(171 days)
The Akervall Technologies mouthguards (ProTech Dent,) are indicated for use in protecting the teeth and reduce damage caused by bruxism or nighttime grinding.
The ProTech Dent guard consists of a polycaprolactone based polymer with a tensile strength significantly higher than EVA( 29.11 MPa versus 22.3 MPa). It comes in a pre-shaped form (1.6 mm thick). The form softens when heated in hot water and can then easily be custom fit to the user's teeth. When the user sucks on the mouth guard it shapes around the teeth with no or minimal space between the material and the teeth. The polymer hardens in about 30 seconds and is then durable so that it does not deform when impacted with forces typically encountered in the mouth.
The provided text describes the 510(k) summary for the "ProTech Dent" mouthguard, focusing on its substantial equivalence to a predicate device. It includes performance data, but not in the format of acceptance criteria and reported device performance for a study proving the device meets those criteria.
However, I can extract the relevant performance data and present what is available, along with the information regarding the study conducted.
Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
The submission focuses on establishing substantial equivalence to a legally marketed predicate device (DenTek Comfort Fit NightGuard, K072147) rather than defining specific acceptance criteria for novel performance claims and then demonstrating adherence to those criteria through a clinical trial or extensive standalone performance study. The "acceptance criteria" here are implied by the comparison to the predicate device's characteristics and the general requirements for mouthguards.
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a 510(k) submission for substantial equivalence, the "acceptance criteria" are not explicitly stated numerical targets for clinical performance but rather a demonstration that the device is "as safe and effective as" the predicate device based on material properties.
| Characteristic | Acceptance Criterion (Implied by Predicate) | Reported Device Performance (ProTech Dent) |
|---|---|---|
| Material | Thermoplastic resin (similar to predicate EVA) | Polycaprolactone based polymer |
| Tensile Strength | At least comparable to predicate (22.3 MPa for EVA) | 29.11 MPa (ProTech Dent) vs. 22.3 MPa (EVA). Reported 3.5 times greater than Den Tek product. (There might be a discrepancy here: 29.11/22.3 is approx. 1.3, not 3.5. This suggests the "3.5 times greater" might refer to a different metric or a qualitative interpretation.) |
| Tensile Elongation | Comparable to predicate | Reported 1.5 times more than Den Tek product. |
| Hardness (Shore) | Comparable to predicate | Comparable to Den Tek Comfort Fit |
| Thickness | Typically 4.0 mm for EVA mouthguards | 1.6 mm |
| Water Sorption | Comparable to predicate | Compared with the predicate device (no specific value given, only "compared") |
| Water Solubility | Comparable to predicate | Compared with the predicate device (no specific value given, only "compared") |
| Young's Modulus | Comparable to predicate | Compared with the predicate device (no specific value given, only "compared") |
| Biocompatibility | Pass cytotoxicity, irritation, and sensitization tests | Passed Cytoxicity, Irritation and Sensitization tests |
| Safety | Safe for dental use | Biocompatibility tests performed (Cytoxicity, Irritation, Sensitization) |
| Indications for Use | Protection against bruxism and grinding; reduction of damage to teeth (same as predicate) | Protection against bruxism and grinding; reduction of damage to teeth |
2. Sample Size Used for the Test Set and Data Provenance
The study described is laboratory-based testing of material properties, not a clinical study with a human test set.
- Sample Size: Not specified for the physical property tests (e.g., how many specimens were tested for tensile strength).
- Data Provenance: The tests compare "ProTech Dent" to "DenTek Comfort Fit mouthguard." The data likely originated from a laboratory setting conducting these specific material property tests. No country of origin is mentioned, but typically for a US submission, such tests would be conducted in accredited labs. The nature of the study (material testing) makes it inherently retrospective for the material samples tested.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This information is not applicable. The "ground truth" for the material property tests is the objective measurement of physical properties (e.g., tensile strength, hardness) by laboratory equipment, not expert consensus or a diagnostic assessment.
4. Adjudication Method for the Test Set
Not applicable, as this was laboratory material testing, not a diagnostic study requiring expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. This submission is for a physical device (mouthguard) and focuses on material properties and substantial equivalence, not a diagnostic AI algorithm that would typically be evaluated with MRMC studies comparing human readers with and without AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
Not applicable, as this is a physical device, not an algorithm.
7. The Type of Ground Truth Used
The ground truth used was objective physical property measurements obtained through standardized laboratory tests (e.g., ASTM tests for hardness and tensile strength).
8. The Sample Size for the Training Set
Not applicable. The "ProTech Dent" is a physical device, not a machine learning model, so there is no training set in the context of an AI algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set.
N/A