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The device provides positive pressure therapy for the treatment of adult obstructive sleep apnea syndrome in self breathing patients weighing over 30kg (66lbs). This product can be used in the home as well as in clinical/hospital environments.

The proposed device is a non-invasive, continuous positive airway pressure ventilator, incorporating a heated respiratory humidifier. The device is intended to treat obstructive sleep apnea by delivering a flow of positive airway pressure at a level prescribed by a physician to splint open the airway and prevent airway collapse. The proposed device is available in three types, which are Aurora, Resware and Zizmer. Each type is available in different models designed with different therapy modes and pressure ranges. The therapy modes are available in four types, which are CPAP, Spontaneous (S), Spontaneous/Timed (S/T) and Timed (T). The pressure range for the proposed devices is available in three types, which are 4-20cm H2O, 4-25cm H2O and 4-30cm H2O. Alarm module is incorporated in the device. The device will generate audio and visual alarm for airway leakage, motor malfunction and high motor temperature. The proposed device is provided non-sterile, and not to be sterilized by the user prior to use. The proposed device can be reused by single patient.

The provided text is a 510(k) Premarket Notification for a medical device (SysMed S/T, a noncontinuous ventilator for treating obstructive sleep apnea). It describes the device, its intended use, and states that non-clinical tests were conducted to demonstrate substantial equivalence to predicate devices based on compliance with various engineering, safety, and biocompatibility standards.

However, this document does NOT describe the acceptance criteria and the study that proves the device meets the acceptance criteria in terms of clinical performance, specifically an AI/ML type of study. The information requested, such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set details, are typically found in clinical validation reports for AI/ML-driven medical devices.

The provided document focuses on demonstrating substantial equivalence based on physical and functional characteristics, and compliance with well-established performance and safety standards for medical ventilators. It does not involve AI/ML performance evaluation as would be described for an AI/ML-driven diagnostic or therapeutic device.

Therefore, I cannot populate the requested table and answer the study-specific questions based on the provided text. The document confirms that non-clinical tests were done to verify compliance with standards, but not a study demonstrating clinical performance against specific acceptance criteria relevant to AI/ML.

Here's why the document doesn't contain the requested information:

• Device Type: The SysMed S/T is a non-continuous ventilator. Its primary function involves delivering positive airway pressure. While it might incorporate some automated features (like therapy modes), the provided document does not indicate it's an AI/ML-driven device that makes diagnostic or treatment recommendations requiring complex clinical validation studies with human readers or AI-specific performance metrics like sensitivity, specificity, or AUC against a ground truth established by experts.
• 510(k) Process: The 510(k) pathway for medical device clearance primarily focuses on demonstrating "substantial equivalence" to a legally marketed predicate device. This often involves engineering bench testing, biocompatibility testing, and comparison of technical specifications, rather than a full-scale clinical trial or AI/ML performance study unless the device introduces novel technology or significant changes affecting safety or effectiveness.
• Lack of Clinical Data/AI Performance Metrics: The "Non-Clinical Test Conclusion" section lists various industry standards (e.g., IEC, ISO) that the device complies with, relating to electrical safety, electromagnetic compatibility, alarm systems, home healthcare environment use, sleep apnea therapy equipment, humidifying equipment, and biocompatibility. These are typical engineering and safety tests, not clinical performance studies for an AI/ML algorithm.

If this were an AI/ML device, the "Non-Clinical Test Conclusion" or a separate "Clinical Study" section would detail how the AI's performance was measured against a clinically relevant ground truth, including metrics like sensitivity, specificity, or area under the ROC curve, and would address the points in your query.

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