(362 days)
The Contour Technology Muscle Stimulator is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The Contour Technology Muscle Stimulator may therefore be considered a technique or method for muscle training.
The Contour Technology Muscle Stimulator Ab Belt accessory is intended for use on abdominal muscles only for strengthening and toning of abdominal muscles.
The Contour Technology Muscle Stimulator BackPad accessory is intended for use on the lower back muscles only.
The Contour Technology Muscle Stimulator is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The Contour Technology Muscle Stimulator may therefore be considered a technique or method for muscle training for improvement of muscle tone, for the strengthening of the following muscles: upper back, lower/mid back, lower back, biceps, triceps, forearm-flexor, forearm-extensor, deltoids, abdominal, gluteus, hamstrings, quadriceps, and calves for the development of firmer muscles.
The electrical stimulation is delivered to the muscles through two channels. The output signal is monophasic, rectangular and based on a regulated voltage technology. The parameters (pulse rate, pulse duration, stimulation time, rest time) are optimized for each program. The power is supplied by 4 AAA batteries.
Pulses, transmitted by the Contour Technology Muscle Stimulator are sent to Gel Pad electrodes placed over the muscle region. The signal reaches out to the motor neuron that innervates the muscle fiber resulting in contraction of the muscle. The energy is delivered through 2-3 pairs of gel pads. Optional accessories are available to allow for hands free operation of the device when placed on the abdomen or back.
- Table of Acceptance Criteria and Reported Device Performance:
The document outlines conformity to the FDA Draft Guidance for Industry and FDA Staff, Class II Special Controls Guidance Document: Powered Muscle Stimulator with Limited Output for Muscle Conditioning.
The non-clinical tests performed are:
- System and Software Requirements Verification Testing
- Environmental Testing
- Safety Testing
- Unit & Integration Testing
- ESD / EMI Testing
- Stress Testing
- Shipping Testing
- Simulated Use Testing (Usability Testing)
The document states: "The performance data demonstrates that the device meets all the product specifications and included electrical output waveforms, energy density, safety and electromagnetic compatibility testing."
While specific numerical acceptance criteria for each test are not explicitly detailed in the provided text, the qualitative statement above indicates that the device met the required specifications derived from the guidance document.
- Sample Size for Test Set and Data Provenance:
The document does not specify a distinct "test set" sample size in terms of patient data or clinical cases. The performance testing appears to be primarily non-clinical, focusing on the device's technical specifications and safety rather than performance on a biological sample set. The data provenance is not applicable in the context of clinical data, as no clinical studies are reported.
- Number of Experts and Qualifications for Ground Truth:
Not applicable. The document explicitly states, "No applicable. This device does not diagnose, cure, mitigate, treat or prevent disease or affect the function of the human body," when discussing clinical performance data. Therefore, there was no ground truth based on expert clinical assessment for a test set.
- Adjudication Method for the Test Set:
Not applicable, as no clinical test set requiring expert adjudication is mentioned.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study was mentioned. The submission is for a medical device (muscle stimulator), not an AI algorithm for diagnostic or prognostic purposes, and therefore, human reader performance with or without AI assistance is not relevant to this submission.
- Standalone (Algorithm Only) Performance Study:
Not applicable. This is a medical device (muscle stimulator), not an AI algorithm.
- Type of Ground Truth Used:
The ground truth or performance validation relied on meeting "product specifications and included electrical output waveforms, energy density, safety and electromagnetic compatibility testing" as per the FDA Draft Guidance for Industry and FDA Staff, Class II Special Controls Guidance Document: Powered Muscle Stimulator with Limited Output for Muscle Conditioning. This represents a technical/engineering ground truth tied to regulatory standards rather than clinical outcomes or expert consensus on biological data.
- Sample Size for the Training Set:
Not applicable, as this is a medical device and not an AI algorithm that would typically involve a "training set" of data.
- How Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set mentioned in the context of this device submission.
§ 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).