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The intended use for the Nasal Mask Oral Appliance Holder is that is may be used with or without the complete Oral Appliance approved for Snoring and OSA to serve as an accessory to hold a Nasal Mask on a patient's face. The designed attachment can be fitted to hold the nasal mask in place via an oral appliance secured by the upper teeth of the patient. The accessory will have the same indications for use as those of the equipment to which it is an accessory.

1. The Universal Nasal Mask Oral Appliance Holder includes the Extension Bracket with Mask Flange which attaches to the upper tray of the Oral Appliance, approved under K972061. This device would be considered an accessory to the Nasal Mask and is designed to hold the Nasal Mask in place. It is an alternative to the use of standard headgear. It is adaptable to several different nasal masks styles.
2. In combination with the already approved, K972061, Oral Appliance which has both an upper and lower tray. The upper tray has a fitting which permits the attachment of the Extension Bracket with Mask Flange. This combined device permits therapy for OSA and snoring by an oral device and a positive airway pressure delivery device.

The provided text describes a 510(k) premarket notification for a medical device, which focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific performance acceptance criteria through a clinical study with statistical endpoints. Therefore, many of the requested elements (sample size, expert qualifications, adjudication, MRMC studies, standalone performance, training set details) are not typically included in this type of submission and are not present in the provided document.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not outline specific numerical acceptance criteria or present quantitative performance data. Instead, it relies on a comparison of attributes and the assertion that "There is no significant difference" in performance relevant to safety and effectiveness compared to predicate devices. The "Performance Testing" section explicitly states "None applicable under Section 514" and "Equivalent leak rates," indicating that specific performance tests for this type of accessory device were not considered necessary beyond demonstrating functional equivalence.

2. Sample Size and Data Provenance for Test Set

Not applicable. The document does not describe a clinical test set with a specific sample size. The demonstration of equivalence is based on a comparison of design attributes and intended uses with predicate devices.

3. Number and Qualifications of Experts for Ground Truth

Not applicable. No ground truth establishment by experts is described, as this is a regulatory submission for device equivalence, not a performance study requiring ground truth.

4. Adjudication Method

Not applicable. There is no mention of adjudication, as this is not a study involving expert review or conflict resolution.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. No MRMC study was conducted or referenced. This type of study is more common for diagnostic or AI-driven devices where human interpreter performance is being evaluated.

6. Standalone Performance Study

Not applicable. No standalone performance study (algorithm only, without human-in-the-loop performance) was conducted or described. The device is a physical accessory, not an algorithm.

7. Type of Ground Truth Used

Not applicable. The submission relies on establishing substantial equivalence to existing, legally marketed predicate devices rather than validating performance against an independent "ground truth." The implicit "ground truth" is the established safety and effectiveness of the predicate devices.

8. Sample Size for the Training Set

Not applicable. This is a submission for a physical medical device accessory, not an AI or algorithm-driven device that typically 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 device.

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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.

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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