(77 days)
BISCOVER LV is a low-viscosity, light-cured resin formulation used to seal restorations and enamel while leaving a smooth polished surface.
BISCOVER LV is used to Seal and Polish:
- Direct composites (cured)
- Indirect composites
- Provisionals
- Acrylic appliances
- Resin-modified Glass Ionomers
- Enamel before or after orthodontic bracket placement
- Etched Enamel
BISCOVER LV is a low viscosity, light-cured resin formulation used to seal restorations and etched enamel while leaving a smooth polished surface. Due to its unique proprietary chemistry, BISCOVER LV cures without any sticky oxygen-inhibited layer. BISCOVER LV may reduce or even eliminate the need for manual polishing.
The provided document is a 510(k) premarket notification summary and the FDA's substantial equivalence letter for a dental surface sealant named BISCOVER LV. It does not contain information about a study with specific acceptance criteria that proves device performance in the way typically seen for diagnostic or AI-enabled devices.
Instead, the document focuses on demonstrating substantial equivalence to a predicate device based on its intended use, chemical composition, and mechanical/physical properties. Here's a breakdown of the information that is available, structured to match your request where possible, and noting where information is absent:
1. Table of acceptance criteria and the reported device performance
| Property/Characteristic | Acceptance Criteria (Predicate) | Reported Device Performance (BISCOVER LV) |
|---|---|---|
| Intended use | Resin sealant | Resin sealant |
| Chemical composition | Light-Cured, Multifunctional Acrylate Resin | Light-Cured, Multifunctional Acrylate Resin |
| Mechanical/physical properties | Low viscosity clear resin liquid, light cured to smooth polish surface | Low viscosity clear resin liquid, light cured to smooth polish surface |
| Biocompatibility | Not explicitly stated as a criterion, but implied | Non-toxic (based on testing) |
Note: The "acceptance criteria" here are implicitly the characteristics of the predicate device, BISCOVER Liquid Polish, as the goal is to demonstrate "substantial equivalence." The reported performance for BISCOVER LV essentially matches these characteristics, indicating it meets the implicit "acceptance criteria" for equivalence.
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 provided in the document. The submission states, "Side by side comparisons of BISCOVER LV to the predicate device BISCOVER Liquid Polish clearly demonstrates that the applicant device is substantially equivalent to the legally marketed device." However, no details on the sample size or provenance of these comparisons are given.
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 and not provided. This type of information is relevant for studies involving subjective human assessment or diagnostic accuracy, which is not the nature of this submission for a dental material.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided. This is typically relevant for studies where a "ground truth" needs to be established through expert consensus, which wasn't the method for evaluating this dental material.
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 and not provided. This type of study is relevant for diagnostic devices involving human interpretation, especially AI-assisted ones. BISCOVER LV is a dental material, not a diagnostic tool, and involves no "human readers" in this context.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable and not provided. This is relevant for AI algorithms, which BISCOVER LV is not. The evaluation of BISCOVER LV involved direct testing of its material properties and comparison to a predicate device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" in this context is the established characteristics and performance of the predicate device (BISCOVER Liquid Polish). The "study" (or rather, the testing) aimed to show that BISCOVER LV possessed similar or identical properties (intended use, chemical composition, mechanical/physical properties) and was biocompatible.
8. The sample size for the training set
This information is not applicable and not provided. Dental materials are not "trained" like AI algorithms. Their properties are inherent to their formulation and manufacturing process, and verified through laboratory and biocompatibility testing.
9. How the ground truth for the training set was established
This information is not applicable and not provided. As above, the concept of a "training set" and "ground truth for a training set" does not apply to the evaluation of this dental material. The "ground truth" for the comparison was derived from the characteristics of the legally marketed predicate device.
Summary of the Study/Evaluation:
The provided document describes a substantial equivalence determination rather than a traditional clinical study with defined performance metrics against a ground truth as one might expect for a diagnostic device. The "study" involved:
- Comparison of properties: Side-by-side comparison of BISCOVER LV's intended use, chemical composition, and mechanical/physical properties with those of the predicate device, BISCOVER Liquid Polish.
- Biocompatibility testing: BISCOVER LV was tested and found to be non-toxic.
The conclusion drawn is that BISCOVER LV is "substantially equivalent" to BISCOVER Liquid Polish, satisfying the requirements for 510(k) clearance based on its safety and efficacy being comparable to a legally marketed device. Specific details on the methodologies (e.g., how many samples were tested for viscosity or surface smoothness, what exact biocompatibility tests were performed) are not included in this summary.
§ 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.