(205 days)
Body Control System is indicated for the improvement of buttocks muscles tone, for strengthening of buttocks muscles.
Contraindicated use on injured or otherwise impaired muscles
Not intended for use in any therapy or for the treatment of any medical conditions or diseases
Body Control System "BS" is a 2 channel battery operated muscle stimulation system specifically designed to exercise the buttocks' muscles, It comprises namely an electronic stimulator module which generates the required stimulation signals.
Body Control System "BS" comprises a short with integral electrodes, which connects the signals from the stimulator to the skin. The built-in electrodes are located on the inner surface of the accessories. The product is supplied with the cream VC 57B/53 - 148, a User's Guide and a carry case.
This document outlines the acceptance criteria and supporting study for the "Body Control System 'BS'" muscle stimulator.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Electrical Safety | Compliance with IEC 60601-1 and -2-10 standards. | Testing was carried out to assure compliance with recognized electrical safety standards: IEC 60601-1 and -2-10 standards for electrical safety. (Implied compliance through "assurance of compliance"). |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2 standard. | Testing was carried out to assure compliance with IEC 60601-1-2 standard for electromagnetic compatibility. (Implied compliance through "assurance of compliance"). |
| Software Functionality | Compliance with IEC 60601-1-4 standard. | Testing was carried out to assure compliance with IEC 60601-1-4 standard for the software. (Implied compliance through "assurance of compliance"). |
| Risk Management | Compliance with ISO 14971:2007 (implied as it's listed with software standard). | (ISO 14971 : 2007) - Implied compliance through inclusion in the list of standards applied for performance data verification. |
| FDA Guidance | Verification against requirements of FDA Guidance for Pre Market Submissions and for Software contained in Medical Devices. | Performance data were also verified versus the requirements of the FDA Guidance for Pre Market Submissions and for Software contained in Medical Devices. (Implied compliance through "verification"). |
| Substantial Equivalence to Predicate Devices | Technological characteristics, features, specifications, materials, mode of operation, and intended use are substantially equivalent to predicate devices (SPORT-ELEC Body Control System K081026 and Slendertone System Short K070142). Differences do not raise new issues of safety or effectiveness. | The technological characteristics, features, specifications, materials, mode of operation, and intended use of the Body Control System Short summary device are substantially equivalent to the predicate devices quoted above. The differences that exist between the devices do not raise new issues of safety or effectiveness regarding the Body Control System Device. The short of the Body Control System "BS" use the same as the BCS training system and Slendertone System Short 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 is integrated to the garment. (Explicit statement of substantial equivalence). |
2. Sample Size for the Test Set and Data Provenance
The provided document does not specify a separate "test set" in the context of clinical performance testing. The reported "performance data" refers to compliance with various electrical safety, EMC, software, and risk management standards. These typically involve testing conducted on the device itself and its components, rather than human subjects or a clinical test set in the traditional sense of evaluating diagnostic or therapeutic accuracy.
Therefore, information on:
- Sample size used for the test set: Not applicable/not provided in the context of clinical outcomes.
- Data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable/not provided. The performance data is based on compliance testing to international standards, which is generally conducted by accredited labs.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable/not provided as the "performance data" focuses on engineering and regulatory compliance (electrical safety, EMC, software) rather than a clinical performance study requiring a ground truth established by experts.
4. Adjudication Method for the Test Set
This information is not applicable/not provided for the reasons stated above.
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
An MRMC comparative effectiveness study was not done. The device is an electro-muscle stimulator, not an AI-powered diagnostic or assistive technology for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance study in the context of an algorithm's performance was not done. The "performance data" refers to the device's compliance with safety and technical standards for a physical medical device.
7. The type of ground truth used
The "ground truth" for the reported performance data is the established international standards (IEC 60601-1, -2-10, -1-2, -1-4) and regulatory guidance (FDA Guidance for Pre Market Submissions and for Software contained in Medical Devices) themselves. Compliance is assessed against the requirements and specifications outlined in these standards.
8. The sample size for the training set
This information is not applicable/not provided. The device is not an AI/machine learning model that requires a "training set."
9. How the ground truth for the training set was established
This information is not applicable/not provided for the same reason as above.
§ 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).