(87 days)
The BioRehab System is used for electromyography (EMG) biofeedback support of relaxation and muscle reeducation. The BioRehab System may be used by licensed medical practitioners to support their methods of muscle relaxation and reeducation/rehabilitation. The BioRehab System can be used in hospital, physician office, clinics, long-term patient care facilities, home and other therapy locations.
The BioRehab System consists of an EMG amplifier, computer and software. Under the care and guidance of a physician or therapist, the BioRehab System supports relaxation and muscle reeducation by the application of electromyography (EMG) biofeedback. The BioRehab System supports patient game playing under EMG control. The patient consciously controls the EMG signal level from the therapist's selected muscle groups.
This document is a 510(k) premarket notification for the Nicolet Biomedical BioRehab System, a biofeedback device. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving the device meets specific acceptance criteria through a study with defined performance metrics. Therefore, the information requested in your prompt regarding acceptance criteria and a study to prove it is not typically found or required in a 510(k) submission like this one.
Here's why and what information can be extracted/inferred:
- 510(k) Submissions Focus on Substantial Equivalence: The primary goal of a 510(k) is to demonstrate that the new device is as safe and effective as a legally marketed predicate device. It does not usually involve extensive clinical trials or performance studies with predefined acceptance criteria in the same way a Premarket Approval (PMA) application would.
- "Summary of Safety and Effectiveness" vs. "Performance Study": The document explicitly states "Summary of Safety and Effectiveness". This summarization points towards a comparison with predicate devices, not a de novo study with acceptance criteria.
Therefore, I cannot populate the table or answer most of your numbered questions directly from the provided text because this type of study was not performed or reported in this 510(k) submission.
However, I can extract information related to the device and its intended use:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated as this is a 510(k) submission for substantial equivalence. The "acceptance criteria" here implicitly is that the device is as safe and effective as the predicate devices.
- Reported Device Performance: The document states:
- "The BioRehab System applies EMG signal detection and amplification to support relaxation and muscle reeducation therapy."
- "The EMG signal output of the BioRehab system is qualitative not quantitative."
- "Under control of the therapist, an EMG signal threshold is set for the patient to support control of the computer cursor."
- "The control of the computer cursor supports patient game playing on the computer."
- Conclusion: "The characteristics of the BioRehab System are substantially equivalent to the predicate devices. No new questions of safety or effectiveness are raised."
The following numbered items cannot be answered from the provided text for the reasons explained above:
- Sample sizes used for the test set and the data provenance: Not applicable to a 510(k) predicated on substantial equivalence without specific performance studies described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- 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. This device is a biofeedback system, not an AI-assisted diagnostic tool for human readers.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. The device is used "Under the care and guidance of a physician or therapist" and involves "patient game playing under EMG control," indicating a human-in-the-loop system.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to a 510(k) for substantial equivalence.
- The sample size for the training set: Not applicable, as this is not a machine learning device or a study describing a training set.
- How the ground truth for the training set was established: Not applicable.
§ 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.