(306 days)
"Compex® Sport" is intended to stimulate healthy muscles in order to improve or facilitate muscle performance.
"Compex® Sport" is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. None of the "Compex® Sport" training programs is designed for injured or ailing muscles and its use on such muscles is contraindicated.
The "Compex® Sport" electrical impulses allow triggering action potentials on motoneurones of motor nerves (excitations). These excitations of motoneurones are transmitted to the muscle fibers via 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 "Compex® Sport" can impose on the stimulated muscles are able to improve or facilitate muscle performance. "Compex® Sport" may therefore be considered a technique of muscle training.
"Compex® Sport" is a portable, battery operated neuromuscular electrical stimulator. Equipped with four channels, it works with a rechargeable battery and offers an easy-to-read LCD display.
The acceptance criteria and the study proving the device meets them are described below:
1. Acceptance Criteria and Reported Device Performance
The provided document describes both the safety and effectiveness of the "Compex® Sport" device. Since this is a 510(k) submission, the primary acceptance criteria for the device are based on demonstrating substantial equivalence to a predicate device ("Compex® 2") and providing evidence of safe and effective use for its intended purpose.
While explicit, quantitative "acceptance criteria" are not presented in a typical table format for performance metrics in this 510(k) submission, the document details the safety and effectiveness as follows:
| Acceptance Criteria (Inferred from 510(k) Requirements) | Reported Device Performance |
|---|---|
| Safety: Device is safe for intended use without medical supervision. | - Post-market surveillance: Over 66,000 "Compex® Sport" devices sold in 7 European countries over more than four years with no reported adverse events. |
- Consumer complaints: 26 complaints, with only 3 related to reversible skin irritations (no serious physical injuries).
- Technical Safety Features: Biphasic rectangular impulses prevent electrochemical burns; programs start with nil intensity; four independent channels prevent power accumulation; constant current generator and "Electrode default" mechanism prevent skin burns/irritations.
- Measures to Prevent Misuse: Warnings (LCD, user manual, electrode packaging) for contraindications, off-label uses, electrode placement, deteriorated electrodes, and infection prevention. |
| Effectiveness: Device effectively stimulates healthy muscles to improve/facilitate muscle performance. | - Mechanism of Action: "Compex® Sport" generates electrical impulses that trigger action potentials on motor nerve fibers, leading to mechanical muscle responses and various types of muscle work. - Support from Peer-reviewed Articles: Efficacy for all proposed programs (Endurance, Resistance, Strength, Explosive Strength, Potentiation, Active Recovery) is supported by peer-reviewed scientific literature (referenced in Section 8.2.1-8.2.6 of the original 510(k) document, though not fully reproduced here).
- Specific Effectiveness Features: "Compex® Sport" Training Planner (CD-ROM) for appropriate use and high "space recruitment" of muscular fibers through specific technical features. |
| Substantial Equivalence: Device is as safe and effective as a legally marketed predicate device. | - Technical Characteristics Comparison: Detailed table (Section 4.1) comparing "Compex® 2" (predicate) and "Compex® Sport" showing many 'same' characteristics (e.g., constant current generator, four independent channels, biphasic impulses, maximum current, battery, display type). - Differences Justification: Minor differences in impulse width, maximum quantity of electricity, and pulse frequency range are explained and justified as not affecting safety or effectiveness for the new intended use (e.g., "Compex® Sport" doesn't need higher frequencies as it lacks TENS programs). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a specific "test set" in the context of a formal clinical trial with a defined sample size for performance evaluation. Instead, the safety and effectiveness data are primarily based on:
- Post-market surveillance data: This involves the sales and complaint history of over 66,000 "Compex® Sport" devices already marketed in Europe.
- Data Provenance: Retrospective, post-market data from seven European countries (Switzerland, France, Italy, Belgium, Spain, Germany, and the Netherlands).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
There is no mention of a "test set" for which ground truth was established by experts in the context of device performance metrics. The effectiveness claims are supported by peer-reviewed scientific articles (Section 8.2 of the 510(k) not fully detailed here). These articles would have their own methodologies for establishing ground truth regarding muscle performance changes, likely involving physiological measurements, but the number and qualifications of experts involved in those studies are not detailed in this submission.
4. Adjudication Method for the Test Set
Not applicable, as a specific "test set" for performance evaluation requiring adjudication of results is not described. The safety data relies on the direct reporting of consumer complaints to the manufacturer, followed by the manufacturer's internal investigation.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No Multi-Reader Multi-Case (MRMC) comparative effectiveness study is mentioned. The device, "Compex® Sport," is a standalone physical product for muscle stimulation, not an AI or imaging diagnostic tool that would typically involve human readers interpreting cases.
6. Standalone Performance Study (Algorithm Only)
The "Compex® Sport" is a physical device, not an algorithm. Therefore, a standalone (algorithm only) performance study is not applicable. The core function of the device is to generate electrical impulses with specific parameters. Its "performance" is demonstrated through its technical specifications (Section 4.1) and the physiological effects those impulses are shown to produce, drawing on existing scientific literature.
7. Type of Ground Truth Used
The ground truth for the effectiveness claims is derived from peer-reviewed scientific literature (Sections 6.1 and 8.2 of the 510(k) submission). This literature supports the physiological effects of electrical muscle stimulation on various aspects of muscle performance (endurance, resistance, strength, etc.). For safety, the "ground truth" is defined by the absence of severe adverse events and the low incidence rate of minor complaints in the real-world usage of the device over several years.
8. Sample Size for the Training Set
Not applicable. This device is a physical product (neuromuscular electrical stimulator), not a machine learning model that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for this device.
§ 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).