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510(k) Data Aggregation
(89 days)
Direct restoration of Class I, II, III and V cavities (ideally Class I and II), base or liner, core build-ups.
DenMat Bulk Fill is a tooth shaded, radiopaque, dual-cured (auto-cure with light-cure acceleration) composite that offers an unlimited depth of cure in a single application without multiple layers and lightcuring when allowed to self-cure. DenMat Bulk Fill has the handling properties of a low viscosity or "flowable" composite that allows for adaptation to the prepared cavity walls. DenMat Bulk Fill is also ideal for core buildups, and any application where light transmission is inadequate. It is provided in multiple shades.
This a medical device for tooth restoration, not an AI/ML device. Thus, the questions surrounding AI/ML device performance are not applicable.
1. A table of acceptance criteria and the reported device performance:
| Performance Metric | Acceptance Criteria (based on ISO 4049:2019 unless otherwise specified) | DenMat Bulk Fill Performance | Primary Predicate (Stela Automix) Performance | Reference Device (DMRC Bulk Fill) Performance |
|---|---|---|---|---|
| Work time (seconds) - self-cure | Similar to predicate and reference devices | 105 | 130 | 90 |
| Set time (seconds) - self-cure | Similar to predicate and reference devices | 145 | 170 | 125 |
| Flexural strength (MPa) | > 80 | 119 | 137 | 118 |
| Diametral strength (MPa) | > 28 | 52 | 56 | 54 |
| Water sorption (µg/mm³) | < 40 | 13 | 28 | 7 |
| Water solubility (µg/mm³) | < 7.5 | 0.1 | -2.5 (Indicating net water loss) | 0.8 |
| Color stability | Pass | Pass | Pass | Pass |
| Biocompatibility | Acceptable for intended use (no significant adverse effects) | Pass | Not explicitly stated in table, but implied by substantial equivalence | Not explicitly stated in table, but implied by substantial equivalence |
| Curing light wavelength (nm) | 400 - 500 (Same as reference device) | 400 - 500 | N/A (Self-cure only) | 400 - 500 |
| Curing time (seconds) - light cure | 10 (Same as reference device) | 10 | N/A (Self-cure only) | 10 |
| Curing light Intensity (mW/cm²) | > 600 for halogen light & per manufacturing suggestions for LED lights (Similar to reference device) | > 1000 | N/A (Self-cure only) | > 600 for halogen light and per manufacturing suggestions for LED lights |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not specify exact sample sizes for each performance test. It refers to "Non-clinical performance evaluations" and "DenMat internal testing methods." There is no information regarding the country of origin of the data or whether it was retrospective or prospective.
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 is a non-AI/ML medical device submission. The concept of "ground truth" established by experts, as typically applied in AI/ML studies (e.g., radiologists interpreting images), is not relevant here. Performance criteria are based on established international standards for dental materials (e.g., ISO 4049).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as this is a non-AI/ML medical device submission. Adjudication methods are typically used in clinical trials involving human readers or evaluators, which is not the primary mode of evaluation for this materials-based device.
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:
Not applicable, as this is a non-AI/ML medical device submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable, as this is a non-AI/ML medical device submission.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for this device's performance is based on well-established international standards for dental materials (e.g., ISO 4049:2019, ANSI/ADA Standard No. 27-2016, ISO 7491:2000) and internal testing methods. For biocompatibility, it's based on ISO 10993 series of standards. These standards define the acceptable physical, chemical, and biological properties for these types of materials.
8. The sample size for the training set:
Not applicable, as this is a non-AI/ML medical device submission. There is no concept of a "training set" for this type of device.
9. How the ground truth for the training set was established:
Not applicable, as this is a non-AI/ML medical device submission.
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