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Indicated for

• Cavity Classes III, IV, V, and VI .
• Cavity Classes I and II where the cavity preparation is less than ½ of the intercuspal distance

DYRACT® EXTRA RESTORATIVE is a hybrid resin-DEVICE DESCRIPTION: DEVICE DESCREATIve material for use in filling all dental cavity classes. The direct Composite Testorative maingle paste that is filled into a cavity in increments up to 2 mm before visible light curing.

The provided text is a 510(k) summary for the DENTSPLY International DYRACT® EXTRA RESTORATIVE dental material. This type of submission identifies a device's substantial equivalence to a predicate device and does not typically include detailed studies with acceptance criteria, sample sizes, ground truth establishment, or comparative effectiveness studies as would be found in a Premarket Approval (PMA) application or a more extensive clinical trial report.

Therefore, many of the requested details about acceptance criteria and study particulars are not available in the provided document. The 510(k) process focuses on demonstrating substantial equivalence to a previously legally marketed predicate device, rather than proving performance against specific acceptance criteria through novel studies.

Here's a breakdown of the information that can be extracted or inferred, and what is not available:

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

• Not Available. The 510(k) summary does not provide specific acceptance criteria or reported device performance in the manner of a clinical trial or engineering specification study. Instead, it states that the device's components are "present in marketed devices and found to be safe for dental use" and that "the prop and of the support the safety and effectiveness of DYRACT® EXTRA RESTORATIVE for the indicated uses." This suggests reliance on the predicate device's established performance and the known safety of the components.

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

• Not Available. This information pertains to a specific study, which is not detailed in the 510(k) summary. Given the 510(k) nature, a test set in the context of device performance testing (beyond perhaps material property testing, which isn't detailed here) would likely not have been part of this submission.
• Data Provenance: Not specified.

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 / Not Available. Ground truth establishment by experts for a test set is relevant for diagnostic or AI-assisted devices where human interpretation is being compared or enhanced. This device is a dental restorative material. Its effectiveness and safety would typically be assessed through material science testing, biocompatibility studies, and potentially clinical observations over time, not through expert consensus on interpretations.

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

• Not Applicable / Not Available. Similar to point 3, adjudication methods are typically used in studies involving human interpretation or subjective assessments. This is not relevant for a dental restorative material's submission based on substantial equivalence.

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. MRMC studies are used for diagnostic imaging devices, particularly those involving AI. This device is a dental restorative material, so an MRMC study is not relevant.

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

• Not Applicable. This question relates to AI or automated diagnostic algorithms. This device is a dental restorative material, not an algorithm.

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

• Not Applicable / Not Available. For a restorative material, "ground truth" might refer to material properties meeting specifications, clinical success rates (e.g., retention, absence of secondary caries, patient satisfaction), or biocompatibility assessments. The document does not specify these types of "ground truth" or how they were established or evaluated in a study. The primary "ground truth" for a 510(k) in this context is the predicate device's established safety and effectiveness.

8. The sample size for the training set

• Not Applicable / Not Available. This question relates to machine learning models. This device is a dental restorative material and does not involve a training set for an algorithm.

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

• Not Applicable / Not Available. As above, this question relates to machine learning models, which are not relevant to this device.

In summary:

The provided 510(k) summary for DYRACT® EXTRA RESTORATIVE aims to demonstrate substantial equivalence to predicate devices (Dyract® AP Restorative, K973235 and Quixx® Posterior Restorative, K040144). It asserts that the components are common, safe, and effective. The submission does not include details of specific performance studies, test sets, or ground truth establishment that would be characteristic of a more rigorous clinical trial for a novel device or an AI-powered diagnostic tool.

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