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The Panthera Anti-Snoring Device is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA) in adults.

The Panthera Anti-Snoring Device is a removable intraoral device used for treating snoring and mild to moderate obstructive sleep apnea. It consists of two custom fabricated splints that fit separately over the upper and lower teeth and engage by means of adjustable rods.

The device functions as a mandibular repositioner, maintaining the lower jaw in a forward position during sleep. This mechanical protrusion acts to increase the patient's pharyngeal space, improving their ability to exchange air during sleep.

The device is a prescription customized for each patient and has an adjustment mechanism enabling the amount of mandibular advancement to be set by the dentist or physician at the time of fitting the device. The device can be adjusted only by the dentist. The maximum protrusion of the device is 15 mm in 1 mm increments.

This document is a 510(k) premarket notification for "The Panthera Anti-Snoring Device." It is a submission to the FDA seeking to demonstrate substantial equivalence to a predicate device, the Narval CC.

Based on the provided text, the device itself is a physical medical device, not an AI/ML algorithm. Therefore, many of the requested fields related to AI/ML studies (like training/test sets, ground truth methodology, expert adjudication, MRMC studies) are not applicable.

Here's the information extracted and formatted as requested, with explanations for non-applicable fields:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a physical medical device seeking substantial equivalence, the "acceptance criteria" are generally based on physical and material properties, and the "reported device performance" is a comparison to the predicate. The document doesn't explicitly state numerical acceptance criteria in the way one would for an AI algorithm's performance metrics. Instead, it focuses on demonstrating equivalence in design, materials, and intended use.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This device is not an AI/ML algorithm, and no clinical "test set" in the context of algorithm evaluation was used. The submission states, "Panthera dental performed no clinical testing." The demonstration of safety and effectiveness relies on non-clinical testing (physical properties, biocompatibility) and comparison to a legally marketed predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No ground truth establishment by experts for a test set was performed as part of this 510(k) submission for a physical device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No test set requiring expert adjudication was used.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI/ML device and no MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. "Ground truth" in the context of AI/ML evaluation is not relevant for this physical device submission. The safety and effectiveness are established through material characterization, design specifications, and comparison to the predicate device's established performance.

8. The sample size for the training set

Not applicable. This is not an AI/ML algorithm.

9. How the ground truth for the training set was established

Not applicable. This is not an AI/ML algorithm.

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