Search Results

belleGlass HP Enamel 2 is a dual cured composite material for use with the belleGlass HP (heat and pressure) crown and bridge fabrication system to produce high wear resistance and permanent surface luster for composite crowns and bridges.

belleGlass HP Enamel 2 is dual cured composite material for use with the belleGlass HP (heat and pressure) crown and bridge fabrication system to produce high wear resistance and permanent surface luster for composite crowns and bridges. The belleGlass HP crown and bridge fabrication system is comprised of a!! the components necessary for a dental laboratory to fabricate composite resin-based crowns and bridges and cure them using both light activation combined with a final heat and pressure curing cycle in the belleGlass HP automatic curing device.

The provided text is related to a 510(k) premarket notification for a dental restorative material, "belleGlass HP Enamel 2." This document focuses on demonstrating substantial equivalence to a predicate device and securing market clearance from the FDA.

Crucially, this document does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or MRMC studies. The information provided is for regulatory clearance based on substantial equivalence, not for a clinical or performance study demonstrating the device meets specific acceptance criteria in the way described in the prompt.

Therefore, I cannot extract the requested information from the provided text.

To answer your request, the document would need to include details of a study that measured specific performance metrics (e.g., wear resistance, bond strength, flexural strength) for belleGlass HP Enamel 2, compared these metrics against predefined acceptance criteria, and provided details on the study design, data, and analysis.

Ask a specific question about this device

Ask a specific question about this device

BelleGlass Dual Cure Enamel Repair Resin is indicated for use with the BelleGlass HP Heat + Pressure Cure Composite Crown and Bridge Fabrication System when it is necessary to perform minor adjustments or repairs to an appliance during the fabrication procedure.

BelleGlass HP Dual Cure Enamel Repair Material is a reformulation of the heat + pressure cure material to allow the material to be light cured so that it is more stable during the transfer to the Heat + Pressure Curing Device. A very small amount of photoinitiating agent (

The provided text discusses the BelleGlass HP Enamel Repair Material, a dental product, and its reformulation into the BelleGlass HP Dual Cure Enamel Repair Material. The document is a 510(k) summary for a medical device, focusing on demonstrating substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study information provided, noting that much of the requested information (especially regarding clinical study methodology, ground truth establishment, and multi-reader studies) is not applicable or not explicitly detailed for this type of device and submission. This is a material modification that relies on bench testing and biocompatibility assessments, rather than large-scale clinical trials often associated with AI/diagnostic devices.

1. Table of Acceptance Criteria and Reported Device Performance

• Cytotoxicity: Agar Diffusion Test USP
• Mutagenicity: Salmonella Typhimurium REVERSE MUTATION ASSAY (Ames Test) |
  | Efficacy/Performance | Performs "as well or better than" the current heat and pressure cured material for its intended purpose. | "Results of this bench testing indicates that the dual cure material performs as well or better than the heat + pressure cured material." (Actual results provided elsewhere in the submission, not in this excerpt). |
  | Intended Use | Indicated for minor adjustments or repairs to appliances during fabrication in conjunction with the BelleGlass HP system. | "BelleGlass Dual Cure Enamel Repair Resin is indicated for use with the BelleGlass HP Heat + Pressure Cure Composite Crown and Bridge Fabrication System when it is necessary to perform minor adjustments or repairs to an appliance during the fabrication procedure." |
  | Substantial Equivalence | Equivalent to the predicate device (BelleGlass HP Heat and Pressure Cure Enamel Repair Material). | FDA determined the device is "substantially equivalent" to devices marketed prior to May 28, 1976. |

2. Sample size used for the test set and the data provenance

• Test Set Sample Size: Not explicitly stated. The "testing consisted of the following" refers to a biological and efficacy evaluation, not a patient-based test set in the conventional sense. For the biocompatibility tests (Cytotoxicity and Mutagenicity), the sample sizes would be described by the specifics of those assays, which typically involve cell cultures and bacterial colonies. For the efficacy bench testing, the number of samples (e.g., repaired appliances, test specimens) is not provided.
• Data Provenance: The biocompatibility testing was performed by "Independent Laboratory Evaluation by Toxicon Corporation." The efficacy testing was "bench testing." No country of origin for specific "data" is mentioned, as it primarily involves laboratory and bench studies. It is a prospective evaluation of the reformulated product.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable in the context of this submission. This is a material science and biocompatibility assessment, not a diagnostic device requiring expert interpretation for "ground truth" in clinical images or similar data. The ground truth for biocompatibility is established by the standardized protocols of the tests themselves (USP Agar Diffusion Test, Ames Test). The efficacy "ground truth" would be based on measurable material properties and performance against specified criteria in a lab setting, validated by material scientists or engineers, but no specific "experts" for ground truth establishment are mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. As this is not a diagnostic imaging or clinical interpretation study, no adjudication method like 2+1 or 3+1 (which are common in expert consensus for medical image interpretation) would be used. The biocompatibility tests have objective endpoints, and the efficacy bench tests would rely on established measurement protocols.

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

• No. An MRMC comparative effectiveness study is not mentioned and is not relevant for this type of dental material modification submission. This study design is typically used for diagnostic devices, especially those incorporating AI, to assess radiologists' or other clinicians' performance with and without AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• No. This is not an AI/algorithm-based device. "Standalone performance" is not a relevant concept here. The device itself (a repair material) is a physical product, not a software algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Biological Endpoints for Safety: For biocompatibility, the ground truth is based on the objective results of standardized in-vitro tests:
  • Cytotoxicity: Cell viability/response as per USP Agar Diffusion Test.
  • Mutagenicity: Bacterial mutation rates as per Salmonella Typhimurium REVERSE MUTATION ASSAY (Ames Test).
• Bench Testing Results for Efficacy: For efficacy, the ground truth would be based on measured material properties and performance characteristics (e.g., strength, flow, stability, cure characteristics) as compared to the predicate device in a laboratory setting. No "expert consensus" or "pathology" in the diagnostic sense is mentioned.

8. The sample size for the training set

• Not applicable. This device is a material, not a machine learning model, so there is no "training set" in the context of AI or algorithm development. The development process would involve formulation, lab testing, and refinement, but not in the sense of training a model with data.

9. How the ground truth for the training set was established

• Not applicable. As there is no training set for an AI model, this question does not apply.

Ask a specific question about this device