Search Results

Protect-It Custom Fit Dental Guard is indicated for protection against bruxism or nighttime teeth grinding. It is intended to reduce damage to teeth associated with bruxing or nighttime teeth grinding.

Protect-It Custom Fit Dental Guard is an over-the-counter device to be used by lay people for protection against the effects of nighttime teeth grinding. It is made of a single thermoplastic resin, ethylene vinyl acetate copolymer, EVA, which is easily molded to the teeth when heated. It is a full-occlusal guard worn on the upper teeth, providing a cushion to separate the upper and lower teeth and keep them apart while sleeping, thus reducing the damage to teeth associated with bruxism.

The provided text is a 510(k) premarket notification for a medical device: DOC Brands, Inc.'s Protect-It Custom Fit Dental Guard. This type of submission aims to demonstrate substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a clinical study as would typically be done for a new or high-risk device.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, a test set, expert adjudication, MRMC studies, standalone performance, or training set details for an AI/ML device.

The relevant sections of the document describe:

• Substantial Equivalence Discussion: This is the core of the submission, comparing the subject device to a predicate (DenTek Oral Care, Inc.'s Ready-Fit Disposable Dental Guard - K151149) and a reference device (DenTek Oral Care, Inc.'s Custom Comfort Nightguard Version 2 - K091660) across various characteristics like manufacturer, 510(k) #, device classification, regulation #, product code, regulatory class, description, packaging, design, indications for use, OTC/Rx status, user population, technological characteristics, duration of use, materials, physical properties (tensile strength, elongation, hardness, melt index, density), fit, dimensions, weight, sterilization, and cleaning method.
• Non-Clinical Performance Testing: This section details "bench testing" and "biocompatibility testing."
  • Bench Testing: An "in-home use test (IHUT)" was conducted to validate the design and performance expectations, specifically verifying reusability. The document references "Section 18: Bench Testing, Attachment 4A: Bench Test Protocol, 4B: Bench Test Engineering Study, and Attachment 4C: Bench Test Data" which are not provided in the given text.
  • Biocompatibility Testing: Four tests were performed according to ISO standards: In-vitro Cytotoxicity (ISO 10993-5:2009(E)), Skin Sensitization (ISO 10993-10:2021(E)), Intracutaneous Reactivity (ISO 10993-23:2021(E)), and Oral Mucosa Irritation (ISO 10993-23:2021(E)). The results indicated the device was non-cytotoxic, non-sensitizer, non-reactive, and non-irritant, respectively.

In summary, the provided document is a regulatory submission for substantial equivalence of a physical dental guard, not a study proving an AI/ML device meets acceptance criteria through a rigorous test set and expert review. Therefore, I cannot extract the specific information requested in your prompt.

Ask a specific question about this device

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.

Ask a specific question about this device