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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.

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This is a diagnostic device for use upon the order of a physician and under the supervision of qualified health care professional. The device is used in the assessment of sleep related disorders by recording a range of physiologic parameters during sleep. These parameters are presented graphically on a computer screen for diagnostic review, similar in application to the use of a traditional paper based polygraph recorder. This device does not provide alarms, is not intended for use as an automated apnea monitor, and does not provide automated diagnostic analysis.

Nightron Polysomnography System

I need more information to provide a comprehensive answer. The provided text is a 510(k) clearance letter for the "Nightron Polysomnography System," which indicates the device is substantially equivalent to a predicate device. However, this letter does not contain details about specific acceptance criteria or a study proving that the device meets those criteria.

Typically, such information would be found within the original 510(k) submission document itself, or in supporting studies referenced in that submission, which are not provided in the input.

The document primarily focuses on:

• Device Name & Regulatory Information: Nightron Polysomnography System, 21 CFR 882.1400 (Electroencephalograph), Class II, Product Code OLV.
• Indications for Use: Diagnostic device for assessing sleep-related disorders by recording physiologic parameters for diagnostic review, similar to a traditional polygraph.
• Limitations: Does not provide alarms, not for automated apnea monitoring, no automated diagnostic analysis.
• Substantial Equivalence: A statement that FDA has determined the device is substantially equivalent to legally marketed predicate devices.

Without the actual study report or the details from the 510(k) submission describing performance testing, I cannot fill out the requested table and answer questions 2-9.

To answer your request, I would need additional documents, specifically the performance testing section of the 510(k) submission or any referenced clinical/non-clinical studies that demonstrate the device's performance.

Ask a specific question about this device

Ask a specific question about this device