(268 days)
Body Control System 4M is indicated for the improvement of muscle tone and firmness, for strengthening muscles in arms, abdomen, thighs and buttocks areas.
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 "4M" is a 2 channel battery operated muscle stimulation system specifically designed to exercise the muscles, It comprises namely an electronic stimulator module which generates the required stimulation signals. Body Control System "4M" comprises 4 electrodes, which connects the signals from the stimulator to the skin. The product is supplied with a User's Guide and a carry case.
The provided text is a 510(k) summary for the SPORT-ELEC Body Control System "4M," a muscle stimulator. It details predicate devices, general device description, intended use, and states that testing was performed to assure compliance with electrical safety and electromagnetic compatibility standards. However, it does not contain information about acceptance criteria or specific studies proving the device meets performance criteria related to its intended use (muscle firming, toning, strengthening).
Therefore, I cannot provide the requested information in the table format because the data is absent from the provided document.
Here's a breakdown of why each point cannot be addressed:
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A table of acceptance criteria and the reported device performance: The document states that performance data "were also verified versus the requirements of the FDA Guidance for Pre Market Submissions and for Software contained in Medical Devices." However, it does not specify what those performance requirements (acceptance criteria) were for muscle tone, firmness, or strengthening, nor does it present any reported device performance data against such criteria. The "Performance data" section only lists compliance with electrical safety, electromagnetic compatibility, and software standards.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No performance study data is presented, so sample size and provenance are not mentioned.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable as no performance study is described.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable as no performance study is described.
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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 involving human readers.
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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.
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The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable as no performance study is described.
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The sample size for the training set: Not applicable as no performance study or machine learning algorithm is described.
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How the ground truth for the training set was established: Not applicable as no performance study or machine learning algorithm is described.
The document primarily focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and compliance with general safety standards, rather than presenting clinical or performance data for the specific indications of use (muscle toning, firming, strengthening).
§ 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).