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The Winx Sleep Therapy System is indicated for home use in the treatment of obstructive sleep apnea (OSA) in adults.

The Winx Sleep Therapy System consists of four (4) main components: a small electronic bedside console, a soft polymer mouthpiece, a flexible polymer tube that connects the mouthpiece to the console, and a physicians' software application (Winx Data Management Software) that allows clinicians to download usage data from the console and generate patient usage reports. The mouthpiece is an intraoral device that is worn during sleep. The system is designed to increase airway patency and decrease airway obstruction.

The provided text does not contain detailed acceptance criteria, device performance data in a quantitative format, or descriptions of studies that prove the device meets specific acceptance criteria. The document is primarily a 510(k) summary for regulatory clearance, focusing on substantial equivalence to a predicate device.

However, based on the information provided, here's what can be extracted and what is explicitly not available:

1. Table of Acceptance Criteria and Reported Device Performance:

No specific, quantitative acceptance criteria or corresponding device performance values are reported in the provided text. The document broadly states: "Performance testing demonstrate that the Winx Sleep Therapy System is safe and effective for its intended use and substantially equivalent to the predicate." This is a general statement, not a table of specific metrics.

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

This information is not provided in the text. There is no mention of a specific "test set" or its size, nor is there any information about the country of origin of data or whether it was retrospective or prospective.

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

This information is not provided in the text. There is no mention of experts, ground truth establishment methods, or their qualifications.

4. Adjudication Method for the Test Set:

This information is not provided in the text.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

This information is not provided in the text. There is no mention of a comparative effectiveness study involving human readers or the effect size of AI assistance. The device in question is a physical device (intraoral pressure device), not an AI algorithm for interpretation.

6. Standalone (Algorithm Only) Performance Study:

This information is not provided in the text. The device is a physical system, not an algorithm, so a "standalone" algorithmic performance study is not applicable in the way it would be for AI software.

7. Type of Ground Truth Used:

This information is not provided in the text. Given the nature of a physical device for OSA treatment, "ground truth" would typically refer to clinical outcomes (e.g., AHI reduction) measured by polysomnography, but this is not mentioned.

8. Sample Size for the Training Set:

This information is not provided in the text. There is no mention of a "training set" as this device is not an AI/ML algorithm that requires training data in the conventional sense.

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

This information is not provided in the text. As there's no training set mentioned, the establishment of ground truth for it is also not discussed.

Summary of what is present:

• Indications for Use: The Winx Sleep Therapy System is indicated for home use in the treatment of obstructive sleep apnea (OSA) in adults.
• Substantial Equivalence: The device claims substantial equivalence to the 'Attune Sleep Apnea System' (K111549).
• Performance Claim: "Performance testing demonstrate that the Winx Sleep Therapy System is safe and effective for its intended use and substantially equivalent to the predicate." This is a general statement required for regulatory submission.

To reiterate, the provided text is a regulatory filing summary for a physical medical device, not a scientific publication detailing comprehensive performance studies with acceptance criteria, sample sizes, and ground truth methodologies often associated with AI/ML device evaluations.

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