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TESCERA Opaquer/Sculpting Resin is a pre-wetting agent for placing and sculpting layers of composites.

When mixed with TESCERA Opaquer Powder, TESCERA Opaquer/Sculpting Resin is a dual-cured material (light/heat) used to opaque/mask metal substrates and other materials used in dental restorations.

TESCERA Opaquer/Sculpting Resin is a dual-cured (light/heat), low viscosity resin for used for wetting composite instruments. With TESCERA Opaquer Powder, TESCERA Opaquer/Sculpting Resin is a dual-cured (light/heat) tooth colored opaquing/masking composite system specially formulated to opaque/mask the substrates used in dental restorations.

This document describes a 510(k) premarket notification for a dental device, comparing it to predicate devices. It does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria through empirical testing with a defined sample size, ground truth, or expert evaluation.

The provided text focuses on establishing substantial equivalence based on intended use, chemical composition, and mechanical/physical properties compared to existing legally marketed devices, rather than a clinical or performance study with defined acceptance criteria.

Therefore, I cannot fulfill your request for information regarding acceptance criteria and a study proving the device meets those criteria because the provided text does not contain this type of data.

Specifically, the document states: "Side by side comparisons of TESCERA Opaquer/Sculpting Resin and Opaquer Powder to the predicate devices D/C OPAQUER and MODELING RESIN clearly demonstrate that the applicant device is substantially equivalent to the legally marked devices. TESCERA Opaquer/Sculpting Resin and Opaquer Powder were tested for biocompatibility and they were found to be non-toxic. It is concluded that the information supplied in this submission has proven the safety and efficacy of TESCERA Opaquer/Sculpting Resin and Opaquer Powder." This indicates a comparison for substantial equivalence and biocompatibility testing, not a performance study with acceptance criteria.

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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.

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.

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