(83 days)
EMS: The Compex Sport Elite is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The work imposed on the muscles by the Compex is not suitable for rehable for rehabilitation or physiotherapy.
TENS: The Compex Sport Elite TENS is intended for:
· Temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities
· They symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.
The Compex® Sport Elite is an Over-The-Counter device to be used by adults only.
The Compex® Sport Elite is an electrical stimulation device, which stimulates healthy muscles by means of electrical impulses transmitted by electrodes. The electrical pulses generated by the Compex® Sport Elite stimulate motor nerves to stimulate a muscular response. Depending on the parameters of the electrical impulses (pulse frequency, duration of contraction, duration of rest, and total session duration), different types of muscle work can be imposed on the stimulated muscles. The Compex® Sport Elite may therefore be considered a technique of muscle training.
TENS (Transcutaneous Electrical Nerve Stimulation) and NMES (NeuroMuscular Electrical Stimulation) target different nerve groups of the body. TENS is specifically targets the sensory nerves, which are responsible for sending pain signals to the brain. NMES targets the muscle itself, specifically through the motor nerves. This allows the NMES machine to create a muscle contraction to recruit more muscle fibers when training; warming up or recovering.
The Compex® Sport Elite system consists of these components:
- 1x Stimulator
- 1x Lead Wire Set
- 2x Small Performance Snap Electrode package ●
- 2x Large Performance Snap Electrode package
- 1x Battery Charger ●
These components are packaged together in a carrying case along with the user guide and a battery charger.
The stimulator is a microprocessor controlled 4 channels 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 provided document is a 510(k) premarket notification for the Compex® Sport Elite, a powered muscle stimulator. It focuses on demonstrating substantial equivalence to predicate devices (Compex Sport Plus and Strive) rather than providing extensive clinical study data for acceptance criteria.
Therefore, the information requested regarding a study proving acceptance criteria for device performance is largely not available in this document. The document primarily describes the technical characteristics of the new device and compares them to predicate devices, along with adherence to electrical safety, electromagnetic compatibility, software verification, and usability standards.
Here's a breakdown of the available information based on your request:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" for a study in numerical terms like sensitivity, specificity, or improvement effect size. Instead, it demonstrates compliance with recognized medical device standards and provides detailed comparisons of technical specifications to predicate devices. The "performance" is therefore reported in terms of these technical characteristics.
| Acceptance Criteria (Inferred/Stated) | Reported Device Performance (Compex Sport Elite) |
|---|---|
| Electrical Safety & Essential Performance (as per IEC 60601-1) | Complies with IEC 60601-1 |
| Electromagnetic Compatibility (as per IEC 60601-1-2) | Complies with IEC 60601-1-2 |
| Use in Home Healthcare Environment (as per IEC 60601-1-11) | Complies with IEC 60601-1-11 |
| Performance of Nerve and Muscle Stimulators (as per IEC 60601-2-10) | Complies with IEC 60601-2-10 |
| Software Verification (meets design requirements) | Software verified in accordance with FDA guidance "General Principles of Software Validation, January 11, 2002." Demonstrated to meet design requirements. Cybersecurity vulnerability and management approach established. |
| Usability/Human Factors (meets requirements, appropriate for users/environment, mitigates use-related risks) | Usability/Human Factors testing performed. Demonstrated that established requirements for usability were met, and the design is appropriate for intended users and use environment. The study substantiates acceptability of use-related risks. |
| Conformity with other standards (e.g., Risk Management, Software Life Cycle) | Complies with ISO 14971 (Risk Management) and AAMI/ANSI /IEC 62304 (Software Life Cycle Processes). |
| Technical Specifications (e.g., Waveform, Max Output Voltage/Current, Pulse Width, Frequency, Net Charge, Max Phase Charge, Max Current Density, Max Power Density) | Detailed specifications are provided in the comparison tables for the new device (Compex Sport Elite) and predicate devices. For most parameters (waveform, shape, voltages, currents, pulse widths, frequencies for NMES programs), the Compex Sport Elite matches or is similar to the Compex Sport Plus. For TENS specific parameters, it aligns with or is similar to the Strive. Differences are noted but deemed not to raise safety and effectiveness questions (e.g., Compex Sport Elite has two output modes (NMES/TENS) vs. Compex Sport Plus (NMES) and Strive (TENS)). Specific values are extensive in the source document and are essentially the "reported performance" for these technical aspects. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The performance testing described (electrical safety, EMC, software, usability) are typically internal validation tests and not clinical studies involving patient data.
3. 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)
This information is not provided. The "ground truth" in this context would likely be compliance with engineering standards, software requirements, and usability principles, assessed by engineers and human factors specialists rather than medical experts for clinical outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. Standard engineering and software verification often involve peer reviews and structured testing, but specific adjudication methods like those used in clinical trials (e.g., 2+1 consensus) are not applicable or mentioned here.
5. 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
No MRMC comparative effectiveness study was done or reported. This device is a muscle stimulator, not an AI diagnostic tool, so this type of study is not relevant to its regulatory submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is a physical muscle stimulator and does not involve AI algorithms in the way described for "standalone performance" in AI/CADe devices. Its "standalone performance" is essentially its ability to meet the technical specifications and safety standards independently. This was assessed through the electrical safety, EMC, software verification, and usability testing, as detailed above.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this submission is compliance with:
- Recognized consensus standards (IEC 60601-1, -1-2, -1-11, -2-10, IEC 62366, ISO 14971, AAMI/ANSI/IEC 62304).
- Design requirements for software functionality.
- Usability requirements for safe and effective user interaction.
There is no mention of clinical expert consensus, pathology, or outcomes data being used as ground truth for this 510(k) submission, as the submission explicitly states: "This submission does not contain clinical data."
8. The sample size for the training set
This information is not applicable/not provided for this type of device and submission. The device is not an AI/machine learning model that requires a "training set."
9. How the ground truth for the training set was established
This information is not applicable/not provided 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).