(80 days)
The TAP is intended to reduce or alleviate night time snoring and mild to moderate obstructive sleep apnea, OSA.
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 text describes a medical device called "TAP" (an oral appliance) for reducing snoring and mild to moderate obstructive sleep apnea (OSA). However, the document is a 510(k) premarket notification summary from 1996, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a rigorous study proving device performance against those criteria in the modern sense of AI/medical imaging devices.
Here's a breakdown of what can be extracted and what information is missing based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The concept of explicit "acceptance criteria" for performance metrics like sensitivity, specificity, accuracy, or a specific range of improvement (e.g., AHI reduction by X%) is not clearly defined in this 510(k) summary as it would be for a modern AI device. Instead, the performance is compared qualitatively or with a single percentage to predicate devices.
| Metric | Acceptance Criteria (Implicit/Inferred) | Reported Device Performance (TAP) |
|---|---|---|
| Reduce/Alleviate Snoring | Yes (similar to predicates) | Yes |
| Indicated for mild to moderate OSA | Yes (similar to predicates) | Yes |
| AHI Reduction | Comparable to CPAP (predicate claim) | 72% reduced AHI in patients |
| Allows Jaw Movement (lateral/vertical) | Yes (a distinguishing feature) | Yes |
| Allows Unhooking for easy removal | Yes (a distinguishing feature) | Yes |
| Permits talking/drinking with appliance in place | Yes (a distinguishing feature) | Yes |
| Permits breathing through mouth | Yes (a distinguishing feature) | Yes |
Note: The "acceptance criteria" are inferred from the attributes compared against predicate devices. The document does not state quantitative thresholds that the TAP device needed to meet directly.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. The text mentions "72% reduced AHI in patients" but does not specify the number of patients, how they were selected, or where the data came from.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided. The assessment of AHI reduction or other clinical outcomes would typically involve medical professionals, but their number and qualifications are not detailed.
4. Adjudication Method for the Test Set
This information is not provided.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, and its effect size
This information is not provided. MRMC studies are typically associated with imaging diagnostics or AI-assisted diagnostic tools, which is not the nature of this physical oral appliance. The document focuses on the device's physical and functional attributes compared to predicate devices.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable as the TAP device is a physical oral appliance, not an algorithm or AI system. Human intervention (e.g., fitting by a dentist) is inherent to its use.
7. The type of ground truth used
Based on the mention of "reduced AHI in patients," the ground truth would likely be polysomnography (PSG) results or other objective measures of sleep apnea severity, which are considered clinical outcomes/pathology in this context. The reduction in AHI is a direct clinical measure related to the device's effectiveness.
8. The sample size for the training set
This information is not provided. The concept of a "training set" in the context of device development (especially for mechanical devices like this pre-AI era) is not directly applicable in the same way it is for AI algorithms. Development would involve engineering, material testing, and potentially small-scale clinical trials rather than data-driven machine learning training.
9. How the ground truth for the training set was established
This information is not provided and is largely not applicable for this type of device and submission. If any early clinical data informed design, it would likely have involved similar clinical outcome measures (e.g., AHI reduction from PSG), but the process is not detailed as "ground truth establishment for training."
§ 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.”