(78 days)
The AlphaOne EEG biofeedback system is intended for use in relaxation training. In applications for relaxation training, the AlphaOne system provides visual and/or auditory signals that correlate with changes in EEG activity useful for achieving a state of relaxation. This device does not provide alarms and does not provide automated diagnostic analysis of EEG data.
AlphaOne EEG Biofeedback System
The provided document is a 510(k) clearance letter from the FDA for the AlphaOne EEG Biofeedback System. It confirms that the device is substantially equivalent to a legally marketed predicate device for its stated indications for use.
Crucially, this document does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications. The letter primarily addresses the regulatory approval process based on substantial equivalence, not detailed clinical or performance study results.
The key information provided in the document regarding the device is:
- Device Name: AlphaOne EEG Biofeedback System
- Regulation Number: 21 CFR 882.5050
- Regulation Name: Biofeedback Device
- Regulatory Class: Class II
- Product Code: HCC, GWQ
- Indications For Use: "The AlphaOne EEG biofeedback system is intended for use in relaxation training. In applications for relaxation training, the AlphaOne system provides visual and/or auditory signals that correlate with changes in EEG activity useful for achieving a state of relaxation. This device does not provide alarms and does not provide automated diagnostic analysis of EEG data."
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them because that information is not present in the provided text. This type of detailed performance data would typically be found in the 510(k) submission summary or a separate clinical study report, which is not part of this FDA clearance letter.
§ 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.