(44 days)
SURFACE COAT is used to glaze/polish following restorations:
- Direct and indirect composite resins
- Acrylic provisional crowns and bridges
- Acrylic appliances
- Glass ionomers and resin-modified glass ionomers
SURFACE COAT is a single-component, light-cure resin glaze material that provides a clear and smooth surface, consisting of a multi-functional acrylate monomer that provides excellent durability and may reduce or even eliminate the need for manual polishing. SURFACE COAT has virtually no surface oxygen inhibition layer.
The provided 510(k) summary for K063228 (SURFACE COAT) does not contain the detailed information necessary to fully answer your request regarding acceptance criteria and a study proving the device meets those criteria.
This document is a 510(k) premarket notification, which largely focuses on demonstrating substantial equivalence to predicate devices rather than presenting a detailed performance study with acceptance criteria in the manner you've outlined for clinical or diagnostic devices.
However, based on the available information, I can extract and infer some aspects:
1. Table of Acceptance Criteria and Reported Device Performance
The document states: "Since there is no applicable FDA's recognized standard or international standard concerning performance of this type of device, certain specifications are designed for SURFACE COAT, the applicant device, and tested accordingly in comparison with the predicate devices validating that the applicant device is substantially equivalent to the predicate devices in terms of the effectiveness and performance."
This indicates that internal specifications were used, but these specific specifications and their corresponding performance metrics are not detailed in this 510(k) summary. It only mentions that the device was tested accordingly and validated against predicate devices for effectiveness and performance.
| Acceptance Criterion (Type & Metric) | Reported Device Performance |
|---|---|
| Not Specified | Not Specified |
| (Likely internal specifications related to properties like durability, surface smoothness, oxygen inhibition layer characteristics relevant to a resin glaze material) | (Performed comparably or superiorly to predicate devices based on unspecified internal tests) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample size for test set: Not specified.
- Data provenance: Not specified. Since it's a materials science submission, it's highly likely to be laboratory/bench testing data rather than patient data from a specific country, and thus, "retrospective or prospective" would not apply in the typical clinical sense.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- This type of information (experts establishing ground truth) is typical for clinical studies involving diagnosis or interpretation. For a dental material, "ground truth" would likely be established through objective laboratory measurements and material science standards/tests, not expert consensus in the diagnostic sense.
- Not applicable/Not specified.
4. Adjudication Method for the Test Set
- Not applicable/Not specified for this type of material performance testing.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
- No. This type of study is for diagnostic devices involving human readers interpreting images or data. It is not relevant for a dental resin glaze material.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a material, not a software algorithm.
7. The Type of Ground Truth Used
- For a material like "SURFACE COAT," the "ground truth" would be established by the physical and chemical properties of the material as measured by standardized laboratory methods (e.g., tests for hardness, wear resistance, bond strength, surface smoothness, oxygen inhibition layer thickness).
- The document implies these were internal "specifications" and comparisons to predicate devices for "effectiveness and performance."
8. The Sample Size for the Training Set
- Not applicable/Not specified. The concept of a "training set" is usually for machine learning algorithms. For material development, various formulations and batches might be tested during R&D, but this isn't typically referred to as a "training set" in the context of regulatory submissions for materials.
9. How the Ground Truth for the Training Set was Established
- Not applicable/Not specified.
Summary of Study Information (as inferable from the document):
The submission relies on demonstrating substantial equivalence to predicate devices (BISCOVER LIQUID POLISH, BISCOVER LV, etc.) rather than a full de novo performance study against explicit acceptance criteria.
The study performed was a comparison of the SURFACE COAT's effectiveness and performance characteristics against those of the predicate devices. The exact nature of these tests (e.g., specific mechanical properties tested, methods used) and their quantitative results are not disclosed in this summary. The manufacturer states that "certain specifications are designed for SURFACE COAT...and tested accordingly in comparison with the predicate devices validating that the applicant device is substantially equivalent." This implies bench testing to show similar or superior material properties relative to the predicates.
In essence, the "study" for this 510(k) demonstrated that the new device performs sufficiently similar to already approved devices, making it substantially equivalent, without needing to define new, explicit clinical acceptance criteria in the format you requested.
§ 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.