(209 days)
Body Control is indicated for the improvement of muscle tone, for strengthening of muscles and for the development of firmer muscles. It is indicated for use on the abdominal 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 is a 2 channel battery operated muscle stimulation system specifically designed to exercise the abdominal muscles. It is comprised of an electronic stimulator module which generates the required stimulation signals.
Body Control is comprised of a belt 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 belts. The product is supplied with the cream VC 57B/53 -148, a User's Guide and a carry case.
Here's a breakdown of the acceptance criteria and the study information for the Body Control device, based on the provided text:
Preamble:
It's important to note that the provided document is a 510(k) Premarket Notification summary for a traditional submission, which focuses on demonstrating substantial equivalence to a predicate device. This type of submission often relies on a comparison to existing devices and adherence to recognized standards rather than extensive clinical efficacy studies with specific acceptance criteria related to a novel clinical endpoint. The "performance data" described here primarily refers to electrical safety and electromagnetic compatibility, which are foundational for any medical device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Standard | Reported Device Performance (Compliance) |
|---|---|---|
| Electrical Safety | IEC 60601-1 | Compliance Assured |
| Electrical Safety (Specific) | IEC 60601-2-10 | Compliance Assured |
| Electromagnetic Compatibility (EMC) | IEC 60601-1-2 | Compliance Assured |
| Software | IEC 60601-1-4 | Compliance Assured |
| Performance Data (General) | FDA Guidance for Pre Market Submissions and for Software contained in Medical Devices | Verified vs. requirements |
| Substantial Equivalence | Technological characteristics, features, specifications, materials, mode of operation, and intended use are substantially equivalent to predicate device (SPORT-ELEC ABDOMINAL Training System, K061914). Differences do not raise new safety or effectiveness issues. | Achieved (FDA concurrence with 510(k) clearance) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a specific clinical "test set" in the context of efficacy or clinical performance for the Body Control device. The testing mentioned relates to adherence to electrical safety, EMC, and software standards. These types of tests are typically conducted on a representative sample of the devices themselves, rather than a human "test set" for clinical outcomes.
- Sample Size for Test Set: Not applicable in the context of clinical efficacy; refers to device samples for engineering standards testing.
- Data Provenance: Not applicable in the context of clinical efficacy; testing against standards is typically done in controlled lab environments.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document as it pertains to clinical performance evaluation, which was not the primary focus of this 510(k) submission. The "ground truth" here is the adherence to engineering standards.
4. Adjudication Method for the Test Set
This information is not provided as there is no mention of a human-centric "test set" requiring adjudication for clinical outcomes.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and Effect Size
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for imaging devices where human readers interpret data, often with and without AI assistance. The Body Control device is a powered muscle stimulator, and its approval relies on electrical safety, EMC, software compliance, and substantial equivalence to a predicate device, not on interpreting diagnostic images.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not Applicable. The Body Control device is a physical muscle stimulator, not an algorithm or AI system for standalone performance evaluation in the typical sense of AI/ML devices. Its "performance" relates to its physical function and electrical characteristics.
7. The Type of Ground Truth Used
The "ground truth" for this submission is primarily:
- Compliance with recognized electrical safety standards (IEC 60601-1, IEC 60601-2-10).
- Compliance with electromagnetic compatibility standards (IEC 60601-1-2).
- Compliance with software standards (IEC 60601-1-4).
- Demonstrated substantial equivalence to a previously cleared predicate device (SPORT-ELEC ABDOMINAL Training System, K061914) in terms of technological characteristics, features, specifications, materials, mode of operation, and intended use.
8. The Sample Size for the Training Set
Not Applicable. The document describes a physical medical device (muscle stimulator), not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
Not Applicable. As no AI/ML algorithm training set is mentioned, the method for establishing its ground truth is not relevant.
§ 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).