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• Direct, light cured composite and compomer restorations.
• Light cured resin cemented veneers.
• Composite, ceramic and amalgam repairs.
• Cavity varnish for use with fresh amalgam.
• Indirect restorations and endodontic posts cemented with Calibra® Ceram.
• Desensitization of exposed dentin.
• Surface treatment of zirconia, metal, and composite.
  In combination with DENTSPLY Self Cure Activator:
• Direct dual cure / self-cure composite restorations and core build-ups.
• Cementation of indirect restorations and endodontic posts using dual cure / self-cure resin cements.

Prime&Bond active™ Universal Adhesive is a (meth) acrylate-based material which functions as a combined etch-and-rinse (Total-Etch), selfetch and selective-etch dental adhesive. It offers a simple adhesive application technique for both direct and indirect indications and bonds to enamel, dentin, composites, zirconia, and metals. When used with DENTSPLY Self Cure Activator, Prime&Bond active™ Universal Adhesive is compatible with dual cure / self-cure resin cements, composites and core build-ups materials. Prime&Bond active™ universal adhesive offers operators the choice of enamel and dentin pre-treatment: Self-etch mode: no phosphoric acid etching prior to application; Selective enamel-etch mode: selective phosphoric acid etching of enamel; Etch-and-rinse mode: phosphoric acid etching of both enamel and dentin.

The provided text describes the regulatory clearance for the "Prime&Bond active™ Universal Adhesive" and focuses on demonstrating substantial equivalence to a predicate device. This document does NOT contain information about a study proving the device meets specific acceptance criteria in the context of AI/ML device performance (e.g., accuracy, sensitivity, specificity, or human-in-the-loop improvement).

The document is a 510(k) summary for a dental adhesive, which is a physical material, not an AI/ML software device. Therefore, the questions related to AI/ML device performance metrics, sample sizes for test/training sets, ground truth establishment, expert adjudication, and MRMC studies are not applicable to the content provided.

However, I can extract information regarding the non-clinical performance data that was submitted to demonstrate substantial equivalence, which serves as the "study that proves the device meets the acceptance criteria" in this context.

Here's a breakdown based on the information provided, reinterpreting "acceptance criteria" and "study" to fit the type of device and submission:

1. Table of Acceptance Criteria and Reported Device Performance:

The document generally states that the device "satisfactorily met the requirements" of the non-clinical bench testing. Specific acceptance criteria are not numerically detailed in the given text; they are referenced as "requirements" of internal methods or ISO standards. However, the types of tests performed indicate the areas where performance was evaluated.

2. Sample size(s) used for the test set and the data provenance:

• Sample Size: Not specified in the provided text for any of the bench tests.
• Data Provenance: The tests are described as "in vitro bench tests" and "non-clinical bench testing." The location and retrospective/prospective nature are not stated, but "in vitro" implies laboratory-based testing.

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

• Not applicable. This is a material-based device, not an AI/ML diagnostic tool requiring expert ground truth for imaging or similar data. The "ground truth" for these tests would be the measured physical and chemical properties themselves, verified by standard laboratory procedures.

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

• Not applicable, as this is not an AI/ML diagnostic device requiring adjudication of expert interpretations.

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. This is not an AI/ML device.

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

• No. This is not an AI/ML device.

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

• For the physical properties tests: The "ground truth" is established by the methods themselves (e.g., pH meter readings, density measurements, force gauges for shear bond strength) against pre-defined internal or ISO standard specifications.
• For biocompatibility: Ground truth is established by the results of standardized biological assays (e.g., cell viability in cytotoxicity tests, chemical identification and quantification in leachable studies) against allowable limits set by standards like EN ISO 10993-1.

8. The sample size for the training set:

• Not applicable. This device does not involve a "training set" in the context of AI/ML.

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

• Not applicable.

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• Final cementation of ceramic, composite, or metal inlays, onlays, crowns, bridges, posts, and screws.
• Final cementation of ceramic, composite, or metal restorations on implant abutments.
• Permament cementation of ceramic or composite veneers.

EDS Universal Cement is an automix, dual-curing, self-adhesive resin cement. This multi-purpose device can be used to affix a variety of ceramic, composite, or metal restorations without the aid of an etchant or bonding agent. The device is comprised of two pastes (base and catalyst) that contain dimethacrylate resins, inorqanic filler particles (60% by wt), and a photoinitiator system. The mixing ratio is roughly 1 part base to 1 part catalyst. The device is packaged in a 5 mL dualbarreled syringe and comes in three shades: translucent (white), opaque (white), and A2 (tooth colored). EDS Universal Cement provides a bond between tooth surfaces (dentin and enamel) and ceramic, composite, and metal restorations. The device provides radiopacity and is resistant to mechanical stress and water damage. EDS Universal Cement is provided non-sterile and has a shelf-life of two years.

The provided document is a 510(k) premarket notification for a dental cement (EDS Universal Cement). It does not describe an AI/ML powered device, nor does it contain information about acceptance criteria or a study proving the device meets said criteria in the context of AI/ML performance metrics.

However, based on the document, I can extract information related to product testing and equivalence to predicate devices, which serves a similar purpose to acceptance criteria and studies in regulatory submissions for traditional medical devices.

Here's an interpretation of the request using the available information for a non-AI/ML device:

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

The document does not explicitly state "acceptance criteria" with numerical thresholds for performance. Instead, it relies on demonstrating equivalence to a legally marketed predicate device (Unicem HM). The performance is reported through a series of tests against this predicate.

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

The document does not specify the exact sample sizes for the individual tests (e.g., number of samples for shear bond strength, number of animals for in vivo tests). It generally refers to "samples of the subject and predicate devices."

