(80 days)
Ketac-Fil® Aplicap® Plus is a glass ionomer cement material indicated for the following uses: (1) fillings of Black Classes III and V cavities; (2) wedge-shaped defects; (3) fissure sealing; (4) small Black Class I cavities: (5) deciduous teeth; and (6) core build-ups.
Ketac-Fil® Aplicap® Plus is a modified glass ionomer cement material. Modifications have been made to the following ESPE 510(k)s for glass ionomer cement material: (1) Photac-Fil® Aplicap® (K925027); and (2) Ketac-Molar® Aplicap® (K960954), to create a slightly modified product with two new pigments.
This 510(k) summary describes a modified glass ionomer cement material, Ketac-Fil® Aplicap® Plus, which is a dental material and not an AI/ML device. Therefore, the questions related to AI/ML device performance, such as sample size for test/training sets, ground truth establishment, expert adjudication, and MRMC studies, are not applicable.
Here's an analysis based on the provided text, focusing on the available information for this type of device:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (if quantifiable) | Reported Device Performance (if quantifiable) |
|---|---|---|
| Material Properties | Meets requirements of relevant DIN and ISO standards for dental cement. | Ketac-Fil® Aplicap® Plus meets the requirements of relevant DIN and ISO standards for dental cement. (Implies satisfactory performance for properties like compressive strength, flexural strength, wear resistance, etc., as per standards). |
| Biocompatibility | Acceptable results for cytotoxicity, mutagenicity, eye irritation, skin irritation, sensitization, and acute oral toxicity. | Cytotoxicity, mutagenicity, eye irritation, skin irritation, sensitization, and acute oral toxicity tests have been conducted, and results are provided (and implicitly found acceptable, leading to clearance). |
| Equivalence to Predicates | Substantially similar intended uses and material composition (powder ingredients similar with slight modifications, liquid portion identical). | Ketac-Fil® Aplicap® Plus and Photac-Fil® Aplicap® have substantially similar intended uses and similar powder ingredients (except for a slightly modified silicate glass and new pigments). Ketac-Fil® Aplicap® Plus and Ketac-Molar® Aplicap® have similar intended uses and identical liquid portions. |
| Aesthetics/Translucency | New pigments provide better translucency and improved aesthetics. | Reason for modification is "to provide the user of conventional glass ionomer cement products with additional cement shade options of better translucency and improved aesthetics." (This is a design goal, and the clearance implies it was achieved to a satisfactory degree). |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not applicable. This submission is for a physical material (dental cement), not an AI/ML device involving test sets of data. The "tests" refer to physical, chemical, and biological laboratory testing of the material itself.
- The tests were conducted by ESPE in Germany.
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)
- Not applicable. This is not an AI/ML device where "ground truth" is established by human experts on a dataset. The "ground truth" in this context would be objective measurements from laboratory tests and compliance with recognized standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert interpretations of data (e.g., medical images) in AI/ML studies. For a dental cement, acceptance is based on predefined physical, chemical, and biological test outcomes against specified standards.
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. This is not an AI/ML device, and no human "readers" or diagnostic tasks are involved in its primary function that would necessitate an MRMC study.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For this device, the "ground truth" for demonstrating substantial equivalence and safety/effectiveness relies on:
- Objective laboratory measurements: Physical properties (e.g., relevant to DIN/ISO standards), chemical composition, and biocompatibility assays (cytotoxicity, mutagenicity, etc.).
- Compliance with recognized standards: Adherence to DIN and ISO standards for dental cement.
- Comparison to predicate devices: Demonstrating similar performance and characteristics to already cleared devices.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/ML device.
§ 872.3275 Dental cement.
(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.