(75 days)
The TAP is intended to reduce or alleviate night time snoring
Target population - - Patients who have a problem with snoring.
Environment of Use - - Home and sleep laboratories
The TAP anti-snoring device is comprised of -
- Lower tray fitted over the lower teeth.
- Upper tray fitted over the upper teeth.
- Impression material
- Hook mechanism to attach lower tray to upper tray
The provided document, K962516, is a Non-Confidential Summary of Safety and Effectiveness for the TAP oral appliance, an anti-snoring device. This document is a 510(k) premarket notification summary and primarily focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study with detailed acceptance criteria and results.
Therefore, the input does not contain the information requested to fully answer your prompt, specifically regarding:
- Acceptance criteria and reported device performance: No specific quantitative acceptance criteria or performance metrics (e.g., reduction in snoring events, decibel reduction) are provided.
- Study details: There is no description of a clinical study or device performance study with sample sizes, data provenance, ground truth establishment, expert qualifications, or adjudication methods. The document explicitly states under "Performance Testing": "None applicable."
- MRMC comparative effectiveness study: No such study is mentioned.
- Standalone performance study: No such study is mentioned.
- Training set details: No training set or ground truth for a training set is mentioned as there is no algorithm described.
Summary based on the provided text:
| Information Requested | Details from Document |
|---|---|
| 1. Table of acceptance criteria and reported device performance | No specific acceptance criteria or quantitative device performance metrics are reported. |
The document demonstrates substantial equivalence to predicate devices. The "Performance Testing" section explicitly states "None applicable." The main performance attributes implicitly assessed by comparison to predicates are:
- Intended to reduce snoring (Yes, same as predicates)
- Works by holding lower jaw forward (Yes, same as predicates)
The "Differences Between Other Legally Marketed Predicate Devices" section states that the differences in design (two-piece construction allowing talking, drinking, and mouth breathing) "do not have a significant effect on the safety or effectiveness of the device." This implies that the device is expected to perform at least comparably to the predicates in reducing snoring, but no specific performance data is provided to qualify this. |
| 2. Sample size used for the test set and data provenance | Not applicable. The document explicitly states "Performance Testing: None applicable." No clinical test set data from prospective or retrospective studies, nor country of origin, is provided. |
| 3. Number of experts used to establish ground truth for test set and qualifications | Not applicable. No test set or ground truth establishment relevant to device performance is described. |
| 4. Adjudication method for the test set | Not applicable. No test set requiring ground truth adjudication is described. |
| 5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done, effect size of human readers improve with AI vs without AI assistance | Not applicable. No MRMC study is mentioned. The device is a physical anti-snoring appliance, not an AI or imaging diagnostic tool, so a MRMC study involving human readers and AI assistance would not be relevant. |
| 6. If a standalone (algorithm only without human-in-the-loop performance) was done | Not applicable. The device is a physical anti-snoring appliance. It is not an algorithm, and therefore, a standalone algorithm performance study is not relevant. |
| 7. The type of ground truth used | Not applicable. No clinical ground truth (e.g., from pathology, outcomes data, expert consensus on snoring reduction results) is presented in this 510(k) summary. The document relies on comparison to predicate devices, assuming their known safety and effectiveness. |
| 8. The sample size for the training set | Not applicable. As this is a physical medical device and not an AI/ML algorithm requiring training, there is no mention of a training set. |
| 9. How the ground truth for the training set was established | Not applicable. There is no training set described. |
§ 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.”