The Slendertone Flex Bottom and thigh toning device is intended for use by healthy persons to apply trans-cutaneous electrical muscle stimulation (EMS) through skin contact electrodes for the following purposes;

Improvement of muscle tone to the bottom and thighs. .
Strengthening of the muscles in the bottom and thighs, specifically the ● quadriceps and hamstrings.
. Improvement to firmness in the bottom and thighs.

Device Description

Slendertone Flex Bottom and thigh toning system is a two- channel battery operated muscle stimulation system specifically designed to exercise the bottom and thigh muscles. It comprises two main components, namely, an electronic stimulator module which generates the required stimulation signals, and a shorts garment with integral electrodes, which connects the signals from the stimulator to the skin. The electrodes are located on the inner surface of the shorts. In effect, the shorts in this case take the place of the lead wires commonly found in most conventional muscle stimulators.

The product is supplied with a set of double- sided adhesive electrodes, an instruction manual, a set of batteries, and a carry pouch. Power is derived from three LRO3 cells located in a compartment protected by a removable battery cover.

Although a two- channel system, there are six electrodes. The electrodes connect adhesively to studs on the inner surface of the shorts. The garment is worn as shorts. with the leg openings and waist secured by Velcro fastening patches. When the shorts are on the body two electrodes (1each side) are located over the gluteal muscles. placed horizontally in the midline of the buttock and the larger two (one at the back of each leg) over the hamstring muscles. Two electrodes are located on either side of the top of the front of the thighs following the linguinal line to act on the quadriceps muscles.

There is no current passed from side to side. Because the user has no access to the wiring or connectors within the shorts, he/she cannot alter the current path and so the possibilities for mis-use are greatly reduced.

AI/ML Overview

The sponsor, Bio-Medical Research Ltd, conducted a prospective, controlled, single-blind, stratified, randomized study with 60 female volunteers to assess the effectiveness of the Slendertone FLEX Bottom & Thigh Toning system.

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes the results of the study and implicitly defines the acceptance criteria through the reported significant improvements.

Acceptance Criteria (Implied)	Reported Device Performance
Significant improvement in muscle tone of the bottom and thighs.	Treated group reported a marked improvement in firmness compared to the control group. The study indicates that users experience a significant improvement in muscle tone.
Significant strengthening of the muscles in the bottom and thighs (quadriceps and hamstrings).	In objective measurements of isokinetic and isometric muscle strength, the treated group showed average increases in muscle strength of 11% (extension torque at 15°) and 38.1% (Flexion torque at 15°). This improvement continued throughout the study duration. Very large differences were observed between the treatment and control groups in terms of muscle strength after 8 weeks.
Significant improvement to firmness in the bottom and thighs.	Treated group reported a marked improvement in firmness compared to the control group. The study indicates that users experience a significant improvement in muscle firmness.

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

Sample Size: 60 female volunteers for the controlled study (test set).
Data Provenance: Prospective data collected in Galway, Ireland, at BMR's consumer research center.

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

The document does not explicitly state the use of "experts" to establish ground truth for individual cases within the test set. The ground truth appears to be based on:

Psychometric tests: Self-reported improvement in firmness, self-image, and well-being.
Objective measurements: Isokinetic and isometric muscle strength measurements.
The study was "designed and carried out by BMR," implying internal scientific or research staff were involved, but specific qualifications of individuals assessing the outcomes are not provided.

4. Adjudication Method for the Test Set:

Not applicable. The ground truth was established through psychometric tests and objective physical measurements rather than expert review requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance:

Not applicable. This device is a muscle stimulator, not an AI-assisted diagnostic or imaging device that would involve human readers.

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

The study assessed the performance of the device itself (the muscle stimulator) without human-in-the-loop performance in the context of an algorithm or AI. The device's performance is its direct effect on users' muscles.

7. The Type of Ground Truth Used:

Self-reported data: Through psychometric tests where the treated group reported improvements in firmness, self-image, and well-being.
Objective physiological measurements: Isokinetic and isometric muscle strength measurements.

8. The Sample Size for the Training Set:

Not applicable. This device is a muscle stimulator, and the presented study is a clinical trial assessing its efficacy, not a machine learning study requiring a separate training set for algorithm development.

9. How the Ground Truth for the Training Set was Established:

Not applicable, as there was no training set for an algorithm.

Summary

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MAR 0 6 2003

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Page 1 of 3 510(k) Summary

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Bio-Medical Research Ltd Parkmore Business Park, West Galway Ireland

510 (k) Summary of Safety and Effectiveness.

