeviceComparison
510(k) Number	K171896	K021115	Not applicable
RegulationNumber	21 CFR § 884.1425	21 CFR § 884.1425	Same
Product Code	HIR	HIR	Same
ClassificationName	Perineometer	Perineometer	Same
Indications forUse	The Feminine Personal Trainer(FPT) is indicated for thestrengthening of the perineal pelvicfloor muscles by providingresistance to an individual'svoluntary contractions of thesemuscles. It seeks to correct,through exercise, urinaryincontinence in women.	NatraTone® is indicated for thestrengthening of the perineal pelvicfloor muscles by providingresistance to an individual'svoluntary contractions of thesemuscles. It seeks to correct,through exercise, UrinaryIncontinence in women.	Same
Over theCounter (OTC)	Yes	Yes	Same
Feature	Resistive vaginal exerciser	Resistive vaginal exerciser	Same
TargetPopulation	Women with mild incontinence	Women with mild incontinence	Same
Anatomical Site	Vagina	Vagina	Same
Single PatientDevice	Yes	Yes	Same
Reusable	Yes	Yes	Same
Sterile	Clean, but not sterile	Clean, but not sterile	Same
Device Design	Hourglass-shaped	Symmetrically S-shaped	Same
Materials	Surgical stainless steel grade 303	Molded medical gradepolycarbonate	Different

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Device Name	Feminine Personal Trainer (FPT)	NatraTone®	DeviceComparison
Dimensions	Standard FPT:Large end diameter: 1.628 inSmall end diameter: 1.248 inLength: 3.503 inWeight: 450 g.Small FPT:Large end diameter: 1.500 inSmall end diameter: 1.125 inLength: 3.500 inWeight: 340 gPetite FPT:Large end diameter: 1.250 inSmall end diameter: 1.100 in	Length: 3.25 inWidth at bulbous base end: 1.35 inWeight: 1 oz (28 q)	Different
	Length: 4.564 inWeight: 340 g.
Packaging	The FPT device is packaged in avelveteen bag inside a clear plastictube with instructions and exercisechart.	NatraToner intra-vaginal training aidis packaged inside of a translucentcarry-case; an instruction book withactivity diary and a personal trainingDVD are all provided in a cardboardbox.	Same
OperatingPrinciple	Resistive pelvic floor strengthener	Resistive pelvic floor strengthener	Same
ResistiveComponent	Weight	Symmetrically S-shaped	Different
Instructions forUse	Manual and video link	Manual	Same

Except for materials, dimensions, and resistive component, all the other device attributes are the same as the predicate device. Nonclinical performance testing has been done to indicate the materials are safe. By using weight as the resistive component, the FPT devices have different dimensions to provide different levels of resistance to individuals instead of a single level of resistance from the predicate device. The minor differences in the technological characteristics between the FPT and the predicate device do not raise different questions of safety or effectiveness.

VII. Non-clinical Performance Testing

Non-clinical performance testing was done utilizing the following standards:

. ISO 10993-5:2009 Biological Evaluation of Medical Devices - Part 5: Tests for In Vitro Cytotoxicity

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ISO 10993-10:2010 Biological Evaluation of Medical Devices Part 10: Tests for . Irritation and Skin Sensitization, Vaginal Irritation and Guinea Pig Maximization Sensitiziation
Test results from the tests listed above supported that the device is not cytotoxic, not irritating, and not sensitizing. The FPT device has been demonstrated to be biocompatible.

VIII. CONCLUSIONS

The FPT device has the same intended use as the predicate. Performance testing of the device supports that the FPT device is as safe and effective as the predicate. Therefore, the FPT device is substantially equivalent to the predicate.

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).