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Used as an impression material in a dual phase impression technique. It may also be used for precise duplication of models. Use Regular Set for capturing multiple unit impressions. It is suitable for all impression techniques where the operator needs a heavy viscosity material. Use Fast Set for capturing one preparation only (single unit crown); ideal for double arch dual phase techniques.

In a two-part catalyst/base hydrophilic vinylpolysiloxane impression material. It is formulated for regular set and fast set. This impression material is a heavy viscosity and is available in (1:1 ratio) cartridges or (5:1 ratio) for bulk delivery.

This 510(k) summary describes a modification to an existing dental impression material, Aquasil Rigid™ Smart Wetting Impression Material (K970433), rather than a new AI/ML device. Therefore, the detailed information requested regarding acceptance criteria and studies for an AI/ML device (e.g., sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment) is not applicable or available in the provided text.

The submission focuses on demonstrating substantial equivalence to the predicate device based on material composition and biocompatibility, not on a performance study of AI/ML capabilities.

Here's an attempt to fill only the relevant (and very limited) information based on the provided text, acknowledging that most questions are not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not Applicable. The submission describes biocompatibility testing for a dental impression material, not a study involving a "test set" in the context of AI/ML or a clinical performance study with human subjects.

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

• Not Applicable. The concept of "ground truth" established by experts is not relevant to the type of biocompatibility testing described.

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

• Not Applicable. Adjudication methods are not relevant to biocompatibility 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:

• Not Applicable. This is not an AI-assisted device.

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

• Not Applicable. This is not an AI algorithm.

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

• Not Applicable. For biocompatibility, the "ground truth" would be the observed biological response according to standardized in vitro or in vivo tests, not expert consensus or pathology in a clinical sense.

8. The sample size for the training set:

• Not Applicable. This is not an AI/ML device, so there is no training set.

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

• Not Applicable. This is not an AI/ML device, so there is no training set or associated ground truth establishment process.

Summary based on the provided text:

The submission for AQUASIL ULTRA RIGID SMART WETTING IMPRESSION MATERIAL (K021413) is a 510(k) premarket notification for a modification to an existing dental impression material. The focus is on demonstrating substantial equivalence to a predicate device (Aquasil Rigid™ Smart Wetting Impression Material, K970433).

The primary "study" mentioned for the modified device is biocompatibility testing. This testing evaluated:

• Uncured material: Cytotoxicity
• Cured material: Cytotoxicity, mutagenicity, irritation, and sensitization

The device passed all these biocompatibility tests. This is the extent of the "device performance" described in the provided document. The basis for safety and effectiveness is that the components have been used in legally marketed devices or found safe for use, and the modified device passed biocompatibility testing, supporting its substantial equivalence to the predicate.

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