(63 days)
The intended use of Bisco's Sculpting Resin is as a pre-wetting agent for placing and sculpting layers of composites and between layers of cured composite
SCULPTING RESIN is a light-cured, low viscosity micro filled (30% by weight) resin formulation for use as a composite sculpting resin. It is supplied in a bottle and syringe. It is used on an instrument to reduce tackiness when shaping composites.
The provided documentation describes a 510(k) premarket notification for a dental device, SCULPTING RESIN. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and performance metrics in the way one might for a novel diagnostic or treatment AI.
Therefore, many of the requested categories are not applicable or cannot be fully addressed from the given text. Below is an interpretation based on the information provided, highlighting what is present and what is missing.
1. A table of acceptance criteria and the reported device performance
For a 510(k) submission focused on substantial equivalence, the "acceptance criteria" are implicitly met by demonstrating that the new device is as safe and effective as the predicate device. The performance is reported in terms of characteristics rather than quantitative outcomes against a predefined threshold.
| Acceptance Criteria (Implicit from Substantial Equivalence Claim) | Reported Device Performance (SCULPTING RESIN) | Predicate Device Performance (ULTRADENT COMPOSITE WETTING RESIN) |
|---|---|---|
| Intended Use Equivalence: Device's intended use matches or is substantially similar to predicate. | Wetting resin. | Wetting resin. |
| Product Description Similarity: Key material properties and composition are comparable. | Light-cured, low viscosity (30% filled), Methacrylates resin for use as a composite sculpting resin. | Light cured, low viscosity (45% filled), Methacrylates resin used as a composite sculpting resin. |
| Delivery System Similarity: Method of delivery to the point of use is comparable. | Bottle and syringe. | Syringe. |
| Biocompatibility: Device is non-toxic and safe for intended use. | Tested for biocompatibility and found to be non-toxic. | (Not explicitly stated for predicate in this summary, but presumed safe as legally marketed.) |
| Safety and Efficacy: The device is safe and effective for its intended use. | Concluded that the information supplied has proven the safety and efficacy. | (Presumed safe and effective as a legally marketed device.) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is not a study involving a "test set" of patient data or clinical outcomes. The "testing" referred to is likely in-vitro physical/chemical property testing and biocompatibility testing of the material itself. The document does not specify the sample sizes for these tests, nor their provenance.
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)
Not applicable. "Ground truth" in the context of expert consensus on patient data or images is not relevant for this type of device submission. The "ground truth" for material properties would be established through standard laboratory testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No expert adjudication method is mentioned or relevant to the information provided.
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
Not applicable. This device is a dental material, not an AI or imaging device, so an MRMC study is completely irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth used here pertains to material properties and biocompatibility. This would have been established through:
- Chemical and physical characterization tests: To determine properties like viscosity, fill percentage, and curing characteristics.
- Biocompatibility testing: Standardized in-vitro and/or in-vivo tests to assess for cytotoxicity, sensitization, irritation, etc., according to standards like ISO 10993.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that requires a "training set."
9. How the ground truth for the training set was established
Not applicable. No training set is involved.
§ 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.