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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):

Non-Clinical Performance Criteria (for Winx Sleep Therapy System using Winx+ Mouthpiece):

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

The "test set" refers to the subjects enrolled in the clinical studies evaluating the Winx+ mouthpiece.

• Randomization Study (comparing Winx+ vs. Winx):

  • Sample Size: 30 subjects for each mouthpiece type (implied, as 12 of 30 for Winx and 19 of 30 for Winx+ are reported).
  • Data Provenance: Not explicitly stated, but clinical studies for FDA submissions typically involve data from within the US or compliant international sites. The lack of specific country information points to a standard clinical trial setting. The study design (randomized, crossover) indicates a prospective collection of data.

• Extension Study (long-term Winx+ follow-up):

  • Sample Size: 23 subjects (18 of 23 achieved success). This study was a 30-day extension of subjects who likely participated in the initial phase or were new enrollees for long-term evaluation. 24 of 29 subjects completed the 30-day home-use period.
  • Data Provenance: Not explicitly stated regarding country, but likely the same as the Randomization Study. This was also a prospective collection of data, following subjects over time.

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

The primary endpoint (Clinical Success) was based on objective physiological measurements: Apnea-Hypopnea Index (AHI) determined by Polysomnography (PSG).

• Number of Experts: Not explicitly stated how many experts reviewed each PSG. However, PSG studies are typically scored by trained and certified sleep technologists, often overseen or interpreted by a Board-Certified Sleep Physician. The document does not specify if multiple independent scorers were used for adjudication.
• Qualifications of Experts: Assumed to be qualified sleep technologists and/or sleep physicians who are experts in interpreting PSG data according to established clinical guidelines for OSA diagnosis and severity. Specific years of experience are not mentioned.

4. Adjudication Method for the Test Set

The ground truth was established by Polysomnography (PSG) readings, with the primary endpoint being "Clinical Success" defined by specific AHI criteria (AHI reduction > 50% and treatment AHI < 20 events per hour).

The document does not explicitly describe an adjudication method for disagreements in PSG scoring if multiple scorers were used. It is standard practice for PSG labs to have quality control and review processes in place, but a formal (e.g., 2+1 or 3+1) adjudication method for the study's ground truth derivation is not detailed. The AHI is an objective metric derived from PSG parameters, generally reducing the need for subjective adjudication found in image-based diagnoses.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done.

This type of study is more common for diagnostic imaging devices where human readers interpret medical images with and without AI assistance. The Winx Sleep Therapy System is a treatment device, and its effectiveness was measured by objective physiological outcomes (AHI from PSG) rather than human interpretation of data. The "comparison" was between two device configurations (Winx vs. Winx+ mouthpiece) in treating patients, not a comparison of human reader performance.

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

The Winx Sleep Therapy System is a medical device, not an AI algorithm. Therefore, the concept of a "standalone" study for an algorithm does not directly apply here.

The device itself operates autonomously, generating negative pressure. The "study" evaluated the device's performance when used by patients, with outcomes measured by clinicians using standard diagnostic tools (PSG). The comparison was between two versions of the device's mouthpiece (Winx vs. Winx+), effectively testing one device (Winx+) in a "standalone" therapeutic capacity against its predicate (Winx).

7. The Type of Ground Truth Used

The ground truth for evaluating effectiveness was based on objective physiological data from Polysomnography (PSG).

• Specifics: The primary endpoint, "Clinical Success," was defined by an Apnea-Hypopnea Index (AHI) reduction of >50% (comparing treatment PSG to control PSG) and a treatment AHI of <20 events per hour. This is a widely accepted clinical metric for Obstructive Sleep Apnea (OSA) severity and treatment success.

8. The Sample Size for the Training Set

The document does not describe a "training set" in the context of an AI algorithm development. The Winx Sleep Therapy System is a physical device.

If we interpret "training set" broadly as the data used to initially develop or refine the device design before the pivotal clinical studies, that information is not provided. The provided text focuses on the clinical studies (Randomization and Extension) used for regulatory submission and demonstrating substantial equivalence.

