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• Missing tooth structure
• Defective restorations

Adhese Universal DC is a dual-curing, single-component dental adhesive for enamel and dentin that is compatible with all etching techniques (self-etch, selective enamel etch, etch & rinse techniques). The areas of application include adhesive cementation of indirect restorations and direct restorative procedures. Adhese Universal DC is available in Free Stand Single Dose units. The applicator is coated with co-initiators required for the self-curing reaction. The initiator and adhesive are mixed together by dipping the applicator into the single dose unit containing the liquid Adhese Universal DC.

The report describes "Adhese Universal DC," a dual-curing dental adhesive. It uses the "Adhese Universal" (K133318) as its predicate device. The information provided heavily focuses on the comparison between the proposed device and the predicate device, especially regarding their working principles, chemical composition, and performance specifications.

Here's an analysis of the provided information concerning acceptance criteria and the study proving adherence:

1. Table of Acceptance Criteria and Reported Device Performance

Deviation Summary: The proposed device, Adhese Universal DC, has a lower acceptance criterion for shear bond strength (Dentin) at ≥20 MPa compared to the predicate's ≥25 MPa. This is explicitly noted in the document, attributing the lower value to the self-curing mode of Adhese Universal DC, which generally exhibits lower values.

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

The document mentions "Bench testing was performed to test the physical property (shear bond strength)." However, it does not provide any specific sample sizes for this testing.

Regarding data provenance, the document does not specify the country of origin of the data. It indicates the testing was "Bench testing," implying laboratory-based testing, but does not clarify if it was retrospective or prospective in data collection approach.

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

This information is not provided as the "test set" and "ground truth" concepts as typically applied to AI/software validation studies (with human experts evaluating outputs) are not relevant here. This is a material science study focused on physical properties, not diagnostic accuracy requiring expert consensus.

4. Adjudication Method for the Test Set

This is not applicable as the study is a bench test measuring physical properties, not a clinical trial or diagnostic accuracy study requiring adjudication of expert opinions.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

This is not applicable. An MRMC study is relevant for assessing human reader performance in conjunction with AI. This document describes the performance of a dental adhesive, not an AI system.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This is not applicable. The device is a dental adhesive, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" in this context is the measured physical property of "Shear bond strength (Dentin)" obtained through laboratory bench testing according to established standards. It's an objective measurement rather than expert consensus, pathology, or outcomes data in the typical sense of AI/diagnostic studies.

8. The Sample Size for the Training Set

This is not applicable. The concept of a "training set" relates to machine learning models. This document describes a physical product, not a software algorithm.

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

This is not applicable for the same reasons as #8.

Summary of the Study and How it Proves Acceptance Criteria:

The study proving the device meets its acceptance criteria is a non-clinical performance bench test. Specifically, it involved measuring the shear bond strength (Dentin) of the Adhese Universal DC in its self-curing mode.

The acceptance criterion for Adhese Universal DC's shear bond strength (Dentin) in self-curing mode was set at ≥20 MPa. While the document states that "The specification for Adhese Universal DC describes lower values (20 MPa) for shear bond strength (dentin) compared to Adhese Universal (25 MPa) due to the self-curing mode," it does not explicitly report the obtained value from the bench testing for Adhese Universal DC. It only states the specification. To definitively prove the device meets the acceptance criteria, the actual measured performance data of Adhese Universal DC on shear bond strength would need to be compared against the ≥20 MPa criterion. The document implies compliance through the "Summary of Performance Specification" which states, "The specification for Adhese Universal DC describes lower values (20 MPa) for shear bond strength (dentin) compared to Adhese Universal (25 MPa) due to the self-curing mode of Adhese Universal DC which generally shows lower values." This statement argues for the reason for the lower criterion but doesn't report the achieved value against that criterion.

The study also included Biocompatibility testing according to ISO 10993-1:2018, ISO 7405:2018, and ISO 14971:2012. The conclusion from this testing was that "The results of the Biocompatibility Assessment for Adhese Universal DC is substantially equivalent to the results of the Biocompatibility Assessment for the predicate device Adhese Universal." This demonstrates the device meets biocompatibility safety criteria by showing equivalence to a legally marketed predicate.

In essence, the study framework described is a comparative non-clinical bench study focusing on physical properties and biocompatibility to establish substantial equivalence to a predicate device for regulatory clearance.

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• Direct-placed light-curing composite and compomer restorations.
• Direct-placed core build-ups with light-, self- and dual-curing composites.
• Repair of fractured composite and compomer restorations.
  – Adhesive cementation of indirect restorations with light- and dual-curing luting composites.
• Sealing of prepared tooth surfaces before temporary / permanent cementation of indirect restorations.
• Desensitization of hypersensitive cervical areas.

Adhese® Universal is a light-curing single-component dental adhesive for enamel and dentin.

The provided text describes the 510(k) summary for the Adhese® Universal dental adhesive. It details its comparison to a predicate device, its intended use, technological characteristics, and testing summary. However, it does not provide detailed acceptance criteria and a study report with the level of detail requested in the prompt, especially for AI/ML device testing.

Here's an analysis based on the information available, and highlighting what is missing in the context of an AI/ML device:

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

Missing Information (Crucial for AI/ML devices): Specific quantitative thresholds for "substantial equivalence" regarding shear bond strength or other performance metrics. The document only states that it was found to be substantially equivalent without detailing how that was determined or the specific numerical results.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Test Set Sample Size: Not explicitly stated. The document mentions "standard shear bond strength method (see ISO 29022 for sample preparation)" but does not specify the number of samples tested for Adhese Universal or the predicate device.
• Data Provenance: Not specified.

Missing Information (Crucial for AI/ML devices): The number of individual teeth or samples tested for bond strength, and their origin (e.g., human cadaveric teeth, bovine teeth, specific age groups, etc.).

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)

This section is not applicable to this device. Adhese® Universal is a dental adhesive, not an AI/ML diagnostic or predictive device that relies on expert interpretation for ground truth. Its performance is measured through physical/mechanical properties like shear bond strength and biocompatibility.

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

This section is not applicable to this device, as it's not an AI/ML device requiring expert adjudication of results. The testing method appears to be laboratory-based physical testing.

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 section is not applicable to this device, as it's not an AI/ML device involving human readers or interpretation.

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

This section is not applicable to this device, as it is a physical dental adhesive, not an algorithm.

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

The "ground truth" for this device's performance would be the direct measurements from laboratory tests:

• Shear bond strength: Measured values (e.g., in MPa) obtained from mechanical testing according to ISO 29022.
• Biocompatibility: Results from tests performed according to ISO 10993 (e.g., cytotoxicity, sensitization, irritation indices).

8. The sample size for the training set

This section is not applicable as this is not an AI/ML device and therefore does not have a training set. The "development" would involve chemical formulation and iterative testing, not machine learning model training.

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

This section is not applicable as this is not an AI/ML device and therefore does not have a training set.

Summary for the provided device in terms of AI/ML criteria:

The provided document describes a dental adhesive (Adhese® Universal), which is a physical material, not an AI/ML device. Therefore, most of the questions related to AI/ML specific testing (such as ground truth establishment by experts, adjudication methods, MRMC studies, training sets, etc.) are not applicable.

The study described (testing for shear bond strength and biocompatibility) is a laboratory-based study comparing the new device against a predicate device to establish substantial equivalence based on physical and biological properties, not cognitive performance. The acceptance criteria are implicitly that the device performs equivalently to the predicate device in these tests. The specific numerical data from these tests is not provided in this summary.

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