(109 days)
The Compex® Sport Plus is intended to stimulate healthy muscles in order to improve or facilitate muscle performance.
The Compex® Sport Plus 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 Plus training programs is designed for injured or ailing muscles and its use on such muscles is contraindicated.
The Compex® Sport Plus electrical impulses allow the triggering of 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 the Compex® Sport Plus can impose on the stimulated muscles are able to improve or facilitate muscle performance.
The Compex® Sport Plus may therefore be considered a technique of muscle training.
The Compex® Sport Plus system consists of these components:
- 1x Stimulator
- 1x Wire Set
- 2x Small Performance Snap Electrode package .
- 2x Large Performance Snap Electrode package
- . 1x Fast Charger
These components are packaged together in a carrying case along with the user manual, belt clip and a battery charger.
The stimulator is a microprocessor controlled 4 channels neuro-muscular electro-stimulator. The stimulator drives each output channel independently based upon the parameters pre-defined for a program selected by the user. The user operates the device through a User Interface (UI) consisting of a graphic LCD, keypad controls and supporting software. The User Interface is made up of different menus that allow the following functions: set up the device (Options Menu), select a desired category (Category Menu), select a preset program (Treatments' Menu), tune a selected program (Stimulation Menu), and adjust the stimulation intensities (Level Menu).
The stimulator is housed in a molded portable plastic case with a viewable LCD display, an accessible keypad, and accessible battery storage compartment. The case shape is rectangular.
The LCD is located on the upper half of the rectangular face of the device, above the keypad. The display is a graphic display capable of showing alpha numeric characters (including lower case characters), most standard ASCII symbols, and graphics appropriate to assist the user in selecting a desirable exercise routine. The LCD is used to display system information to the user.
The device is equipped with a keypad composed of push buttons which is located below the LCD. The function is defined by a symbol on the LCD corresponding to the button below.
Power for the device is provided from a 4.6 Volt rechargeable Ni-MH battery pack. The power source is housed behind an operator access panel on the back of the device cover.
Each lead wire will connect the output of the stimulator to the electrodes for each output channel. Each lead wire will be connected to the stimulator using a high friction, forced fitting, mechanically shielded connector. Electrode connection shall be a mechanically shielded snap connector (Compliant with protected lead wire and patient cable safety requirements).
Electrode configurations are made up of existing electrodes are configured for the intended use applications and may be unique to one or more application. Up to four Active/Passive sets of electrodes are required. Each electrode set requires a lead/connector assembly. The electrode connector shall be compatible with the cable connector. The electrode assembly shall be compliant with regulatory requirements.
The electrodes (non sterile electrodes) are applied parts which conform to the BF classification of the IEC60601-1 standard and the particular safety standard for nerves and muscles stimulators: IEC60601-2-10.
It is not possible to connect the stimulator to the charger at the same time as the lead wires. Connecting a charger to the stimulator results in an automatic start of the charging procedure which is indicated by a symbol on the LCD showing the status of the battery pack. The battery pack of the stimulator shall be charged by a switching adapter able to supply an output current of 1.4 A +/-100 mA and an output voltage of 9 VDC +/- 2%. The primary plug shall be of American 2 pin AC type able to handle input voltage from 90 to 240 VAC and at a maximum input current of 0.5 A. The secondary plug, to be attached to the stimulator, shall be a straight jack plug with the following dimensions, outer diameter: 3.5 mm, inner diameter: 1.3 mm and length: 9 mm. The charger shall have short circuit protection. Maximum dimensions of the charger shall be 72 x 52 x 35 mm.
Here's an analysis of the provided text regarding the Compex® Sport Plus device's acceptance criteria and studies:
Summary of Acceptance Criteria and Reported Device Performance
Based on the provided 510(k) summary, the device's acceptance criteria are primarily centered around its intended use and functional equivalence to predicate devices, rather than specific quantitative performance metrics. The document explicitly states the device is "substantially equivalent" to predicate devices, implying that its performance is expected to meet similar standards.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Intended Use Equivalence: Stimulate healthy muscles to improve/facilitate muscle performance. | The Compex® Sport Plus has the "same intended use" as the predicate devices (Compex® Sport K011880 and Globus Premium Sport and fitness Muscle Stimulators K061632). It applies electrical impulses to motoneurones to generate muscle fiber responses, allowing for different types of muscle work to improve/facilitate performance. |
| Safety: Device operates safely in accordance with medical device standards. | The electrodes conform to BF classification of IEC60601-1 and IEC60601-2-10 (particular safety standard for nerves and muscle stimulators). The charger has short circuit protection. The device is microprocessor-controlled and operates independently based on pre-defined parameters. |
| Functional Equivalence: The device's programs and features achieve the stated aims for muscle training and recovery. | Training Programs: "Endurance," "Resistance," "Strength," and "Explosive Strength" programs are described to impose specific patterns of activity to improve corresponding muscle performance aspects (e.g., aerobic metabolism, glycolysis metabolism, cross-sectional area, strength/contraction speed). Each has five working levels. |
| Other Programs: "Potentiation," "Active Recovery," "Recovery Plus," "Pre-Warmup," and "Massage" programs are described with their intended effects (e.g., "Twitch potentiation," increased blood flow, faster lactic acid reduction, muscle preparation, gentle muscle twitches for recovery). | |
| Component Performance: Individual components (stimulator, wire set, electrodes, charger) function as designed. | The stimulator is a microprocessor-controlled 4-channel device with independent output. The UI allows for setup, program selection, tuning, and intensity adjustment. Electrodes are configured for intended use; lead wires and connectors compliant. The charger meets specified electrical and physical parameters. |
Study Information:
The provided document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting new clinical study data to prove the device meets novel acceptance criteria. Therefore, most of the requested information about a dedicated study proving acceptance criteria is not present in this document.
Here's what can be inferred or explicitly stated:
- A table of acceptance criteria and the reported device performance: See the table above for inferred acceptance criteria (based on intended use and general safety/performance expectations for this type of device) and performance described.
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not provided. The document does not describe a specific clinical "test set" or clinical study with patient data for this device. The demonstration of safety and effectiveness appears to be primarily through engineering and biocompatibility testing (implied by adherence to standards like IEC60601-1) and the successful claim of substantial equivalence.
- 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/Not provided. Since there's no described clinical "test set" with ground truth determination, this information is not relevant to this submission.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/Not provided.
- 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 imaging tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical muscle stimulator and does not rely on an algorithm for standalone diagnostic performance in the way described for AI/diagnostic devices. Its "performance" is its ability to deliver specified electrical impulses and elicit muscle responses, which is implicitly demonstrated through its design consistency with predicate devices.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable/Not provided. For substantial equivalence, the "ground truth" is often the well-established performance and safety profile of the predicate device, demonstrated through years of safe marketing.
- The sample size for the training set: Not applicable/Not provided. This device is not an AI/machine learning device that requires a "training set" in the conventional sense for developing an algorithm.
- How the ground truth for the training set was established: Not applicable/Not provided.
Conclusion:
The 510(k) submission for the Compex® Sport Plus primarily relies on demonstrating substantial equivalence to existing, legally marketed predicate devices (Compex® Sport K011880 and Globus Premium Sport and fitness Muscle Stimulators K061632). This pathway to market clearance does not typically involve new clinical studies with "test sets," "ground truth," or "training sets" as would be seen for novel devices, especially those incorporating AI or new diagnostic methods. Instead, the focus is on showing that the new device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness compared to the predicates. The descriptions of its programs and components serve to illustrate these similarities.
§ 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).