(153 days)
Ready-Fit Disposable Dental Guard is indicated for protection for nighttime teeth grinding or bruxism. It is intended to reduce damage to teeth by cushioning them and keeping them apart during grinding.
Ready-Fit Disposable Dental Guard is a ready-to-wear, posterior-only occlusive mouthquard, with two molar bite surfaces each consisting of three cylinders (bite tubes) connected by a buccal retention band.
The provided document is a 510(k) summary for the DenTek Ready-Fit Disposable Dental Guard. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria in the manner typically seen for novel medical devices, especially those involving AI or complex performance metrics.
Based on the document, here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in a quantitative, measurable format with specific thresholds that the device performance is then measured against. Instead, the "Substantial Equivalence Chart" acts as a comparison against a predicate device across various attributes. The 'Conclusion' column in this chart implicitly serves as a form of acceptance, indicating whether the subject device is considered "Equivalent" or "Substantially Equivalent" to the predicate.
| Acceptance Criteria (Implied by Predicate Comparison) | Reported Device Performance (Subject Device K151149) |
|---|---|
| Indications for Use: Equivalent to predicate's protection for nighttime teeth grinding/bruxism, reducing damage to teeth by cushioning and keeping them apart. | Ready-Fit Disposable Dental Guard is indicated for protection for nighttime teeth grinding or bruxism. It is intended to reduce damage to teeth by cushioning them and keeping them apart during grinding. (Equivalent to predicate) |
| User Population: OTC, age 18 and up | OTC, age 18 and up (Equivalent to predicate) |
| Technological Characteristics: Posterior-occlusive mouthguard with two molar bite surfaces connected by a buccal retaining strap, serving the same purpose as the predicate's bite plates. | A posterior-occlusive mouthguard, comprised of two molar bite surfaces, each with 3 cylinders (bite tubes), connected by a buccal retaining strap. (Substantially Equivalent to predicate; design differences do not affect substantial equivalence as they serve the same purpose) |
| Materials: Comprised completely of EMA material | Comprised completely of EMA material (Equivalent to predicate) |
| Fit: One Size Fits All, worn on upper or lower teeth | One Size Fits All, worn on upper or lower teeth (Equivalent to predicate) |
| Dimensions (l x w x h): Similar to predicate (4.5cm L x 3.5cm W x 1.7cm H) | 3.8cm L x 3.9cm W x 1.9cm H (Substantially Equivalent to predicate; differences are very small and have similar overall shape/function) |
| Weight: Similar to predicate (0.06 ounce) | 0.04 ounce (Substantially Equivalent to predicate; differences are very small and have similar overall shape/function) |
| Sterilization: Not provided sterile | Device is not provided sterile. (Equivalent to predicate) |
| Method of Disinfection or Cleaning: Discarded after one night's use, no cleaning instructions | The device is meant to be discarded after one night's use. No instructions for cleaning are included. (Equivalent to predicate) |
| Standards with which Device Complies: None specified for Product Code OBR | None specified for Product Code OBR (Equivalent to predicate) |
| Bench Test Results: Material properties (density, melt flow, Shore Hardness A and D, tensile strength, elongation at break, tensile modulus) consistent with intended use and performance. | DenTek conducted an in-home use test (IHUT) to validate that the design meets intended use and performance. Physical properties testing (ASTM D792, ISO 1183, ASTM D1238, ISO 1133) and mechanical properties tests (ASTM 2240, ISO 868, ASTM 638, ISO 527-2) were conducted on the material. |
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: The document mentions an "in-home use test (IHUT)" but does not specify the sample size for this test.
- Data Provenance: The IHUT was conducted in April 2015. No country of origin is specified, but given the company's address is in Maryville, Tennessee, USA, it's highly likely the test was conducted in the USA. It appears to be a prospective test, as it was conducted specifically to validate the device's design.
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)
This section is not applicable as the device is a dental guard, not an AI or diagnostic imaging device that typically requires expert-established ground truth for its performance evaluation. The "in-home use test" would likely involve user feedback on fit, comfort, and perceived effectiveness in protecting against grinding, rather than expert interpretation of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. The device's evaluation is not based on expert interpretation or medical imaging, so adjudication methods commonly used in those contexts are not relevant here.
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
This is not applicable. The device is a physical dental guard, not an AI or diagnostic assistance tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical dental guard, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the physical properties and mechanical properties tests, the "ground truth" would be established by the standardized testing procedures (e.g., ASTM D792 for density, ASTM D1238 for melt flow, etc.) and their inherent methodologies for measuring material characteristics.
For the "in-home use test (IHUT)," the "ground truth" or validation would likely be based on user feedback and self-reported outcomes regarding the device's fit, comfort, and efficacy in protecting against teeth grinding, aligning with the stated "intended use and performance."
8. The sample size for the training set
This is not applicable. This document describes a physical medical device (dental guard), not a machine learning or AI model that requires a training set.
9. How the ground truth for the training set was established
This is not applicable. No training set is mentioned or implied for this physical device.
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