MAXEMS, MODELS 1000 AND 2000

• K Number: K091248
• Device Name: MAXEMS, MODELS 1000 AND 2000
• Manufacturer: BIO PROTECH, INC.
• Date Cleared: 2009-11-30 ( 216 days)
• Product Code: IPF
• Regulation Number: 890.5850
• Type: Traditional
• Panel: PM
• Reference & Predicate Devices: K072795 , K020750

Intended Use

1. Relax muscles
2. Prevention or retardation of disuse atrophy
3. Increasing local blood circulation
4. Muscle re-education
5. Immediate post-surgical stimulation of calf muscle to prevent venous thrombosis
6. Maintaining or increasing range of motion

Device Description

The MAXEMS are battery operated pulse generators that send electrical impulses through electrodes to the body and reach the underlying muscle group. The devices are provided with two controllable output channels, each independent of each other. An electrode pair can be connected to each output channel. Use of legally marketed, standard carbon film electrodes with a biocompatible adhesive, that are a minimum of 48mmx48mm in size and have an impedance of less than 2k ohms is recommended. The MAXEMS 1000 is an analogue unit with dual channels and a selectable pulse rate of 5, 30, and 100 Hz. The MAXEMS 2000 is a digital unit with an adjustable pulse rate from 1 to 150Hz.

AI/ML Overview

The provided text states that no clinical data was included in the submission for the MAXEMS 1000/2000 devices. Therefore, there is no study described that proves the device meets acceptance criteria based on clinical performance.

Instead, the determination of substantial equivalence was based on non-clinical tests, which concluded that "The MAXEMS series is as safe and effective as the predicate devices cited above."

Given the absence of clinical data, the following information cannot be extracted from the provided text:

1. A table of acceptance criteria and the reported device performance: No clinical performance data is reported.
2. Sample size used for the test set and the data provenance: No clinical test set was used.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as there was no clinical test set requiring expert ground truth.
4. Adjudication method for the test set: Not applicable.
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, as this is not an AI device and no clinical effectiveness study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an algorithm-based device.
7. The type of ground truth used: Not applicable for clinical ground truth.
8. The sample size for the training set: Not applicable, as there was no clinical training set.
9. How the ground truth for the training set was established: Not applicable.

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).