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Direct Bonding Applications

• Light-cured composite and compomer restorations. .
• . Composite/ceramic/metal repairs.
• o Cavity sealing for amalgam restorations.
• Sealing of hypersensitive and/or exposed root surfaces. .
• . Core build-ups (self-cured, light-cured, or dual-cured).

Indirect Bonding Applications

• Veneers. .
• . Self-cure, dual-cure, light-cure resin cements and core buildup materials.
• Porcelain, ceramic (including zirconia-based, lithium disilicate-based and . alumina-based), composite, and metal-based (including precious and non-precious metal inlays, onlays, crowns, bridges.
• . Endodontic posts.
• Cavity sealing as a pretreatment for indirect restorations. .

OptiBond eXTRa Universal is a two-component universal adhesive system including a PRIMER and an ADHESIVE. The OptiBond eXTRa Universal PRIMER provides effective etching to enamel and dentin without the need for a separate phosphoric acid etch, thus simplifying the bonding procedure (self-etch technique). OptiBond eXTRa Universal is compatible with total etch and selective etch techniques. The OptiBond eXTRa Universal ADHESIVE is 15% filled with 0.4 micron barium glass to help reinforce bond strength.

The provided document describes the FDA 510(k) premarket notification for the device "OptiBond eXTRa Universal". This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a study design to meet those criteria as would be typical for an AI/ML device.

However, based on the non-clinical performance data and the comparison table, we can infer the acceptance criteria and the "study" (bench testing) that proves the device meets (or is substantially equivalent to) those criteria.

Here's the breakdown:

1. A table of acceptance criteria and the reported device performance

Since this is a substantial equivalence submission for a dental bonding agent and not an AI/ML device, the "acceptance criteria" are implied by demonstrating performance similar to the predicate device. The primary performance metric mentioned is shear bond strength to various substrates, which would have implicit targets aligned with the predicate's known performance.

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

The document does not specify the exact sample size for the shear bond strength testing. It states: "Bench testing was conducted on a variety of self-cure or dual-cure resin cements and core-build up materials." and "OptiBond eXTRa Universal has been tested for its shear bond strength against a variety of materials (including enamel, dentin, and common substrates) in all etching modes."

• Sample Size: Not explicitly stated. The phrase "a variety of" implies multiple samples per test condition.
• Data Provenance: The testing appears to be retrospective (conducted by the manufacturer, Kerr Corporation, likely in a lab environment). The country of origin for the data is not specified, but the manufacturer is based in Orange, California, USA.

The document also mentions these relevant standards for testing:

• ISO 10993-1: 2009 Biological Evaluation of Medical Devices
• ISO 10993-3:2003 Biological Evaluation of Medical Devices- Part 3: Tests for Genotoxicity, Carcinogenicity, and Reproductive Toxicity
• ISO 10993-5:2009 Biological Evaluation of Medical Devices- Part 5: Tests for in Vitro Cytotoxicity
• ISO 10993-6:2007 Biological Evaluation of Medical Devices- Part 6: Tests for Local Effects after Implantation
• ISO 10993-10:2010 Biological Evaluation of Medical Devices- Part 10: Tests for Irritation and Skin Sensitization
• ISO 14971:2007 Risk Management
• ISO 29022:2013* Dentistry Adhesive-Notched Edge Sheer Bond Strength Test - Testing of Adhesion to Tooth Structure

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

This information is not applicable as the device is a dental bonding agent, not an AI/ML device requiring expert ground truth for image interpretation or diagnosis. The "ground truth" for its performance is derived from standardized physical and chemical tests (e.g., measuring bond strength, cytotoxicity).

4. Adjudication method for the test set

This is not applicable as there is no expert adjudication process for this type of device and its performance testing. Performance is measured objectively through lab tests.

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 is not applicable. This is not an AI/ML device, and no MRMC study was conducted. There is no human-in-the-loop performance with this product.

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

This is not applicable. This is not an AI/ML device.

7. The type of ground truth used

The "ground truth" for this device's performance is established through objective laboratory measurements based on international standards for dental materials and biocompatibility:

• Shear bond strength values: Measured using standardized methods (e.g., ISO 29022).
• Biocompatibility test results: Measured as per ISO 10993 standards (e.g., cytotoxicity, genotoxicity, irritation).
• Chemical composition compatibility: Verified through material science and chemical analysis.

8. The sample size for the training set

This is not applicable. This is a physical medical device (dental bonding agent), not an AI/ML algorithm that requires a training set.

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

This is not applicable as there is no training set for this type of device.

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