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The Body System is intended for muscle conditioning to stimulate healthy muscles.

The Body System is not intended to be used in conjunction with therapy or treatment of medical conditions of any kind. The Body System is intended to be operated by a trained professional who is present to monitor treatment.

Body System (available in models: SX101 and OS2911). Both models utilize the same internal electrical components. The models differ only in the control/display features and exterior casing/dimensions. The Body System is a Powered Muscle Stimulator with 16 channel ports using self adhesive pad applicators attached to the body for muscle conditioning. The pad applicator is a 510K cleared device (K970426), itself.

The Body System uses the same technological characteristics as the predicate devices (listed below); it is an electrically powered device that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area. The Body System muscle stimulators provide selections of different programs through manual adjustment of five different frequency programs of the device from 200 Hz, to 1250 Hz. The Body System has a maximum output voltage of 88V @ 2k Ω, rated at 200 volts. A display shows the balance treatment time. The output signal is biphasic, rectangular and based on a voltage and current regulated technology. All channel outputs are isolated from each other; they have their own transformers and amplifiers which are Independent from neighboring channels or outputs. The only commonality between the outputs are their connectors to the power supply, the start button, the programs button, and the pulse button. The Body System power source is 110 V - 240 V AC Mains, 50-60 Hz. The patient leakage current tested at 240VAC 60Hz is 5 microamps for both the normal and fault conditions. The Body System Channels are synchronous and are isolated by separate transformers.

The provided document is a 510(k) Premarket Notification for the "Body System" device, a powered muscle stimulator. It focuses on demonstrating substantial equivalence to predicate devices rather than proving specific clinical or diagnostic performance through a typical study with acceptance criteria.

Therefore, the information required to answer the prompt (acceptance criteria, study details, expert involvement, ground truth, etc.) is not present in this document. This submission primarily relies on non-clinical performance data (electrical safety, biocompatibility, electromagnetic compatibility) and a comparison of technological characteristics to already cleared devices.

Specifically:

• There are no acceptance criteria listed for clinical or diagnostic performance, as the device is not claiming to diagnose or treat medical conditions, but rather for "muscle conditioning to stimulate healthy muscles."
• There is no study described to prove the device meets performance criteria in the way a diagnostic AI/ML device would, as this is a physical muscle stimulator. The "non-clinical performance data" mentioned refers to engineering and safety tests, not a clinical trial.
• No sample size for test sets or training sets are provided because there isn't a machine learning algorithm being trained or tested for diagnostic performance.
• No experts were used to establish ground truth for any diagnostic test set, as such a test set does not exist for this device's intended use.
• No adjudication method, MRMC comparative effectiveness study, or standalone algorithm performance are discussed.
• No ground truth type is specified, again, because there is no diagnostic or classification task being performed by an algorithm.

The document states:

• "The Body System has been tested to establish is safety and performance. Performed on the The following tests have been performed on the patient contacting parts: Biocompatibility - Cytotoxicity (ISO-10993-5) - result: Pass, Biocompatibility – irritation (ISO-10993-10) – result: Pass, Biocompatibility - Sensitization (ISO-10993-10) - result: Pass. Performance – including Output Waveforms of the Body System as compared to a predicate. Electromagnetic Compatibility - according to EN 60601-1-2:2015, IEC 60601-1-2:2014, IEC 60601-2-10 2012 + A1 2016. Electrical Safety – according to IEC 60601-1-6:2010, AMD1:2013, IEC 60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007)." (Page 5)
• The "Comparison of the Subject and Predicate Devices" table (Pages 6-7) details technical specifications (e.g., maximum output voltage, frequency range, waveform) to demonstrate similarity to commercially available devices. The acceptance criteria for these would be meeting the specified electrical and physical parameters, and passing the relevant safety standards (ISO and IEC). For instance, for "Biocompatibility," the reported performance is "Pass" against the ISO standards. For electrical parameters like "Maximum Output Voltage," the reported performance is "58V @ 500 Ω, 88V @ 2k Ω" for the subject device, which is compared to the predicate devices' outputs to argue for substantial equivalence.

In summary, this document proves the device's safety and electrical performance through non-clinical testing and comparison to predicates, not through a clinical performance study with the types of acceptance criteria and methodologies typically used for AI/ML or diagnostic devices.

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