(105 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 same capabilities as the predecessor 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. The device is essentially identical to the predecessor device except that it utilizes wireless (Bluetooth) technology to transfer EMG data to host computer without a cable and to eliminate any connection between the patient and line voltage.
The provided text is a 510(k) summary for the Myotronics-Noromed Model MES 9200 EMG System. This submission focuses on demonstrating substantial equivalence to a predicate device (Model MES 9000 EMG System) rather than clinical performance against specific acceptance criteria. The key change is the introduction of wireless (Bluetooth) technology and battery operation to improve safety and data transfer.
Therefore, the document does not contain a detailed study proving the device meets specific performance acceptance criteria in the manner you've described for AI/CADe devices. There are no reported device performance metrics, sample sizes for test or training sets, expert consensus, or information on adjudication methods for clinical performance.
Here's a breakdown of what can be extracted based on your request, and what is missing:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as performance metrics. The implicit acceptance criterion for a 510(k) is "substantial equivalence" to a predicate device. This means demonstrating that the new device has the same intended use, fundamental scientific technology, and does not raise new questions of safety or effectiveness.
- Reported Device Performance: Not provided in terms of diagnostic accuracy, sensitivity, specificity, etc. The document highlights the functional equivalence and safety improvements over the predicate.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable / Missing: No information about a test set for clinical performance evaluation is mentioned. The submission focuses on engineering design changes and comparing them to the predicate device.
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)
- Not Applicable / Missing: No clinical "ground truth" establishment is described for a performance study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable / Missing: No clinical performance study requiring adjudication is described.
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 / Missing: This is not an AI/CADe device. No MRMC study was conducted or is relevant for this type of 510(k) submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable / Missing: This device is an EMG system, not an algorithm, so this concept does not apply.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable / Missing: No clinical ground truth is established or discussed as the focus is on device modification and safety.
8. The sample size for the training set
- Not Applicable / Missing: This device does not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
- Not Applicable / Missing: As above, no training set or associated ground truth establishment is relevant to this submission.
Summary of the Study (as described in the 510(k) Summary):
The "study" or justification for substantial equivalence presented in the 510(k) summary is a comparison of the new device (Model MES 9200) to its legally marketed predicate device (Model MES 9000).
- Objective: To demonstrate that the Model MES 9200 EMG System is substantially equivalent to the Model MES 9000.
- Methodology: The comparison highlights that the new device has the "same intended uses and fundamental scientific technology." The primary design change addressed is the incorporation of "wireless (Bluetooth) technology to transfer EMG data to host computer without a cable and to eliminate any connection between the patient and line voltage." This change is presented as an improvement in safety and convenience without altering the core functionality or intended use.
- Proof of Meeting (Implicit) Acceptance Criteria: The FDA's issuance of a substantial equivalence determination (K111687) serves as the "proof" that the device meets the regulatory acceptance criteria for market clearance under the 510(k) pathway. This determination is based on the provided comparison and assurances that the changes do not raise new questions of safety or effectiveness.
In essence, this 510(k) is about establishing regulatory clearance for a device modification, not a clinical performance study of a new diagnostic algorithm.
§ 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.