(385 days)
CT5 is indicated for the improvement of abdominal muscle tone, for strengthening of abdominal muscles and for the development of a firmer abdomen
CT5 is a 2 channel battery operated muscle stimulation system specifically designed to exercise the abdominal muscles. It comprises namely an electronic stimulator module which generates the required stimulation signals.
CT5 comprises 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 belt, which take the place of the lead wires.
The product is supplied with the cream VC 57B/53 -148, a User's Guide and a carry case.
The provided text describes the SPORT-ELEC CT5 muscle stimulator and its premarket notification to the FDA. The information focuses on its substantial equivalence to a predicate device and compliance with safety standards, rather than a clinical study demonstrating specific performance metrics against pre-defined acceptance criteria for muscle improvement.
Here's a breakdown based on your request, highlighting where information is not present in the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Not Explicitly Stated for Muscle Tone Improvement) | Reported Device Performance |
|---|---|
| No specific quantitative acceptance criteria for "improvement of muscle tone," "strengthening," or "development of a firmer abdomen" are provided in the document. | The device (CT5) is stated to be substantially equivalent to a predicate device (SLENDERTONE FLEX ABDOMINAL Training System, K030708) in its delivery of the stimulation signal and similar parameter settings. The differences between the devices "do not raise new issues of safety or effectiveness." |
| Compliance with electrical safety standards (e.g., IEC 60601-1 and -2-10) | Compliance claimed. |
| Compliance with electromagnetic compatibility (IEC 60601-1-2) | Compliance claimed. |
| Compliance with software standards (IEC 60601-1-4) | Compliance claimed. |
| Compliance with FDA Guidances for Pre Market Submissions and for Software contained in Medical Devices | Compliance claimed. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not mentioned. The document describes compliance with electrical and software standards, but no clinical study with a test set of participants for evaluating muscle improvement is detailed.
- Data Provenance: Not applicable for a clinical test set from the provided text, as no such study is described. The device is manufactured by SPORT-ELEC S.A. based in France.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Not Applicable: No clinical study or test set requiring expert ground truth establishment for muscle improvement is described in the provided text. The document focuses on regulatory compliance and substantial equivalence to a predicate device.
4. Adjudication Method for the Test Set
- Not Applicable: No clinical study or test set requiring adjudication is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- No: The provided text does not mention an MRMC comparative effectiveness study, or any clinical study comparing human readers (or users) with and without AI assistance for muscle improvement.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not Applicable: This device is a muscle stimulator, not an algorithm, so "standalone performance" in the context of AI is not relevant. The device requires human application and use.
7. The Type of Ground Truth Used
- Not Applicable: For the claims of "improvement of abdominal muscle tone, for strengthening of abdominal muscles and for the development of a firmer abdomen," no clinical ground truth (e.g., physiological measurements, expert assessment, outcomes data) is described in the provided document. The regulatory pathway here relies on substantial equivalence to a previously cleared device for the stated indications, rather than new clinical efficacy data for these specific claims.
8. The Sample Size for the Training Set
- Not Applicable: This device is not an AI/ML algorithm that would typically have a "training set." The engineering and safety testing performed would not involve such a concept.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable: As above, this device does not utilize a training set in the context of AI/ML.
§ 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).