(1070 days)
The intended use of the Model ME300 Muscle Tester is to record EMG sensory feedback signals to be used in various programs of muscle reeducation and relaxation training.
The ME300 is a portable, battery powered EMG recorder. The ME300 is an electronic device used to gather and display electrophysiological signals obtained from muscle activity. These signals are used in programs related to muscle re-education and relaxation training. The signals are received via conductive adhesive skin electrodes and may be displayed or stored for display at a later time. Signals may be gathered from two channels. Data downloading or transfer is via a standard fiber optic cable to a PC. The product does not relay any electrical or stimulatory signals to the body. It is only a signal recorder with display capabilities.
This document, K943535, does not describe a study to prove the device meets specific performance acceptance criteria beyond safety and electromagnetic compatibility (EMC). Instead, it primarily focuses on establishing substantial equivalence to predicate devices.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not specify quantitative performance acceptance criteria (e.g., accuracy, sensitivity, specificity) for the ME300 Muscle Tester's ability to record EMG signals. The "acceptance" is primarily based on meeting safety and EMC standards and demonstrating substantial equivalence in function to existing devices.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Electrical Safety | Meets the requirements of IEC 601-1-2 |
| EMC Safety | Meets the requirements of IEC 801-2, IEC 801-3, EN55011, and the EMC Directive |
| Functionality | Gathers electrophysiological signals (EMG) and displays them for muscle re-education and relaxation training, deemed substantially equivalent to predicate devices (Myotrac and Myoexcerciser). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a clinical performance study with a "test set" in the context of device accuracy or effectiveness. The "testing" mentioned refers to electrical and EMC safety compliance. Therefore, information on sample size and data provenance for a performance test set is not applicable to this submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
As there is no described clinical performance "test set" requiring ground truth establishment, this information is not applicable.
4. Adjudication Method for the Test Set
Since no clinical performance "test set" is described, an adjudication method is not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study is described in this document. The submission focuses on substantial equivalence based on technological characteristics and intended use, not on comparing a human reader's performance with and without AI assistance. Therefore, information about effect size is not applicable.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The ME300 Muscle Tester is a signal recorder and display device. It does not incorporate an AI algorithm for interpretation or diagnosis. Therefore, a standalone algorithm performance study is not applicable.
7. Type of Ground Truth Used
For the safety and EMC testing, the "ground truth" was compliance with established international and European safety standards (IEC, EN, EMC Directive). For the substantial equivalence claim, the "ground truth" was the functional and safety characteristics of the predicate devices (Myotrac and Myoexcerciser) as accepted by the FDA. There is no biological or clinical "ground truth" based on pathology or outcomes data mentioned for device performance itself.
8. Sample Size for the Training Set
The ME300 Muscle Tester is a hardware device for recording physiological signals; it does not utilize a machine learning algorithm that requires a "training set." Therefore, this information is not applicable.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for a machine learning algorithm, this information is not applicable.
In summary: This 510(k) submission for the ME300 Muscle Tester is a pre-amendments substantial equivalence claim. It relies on demonstrating that the device is as safe and effective as legally marketed predicate devices by showing equivalent technological characteristics and intended use, along with compliance with relevant electrical and EMC safety standards. It does not present a clinical performance study with specific quantitative acceptance criteria or a "test set" in the way modern AI/ML device submissions would.
§ 882.5050 Biofeedback device.
(a)
Identification. A biofeedback device is an instrument that provides a visual or auditory signal corresponding to the status of one or more of a patient's physiological parameters (e.g., brain alpha wave activity, muscle activity, skin temperature, etc.) so that the patient can control voluntarily these physiological parameters.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter when it is a prescription battery powered device that is indicated for relaxation training and muscle reeducation and prescription use, subject to § 882.9.