(29 days)
- For evaluation of the status of muscles at rest and in function
- As an aid in muscle re-education and muscle relaxation therapy
- Provides ability to compare new captured data with past data to assess progress in treating patients relaxation state
The device incorporates circuitry enabling the capabilities of the two predecessor devices to be offered as a single device. It is a computer based system offering options capable of evaluating muscle groups at rest or in function by means of surface electromyography. Muscle activity is quantified by means of re-usable or disposable surface electrodes positioned over the muscle groups being studied. Up to eight sites can be monitored simultaneously and displayed in time or frequency domains.
This document is a 510(k) summary and an FDA clearance letter for the Myotronics-Noromed, Inc. Model MES-9000/EMG System. It primarily focuses on demonstrating substantial equivalence to predicate devices for regulatory approval, rather than providing a detailed study report with specific acceptance criteria and performance metrics typically found in clinical trial publications.
Therefore, much of the requested information regarding specific acceptance criteria, detailed study design, sample sizes, expert qualifications, and ground truth establishment is not available in the provided text.
Here's what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance
This information is not explicitly stated in the provided documents. Regulatory submissions for devices like this typically focus on demonstrating "substantial equivalence" to a predicate device, meaning it performs as safely and effectively as a device already on the market. This often involves showing that the new device has similar technical characteristics and achieves similar results in relevant tests, but explicit acceptance criteria with numerical performance targets are not detailed here.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not available in the provided text. No specific "test set" or study data are described in terms of sample size or provenance.
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 available in the provided text.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not available in the provided text.
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
This information is not available in the provided text. The MES-9000/EMG System is a biofeedback device for muscle evaluation, not an AI-assisted diagnostic imaging tool that would typically undergo MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not available in the provided text. Given the nature of a biofeedback EMG system, it is inherently used with a human (patient and clinician), so a "standalone algorithm only" performance assessment is less applicable in the sense of a fully automated diagnostic system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not available in the provided text.
8. The sample size for the training set
This information is not available in the provided text. This device is from 2001, and the concept of "training sets" as understood in modern AI/machine learning was not generally a primary focus of regulatory submissions for medical devices of this type at that time. The submission emphasizes hardware and software enhancements and functional equivalence to previous models.
9. How the ground truth for the training set was established
This information is not available in the provided text.
Summary of available information related to performance and equivalence:
- Device Name: Model MES-9000/EMG System
- Intended Use: Used in evaluation and recording of muscle status, at rest and in function, as an aid in muscle re-education and muscle relaxation therapy, and to provide ability to compare new captured data with past data to assess progress in treating patients relaxation state.
- Comparison to Predicate Devices: The device is "substantially equivalent" to its predecessors, Models ND-2000 (K922838A) and ND-8000 (K922270 & K992439). The design change is primarily to "update and enhance the electronic components and software to state-of-the-art and to provide the capabilities of the two predecessor devices as a single device."
- Fundamental Scientific Technology: The device uses the "same intended uses and fundamental scientific technology" as its predecessors: computer-based surface electromyography (SEMG).
- Performance (Implied by Substantial Equivalence): The device is presumed to perform comparably to the predicate devices in terms of accurately measuring and displaying muscle activity via SEMG, facilitating muscle re-education/relaxation therapy, and tracking patient progress. The specific "performance" relies on the established safety and effectiveness of the predicate devices.
§ 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.