(46 days)
CLEARFIL AP-X PLT is indicated for the following applications:
- Class I, II, V restorations of posterior teeth
- Class III, IV, V restorations of anterior teeth
- Cervical cavities or defects involving root surfaces
This product is classified into Tooth shade Resin Material, CFR 29 Section 872.3690, because it is a device composed of materials such as bisphenol A glycidylmethacrylate (Bis-GMA) intended to restore carious or structural defects in teeth.
This 510(k) summary describes a new dental restorative material, CLEARFIL AP-X PLT, which is substantially equivalent to a previously cleared device, CLEARFIL AP-X. Due to this substantial equivalence claim for a dental material, the provided document does not contain information typically found in studies for AI/ML-powered medical devices. Therefore, I cannot provide a detailed response for points 2 through 9 as they are not applicable or the information is not present in the provided text.
Here's what I can extract and infer based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a 510(k) for a dental material, "acceptance criteria" and "device performance" are typically related to material properties (e.g., strength, biocompatibility, setting time, wear resistance, color stability) which are evaluated against industry standards or the predicate device's established performance. The submission is based on substantial equivalence, implying that the new device meets or performs similarly to the predicate.
| Acceptance Criteria Category | Reported Device Performance (CLEARFIL AP-X PLT) |
|---|---|
| Technological Characteristics | Substantially the same as CLEARFIL AP-X (K012740) |
| Chemical Ingredients | Substantially the same as CLEARFIL AP-X (K012740) |
| Safety | Substantially the same as CLEARFIL AP-X (K012740) |
| Intended Use | Same as CLEARFIL AP-X (K012740) |
| Classification | Same as CLEARFIL AP-X (K012740) - Tooth shade resin material, 21 CFR 872.3690 |
Study Proving Acceptance Criteria:
The document states, "This device is substantially same to CLEARFIL AP-X manufactured by Kuraray Medical Inc. (K012740). Therefore CLEARFIL AP-X and CLEARFIL AP-X PLT are substantially equivalent on the technological characteristics, chemical ingredients and safety."
This statement implies that the "study" proving acceptance criteria is a comparison of the new device (CLEARFIL AP-X PLT) to its predicate device (CLEARFIL AP-X) across these characteristics. However, the details of this comparative study (e.g., specific tests, methodologies, results of material properties) are not included in this 510(k) summary. These details would typically be in the full submission, but not in the summary document.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable to this type of 510(k) submission for a dental composite material, which does not involve a "test set" in the context of an AI/ML device. The "test" here refers to material testing or equivalence comparisons, not clinical image or diagnostic data.
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 information is not applicable. "Ground truth" in the context of expert consensus or clinical diagnosis is not relevant for this material-based device submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods are typically used for establishing ground truth in diagnostic studies, not for material equivalence comparisons.
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
This information is not applicable as this is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable as this is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable in the typical sense. For a dental material, "ground truth" might refer to established physical, chemical, and biological properties measured by standardized tests, rather than clinical diagnostic ground truth. The basis for declaring equivalence is a comparison of these material properties, not a diagnostic outcome.
8. The sample size for the training set
This information is not applicable as this is not an AI/ML device.
9. How the ground truth for the training set was established
This information is not applicable as this is not an AI/ML device.
§ 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.