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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 and two (2) sizing methods. The components are: 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 sizing methods include: a sizing template and an iPhone sizing application (Winx Mouthpiece Sizing Application). The mouthpiece is an intraoral device that is worn during sleep. The system is designed to increase airway patency and decrease airway obstruction.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance for Winx Sleep Therapy System (Winx+ Mouthpiece)

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary focuses on demonstrating substantial equivalence of the Winx+ mouthpiece to the predicate Winx mouthpiece, rather than setting entirely new, independent acceptance criteria for the Winx+ system. However, specific performance targets and safety metrics were evaluated.

Clinical Performance Acceptance Criteria (derived implicitly from non-inferiority claims):

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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 and two (2) sizing methods. The components are: 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 sizing methods include: a sizing template and an iPhone sizing application (Winx Mouthpiece Sizing Application). 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 is a 510(k) summary for the Winx Sleep Therapy System, which is an intraoral device for obstructive sleep apnea. It describes the device, its intended use, and states that it is substantially equivalent to a predicate device based on performance data from bench testing.

However, the document does not contain the following information:

• A table of acceptance criteria and reported device performance. The document only states that "Results of bench testing demonstrate that the Winx Sleep Therapy System is safe and effective for its intended use and substantially equivalent to the predicate." It does not provide specific performance metrics or acceptance thresholds.
• Details about any clinical study, including sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies. The approval explicitly states it's based on "bench testing" and not clinical trial data.
• Sample sizes for training sets. As there's no mention of a clinical study or an AI/algorithm-only performance evaluation, this information is not applicable and not present.

Therefore, many of your specific questions cannot be answered from the provided text. The document refers to "Performance Data" but then immediately states that "Results of bench testing demonstrate..." This indicates that the evaluation for substantial equivalence was primarily based on non-clinical (bench) testing, not on human clinical trials that would involve the collection of efficacy data against specific acceptance criteria.

Summary of available information vs. requested information:

1. A table of acceptance criteria and the reported device performance: Not provided. The document states "Results of bench testing demonstrate that the Winx Sleep Therapy System is safe and effective for its intended use and substantially equivalent to the predicate" but does not quantify performance or acceptance criteria.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable/Not provided. The evaluation was based on bench testing, not a clinical test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable/Not provided. No clinical test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/Not provided. No clinical test set.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable/Not provided. This device is for sleep therapy, not an AI diagnostic imaging tool; therefore, MRMC studies are not relevant in this context and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable/Not provided. No mention of an AI algorithm being evaluated.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable/Not provided. The evaluation was based on a comparison to a predicate device via bench testing, not clinical outcomes or expert ground truth.
8. The sample size for the training set: Not applicable/Not provided. No AI algorithm is mentioned, and therefore no training set.
9. How the ground truth for the training set was established: Not applicable/Not provided. No AI algorithm and no training set.

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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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