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510(k) Data Aggregation
(79 days)
The TOA is intended to reduce or alleviate night time snoring and obstructive sleep apnea, OSA.
The TOA 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
Here's an analysis of the provided text regarding the TOA Anti-snoring device, focusing on acceptance criteria and supporting studies, formatted as requested:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria in the typical sense of numerical thresholds that the new device must meet to demonstrate safety and effectiveness. Instead, it relies on substantial equivalence to predicate devices. The "Performance Testing" section in the comparison table is the closest equivalent to reporting on device performance relative to a defined metric.
| Metric/Attribute | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (TOA) |
|---|---|---|
| Reduction in Apnea-Hypopnea Index (AHI) in patients | 72% (based on NPB TAP predicate) | 72% |
| AHI performance comparable to CPAP | Yes (based on NPB TAP predicate) | Yes |
| Intended as intraoral device | Yes | Yes |
| Intended to reduce/alleviate snoring | Yes | Yes |
| Indicated for mild to moderate OSA | Yes | Yes |
| Indicated for single patient multi-use | Yes | Yes |
| Indicated for home/sleep labs | Yes | Yes |
| Rigid tray pieces | Yes | Yes |
| Heat sensitive impermissible material | Yes | Yes |
| Separate tray pieces | Yes | Yes |
| Custom fit | Yes | Yes |
| Works by holding lower jaw forward | Yes | Yes |
| Can be adjusted or refit | Yes | Yes |
| Placed in mouth each evening | Yes | Yes |
| Cleaned daily | Yes | Yes |
| Permits lateral/vertical jaw movement | Yes (TOA, NPB TAP) | Yes |
| Upper/lower tray unhook for easy removal | Yes (TOA, NPB TAP) | Yes |
| Permits talking and drinking | Yes (TOA, NPB TAP) | Yes |
| Permits breathing through mouth | Yes (TOA, NPB TAP) | Yes |
| Rigid tray material | Yes | Yes |
| Heat-sensitive impression material | Yes | Yes |
| None applicable under Section 514 (Performance Testing) | Yes | Yes |
2. Sample Size for Test Set and Data Provenance
The provided summary does not contain information about a specific test set or clinical study conducted for the TOA device itself to establish the 72% AHI reduction. The 72% figure appears to be directly copied from the performance claimed by the predicate device, NPB TAP (K962516), implying that if the TOA device is "substantially equivalent" in design and intended use, its performance would also be substantially equivalent.
Therefore, there is no direct information on:
- Sample size used for a test set.
- Data provenance (country of origin, retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Since no specific study for the TOA device is described, there's no information on experts used to establish ground truth or their qualifications. The performance metric of "reduced AHI" is a quantifiable physiological measurement typically derived from polysomnography studies, not expert consensus in the way a diagnostic image might be.
4. Adjudication Method for the Test Set
Not applicable, as no specific test set or study for the TOA device is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done or described in this submission. The device is not a diagnostic tool where "human readers" would be involved in interpreting outputs. It's a therapeutic device for a physiological condition.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable to an anti-snoring oral appliance. The device itself is the intervention, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the reported performance (72% AHI reduction) would be physiological measurements from polysomnography (PSG) studies that quantify snoring events and apneas/hypopneas. However, this "ground truth" data is attributed to the predicate device (NPB TAP), not presented as directly generated by a study on the TOA device.
8. Sample Size for the Training Set
Not applicable. The TOA is a physical medical device, not an AI/algorithm-based system that requires a "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this type of device.
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