(162 days)
The Neux NXPRO Neuromuscular Electrical Stimulation Device is intended for the stimulation of healthy muscles in order to improve or facilitate muscle performance.
The Neux NXPRO is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. The NeuX NXPRO is not designed for use on injured or ailing muscles and its use on such muscles is contraindicated.
The NeuX NXPRO's electrical impulses allow triggering action potential on motor nerves (excitations). These excitations of motor neurons are transmitted to the motor endplate where they generate mechanical muscle fiber responses that correspond to muscle work. Depending on the parameters of the electrical impulses (pulse frequency, duration of contraction, duration of rest, & total session duration), different types of muscle work can be imposed on the stimulated muscles.
The various types of muscle work that the NeuX NXPRPO can impose on the stimulated muscles are able to improve or facilitate muscle performance. The NeuX NXPRO is considered a technique of muscle training.
The NeuX NXPRO Neuromuscular Electrical Stimulation Device generates electrical impulses the result in a triggering action potential on motor neurons of motor nerves (excitations). These excitations of motor neurons are transmitted to the muscle fibers through the system electrodes where they generate mechanical muscle fiber responses that correspond to muscle work. Depending on the parameters of the electrical impulses: (a) pulse frequency; (b) duration of muscle contraction; (c) duration of rest; and (d) total session duration; different types of muscle work can be imposed on the stimulated muscles. The various types of muscle work that the NXPRO can impose on the stimulated muscles are able to improve or facilitate muscle performance.
Note: the application of the NXPRO is considered a technique of muscle training.
The provided text is a 510(k) summary for the NeuX NXPRO Neuromuscular Electrical Stimulation Device, seeking substantial equivalence to a predicate device (ARP Manufacturing – ARP Sport Device). This type of submission focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than proving efficacy through clinical outcome studies with predefined acceptance criteria for AI or diagnostic performance metrics.
Therefore, the document does not contain the information requested regarding acceptance criteria related to AI/diagnostic performance, study design (sample size for test set, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance), or ground truth establishment for AI model training.
The document primarily discusses:
- Device Description and Intended Use: The NXPRO stimulates healthy muscles for performance improvement and is not intended for treatment of medical conditions or use on injured muscles.
- Technological Characteristics: Details on waveform, output specifications, environmental conditions, and compliance with electrical and mechanical safety standards (IEC 60601 series).
- Comparison to Predicate Device: A detailed table comparing the NXPRO with the predicate ARP Sport device, highlighting similarities in product code, regulation, device class, intended use, and general electrical properties. Many specific output characteristics of the predicate device are listed as "Not Publically Available."
- Non-Clinical Performance Testing: States that bench testing demonstrated the NXPRO provided the "same performance characteristics as the predicate device" and successfully passed all tests required by IEC 60601-1, 3rd Edition.
- Non-clinical Safety Tests: Lists compliance with various IEC 60601 standards for electrical and mechanical safety.
- Conclusion: The device is substantially equivalent to the predicate because its intended use is the same, technological differences do not raise new safety or effectiveness questions, and performance testing (bench testing) demonstrates it is as safe and effective.
No information is provided on:
- A table of acceptance criteria and reported device performance related to diagnostic accuracy or AI metrics. The "acceptance criteria" here are implicitly related to meeting safety standards and demonstrating comparable performance to the predicate via electrical output measurements, not diagnostic outcomes.
- Sample size used for a "test set" in the context of an AI study. The testing mentioned is bench testing for electrical characteristics.
- Data provenance or retrospective/prospective nature of a clinical study.
- Number or qualifications of experts used for ground truth (as there's no diagnostic AI component).
- Adjudication method.
- MRMC comparative effectiveness study or human reader improvement.
- Standalone (algorithm only) performance.
- Type of ground truth (beyond meeting electrical safety standards).
- Training set sample size or ground truth establishment for a training set (as no AI model training is described).
This document describes a regulatory filing for a physical medical device, not a software as a medical device (SaMD) or an AI-powered diagnostic tool, which would typically involve the requested performance study details.
§ 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).