Search Results

intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.

The MuscleMax™ Plus is a disposable single patient use (Electrical Muscle Stimulator) intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area. The output waveform consists of a 2200Hz biphasic, symmetrical one period signal (zero net DC component) in a series of low frequency (72 pps) bursts. Testing confirmed the device to fall within the acceptance criteria of 75uC for maximum charge per pulse when tested with a 500, 2K, and 10K Ohm load and the functional battery life of the device to exceed the minimum specification of 100 hours at maximum intensity. Because the wave is an alternating current, there is no net polar effects to cause long-term positive ion concentrations within the tissues beneath either electrode. The ON/OFF and intensity functions are controlled with a dial into the housing to reduce the potential recessed for inadvertent changes in intensity or accidental turning ON of the device. The unit has a green LED indicating when the unit is ON and releasing an electrical current, and a yellow LED indicating the unit is in the 20 second OFF cycle and will begin to release an electrical current within 20 seconds. The yellow LED warns the user not to increase the intensity until the green LED is illuminated to avoid inadvertent increases in output. The device is supplied with pre-gelled conductive electrode pads which have been cleared for marketing by the Food and Drug Administration under K912461. The electrode leads are strain relieved and designed to remain securely attached to the device (not removable), reducing the potential for attaching to AC power lines. The device is powered by four (4) 1.5 volt DC batteries contained within the housing.

Here's an analysis of the provided text regarding the MuscleMax™ Plus, focusing on the requested acceptance criteria and study information:

Based on the provided text, the MuscleMax™ Plus is an Electrical Muscle Stimulator (EMS) device, not an AI/ML-driven device that would typically involve the comprehensive "AI-specific" studies you've outlined. The information describes a hardware device with specific electrical and functional criteria, as opposed to an algorithm that processes data for diagnostic or predictive purposes.

Therefore, many of the requested fields pertaining to AI/ML device studies (like sample sizes for test and training sets, expert ground truth, adjudication, MRMC studies, standalone performance with AI, etc.) are not applicable to this traditional EMS device.

Here's the breakdown of the information that is available or can be inferred, and where the AI-specific questions are not applicable:

MuscleMax™ Plus Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Not Applicable in the traditional sense for an AI/ML model. The text describes testing of the physical properties and performance of the device. It doesn't specify a "test set" of patient data or a number of devices tested for these criteria. The testing confirmed the device properties.
• Data Provenance: The testing was conducted internally by Smith & Nephew DonJoy Inc. The location is Carlsbad, CA, U.S.A. It's a prospective internal test, though the quantity of units tested is not specified.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Not Applicable. Ground truth for this type of device refers to engineering specifications and performance measurements, not expert annotations of patient data.

4. Adjudication Method for the Test Set

• Not Applicable. This is relevant for subjective assessments or disagreements in AI model ground truth, not for objective electrical and functional device testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No. This is not relevant for a direct EMS device. MRMC studies compare human performance (often with and without AI assistance) on clinical cases.

6. If a Standalone (i.e. algorithm only, without human-in-the-loop performance) Study Was Done

• Not Applicable. This device is not an algorithm that operates in a standalone capacity that would be evaluated in this manner. Its "performance" is its ability to meet electrical and functional specifications.

7. The Type of Ground Truth Used

• "Engineering Specifications" / "Bench Testing Results". The "ground truth" for this device's performance is adherence to its designed electrical parameters (e.g., charge per pulse, waveform characteristics) and functional specifications (e.g., battery life, LED operation).

8. The Sample Size for the Training Set

• Not Applicable. There is no "training set" as this is not an AI/ML device.

9. How the Ground Truth for the Training Set Was Established

• Not Applicable. There is no "training set" as this is not an AI/ML device.

Summary of the Study that Proves Device Meets Acceptance Criteria:

The provided text states: "Testing confirmed the device to fall within the acceptance criteria of 75uC for maximum charge per pulse when tested with a 500, 2K, and 10K Ohm load and the functional battery life of the device to exceed the minimum specification of 100 hours at maximum intensity."

This indicates an internal engineering and quality assurance testing process performed by Smith & Nephew DonJoy Inc. The "study" here refers to the internal validation and verification processes common for medical devices, specifically bench testing and electrical parameter measurements, to ensure it meets its pre-defined design specifications. The specifics of "how many devices were tested" or "what exact methodology" are not detailed in this summary.

Ask a specific question about this device