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The Nellcor Puritan Bennett Suzanne is intended for use in collecting and recording physiological data to be used in diagnosing sleep disorders. A pediatric through adult patient population is intended for the Suzanne, which can be used in either home or hospital environments.

The Suzanne System is composed of a data recorder that contains the electronics and software necessary to capture the physiological information of each sensor and to store this information in a Flash card or to send it to a computer via a serial communication port. The information that can be recorded by the Suzanne System is : - · EEG signals - · ECG signals - · Pressure signals - · Thoracic movements - Abdominal movements - Breath detection (through bucco-nasal thermistor) . - Flow (through pneumotachometer) - Envelope of ambient sound . - Body position . - Ambient light detection . - Arterial oxyhemoglobin saturation (SpO2) . - Pulse rate . The signals are amplified by different amplifiers contained in elements of the system known as headboxes. When used in a home environment, the data is recorded in the flash card and the clinician uses a setup unit to check that the system works correctly and to set the recording starting time. When used in a clinical environment, the system can be used as described above or data can be recorded to a computer with the use of a PC application software. The system is powered by an internal battery or by a DC power supply.

This document is a 510(k) summary for the Nellcor Puritan Bennett Suzanne Polysomnograph System. It describes the device, its intended use, and compares it to a legally marketed predicate device. The primary change in the modified device is the addition of new pulse oximetry technology. This document asserts that the modifications do not raise new questions of safety or effectiveness.

However, the provided document does not contain the detailed information required to answer your request about acceptance criteria and a study proving the device meets those criteria. Specifically, it lacks:

• A table of acceptance criteria and reported device performance.
• Information on sample sizes, data provenance, number of experts, adjudication methods, or ground truth for a test set.
• Details about multi-reader multi-case (MRMC) comparative effectiveness studies.
• Information on standalone algorithm performance.
• The type of ground truth used for a study.
• Sample size and ground truth establishment for a training set.

The document states that "Clinical and non-clinical tests were performed to support the determination of substantial equivalence" and that "The technological characteristics of the modified Suzanne and the results of clinical and non-clinical tests do not raise any new questions of safety or effectiveness when compared to the legally marketed (unmodified) device." However, it does not provide the specifics of these tests or their results.

Therefore, based solely on the provided text, I cannot complete your request. The document describes the regulatory submission process and the determination of substantial equivalence, but it does not detail the specific performance studies and their results.

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