(87 days)
The myTAP2 is intended for use on adult patients 18 years of age or older as an aid for the reduction of snoring.
The myTAP2 is an oral appliance design concept based upon the use of a standard set of upper and lower travs filled with an impression material. A screw is used to advance the lower tray. The myTAP2 is of a design often referred to as a "Boil and Bite" and the concept of advancement is commonly referred to as a Mandibular Repositioning Device (MRD).
Based on the provided text, the device in question is the myTAP2, an intraoral device intended for the reduction of snoring. The document is a 510(k) summary for its premarket notification to the FDA.
Here's the breakdown of the acceptance criteria and the study that proves the device meets them:
No specific acceptance criteria table or quantitative performance data is provided in this 510(k) summary. The document focuses on demonstrating substantial equivalence to a predicate device (SnoreRx - K170825) rather than presenting a detailed clinical study with pre-defined acceptance metrics for efficacy (e.g., percentage reduction in AHI, or snore count).
The "study" in this context is the non-clinical performance testing and biocompatibility testing conducted to show the myTAP2 is as safe and effective as its predicate.
Non-Clinical Performance Testing and Biocompatibility (The "Study")
The provided text describes the non-clinical and biocompatibility tests conducted to support the substantial equivalence of the myTAP2 to the predicate device, SnoreRx (K170825). It does not describe a clinical study of human performance or a multi-reader multi-case (MRMC) study.
1. Table of Acceptance Criteria and Reported Device Performance
Note: The document does not provide a quantitative table of acceptance criteria or performance results like sensitivity, specificity, or AUC for snoring reduction. The "acceptance" here is demonstrated by meeting the safety and basic functional requirements through non-clinical testing and by being substantially equivalent to a legally marketed predicate.
The table below summarizes the types of testing performed and the general conclusion regarding their success in supporting substantial equivalence.
| Acceptance Criteria (Category) | Reported Device Performance (MyTAP2) |
|---|---|
| Functional / Durability | Functional testing for durability after multiple cleanings equivalent to 365 days use. |
| Mechanical Properties | Flexural strength testing performed. Mechanical / Tensile testing performed. Drop test performed. |
| Biocompatibility (ISO 10993-1) | All materials considered: Surface Contacting, Mucosal membrane, with duration of use prolonged > 24 hours ≤ 30 days. |
| Tests performed: |
- Cytotoxicity
- Sensitization
- Irritation
- Acute Systemic Toxicity
Conclusion: Tests appear to have been passed, as the claim of substantial equivalence is made with these tests as supporting evidence, indicating the device materials are safe for their intended use and contact duration. Specific numerical results are not provided. |
| Operational Principle | Uses a screw adjustment mechanism to advance the lower jaw, similar to the predicate's principle of mandibular repositioning.
Conclusion: The document asserts, "The difference in advancement means does not raise different concerns of safety or effectiveness from the predicate." |
| Indications for Use | Intended for use on adult patients 18 years of age or older as an aid for the reduction of snoring.
Conclusion: "Similar to predicate - SnoreRx - K170825 - indicated as an aid for the reduction of snoring." |
| Patient Population | Adult patients 18 years and older.
Conclusion: "Similar to predicate - SnoreRx - K170825 - 18 years and older." |
| Contraindications/Warnings | Contraindications and warnings are similar to the predicate device.
Conclusion: "The contraindications are similar for both devices." Changes were made to labeling deemed "applicable and appropriate." |
| OTC Designation | Over-The-Counter (OTC) designation.
Conclusion: "Both are OTC designation and thus similar" to the predicate, which was also cleared for OTC. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable in the context of a clinical test set for AI performance. The studies performed were non-clinical (durability, mechanical, biocompatibility). For these tests, sample sizes would refer to the number of devices or material samples tested, but these specific numbers are not provided in the summary.
- Data Provenance: Not applicable for non-clinical testing. The tests would have been performed in a lab setting, likely by the manufacturer or a contracted testing facility.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable. This is a medical device for snoring, and the submission is based on substantial equivalence demonstrated through non-clinical performance and biocompatibility testing, not on a clinical AI performance study requiring expert ground truth for image interpretation or diagnosis.
4. Adjudication Method for the Test Set
- Not applicable. No expert adjudication process is described as part of non-clinical testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No, an MRMC comparative effectiveness study was not done. The submission focuses on substantial equivalence based on non-clinical performance and similarity in design and indications to a predicate device. This type of study would typically be conducted for diagnostic AI devices, not for a physical intraoral device for snoring.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical intraoral appliance, not an algorithm or AI system.
7. The Type of Ground Truth Used
- For Non-Clinical Testing: The "ground truth" for the non-clinical tests (durability, strength, biocompatibility) is established by adherence to industry standards (e.g., ISO 10993-1 for biocompatibility) and engineering specifications. The "truth" is whether the device materials and construction meet the predefined physical, chemical, and biological safety parameters.
- For Efficacy (Snoring Reduction): The document does not present a clinical study for efficacy with ground truth data (e.g., from polysomnography or snore monitors). The efficacy claim is based on the substantial equivalence to the predicate device, which itself is cleared as "an aid for the reduction of snoring," implying a known mechanism of action.
8. The Sample Size for the Training Set
- Not applicable. This is not an AI/machine learning device.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. This is not an AI/machine learning device.
§ 872.5570 Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea.
(a)
Identification. Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea are devices that are worn during sleep to reduce the incidence of snoring and to treat obstructive sleep apnea. The devices are designed to increase the patency of the airway and to decrease air turbulence and airway obstruction. The classification includes palatal lifting devices, tongue retaining devices, and mandibular repositioning devices.(b)
Classification. Class II (special controls). The special control for these devices is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea; Guidance for Industry and FDA.”