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

As there is no mention of a "training set" for an AI algorithm, or detailed information about the early development data for the physical device, this information is not available in the provided text. The non-clinical performance data (design verification, electrical, biocompatibility, etc.) were conducted to evaluate the device against engineering specifications and regulatory standards, which serve as foundational "ground truths" for safe and effective device design.

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

The Attune Sleep Apnea System consists of three (3) main components: a small electronic bedside console, a soft polymer mouthpiece, and a flexible polymer tube that connects the mouthpiece to the console. A mouthpiece holder is provided for mouthpiece storage and use during weekly system cleaning.

The mouthpiece is an intraoral device that is worn during sleep. The system is designed to increase airway patency and decrease airway obstruction.

Console: The console generates a gentle negative pressure, collects excess saliva, records patient use time, and monitors pressure. The console is provided with a power cord, which connects to a standard electrical outlet. An optional laboratory console is available for use in a sleep laboratory. The laboratory console includes wires that extend from the console. The wires connect to the sleep laboratory's polysomnography (PSG) system, allowing the sleep technicians to view the console's pressure on the same monitor as the other PSG channels.

Mouthpiece: The mouthpiece is provided in ten (10) discrete sizes. Sleep technicians use a bite wax to obtain an impression of each patient's teeth and a sizing template to determine the best mouthpiece size.

Tubing: The tubing connects to the console by screwing into the console base and to the mouthpiece with luer connectors.

Use: The patient connects the system and places the mouthpiece in his or her mouth. The mouthpiece is worn during sleep. The console generates a gentle, negative pressure, which is delivered through the mouthpiece into the oral cavity and holds the tongue and soft palate out of the airway.

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

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly states "Clinical Success was prospectively defined as AHI reduction of > 50% and treated AHI < 20." The reported device performance for these criteria is intertwined within the "Clinical Success" rate.

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

• Sample Size for Test Set: 63 subjects in the Primary Endpoint Cohort.
• Data Provenance:
  • Country of Origin: Not explicitly stated, but the study was described as a "multi-center" trial, suggesting it likely took place across several locations, possibly within the United States given the FDA submission.
  • Retrospective or Prospective: Prospective. The study is described as "a four-week, multi-center, prospective, open label, randomized first-night order of control vs. treatment, single-arm trial."

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

This information is not provided in the document. The text does not detail how the AHI (Apnea-Hypopnea Index) measurements were established or adjudicated for the clinical trial, nor does it mention the involvement or qualifications of experts for this purpose.

4. Adjudication Method for the Test Set

This information is not provided in the document. The text does not describe any specific adjudication method (e.g., 2+1, 3+1) used for the clinical trial results.

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

This information is not applicable/not provided. The device described is the "Attune Sleep Apnea System," which is an intraoral device for treating sleep apnea, not an AI or imaging diagnostic tool that would typically involve human readers or MRMC studies.

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

This information is not applicable/not provided. The device is a physical intraoral system, not an algorithm. Therefore, a standalone algorithm performance study is not relevant.

7. The Type of Ground Truth Used

The ground truth used for assessing the device's effectiveness was based on physiological measurements of sleep apnea, specifically:

• AHI reduction of > 50%
• Treated AHI < 20

These measurements are standard metrics derived from polysomnography (PSG) studies, which are considered the gold standard for diagnosing and assessing the severity of sleep apnea. The document mentions "polysomnography (PSG) system" in relation to the laboratory console, implying PSG was the method for collecting relevant data.

8. The Sample Size for the Training Set

This information is not explicitly provided as this type of device (physical medical device) typically undergoes traditional clinical trials, not machine learning model training. The concept of a "training set" in the context of AI/ML is not directly relevant here. However, the document does mention "two feasibility studies" that preceded the pivotal trial.

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

As with point 8, the concept of a "training set" and its ground truth establishment in an AI/ML context is not directly applicable. For the clinical trials, the "ground truth" (i.e., the actual AHI values) would have been established through standard clinical diagnostic procedures, likely polysomnography, as accepted in sleep medicine.

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