(49 days)
Paint-on Polish Agent is indicated for
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- Surface and enamel margin treatment of Direct, light-cured composite restorations.
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- Surface treatment of Indirect restorations; composite resin or methacrylate veneers, inlays, onlays, crown and bridge retainers.
The Paint-on Polish Agent is liquid Polish agent designed eliminate the Polishing procedure by painting the formulation on the surface of restorations directly. It is indicated for use on both permanent and temporary restorations. Paint-on Polish can also be used as a sealant to decrease the micro-leakage at tooth-composite restoration interface. Due to the unique chemistry, Paint-on Polish formulation can be cured by both LED and halogen light. The addition of fillers provides excellent wear resistance for the formulation. The cured coating surface has a strong adhesion to restoration and excellent stain resistance to food and drinks. It also emits blue fluorescence close to enamel surface. Paint-on Polish formulation has a thin oxygen inhibited layer after curing, but it can be easily removed by ethanol or isopropanol without reducing the glossiness of coating.
The provided text does not contain detailed information about specific acceptance criteria or a dedicated study with performance metrics for the DENTSPLY International Paint-on Polish Agent (K670306). The document is a 510(k) summary for a dental device, which generally focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed study results against pre-defined acceptance criteria for a new clinical study.
However, based on the type of information typically found in such submissions and what is hinted at, I can construct a response that addresses your points where possible, and clearly states when information is not available in the provided text.
Here's an attempt to answer your request based only on the provided text:
Acceptance Criteria and Device Performance Study for DENTSPLY International Paint-on Polish Agent (K670306)
The provided submission (K670306) is a 510(k) summary demonstrating substantial equivalence for a dental coating material. While the document mentions performance data, it does not detail specific acceptance criteria or an analytical study with quantitative performance metrics against those criteria in the format requested. The evaluation primarily relies on the prior use of components and biocompatibility testing. No information on a specific, quantitative performance study with defined acceptance criteria is supplied within these documents.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Wear Resistance | (Not specified) | "Excellent wear resistance for the formulation." (Qualitative) |
| Adhesion to Restoration | (Not specified) | "Strong adhesion to restoration." (Qualitative) |
| Stain Resistance | (Not specified) | "Excellent stain resistance to food and drinks." (Qualitative) |
| Biocompatibility | (Not specified) | "Evaluated and passed biocompatibility testing for cytotoxicity, genotoxicity, irritation and sensitization." (Pass/Fail) |
| Curing by LED/Halogen Light | (Not specified) | "Can be cured by both LED and halogen light." (Functional claim) |
| Oxygen Inhibited Layer | (Not specified) | "Thin oxygen inhibited layer after curing, but it can be easily removed by ethanol or isopropanol without reducing the glossiness of coating." (Functional claim) |
| Fluorescence | (Not specified) | "Emits blue fluorescence close to enamel surface." (Functional claim) |
Note: The document largely provides qualitative descriptions of performance rather than specific, measurable acceptance criteria or quantitative results.
2. Sample Size Used for the Test Set and Data Provenance
This information is not available in the provided text. The document refers to "performance data," but does not specify sample sizes for any test set or the provenance (country of origin, retrospective/prospective) of this data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not available in the provided text. The submission focuses on product characteristics and biocompatibility, not expert-adjudicated performance studies.
4. Adjudication Method for the Test Set
This information is not available in the provided text.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No information on an MRMC comparative effectiveness study, or the effect size of human readers improving with or without AI assistance, is provided. This type of study is not relevant to the described device.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance Study
No information on a standalone performance study is provided. This device is a dental material, not an AI algorithm.
7. Type of Ground Truth Used
The "ground truth" for the performance claims appears to be based on laboratory testing (e.g., for wear, adhesion, stain resistance, and biocompatibility). The document does not specify if clinical outcomes or pathology reports were used to establish efficacy in the context of a clinical study.
8. Sample Size for the Training Set
This information is not available in the provided text. The device is a material, not an algorithm that would typically have a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not available in the provided text. As above, this concept (training set and its ground truth) is not applicable to the description of this dental material.
§ 872.3310 Coating material for resin fillings.
(a)
Identification. A coating material for resin fillings is a device intended to be applied to the surface of a restorative resin dental filling to attain a smooth, glaze-like finish on the surface of the filling.(b)
Classification. Class II.