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The DenTek™ Fresh Protect™ Dental Guard is indicated for protection against bruxism or nighttime teeth grinding. It is intended to reduce damage to the teeth and reduce the noise associated with bruxing or grinding.

The DenTek™ Fresh Protect™ Dental Guard is an over-the-counter (OTC) device to be used by lay people for protection against the effects of nighttime teeth grinding. The guard is constructed of an ethylene/vinyl acetate copolymer and utilizes a ready-to-wear, one-size-fits-all design. The fully occlusive guard is worn on the lower teeth, maintaining separation between the upper and lower teeth, thereby preventing the noise and damage associated with teeth grinding.

This document is a 510(k) Premarket Notification from the FDA for a dental guard, not a study evaluating an AI/ML device. Therefore, the requested information regarding acceptance criteria, study details, expert involvement, and ground truth for an AI/ML device is not present.

The document discusses the substantial equivalence of the DenTek™ Fresh Protect™ Dental Guard to a predicate device based on non-clinical performance data and biocompatibility tests.

Here is a summary of the non-clinical performance data presented for the DenTek™ Fresh Protect™ Dental Guard:

Acceptance Criteria and Device Performance (Non-Clinical)

Regarding the other requested points (sample size, data provenance, experts, adjudication, MRMC, standalone, ground truth type, training set size, training set GT):

• Sample sized used for the test set and the data provenance: Not explicitly stated as this is a non-clinical bench testing and biocompatibility assessment, not a clinical study with a patient test set. The tests involved "finished guards" or specific materials.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The ground truth for bench tests would be the measured physical properties or biochemical reactions. For biocompatibility, established ISO standards define the endpoints.
• Adjudication method for the test set: Not applicable for non-clinical bench testing.
• 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 document is not about an AI/ML device.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This document is not about an AI/ML device.
• The type of ground truth used: For the non-clinical tests, the ground truth is derived from the established physical and chemical measurements as per the referenced ISO standards and simulation studies.
• The sample size for the training set: Not applicable. This is not an AI/ML device with a training set.
• How the ground truth for the training set was established: Not applicable.

In conclusion, the provided document is a 510(k) premarket notification for a physical medical device (dental guard) and thus does not contain the information relevant to an AI/ML device's acceptance criteria, study design, or ground truth establishment.

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The Oral B plus Scope Outlast Nighttime Dental Guard is an Over-the-Counter dental guard indicated for the protection against bruxism - the nighttime clenching and grinding of the teeth.

It is intended for use in the mouth at night to reduce damage to the teeth and to prevent the noise associated teeth grinding.

a mouthguard constructed of a propylene-based elastomer. The target area is the oral cavity of individuals that suffer from bruxism, nighttime teeth grinding.

The device works by molding the thermoplastic resin to the individual's mouth. The thermoplastic resin can be molded after submerged in boiling water via the microwave. The molded thermoplastic resin is worn at to reduce damage to the teeth and to prevent the noise associated teeth grinding.

OraLabs Oral-B plus Scope Outlast Nighttime Dental Guard is intended for individuals age 18 and older. Thermoplastic can be molded to fit all sizes.

This 510(k) submission (K113326) for the Oral-B plus Scope Outlast Nighttime Dental Guard focuses on biocompatibility testing as its primary performance data because it is a medical device, and the device is claiming substantial equivalence to a predicate device (Dentek's Custom Comfort Dental Guard, K083400) which would have already established its functional efficacy for bruxism. Therefore, the acceptance criteria and study described here are centered on ensuring the safety of the new device for human contact, particularly due to the addition of flavor.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

The study primarily involved biocompatibility testing on biological models, not a human clinical test set in the traditional sense for efficacy.

• MEM Elution (Cytotoxicity): L-929 Mouse Fibroblast Cells
• Guinea Pig Maximization Sensitization Test: Not explicitly stated, but typically involves a number of guinea pigs (e.g., 10-20 per group).
• Intracutaneous Irritation Test: 3 Rabbits
• Acute Systemic Injection Test: Not explicitly stated, but typically involves a number of animals (e.g., mice).
• SubChronic (14-day) Intravenous Toxicity Study: Non-Swiss Webster Mice (number not specified, but usually involves multiple groups with a control).

Data Provenance: The studies are laboratory-based biocompatibility tests, not tied to a specific country of origin for human data or retrospective/prospective human studies.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

Not applicable in the context of this biocompatibility study. The "ground truth" for these tests is established by recognized international standards (ISO 10993 series) and laboratory best practices, not expert consensus on human cases.

4. Adjudication Method for the Test Set:

Not applicable. Biocompatibility tests have specific endpoints and interpretations as outlined in the ISO standards. The results are typically quantitative or qualitative (pass/fail) based on established thresholds, not subject to expert adjudication of individual cases.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data. This submission is for a physical medical device (dental guard) where the primary concern is safety and functional equivalence, not diagnostic accuracy requiring human reader interpretation.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance):

Not applicable. This device is a physical dental guard, not an algorithm or AI system.

7. Type of Ground Truth Used:

The ground truth used for this submission is based on International Standards (ISO 10993 series) for biocompatibility. These standards define the acceptable biological responses to medical devices.

8. Sample Size for the Training Set:

Not applicable. There is no "training set" in the context of this device and the type of performance testing performed. AI/ML models use training sets, but this is a physical device.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set.

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The Custom Comfort Nightguard Version 2 is indicated for use for protection against bruxism or nighttime teeth grinding. It is intended to reduce damage to the teeth and to prevent the noise associated with bruxing or grinding.

The Custom Comfort Nightguard Version 2 is a fully occlusive nightguard, consisting of a soft, formable material, and non-formable base, which cushions the teeth. When heated and then briefly cooled, the formable material is molded to fit the user's maxillary dentition for maximum retention. The hard base prevents bite-through by users with moderate to severe nocturnal bruxing and cushions the teeth on all occlusal surfaces.

This document is a 510(k) summary for a medical device (Custom Comfort Nightguard Version 2). It indicates that the device has undergone no new clinical studies and instead relies on substantial equivalence to previously cleared predicate devices.

Therefore, the following information cannot be extracted from the provided text:

• Acceptance criteria and reported device performance (no new performance data presented)
• Sample size for the test set and data provenance
• Number of experts and their qualifications for establishing ground truth
• Adjudication method for the test set
• MRMC comparative effectiveness study results or effect size
• Standalone algorithm performance
• Type of ground truth used (for a new study)
• Sample size for the training set
• How ground truth for the training set was established

Explanation:

The document explicitly states its purpose is a "Special 510(k) notice" for a "modification" to existing devices. It concludes that "The minor modifications made to the device do not raise any new questions of safety or effectiveness. Thus, the Custom Comfort Nightguard Version 2 is substantially equivalent to its predicate devices." This means the FDA did not require new performance data or clinical studies for this submission. The device's safety and effectiveness are assumed based on its similarity to previously cleared devices.

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