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• Direct fillings of Class I to V restorations
• Shape and shade corrections

Zircos-com is light-cured, radiopaque hybride composite resin. Zircos-Com is hybride composite resin for anterior and posterior restorations. Zircos-Com is reinforced filler composite.

The provided text does not contain information about acceptance criteria for a device's performance, nor does it describe a study proving the device meets specific performance criteria.

Instead, the document is a 510(k) Summary for a dental composite material called "Zircos-Com," aiming to demonstrate its substantial equivalence to a predicate device ("Grandio SO"). The focus is on comparing the proposed device's characteristics (clinical, technical, and biological) to a legally marketed predicate device, rather than establishing numerical performance metrics against specific acceptance criteria.

The "Non-Clinical Test Conclusion" section (Item 5 on page 4) lists several biocompatibility tests conducted according to ISO standards, but these are for safety and biological compatibility, not functional performance. The conclusion states these tests verify the device "met all design specifications" and was "Substantially Equivalent (SE) to the predicate device," but no specific performance values or acceptance criteria are presented.

The "Clinical Test Conclusion" section (Item 6 on page 4) explicitly states: "No clinical study is included in this submission."

Therefore, I cannot provide the requested information based on the provided text, as it does not contain:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for a test set, data provenance, ground truth establishment for a performance study.
3. Number of experts or their qualifications for establishing ground truth.
4. Adjudication method for a test set.
5. Information on a multi-reader multi-case (MRMC) comparative effectiveness study or human reader improvement with AI.
6. Information on a standalone algorithm performance study.
7. Type of ground truth used for performance evaluation.
8. Sample size for a training set or how its ground truth was established.

The document's purpose is to show that a new device is as safe and effective as an existing one, not to quantify its performance against a new set of criteria in a clinical or standalone study.

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