(92 days)
To reduce or alleviate night time snoring and mild to moderate obstructive sleep apnea (OSA).
The TAP II Anti-Snoring device is comprised of:
- & Lower tray fitted over the lower teeth.
- Upper tray fitted over the upper teeth.
- Impression material
- Hook and Base mechanism to attach lower tray to upper tray.
The provided text does not contain detailed information about specific acceptance criteria for device performance, nor does it describe a study that explicitly proves the device meets such criteria using metrics like sensitivity, specificity, or accuracy. The document is a 510(k) premarket notification summary and an FDA clearance letter, which focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific performance thresholds in a clinical study.
Therefore, many of the requested details related to acceptance criteria, specific study design, sample sizes, expert involvement, and ground truth establishment are not present in the provided text.
However, based on the available information, here's what can be inferred or directly stated:
1. Table of acceptance criteria and the reported device performance:
This information is not provided in the document. The document's purpose is to establish substantial equivalence to predicate devices, not to report on specific performance metrics against defined acceptance criteria.
2. Sample size used for the test set and the data provenance:
This information is not provided in the document. The text does not describe a clinical study with a test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document.
4. Adjudication method for the test set:
This information is not provided in the document.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:
This information is not provided in the document. The device, TAP II, is an oral appliance (anti-snoring device), not an AI-assisted diagnostic tool for which an MRMC study would typically be conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable/not provided in the context of an oral appliance. The TAP II is a physical medical device, not an algorithm.
7. The type of ground truth used:
This information is not provided in the document as no specific clinical study with ground truth establishment is detailed. The basis for substantial equivalence is comparison to legally marketed predicate devices.
8. The sample size for the training set:
This information is not provided in the document. The text does not detail the development of an algorithm that would typically involve a training set.
9. How the ground truth for the training set was established:
This information is not provided in the document.
Summary based on the provided text:
The provided documents, a Non-Confidential Summary of Safety and Effectiveness and an FDA clearance letter for the TAP II oral appliance, primarily focus on demonstrating substantial equivalence to predicate devices. This process does not typically involve the detailed performance studies, acceptance criteria, test sets, or expert ground truth adjudication that would be requested in the prompt. The clearance is based on the device having the same intended use, similar technological characteristics, and being as safe and effective as devices already on the market (listed as Nellcor Puritan Bennett - TAP-K962516, Thornton Oral Appliance - TOA-K972061, OASYS Oral Airway System - K030440).
§ 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.”