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510(k) Data Aggregation
(156 days)
[1] Cementation of crowns, bridges, inlays and onlays
[2] Cementation of veneers
[3] Cementation of adhesion bridges and splints
[4] Cementation of prosthetic restorations on implant abutments and frames
[5] Cementation of posts and cores
[6] Amalgam bonding
The subject device is an adhesive resin cement system. It consists of the cement paste (Paste), Try-in Paste, Tooth Primer, CLEARFIL CERAMIC PRIMER PLUS and K-ETCHANT Syringe. The Paste is a dual-cure (light- and/or self-cure), fluoride-releasing, radiopaque resin cement for ceramics (lithium disilicate, zirconia, etc.), hybrid ceramics, composite resins, and metal restorations. It is supplied in an automix delivery system which mixes equal amounts of two components. It is available in the following 5 shades; Universal (A2), Clear, Brown (A4), White, and Opaque. The Opaque shade should be self-cured for final curing due to its strong opacity. The Try-in Paste is a shade matching material which has approximate color and transparency as the hardened mixture of Paste. The Tooth Primer is a self-etching primer to tooth structures that accelerates the polymerization of the Paste.
The provided text is a 510(k) Summary for the dental cement "PANAVIA V5". It describes the device, its intended use, and comparative studies against predicate devices to establish substantial equivalence.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Section | Requirement | PANAVIA V5 (Subject device) Performance | Acceptance Criteria Met? |
|---|---|---|---|
| 5.2.2 Film thickness, luting materials | < 50 μm | COMPLIES (for all shades: Universal (A2), White, Opaque) | Yes |
| 5.2.4 Working time, Class 1 and Class 3 luting materials | > 60 seconds | COMPLIES (for all shades) | Yes |
| 5.2.5 Setting time, Class 1 materials or 5.2.6 Setting time, Class 3 materials | < 10 min | COMPLIES (for all shades) | Yes |
| 5.2.9 Flexural strength | ≥ 50 MPa | COMPLIES (for all shades) | Yes |
| 5.2.10 Water sorption | ≤ 40 μg/mm³ | COMPLIES (for all shades) | Yes |
| 5.2.10 Solubility | ≤ 7.5 μg/mm³ | COMPLIES (for all shades) | Yes |
| 5.4 Color stability after irradiation and water sorption | No more than a slight change in color shall be observed | COMPLIES (for all shades) | Yes |
| 5.5 Radio-opacity | Equal to or greater than that of the same thickness of aluminum | COMPLIES (for all shades) | Yes |
| Shear Bond Strength (to Dentin) | In-house standard | COMPLIES | Yes |
| Shear Bond Strength (to Enamel) | In-house standard | COMPLIES | Yes |
| Shear Bond Strength (to Metal) | In-house standard | COMPLIES | Yes |
| Shear Bond Strength (to Composite resin) | In-house standard | COMPLIES | Yes |
| Shear Bond Strength (to Ceramic) | In-house standard | COMPLIES | Yes |
| Shear Bond Strength (to Hybrid ceramics) | In-house standard | COMPLIES | Yes |
| Shear Bond Strength (to Amalgam) | In-house standard | COMPLIES | Yes |
| Released fluorine ion test | Lower than that by PANAVIA F2.0 (predicate device) | Confirmed that the released level from the cured one by the subject device was lower than that by PANAVIA F2.0. | Yes |
| Biocompatibility | Compliance with ISO 10993 series and ISO 7405 (Cytotoxicity, Sub-chronic systemic toxicity, Skin irritation, Sensitization, Genotoxicity) | Paste and Tooth Primer: Concluded to be substantially equivalent in biocompatibility to predicate devices. Try-in Paste: Concluded to be substantially equivalent. | Yes |
2. Sample sizes used for the test set and the data provenance
The document does not specify exact sample sizes for each test in the performance evaluation. It only states that tests were performed "according to ISO 4049: 2009" and "ISO/TS 11405: 2003" and that "in-house standard" was used for shear bond strengths. It does not provide information on the country of origin of the data or whether the data was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The studies conducted are primarily in-vitro physical, mechanical, and biological tests, not studies relying on expert clinical assessment for ground truth.
4. Adjudication method for the test set
This information is not applicable as the studies are in-vitro tests and do not involve human adjudication of results in the way a clinical study with image interpretation, for example, would. The results are based on objective measurements against international 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
No, an MRMC comparative effectiveness study was not done. This document is for a dental cement, and such studies are typically performed for diagnostic imaging AI devices, not for material properties.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as the device is a dental cement, not an AI algorithm. The performance evaluation focuses on the material's physical, mechanical, and biological properties.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance criteria is based on:
- International Standards: ISO 4049: 2009 (Dentistry - Polymer-based restorative and materials) and ISO/TS 11405: 2003 (Dentistry - Testing of adhesion to tooth structure and dental restorative materials).
- In-house standards: For shear bond strength tests.
- Biocompatibility Standards: ISO 10993 series and ISO 7405.
These standards define the acceptable range or benchmark for different physical, mechanical, and biological properties.
8. The sample size for the training set
This question is not applicable. The device is a dental cement, and there is no "training set" in the context of an AI algorithm creating a model from data. The tests are direct measurements of the material's properties.
9. How the ground truth for the training set was established
This question is not applicable for the same reasons as #8.
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