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The Porti Physiological Amplifier is intended to be use by or under the directions of a physician for acquisition of EEG, polygraphy and polysomnography signals and transmission of the signals to a PC during recording of neuro-physical/physiological research and exams.

Polygraphy and polysmnography may besides EEG, include physiological information such as EMG, ECG, EGG, EGG, PH, Respiration, Temperature and Oxygen Saturation.

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This document is a 510(k) clearance letter for the Porti 7, a physiological signal amplifier, indicating it is substantially equivalent to legally marketed predicate devices. It does not contain information about the acceptance criteria or a study proving the device meets those criteria. Therefore, I cannot provide the requested information based on the given text.

The document mainly focuses on the regulatory approval process by the FDA, including:

• Device Name: Porti 7
• Regulation Number: 21 CFR 882.1835
• Regulation Name: Physiological signal amplifier
• Regulatory Class: II
• Product Code: GWL
• Indications for Use: Acquisition of EEG, polygraphy, and polysomnography signals and transmission to a PC during recording of neuro-physical/physiological research and exams. This can include physiological information such as EMG, ECG, EGG, pH, Respiration, Temperature, and Oxygen Saturation.

To answer your request, I would need a different document that details the performance study conducted for the Porti 7 and its acceptance criteria.

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The REFA Physiological Amplifier family is intended to be used by or under the direction of a physician for acquisition of EEG, polygraphy and polysomnography signals and transmission of the signals to a PC during recording of neurophysical/ physiological research and exams.

Polygraphy and Polysomnography may besides EEG, include physiological information such as EMG, ECG, EOG, EGG, PH, Respiration, Temperature and Oxygen Saturation.

Not Found

The provided FDA 510(k) summary for K060374, regarding the REFA Physiological Amplifier, does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria.

This document is a letter from the FDA determining that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. It outlines the regulatory classification, general controls, and compliance requirements.

Therefore, I cannot provide the requested information from the given input. The requested details such as a table of acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set information are not present in this regulatory correspondence.

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