FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

Body Control System is a 2 channel battery operated muscle stimulation system specifically designed to exercise the arms and thighs muscles, It comprises namely an electronic stimulator module which generates the required stimulation signals.

Body Control System comprises accessories 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.

AI/ML Overview

This 510(k) submission describes the SPORT-ELEC Body Control System, a muscle stimulator intended for improving muscle tone and strengthening arm and thigh muscles in healthy individuals. The submission focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than proving specific performance metrics through clinical trials. As such, the information you've requested regarding detailed performance criteria and study results in the context of typical AI/diagnostic device evaluations is largely not present in this document.

Here's an analysis based on the provided text:

Acceptance Criteria and Device Performance

This 510(k) submission does not specify quantitative acceptance criteria in terms of clinical performance metrics (e.g., sensitivity, specificity, accuracy, effect size on muscle strength). Instead, it focuses on demonstrating compliance with recognized safety and regulatory standards, and substantial equivalence to predicate devices.

Acceptance Criterion (Implicit)	Reported Device Performance
Electrical Safety Standards Compliance	Testing was carried out to assure compliance with:

IEC 60601-1 (General requirements for basic safety and essential performance of medical electrical equipment)
IEC 60601-2-10 (Particular requirements for the basic safety and essential performance of nerve and muscle stimulators)
|
| Electromagnetic Compatibility (EMC) Compliance | Testing was carried out to assure compliance with:
IEC 60601-1-2 (Collateral Standard: Electromagnetic disturbances - Requirements and tests) |
| Software Life-Cycle Process Compliance | Testing was carried out to assure compliance with:
IEC 60601-1-4 (Collateral Standard: Programmable electrical medical systems) - Note: The document also mentions ISO 14971, which is for risk management, but primarily refers to IEC 60601-1-4 for software. |
| FDA Guidance for Premarket Submissions and Software Compliance | Performance data were verified "versus the requirements of the FDA Guidance for Pre Market Submissions and for Software contained in Medical Devices." |
| Substantial Equivalence (Technological Characteristics) | The technological characteristics, features, specifications, materials, mode of operation, and intended use of the Body Control System Arms and Thighs device are substantially equivalent to the predicate devices (SPORT-ELEC Body Control System REF BCS K 081026, Slendertone System-Arms K 072553, Slendertone flex bottom and thighs toning system K022855). The accessories use the same stimulation signal delivery and have similar parameter settings, with electrode positioning integrated into the garment. The differences existing between the devices "do not raise new issues of safety or effectiveness." |

Study Details (as inferable from the document)

Given that this is a 510(k) submission primarily based on substantial equivalence and compliance with engineering standards, traditional clinical study details are not provided.

Sample size used for the test set and the data provenance: Not applicable in the context of a clinical performance test set for this 510(k). The "testing" mentioned refers to engineering and regulatory compliance rather than clinical efficacy/performance and thus wouldn't involve a 'test set' of patient data in the typical sense. The provenance of any data used for engineering tests is not specified, but it would have been conducted by the manufacturer (SPORT-ELEC S.A., France).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no "ground truth" established by experts for a clinical test set as part of this submission.
Adjudication method 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. This device is a muscle stimulator, not an AI diagnostic tool, and involves no human "readers" or AI assistance in interpretation.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-only device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for clinical performance. The "ground truth" here is the adherence to electrical safety, EMC, and software standards, which is evaluated through engineering tests and documentation. Substantial equivalence relies on comparing the device's technical specifications and intended use to legally marketed predicate devices.
The sample size for the training set: Not applicable. There is no mention or indication of a "training set" in the context of machine learning or AI algorithm development.
How the ground truth for the training set was established: Not applicable.

Summary:

The SPORT-ELEC Body Control System's 510(k) clearance (K091865) relies on demonstrating substantial equivalence to existing predicate devices and compliance with recognized electrical safety and software standards. It is not a submission that presents clinical performance data from a prospective study with a test set, ground truth established by experts, or AI performance metrics. The "acceptance criteria" are regulatory and engineering compliance, rather than clinical efficacy metrics.

Summary

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).