(27 days)
The DenTek Improved Comfort-Fit NightGuard 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 Improved Comfort-Fit NightGuard is a posterior-only occlusion nightguard, consisting of two bite pads connected by a buccal retention strap. The Improved Comfort-Fit consists entirely of ELVAX, a thermoplastic material. The bite pads move along the buccal strap in order to the individual user needs, with the strap always contained within the wings of the bite pads. There are 5 positions of adjustability for each molar pad.
The provided text is a 510(k) summary for the DenTek Oral Care Inc.'s Improved Comfort-Fit NightGuard. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting novel acceptance criteria and a detailed study proving the device meets those criteria.
Therefore, the information required in the prompt (acceptance criteria, device performance tables, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth details, training set sizes) is not available within this 510(k) summary.
Here's a breakdown of why this information is missing and what the document does provide:
- Acceptance Criteria and Device Performance: The document does not describe specific performance metrics (e.g., reduction in tooth wear, noise reduction percentage) or a table of acceptance criteria. Its primary claim is that the "minor differences made in the device for patient comfort do not raise any new questions of safety or effectiveness."
- Study Details (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone): This 510(k) is a Special 510(k) based on modifications to an already cleared device (K072147). For such submissions, manufacturers typically demonstrate that the changes do not adversely affect safety or effectiveness, often through engineering analysis, biocompatibility testing, and sometimes limited human factors or user preference studies, rather than large-scale clinical trials with extensive ground truth establishment. No such detailed study information is provided in this summary.
- Ground Truth: Since there's no detailed study described, there's no mention of how "ground truth" would have been established for performance metrics. The implicit "ground truth" for substantial equivalence is the safety and effectiveness of the predicate device.
- Training Set: This is not an AI/ML device, so there is no concept of a "training set" like in typical AI performance studies.
What the document does state regarding demonstrating equivalence (which is the goal of a 510(k)):
- Purpose: The Improved Comfort-Fit NightGuard is a modification to DenTek Oral Care Inc.'s Comfort Fit NightGuard (K072147).
- Intended Use: Identical to the predicate: protection against bruxism or nighttime teeth grinding, reduction of damage to teeth, and prevention of noise.
- Technological Characteristics: Made entirely of ELVAX (a thermoplastic material), posterior-only occlusion, two bite pads connected by a buccal retention strap, 5 positions of adjustability for each molar pad. The previous version (K072147) would have had very similar characteristics. The "Improved Comfort-Fit" implies minor design changes for user experience rather than fundamental functional differences.
- Substantial Equivalence Argument: "DenTek's Improved Comfort-Fit has the same intended use and similar indications, principles of operation, and technological characteristics as DenTek's Comfort Fit. The minor differences made in the device for patient comfort do not raise any new questions of safety or effectiveness. Thus, the Improved Comfort-Fit is substantially equivalent to its predicate devices."
In summary, this 510(k) notification for a modified physical device does not contain the kind of performance study data and acceptance criteria you would find for an AI/ML diagnostic or treatment device. Its entire premise is that it's so similar to a previously cleared device that extensive new studies are not required to demonstrate safety and effectiveness.
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