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The Twilite Appliance ® is intended to reduce night time snoring and mild to moderate obstructive sleep apnea (OSA) in adults 18 years and older.

The Twilite Appliance ® is a customized oral device intended to mitigate night-time snoring and mild to moderate obstructive sleep apnea. The Twilite Appliance ® is to continuously hold the mandible in an advanced position to prevent the tongue from compressing against the oropharyngeal wall keeping the airway open during sleep.

The provided text describes the "Twilite Appliance®," an intraoral device for snoring and obstructive sleep apnea. However, it does not contain a study proving the device meets specific acceptance criteria in the manner of a clinical trial with reported performance metrics.

Instead, the document details a 510(k) Premarket Notification, which is a submission to the FDA demonstrating that the device is substantially equivalent to a legally marketed predicate device. This process primarily relies on comparing the new device's characteristics and performance to those of an already cleared device, rather than conducting new, extensive clinical studies with specific acceptance criteria that the device must "meet."

Therefore, the requested information elements related to a study proving the device meets acceptance criteria cannot be fully extracted from this document, as such a study (in the sense of a clinical trial with performance targets) was not conducted for substantial equivalence.

Here's an attempt to address your requests based on the provided text, highlighting where the information is absent due to the nature of a 510(k) submission:

1. A table of acceptance criteria and the reported device performance

This information is not present in the document in the format of specific, quantifiable acceptance criteria (e.g., "reduce AHI by X%") and corresponding measured device performance from a clinical trial. The document focuses on demonstrating substantial equivalence to a predicate device based on shared attributes, rather than proving a pre-defined performance against acceptance criteria. The performance testing mentioned is non-clinical (bench testing for material properties).

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

• Sample Size for Test Set: Not applicable. No clinical "test set" in the context of a performance study is described. The submission relies on comparison to a predicate and non-clinical bench testing.
• Data Provenance: Not applicable for a clinical test set. The non-clinical data (material testing) would be from laboratory settings, but geographic origin is not specified.
• Retrospective/Prospective: Not applicable, as no clinical study is described.

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 clinical performance study requiring expert adjudication of a test set is described.

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

Not applicable. No clinical performance study requiring adjudication is described.

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 an oral appliance, not an AI-powered diagnostic tool, and therefore MRMC studies are irrelevant to its evaluation.

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

Not applicable. This device is an oral appliance, not an algorithm.

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

Not applicable. No clinical study with ground truth establishment is described. The "truth" for this submission is substantial equivalence to a legally marketed device.

8. The sample size for the training set

Not applicable. This device does not involve a "training set" in the context of machine learning or complex algorithm development.

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

Not applicable.

Summary of the Device's Evaluation (based on the provided text):

The Twilite Appliance® demonstrated substantial equivalence to the predicate device, Prosomnus [CA] Sleep and Snore Device (K172859), based on the following:

• Identical Indications for Use: Both are intended to reduce nighttime snoring and mild to moderate obstructive sleep apnea (OSA) in adults.
• Similar Technology/Principle of Operation: Both use separate customized trays with a means to advance the mandible/lower jaw.
• Same Environment of Use: Home, Dental and Physician offices, Sleep laboratories.
• Identical Patient Population: Adults 18 years and older.
• Identical Contraindications: Listed contraindications are the same.
• Similar Design and Features: Customized trays, allows lateral and vertical movement, user can breathe through the mouth, works by holding the lower jaw forward, cleaned by rinsing, "single patient, multi-use."
• Similar Materials: The subject device uses materials identical to those cleared under K153490 (Dental Direkt DD BioSplint P) for dental trays and bite splints, and these materials meet dental standards.
• Non-Clinical Performance Testing: Bench testing was performed after manufacture and aging for:
  • Flexural strength / Fracture Toughness
  • Water absorption / solubility (implied, by referencing K153490 which tested these properties for identical materials)
  • Mechanical / Tensile testing (implied, by referencing K153490 which tested these properties for identical materials)
  • Biocompatibility: Materials in contact with the patient are cleared for dental tray use and are identical to those in K153490.

The submission argues that no clinical testing was required because the Twilite Appliance® is identical in principle of operation, technology, and key performance specifications (like maximum advancement distance) to the predicate device. The differences in indications for use for the material reference (K153490) were deemed not to raise new safety or effectiveness concerns not addressed by the predicate.

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