This summary is submitted in accordance with 21 CFR 807.92

1	Submitted by	Bio-Medical Research LtdBMR HouseParkmore Business Park, WestGalwayRepublic of Ireland
	Establishment Registration Number	8020867
	Contact Person	Michelle Sawyer
	Phone	+353 91 774361
	Fax	+353 91 773302
	e-mail	msawyer@des.bmr.ie
	Title	Regulatory Affairs Manager
	Date of Preparation	August 2002.
2	Trade Name of DeviceToning system. Type 511.	Slendertone FLEX Bottom & Thigh
	Common Name	Muscle Stimulator
	Classification name	Powered Muscle Stimulator
3	Identification of predicate device	Slendertone FLEX Abdominal trainingsystem.K010335

20, NJ 41

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Description of Device 4

ട Intended Use

Improvement of muscle tone to the bottom and thighs. .
Strengthening of the muscles in the bottom and thighs, specifically the ● quadriceps and hamstrings.
. Improvement to firmness in the bottom and thighs.

Technological Comparison 6

The Slendertone FLEX Bottom and Thigh Toning System is the same as the Slendertone FLEX Abdominal training system in it's delivery of the stimulation signal and has similar parameter setting. There are similar restrictions between the two devices in that electrode positioning is governed by and integral to the garment. Both products utilise a LCD screen with user compliance logging.

Non clinical Tests

Comparisons of electrical outputs for the two devices show similar results. They have both been designed and independently tested to the following requirements;

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IEC 60601-1:1990 Medical electrical equipment Part 1: General requirements for . safety.
. IEC 60601-2-10
IEC 601-1-1 and appendices A1:1991,A2:1995 ● IEC 601-1-2: EMC requirements
IEC 61000-4-2:1995: Electromagnetic compatibility .
IEC 61000-4-3:1997: Electromagnetic compatibility ●
DD ENV 50204:1996: Electromagnetic compatibility .
EN 55011:1998: radiated emissions. ●

Bio-Medical Research Ltd, (BMR), adheres to recognised and established industry practice, and all devices are subject to final performance testing.

A hazard analysis, a risk analysis and a failure mode effects analysis have been carried out for the device.

2 Controlled study.

BMR conducted a prospective, controlled, single blind, stratified, randomised study with 60 female volunteers to measure the effects of a program of EMS on the bottom and thigh muscles over an eight week period, using the electrode positions and stimulation parameters of the Slendertone FLEX Bottom & Thigh Toning system. The study was designed and carried out by BMR at its consumer research centre in Galway, Ireland.

lo psychometric tests, the treated group in the study reported a marked improvement in firmness compared to the control group over the period of the study. Moreover, the treated group showed improvements in self-image and well - being. The control group did not report such an improvement.

In objective measurements of isokinetic and isometric muscle strength, the treated group showed average increases in muscle strength of 11% (extension torque at 15 ' and 38.1% (Flexion torque at 15'), this improvement continued throughout the study duration.

While marginal improvements shown by the control group were initially observed, this was rationalised as being the result of learning effect and improvement had stabilised by week 4 of the study.

When the Full 8 week study had been completed very large differences were observed between the treatment and control groups in terms of muscle strength.

Weight changes were controlled and pre and post measurements indicated that the treatment group did not change in weight .

ന Test Conclusions

Testing of the stimulation output parameters of the Slendertone Flex Bottom & Thigh toning device indicates that it is safe, and that it provides appropriate stimulation output for the bottom & thigh muscle groups. The controlled study indicates that users experience a significant improvement in muscle tone, strength and muscle firmness.

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Public Health Service

MAR 0 6 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Michelle Sawyer Regulatory Affairs Manager Bio-Medical Research Limited BMR House Parkmore Business Park, West Galway Republic of Ireland

Re: K022855

Trade/Device Name: FLEX Bottom and Thigh Toning System, Type 511 Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX Dated: December 3, 2002 Received: December 6, 2002

Dear Ms. Sawyer:

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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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

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Page 2 - Ms. Michelle Sawyer

comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

Sincerely yours,

B. Mark A. Milliman

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number (if known):

K022855

Bio-Medical Research Ltd.

Device Name: type 511-01 Sponsor Name: Slendertone Flex Bottom & Thigh Toning System,

The device is intended for over the counter sale.

Indications for Use:

Strengthening, toning and firming of the bottom and thigh region. .

Do Not Write Below This Line - Continue on Another Page if Needed

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use Over-The-Counter Use

Mark N. Millenn

ivision Sign-Of Division of General, Restorative and Neurological Devices

510(k) Number K022853

Regulation Number and Section

§ 890.5850 Powered muscle stimulator.

(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).