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The SleepWizard is intended for use in collecting and displaying physiological data to be used in diagnosing sleep disorders such as obstructive sleep apnea in patients weighing over 20 kg in a clinical or home environment.

The system is set up by the clinician using the computer, which is connected to the Data Collector by a cable connecting to the RS232 port, or by a modem. The computer is optically isolated from the Data Collector by circuitry on the Power Board. The patient is prepared for the sleep study as described in the Clinician's Guide and Patient's Guide (Attachments 1 and 3, respectively). A Ground Electrode is connected to the Data Collector and the patient to ensure that the signals collected all are at the same ground potential. Various sensors are connected to the patient and either directly to the Data Collector or to the Extension Box which in rurn is connected to the Data Collector. During the study itself, physiologic signals are detected by the sensors. Except for the pulse oximeter, these signals are then amplified by amplifiers. Each amplifier is designed so that it dedicated to a specific sensor so that all signals are at +3 volts after amplification. The signals are then sent to the Deta Collector, where they are stored and periodically written on the Flashcard. If the Data Collector and computer are both connected to modems, the clinician can view the computer screen while it is being collected from the patient. At the conclusion of data collection (i.e., at the end of the sleep study) the Plashcard is removed from the Data Collector and inserted into the computer so that the data may be processed and printed out for analysis purposes.

The provided text describes a 510(k) summary for the Nellcor Puritan Bennett SleepWizard, a sleep disorders data recorder. The document primarily focuses on demonstrating substantial equivalence to a predicate device and functional testing, rather than detailed performance studies with acceptance criteria for diagnostic accuracy.

Therefore, the requested information, particularly regarding specific acceptance criteria for diagnostic performance, a detailed study proving it, sample sizes for test and training sets, expert qualifications, adjudication methods, and MRMC studies, is not available in the provided text.

The document states: "No clinical studies were required to support a substantial equivalence determination, except for connecting the device to a healthy person and running the system to verify that readable, appropriate signals were being generated." This indicates that the focus of the submission was on functional verification and regulatory equivalence, not on a clinical performance study with diagnostic accuracy metrics against a ground truth.

Here's what can be extracted based on the prompt's requirements, with explicit notation where information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information: The document does not provide specific quantitative acceptance criteria for diagnostic accuracy (e.g., sensitivity, specificity, AUC) or detailed performance metrics beyond "passed all tests" and "generated readable, appropriate signals."

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: "a healthy person" (singular).
• Data Provenance: Not explicitly stated, but implies a simple verification conducted by the manufacturer, likely in a controlled environment. Retrospective/Prospective: Given the limited scope ("healthy person"), it's more akin to a prospective, single-case demonstration.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.
• The ground truth for the "healthy person" test was simply the expectation of "readable, appropriate signals" from a healthy individual, rather than a diagnostic ground truth established by experts.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The "test" was a basic functional verification, not a diagnostic assessment requiring expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• MRMC Study: No. The document explicitly states, "No clinical studies were required to support a substantial equivalence determination, except for connecting the device to a healthy person..."
• Effect Size: Not applicable.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done

• Standalone Study: No. The device is a "Sleep Disorders Data Recorder" intended to collect and display data for clinicians to use in diagnosing. It does not appear to contain an automated diagnostic algorithm that would require a standalone performance study.

7. The Type of Ground Truth Used

• Type of Ground Truth: For the limited verification described, the "ground truth" was a basic expectation of normal physiological signals from a healthy individual, rather than expert consensus on a sleep disorder, pathology, or outcomes data.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This device is a data recorder, not a machine learning algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

• Ground Truth Establishment for Training Set: Not applicable. The device does not utilize a training set.

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