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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.

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.

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.

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.

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