(90 days)
Dentemp Pro-Comfort is indicated for protection against nighttime teeth grinding (bruxism). It is intended to reduce damage to teeth and prevent the noise associated with teeth grinding and bruxism.
Dentemp Pro-Comfort 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 manufactured with a two-shot, injection molded process. The first shot is a hard base of Ethylene Methyl Acrylate material (EMA), which contacts the lower tooth surfaces during grinding and prevents grind-through. The second shot is a soft, moldable surface layer of Ethylene Vinyl Acetate material (EVA), which is formed to hug the upper teeth for a comfortable fit. It is a custom fit dental guard, formed to an individual user's mouth by the traditional heat and form fitting technique. It is a full-occlusal guard worn on the upper teeth, providing a barrier to separate the upper and lower teeth and keep them apart while sleeping, thus reducing the damage to teeth caused by bruxism and preventing the noise associated with teeth grinding.
The provided FDA 510(k) Clearance Letter for the Dentemp Pro-Comfort Dental Guard focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study against specific acceptance criteria for a novel AI/software medical device.
Therefore, many of the requested details about acceptance criteria, ground truth establishment, sample sizes for training/test sets, expert qualifications, and MRMC studies are not applicable to this type of submission. This document describes a traditional 510(k) for a physical medical device (a dental guard), not an AI/software device.
However, I can extract the information that is present and explain why other details are absent based on the nature of this 510(k) submission.
Analysis based on the Provided Document:
The Dentemp Pro-Comfort Dental Guard is a physical medical device, not an AI/software device. Its approval is based on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving performance against quantitative acceptance criteria typical for AI/software in a clinical trial setting.
Therefore, the study performed is a comparative study and in-home use test to demonstrate equivalence, not a standalone performance study with strict numerical acceptance criteria for AI/software metrics.
Here's the breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The concept of "acceptance criteria" as quantitative metrics (e.g., sensitivity, specificity, F1-score) is not explicitly detailed for this physical device in the manner it would be for an AI/software product. Instead, the "performance" is demonstrated through comparative equivalence and successful real-world use.
| Acceptance Criterion (Implicitly for Equivalence) | Reported Device Performance |
|---|---|
| Material Equivalence: Same materials as predicate. | Met: Subject device uses EMA (hard base) and EVA (soft layer), identical to the predicate device, DenTek's Custom Comfort Nightguard Version 2 (K091660). |
| Indications for Use Equivalence: Same intended use as predicate. | Met: Both subject and predicate devices are indicated for protection against nighttime teeth grinding (bruxism), reducing damage to teeth, and preventing noise. |
| Technological Characteristics Equivalence: Similar principles of operation (barrier between teeth). | Met: Both function as a flexible barrier/cushion between upper and lower teeth to prevent bruxing damage and noise. Minor design differences (T-bars vs. concave curve for fit) are deemed not to raise new safety/effectiveness concerns. |
| Biocompatibility: Meet safety standards for body contact. | Met: Biocompatibility requirements met due to identical materials, formulation, processing, sterilization, and geometry to the legally marketed predicate device. No new biocompatibility testing was conducted by the applicant, relying on the predicate's established biocompatibility. |
| Fit Technology Performance (Comparative): Snug custom fit. | Met: A comparative study demonstrated the performance of the T-bars in the subject device (made of EMA) is equivalent to the T-bars in the reference device (Ora-GUARD, K150492, made of polycarbonate) in terms of "dimensional variation after forming." This ensures a snug custom fit. |
| Overall Performance (In-Home Use): Ease of forming, fit, comfort, and effectively keeping teeth apart to prevent bruxing. | Met: An "In-Home Use Test" validated the overall performance of the subject device in terms of these criteria. The device was deemed equivalent to the predicate in these aspects. |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size:
- Comparative Study (Fit Technology): The document states "A comparison study... demonstrated the performance of the T-Bars... is equivalent to the performance of the T-Bars...". It does not specify the number of devices or subjects included in this comparative study.
- In-Home Use Test: "An In-Home Use Test was conducted on the subject device..." The specific number of participants or duration is not provided in this summary.
- Data Provenance: The document does not specify the country of origin for the data or whether the studies were retrospective or prospective, though "In-Home Use Test" typically implies a prospective design.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- This information is not applicable for this type of medical device and submission. The "ground truth" for a physical dental guard is its physical properties, material composition, and functional performance (e.g., fit, comfort, barrier function) assessed through physical and observational tests rather than expert interpretation of complex data (like radiology images for AI).
- The "validation" of the in-home use test would likely involve user feedback rather than expert-adjudicated ground truth.
4. Adjudication Method for the Test Set:
- This information is not applicable. Given that this is a physical device and not an AI/software requiring human interpretation of outputs against a "ground truth," adjudication methods like 2+1 or 3+1 are not relevant.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, this was not done. An MRMC study is relevant for AI/software devices that assist human readers (e.g., radiologists, pathologists) in interpreting medical images or data. This submission is for a physical dental guard.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done:
- No, this was not done. This concept is only applicable to AI/software algorithms. The "standalone" performance for this device would refer to its physical properties and mechanical function, which are assessed via the comparative study and in-home use test.
7. The Type of Ground Truth Used:
- For Material and Design Equivalence: The ground truth is the specified material composition (EMA, EVA) and design features of both the subject and predicate/reference devices, established through engineering specifications and potentially material analysis.
- For Fit Technology Performance: The ground truth is presumably quantitative measurements of dimensional variation after forming, demonstrating that the subject device achieves a fit comparable to the reference device.
- For In-Home Use Test: The ground truth is user experience and self-reported outcomes regarding ease of forming, fit, comfort, and perceived effectiveness in preventing bruxing. This is based on direct observation of functional performance and patient subjective feedback.
8. The Sample Size for the Training Set:
- This information is not applicable. "Training set" refers to data used to train machine learning models. This is a physical device.
9. How the Ground Truth for the Training Set was Established:
- This information is not applicable for the same reason as point 8.
N/A