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The Panthera Anti-Snoring X3 Device is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA) in adults.

The Panthera Anti-Snoring X3 Device is a removable intraoral device used for treating snoring and mild to moderate obstructive sleep apnea. It consists of two customized splints that fit separately over the upper and lower teeth.

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 pharvngeal 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 maximum protrusion of the device is 5 mm in 1 mm increments.

This document is a 510(k) premarket notification for the Panthera Anti-Snoring X3 Device, seeking substantial equivalence to previously marketed devices. The document explicitly states that no human clinical study was deemed necessary to support substantial equivalence (page 12), and therefore, a study proving the device meets acceptance criteria based on human clinical data is not provided in this submission.

The acceptance criteria and device performance are instead established through non-clinical testing, primarily by demonstrating equivalence to a primary predicate device (The Panthera Anti-Snoring Device, K143244) and several reference predicate devices.

Here's a breakdown based on the provided text, addressing your points where possible, and indicating where information is not available due to the nature of this 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance

Since no clinical study was performed, the "reported device performance" against clinical acceptance criteria is not applicable. Instead, the non-clinical testing focused on establishing substantial equivalence based on material properties, design, and mechanical strength.

2. Sample size used for the test set and the data provenance

• Sample size: Not applicable for a clinical test set as no clinical study was performed. For non-clinical testing, specific sample sizes for material and fatigue tests are not provided in this summary but would have been part of the underlying test reports.
• Data provenance: Not applicable in terms of country of origin or retrospective/prospective for a clinical study. The non-clinical testing was conducted by Panthera Dental Inc.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. As no human clinical study was performed, there was no ground truth established by experts for a test set in this 510(k) submission.

4. Adjudication method for the test set

Not applicable. No human clinical study was performed with a test set requiring adjudication.

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 device is a physical intraoral device, not an AI or imaging diagnostic tool, and no MRMC study was performed.

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

For the non-clinical tests, the "ground truth" was established by industry standards (e.g., ASTM D638, NISTIR 8059) and regulatory biocompatibility standards (e.g., ISO 14971, ISO 10993). Equivalence to predicate devices with established safety and effectiveness also serves as a form of "ground truth" for substantial equivalence.

8. The sample size for the training set

Not applicable. No machine learning algorithm or training set was involved.

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

Not applicable. No machine learning algorithm or training set was involved.

Summary of the Study (Non-Clinical Evidence for Substantial Equivalence):

The Panthera Anti-Snoring X3 Device's substantial equivalence was established through non-clinical testing and comparison to legally marketed predicate devices rather than a human clinical study.

• Non-Clinical Testing:

  • Material Equivalence: The device uses the same raw material (polyamide type 12), supplied by EOS, and the same proprietary manufacturing process (Selective Laser Sintering) as its primary predicate, The Panthera Anti-Snoring Device (K143244). This allowed for leveraging performance testing (orthosis polishing, static and dynamic compression resistance) from the predicate's submission.
  • Mechanical Testing: A specific test was conducted to determine build locations for 3-D printing in accordance with FDA guidance and standards (ASTM D638, NISTIR 8059).
  • Fatigue Testing: Because the mechanism for mandibular protrusion differed from the primary predicate (stop-clip system assembly vs. interlocking rods), dedicated fatigue testing was performed on the stop-clip system assembly. The results demonstrated sufficient mechanical strength for its intended clinical application.
  • Biocompatibility: Assessed and confirmed to be biocompatible based on the use of identical materials, supplier, and manufacturing process as the primary predicate device, following ISO standards (14971, 10993-1, 10993-5, 10993-10).

• Rationale for No Clinical Study: The FDA submission states that a human clinical study was "not deemed necessary" because the Panthera AS X3:

  • Does not use a design dissimilar from the reference predicate devices.
  • Does not use new technologies different from the primary and reference predicate devices.
  • Does not deviate from the indications for use identified in the primary and reference predicate devices.

In essence, the "study" proving the device meets its "acceptance criteria" here is a comprehensive non-clinical assessment demonstrating that the device is materially, technologically, and functionally equivalent or superior in specific mechanical aspects to its established predicate devices, which already have demonstrated safety and effectiveness through their own market history or prior submissions.

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