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The Sleep Headbox works in conjunction with Excel Tech Sleep software. This Sleep System is used to acquire and review sleep recordings (polysomnography) in research or clinical environments for:

• Digital recording of high-level output signals (such as EEG, respiratory and oximetry signals) from conventional polygraphic recorders, signal transducers or amplifiers.
• Selection of recorded signal sections for on-screen review, annotation and marking of sleep stages.
• Computer-assisted event marking and quantitative analysis of EEG, respiratory and oximetry signals.
• Computer-assisted reporting of simple measures obtained from the recorded signals (such as magnitude, time and frequency and simple statistical measures of marked events)

The SLEEP System is not intended to replace conventional devices or methods used for sleep monitoring in critical care or intraoperative settings.

The SLEEP System requires competent user input, and its output must be reviewed and interpreted by trained polysomnographers or trained medical professionals who will exercise professional judgment in using this information.

The SLEEP System does not make any judgment of normality or abnormality of the displayed signals or the result of an analysis. In no way are any of the functions represented as being in and of themselves diagnostic.

The SLEEP Headbox is a digital polysomnograph headbox used in conjunction with XLTEK SLEEP Software to acquire and review sleep recordings.

This document is a 510(k) summary for a medical device called the "XLTEK Sleep System," which is a polysomnography headbox. It describes the device's intended use and claims substantial equivalence to previously cleared devices.

Based on the provided text, there is no information presented regarding acceptance criteria or a study proving the device meets acceptance criteria.

The document primarily focuses on:

• Identification of the device and submitting organization.
• Common and Classification names for the device.
• Identification of predicate devices (XLTEK PSG-40 Polysomnography Headbox, Masimo Radical Pulse Oximeter, XLTEK Ambulatory EEG) to establish substantial equivalence.
• Description of the modifications (incorporating Masimo pulse oximetry technology and circuitry from Ambulatory EEG) and a statement that these modifications do not affect intended use, safety, or fundamental scientific technology.
• Indications for Use: Listing the functions of the Sleep Headbox in conjunction with XLTEK SLEEP Software, such as digital recording of signals (EEG, respiratory, oximetry), selection/review of recorded sections, computer-assisted event marking and quantitative analysis, and computer-assisted reporting of measures.
• Limitations on Use: Stating it's not intended to replace conventional devices in critical care or intraoperative settings, requires competent user input and interpretation by trained professionals, and does not make judgments of normality or act as a diagnostic tool.
• FDA correspondence: An FDA letter confirming substantial equivalence and providing regulatory information.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, study details, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, or ground truth establishment because these details are not present in the provided text.

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