FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

EMS: The Compex Sport Elite 3.0 is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The work imposed on the Compex Sport Elite 3.0 programs is not suitable for relabilitation 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:
The symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.

The Compex Sport Elite 3.0 is an Over-the-Counter device to be used by adults only.

Device Description

The Compex Sport Elite 3.0 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 3.0 stimulates motor nerves to stimulate a muscular response. Depending on the parameters of theelectrical impulses (pulse frequency. duration of contraction, duration of rest, and totalsession duration). different types of muscle work can be imposed on the stimulated muscles. The Compex Sport Elite 3.0 may therefore be considered a technique of muscletraining.

TENS (Transcutaneous Electrical Nerve Stimulation) and NMES (NeuroMuscular Electrical Stimulation) target different nerve groups of the body. TENS 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 3.0 system consists of these components:

1x Stimulator
1x Lead WireSet
2x Small Performance Snap Electrodepackages ●
2x Large Performance Snap Electrodepackages
1x Charging Cable ●
1x Carrying Case ●

These components are packaged together in a carrying case along with the user guide and a battery charger.

The electrodes are supplied by Axelgaard Mfg. Co., Inc. and cleared under K130987.

The stimulator is a microprocessor controlled 4-channel electro-stimulator. The stimulator drives each output channel independently based upon the parameters predefined for a program selected by 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), andadiust the stimulation intensities (Level Menu).

AI/ML Overview

The provided document is a 510(k) summary for a medical device, the Compex® Sport Elite 3.0. This type of submission to the FDA focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving de novo safety and effectiveness through extensive clinical trials. Thus, the information requested in your prompt regarding acceptance criteria, sample sizes, expert ground truth, MRMC studies, standalone performance, and training set details for AI/ML-based devices is not applicable to this specific document.

The document primarily addresses acceptance criteria in the context of non-clinical testing and comparison to the predicate device. The study proving the device meets these "acceptance criteria" is a demonstration of substantial equivalence rather than a clinical performance study.

Here's an analysis of the provided information within the context of a 510(k) submission, addressing the questions where applicable:

1. A table of acceptance criteria and the reported device performance:

The document doesn't present "acceptance criteria" in the traditional sense of a performance study with specific numerical thresholds for accuracy, sensitivity, or specificity for an AI/ML device. Instead, the acceptance criteria are implicitly defined by the safety and performance standards the device was tested against and by its substantial equivalence to the predicate device.

The document provides a "Comparison Analysis" (Table 1: Characteristics, Table 2: Output Specifications, Table 3: Software Comparison Analysis) between the subject device (Compex® Sport Elite 3.0) and its predicate device (Compex Sport Elite, K170918). This comparison itself serves as the "reported device performance" against the "acceptance criteria" of being substantially equivalent to the predicate and meeting relevant safety standards.

Table 1: Comparison Analysis - Characteristics (Excerpt)

No	Characteristic	Predicate Device	Subject Device	Same/Similar/Different	Risk Analysis (HAZ-PRO-130)
1	Electrodes connection	[Description]	[Description]	Same	No additional risk.
2	Power Source	Rechargeable Ni-MH battery 4.8V (4 cells AA=R6); replaceable.	Rechargeable Li-ion battery 3.7V (one cell); not replaceable.	Different	Smaller size; reduced weight. User will not handle battery. The battery conforms to IEC 62133-2 and UN DOT 38.3. No additional risk.
...	...	...	...	...	...
24	Ingress Protection	IP20	IP22	Different	IP22 is required by IEC 60601-1-11. Reduced risk.
...	...	...	...	...	...

Table 2: Output Specifications Comparison Analysis (Excerpt)

No	Characteristic	Predicate Device	Subject Device	Same/Similar/Different	Risk analysis
33	Maximum Output Voltage (±10%)	60 V @ 500 Ω, 165 V @ 2 kΩ, 165 V @ 10 kΩ	60 V @ 500 Ω, 165 V @ 2 kΩ, 165 V @ 10 kΩ	Same	No additional risk
35	Pulse Width	NMES: 200 to 400 [µs], TENS: 70 to 300[µs]	NMES: 200 to 400 [µs], TENS: 70 to 300[µs]	Same	No additional risk
...	...	...	...	...	...

Table 3: Software Comparison Analysis (Excerpt)

No	Characteristic	Predicate Device	Subject Device	Same/Similar/Different	Risk Analysis
41	Dual MCU design	[Description]	[Description]	Different master MCU, Same protection MCU	Subject device's master MCU has improved performance for control and user interface. Same protection MCU is used. No additional risk.
47	UI Screens - Placements selection screen	Does not exist, need reference to printed user guide	Using graphic display to inform user the proper location of the treatment electrode pads on a human body diagram.	Different	Subject device offers clearer usage guide. Reduced risk.
...	...	...	...	...	...

The "acceptance criteria" here are that the subject device performs identically or similarly to the predicate device in terms of critical functional and safety parameters, and any differences do not raise new issues of safety or effectiveness. For "Different" or "Similar" characteristics, the risk analysis justifies why these differences do not introduce new risks or even reduce existing ones (e.g., improved ingress protection).

2. Sample sizes used for the test set and the data provenance:

Sample Size: Not applicable. This is a medical device (muscle stimulator), not an AI/ML diagnostic or prognostic system that processes clinical data. The "testing" refers to bench testing and comparison to a predicate, not performance on a clinical test set of patient data.
Data Provenance: Not applicable for clinical data. The provenance for the testing data would be from laboratory bench tests conducted by a Nationally Recognized Test Laboratory (Nemko Shanghai Ltd. Shenzhen Branch).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. Ground truth as in expert consensus on disease status is not relevant for this type of device and submission. The "ground truth" for the device's technical specifications and safety conformity would be the industry standards (e.g., IEC 60601 series) and the specifications of the predicate device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. Adjudication methods are used in clinical studies, particularly for subjective assessments or when establishing ground truth from multiple readers. This is a technical comparison and safety conformity assessment.

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:

Not applicable. This device is an electrical stimulator, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is not an algorithm-only device. Its function is direct physical electrical stimulation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

The "ground truth" for this 510(k) submission is based on:

International safety and performance standards: e.g., ANSI/AAMI ES60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-11, IEC 60601-2-10, IEC 62133-2, ANSI/AAMI/IEC 62304.
Specifications and performance of the legally marketed predicate device (Compex Sport Elite, K170918): The core of the 510(k) submission is to demonstrate that the new device is "substantially equivalent" to this predicate.

8. The sample size for the training set:

Not applicable. There is no AI/ML component with a training set for this device.

9. How the ground truth for the training set was established:

Not applicable. There is no AI/ML component with a training set for this device.

In summary: The provided document is an FDA 510(k) clearance letter and summary for a physical medical device (muscle stimulator). The "study that proves the device meets the acceptance criteria" refers to bench testing against recognized electrical safety and performance standards and a detailed comparison to a legally marketed predicate device to demonstrate substantial equivalence, rather than a clinical trial or performance study typical for AI/ML-driven diagnostic devices.

Summary

Regulation Number and Section

§ 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).