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510(k) Data Aggregation
(347 days)
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):
| Performance Metric | Acceptance Criteria (for Winx+ to be non-inferior to Winx) | Reported Device Performance (Winx+ Mouthpiece) |
|---|---|---|
| Effectiveness (Primary Endpoint): | ||
| Clinical Success Rate (First Night) | Non-inferiority to Winx mouthpiece, defined as AHI reduction of >50% compared to control PSG AND treatment AHI < 20 events per hour, with a delta (margin) set at -0.20 (i.e., Winx+ success rate should not be more than 20% lower than Winx, with statistical significance) | 63.3% (19 of 30 subjects met clinical success criteria) against Winx's 40.0%. P<0.0001 for non-inferiority vs. Winx (with delta = -0.20). |
| Clinical Success Rate (Last Treatment Night - Long-term) | Non-inferiority to a proportion of 40% (likely the predicate's established performance based on previous studies), with a delta (margin) of -0.20. (This implies that for extended use, the Winx+ should maintain a success rate not more than 20% lower than the predicate's established long-term performance). | 78.3% (18 of 23 subjects met clinical success criteria). P<0.001 for non-inferiority against a proportion of 40% (with delta = -0.20). |
| Safety: | No new safety issues identified. No serious or severe adverse events (AEs) related to the device. Minimal, self-resolving adverse events with no need for medical intervention or prescription medication. | No serious or severe AEs reported. 75% of AEs were mild, 25% moderate. All AEs resolved without medical intervention or prescription medication. Mean duration of AEs: 8.4 ± 9.3 days. |
Non-Clinical Performance Criteria (for Winx Sleep Therapy System using Winx+ Mouthpiece):
| Test | Acceptance Criteria | Reported Performance |
|---|---|---|
| Design Verification | Meet engineering specifications (performance, strength, reliability, life, component compatibility) | Pass |
| Electrical Safety | Pass IEC 60601-1 and 60601-1-2 | Pass |
| Biocompatibility | Pass ISO 10993-1 (cytotoxicity, sensitization, oral irritation) | Pass |
| Environmental | Pass environmental testing | Pass |
| Shipping | Pass D4169-09 | Pass |
| Acoustics | Pass ISO 7779 | Pass |
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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