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Chairside® Attachment Processing Material is a dual cure (either self or UV light) pink composite used to process attachments in a chairside or laboratory procedure.

Chairside Attachment Processing Material is a composite that is used to secure denture cap attachments into dentures. These attachments are commonly used in conjunction with dental implants to assist in affixing dentures to the wearer. Chairside Attachment Processing Material can be used chairside (to pick up the attachments from the mouth of the patient) or in a laboratory setting (using a model of the patient's mouth).

The provided text describes a medical device (Chairside® Attachment Processing Material) seeking 510(k) clearance, which is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed predicate device. This type of submission focuses on demonstrating equivalence rather than establishing novel acceptance criteria and proving they are met through a dedicated study.

Therefore, the document does not contain the acceptance criteria or a study designed to prove the device meets specific performance metric acceptance criteria in the way typically seen for a new or significantly modified device where extensive clinical or standalone performance studies against predefined targets are conducted.

Instead, the submission demonstrates "substantial equivalence" to predicate devices based on:

1. Similarities in Usage and Design: The device has the same intended use, operating principle, basic design, similar materials, and packaging as predicate devices.
2. Performance Testing against Standards: Non-clinical data, specifically performance testing, was conducted following established ISO standards (ISO 20795-1 and ISO 4049) relevant to dental materials. This testing aims to show that the device performs similarly to or within the acceptable range for such materials, as represented by the predicates.

Here's a breakdown of the requested information based on the provided text, with explicit notes where the requested information is absent:

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

• Note: The document only states that these tests were performed and that the data "demonstrates substantial equivalence." It does not provide the specific numerical acceptance criteria for each test or the exact performance results of the Chairside® Attachment Processing Material against those criteria. This level of detail is often found in the full 510(k) submission, not typically in the summary.

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

• Sample Size for Test Set: Not specified. The document mentions "non-clinical data" and "performance testing" based on ISO standards. These standards prescribe sample sizes, but the specific number of samples tested for each property (flexural strength, water sorption, etc.) is not detailed in this summary.
• Data Provenance: Not specified. The tests were performed to demonstrate substantial equivalence, likely at Zest Anchors, LLC or a contracted lab. The country of origin and whether it was retrospective or prospective is not applicable as these were lab-based performance tests, not clinical studies.

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. This submission is for a material (dental composite) and relies on objective, standardized physical/chemical property testing (e.g., flexural strength, water sorption) rather than expert interpretation of data or images to establish a "ground truth."

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

• Not applicable. See point 3. This device does not involve human interpretation or subjective judgment on a test set that would require adjudication.

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 material, not an AI-assisted diagnostic tool. No MRMC study was conducted.

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

• Not applicable. This is a dental material. There is no algorithm or AI component.

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

• Objective Material Property Standards: The "ground truth" or reference for evaluating this device's performance relies on established physical and chemical property standards from ISO (e.g., ISO 20795-1, ISO 4049) for comparable dental materials. The performance metrics themselves (e.g., specific flexural strength values) are the "truth" against which the device is measured to demonstrate substantial equivalence to predicates.

8. The sample size for the training set

• Not applicable. There is no "training set" as this is a material, not a machine learning algorithm.

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

• Not applicable. There is no "training set" for this type of device.

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