(111 days)
– As initial layer / first increment in Class I and II composite restorations in permanent teeth
- Restorations in deciduous teeth
Tetric EvoFlow® Bulk Fill is a flowable, light-curing radiopaque composite. As its opacity increases during polymerization, it is also suitable for discolored tooth structure. It is applied in increments of up to 4 mm as an initial layer in Class I and II restorations. Tetric EvoFlow Bulk Fill is intended for use as a dental filling material.
The provided text is a 510(k) summary for a dental device, Tetric EvoFlow Bulk Fill. It details the device's characteristics and its comparison to a predicate device, Tetric EvoCeram Bulk Fill, to demonstrate substantial equivalence.
Here's an analysis of the provided information regarding acceptance criteria and supporting studies:
- A table of acceptance criteria and the reported device performance
The document does not specify general "acceptance criteria" for the device as a whole beyond demonstrating substantial equivalence to the predicate. Instead, it lists specific properties that were tested and compared to the predicate, often referencing ISO 4049.
| Property | Acceptance Criteria (Implicit from ISO 4049 and predicate comparison) | Reported Device Performance (Tetric EvoFlow Bulk Fill) |
|---|---|---|
| Biocompatibility | In accordance with ISO 10993-1:2009 and EN ISO 7405:2008 | Tested for cytotoxicity and Mutagenicity, photoinitiator tested in vitro; assessed via comparison to predicate and literature review. Performance not significantly different from predicate. |
| Flexural Strength | Compared to predicate (K111958) | Tested and compared to predicate |
| Layer thickness/Curing Depth | Max 4mm, compared to predicate (K111958) | Max 4mm, tested and compared to predicate |
| Sensitivity to ambient light | Raised specification criteria (above ISO 4049) | Achieves more than required by ISO 4049 |
| Water Sorption | Compared to predicate (K111958) | Tested and compared to predicate |
| Solubility | Compared to predicate (K111958) | Tested and compared to predicate |
| Radiopacity | Raised specification criteria (above ISO 4049) | Achieves more than required by ISO 4049 |
| Transparency | Compared to predicate (K111958) | Reduced (due to indication as dentin replacement) |
| Flexural Modulus | Compared to predicate (K111958) | Difference found (reflects consistency difference) |
| Vickers hardness profile (at 4mm layer) | Equivalent to predicate (K111958) | Results equivalent |
- 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 provide details on the sample sizes used for the testing, nor does it specify the data provenance (e.g., country of origin, retrospective or prospective). It simply states that the device was "evaluated" and "tested."
- 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 studies described are laboratory-based physical and chemical property tests, not clinical studies requiring expert ground truth for interpretation.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable for the same reason as point 3.
- 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 section is not applicable. The device is a dental filling material, not an AI-assisted diagnostic or imaging device. Therefore, no MRMC study, human readers, or AI assistance is relevant.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable. The device is a physical dental material, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the physical and chemical property tests, the "ground truth" or reference points are defined by established international standards (ISO 4049, ISO 10993-1, EN ISO 7405) and the characteristics of the legally marketed predicate device (Tetric EvoCeram Bulk Fill). For biocompatibility, it also includes literature review.
- The sample size for the training set
This section is not applicable as the device is a physical material and does not involve AI or machine learning that would require a training set.
- How the ground truth for the training set was established
This section is not applicable for the same reason as point 8.
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.