The data provenance is not explicitly stated in terms of country of origin. The study types (biocompatibility, physical properties, adhesion) are all non-clinical in vitro or in vivo (animal) studies, not human clinical studies. Therefore, it is retrospective if the tests were performed on pre-existing batches or prospective if the tests were designed specifically for this submission. The summary does not provide this detail.

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

This concept is not applicable here as these are laboratory-based non-clinical tests for a dental cement, not diagnostic or AI performance evaluation studies requiring expert ground truth. The "ground truth" for these tests would be the established scientific methods and measurements.

4. Adjudication method for the test set

Not applicable for non-clinical laboratory tests. The results are typically objectively measured according to standardized protocols (e.g., ISO standards for biocompatibility, universal testing machine for shear bond strength).

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 is a dental cement, not an AI-powered diagnostic device.

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

Not applicable. This is a dental cement, not an AI-powered device.

7. The type of ground truth used

For biocompatibility tests, the ground truth is established by ISO (International Organization for Standardization) standards (e.g., ISO 10993 series), which define acceptable biological responses.

For physical properties and adhesion tests, the "ground truth" is measured physical and material properties derived from standardized laboratory testing methods (e.g., shear bond strength in MPa). The comparison is against the predicate device's performance under similar testing conditions.

8. The sample size for the training set

Not applicable. This is a traditional medical device, not an AI/ML system requiring a training set.

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

Not applicable. This is a traditional medical device, not an AI/ML system.

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DuoLink II is a dual-cured, radio-apparent composite luting cernent.

The indications of use of DuoLink II are to cement:

• 1. All indirect restorations (ie. crowns, bridges, inlay, and onlays fabricated from metal composite, porcelain, ceramic, zirconia, alumina, etc)
• 2. All endodontic posts (ie. fiber, composite, and metal)
• 3. All abutments (ie. screws)

DuoLink II is a dual-cured, radio-apparent composite luting cement.

This document describes the DuoLink II Composite Luting Cement, a dental device cleared by the FDA. The submission for this device is a 510(k) premarket notification, which demonstrates substantial equivalence to legally marketed predicate devices rather than proving independent safety and efficacy through a standalone study with defined acceptance criteria and performance metrics.

Therefore, the requested information regarding acceptance criteria, specific study details (sample sizes, expert ground truth, adjudication, MRMC, standalone performance), and training set information is generally not applicable in the context of a 510(k) submission for a device like DuoLink II.

A 510(k) submission primarily focuses on comparing the new device's technological characteristics and performance data to established predicate devices to claim substantial equivalence.

Here's an adaptation of the requested table and explanation based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: For a 510(k) submission, "acceptance criteria" are typically met by demonstrating that the new device performs "as well as or better than" its predicate devices, rather than meeting specific numerical thresholds set independently. The "reported device performance" in this context refers to the comparative data presented.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not specified. The document refers to "testing" for physical/mechanical properties and biocompatibility, but the sample sizes for these tests are not provided.
• Data Provenance: The studies appear to be laboratory-based tests conducted to evaluate chemical, physical/mechanical, and biocompatibility aspects. The country of origin and whether they are retrospective or prospective are not detailed. These are likely internal or contract lab studies performed for the submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

• Not Applicable. For a 510(k) submission for a dental cement, ground truth in the sense of expert consensus on clinical outcomes or diagnoses is usually not established. The "ground truth" for the performance data derives from standardized laboratory tests (e.g., ISO standards) and material science principles.

4. Adjudication Method for the Test Set

• Not Applicable. As the "test set" primarily refers to laboratory measurements, there is no expert adjudication method like 2+1 or 3+1 typically used for clinical endpoints or diagnostic accuracy.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No. An MRMC study was not conducted as this is a dental cement, not a diagnostic imaging device. The "comparative effectiveness" is established through laboratory performance comparisons with predicate devices, not human reader performance.

6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance)

• Not Applicable. This device is a material (dental cement), not an algorithm or AI system. Its performance is inherent to its physical, chemical, and biological properties, not a computational output.

7. Type of Ground Truth Used

• The "ground truth" for demonstrating substantial equivalence relies on:
  • Standardized Laboratory Testing: Adherence to standards like ISO 4049:2009 for physical/mechanical properties and ISO 10993-1 for biocompatibility.
  • Chemical Analysis: Comparison of chemical composition to established, legally marketed predicate devices.
  • Predicate Device Performance: The established performance and safety profile of the predicate devices (DuoLink K934596, Calibra K040906, Self-Adhesive Luting Cement K093338) serve as the benchmark for the new device.

8. Sample Size for the Training Set

• Not Applicable. This is a material device; there is no "training set" in the context of machine learning. The term "training set" is not relevant here.

9. How the Ground Truth for the Training Set Was Established

• Not Applicable. As there is no training set, this question is not relevant.

Summary Explanation:

The provided document is a 510(k) summary for a dental cement. The purpose of a 510(k) submission is to demonstrate "substantial equivalence" to a legally marketed predicate device, not to prove de novo safety and effectiveness through extensive clinical trials with specific acceptance criteria as you might find for novel high-risk medical devices or AI/ML-based diagnostics.

The "study" in this context comprises various laboratory tests (chemical composition analysis, physical/mechanical property evaluation including ISO 4049:2009, and biocompatibility testing per ISO 10993-1) which are designed to show that DuoLink II functions similarly to and is as safe and effective as its predicate devices. The "acceptance criteria" are implicitly met by showing that the new device is "as well as or better than" the predicate devices in these measured aspects. The FDA's clearance (K101787) indicates that this substantial equivalence was successfully demonstrated.

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