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AQUASIL EASY MIX PUTTY IMPRESSION MATERIAL is used as a tray material in a dual phase impression Technique. It is designed for taking multiple unit impressions of teeth and/or oral tissue.

AQUASIL EASY MIX PUTTY IMPRESSION MATERIAL is a very high viscosity, elastomeric impression material with excellent hydrophilic properties, dimensional accuracy, high tear strength, and resistance to permanent deformation. AQUASIL EASY MIX PUTTY IMPRESSION MATERIAL consists of two-components (base paste and catalyst paste) which harden to form a base for final impressions. AQUASIL EASY MIX PUTTY IMPRESSION MATERIAL with "smart wetting" improves both wetting on the tooth surface and model detail reproduction. AQUASIL EASY MIX PUTTY IMPRESSION MATERIAL is designed to be used with Aquasil Regular Set Impression Materials.

The provided text is a 510(k) Summary for a dental impression material. It describes the device, its intended use, and its technological characteristics. However, it does NOT contain the detailed information necessary to complete the requested table regarding acceptance criteria and a study proving the device meets those criteria, especially for a medical AI/ML device.

The document discusses biocompatibility testing performed on a predicate device (Aquasil Smart Wetting Impression Material, K943574) and uses that information to justify that additional biocompatibility testing for the new device (AQUASIL™ EASY MIX PUTTY IMPRESSION MATERIAL) is unnecessary due to similarity in formulation and components.

Here's a breakdown of what can be extracted and what cannot:

Information that CANNOT be extracted from the provided text for an AI/ML device context:

• Acceptance Criteria Table and Reported Device Performance (for AI/ML metrics): The document discusses biocompatibility of the impression material, not performance metrics like sensitivity, specificity, AUC, etc., that would be relevant for an AI/ML device.
• Sample size for the test set and data provenance: No such information is present as the "study" is about biocompatibility of a dental material.
• Number of experts and their qualifications for ground truth: Not applicable for this type of device.
• Adjudication method: Not applicable.
• Multi Reader Multi Case (MRMC) comparative effectiveness study information: Not applicable.
• Standalone (algorithm only) performance: Not applicable.
• Type of ground truth used (for disease detection/diagnosis): Not applicable.
• Sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

Information that CAN be inferred or extracted related to the device's "study" for biocompatibility:

The "study" referenced is largely a series of biocompatibility tests performed on a predicate device (Aquasil Smart Wetting Impression Material, K943574) and the components of the new device. The new device's acceptance is based on the similarity to its predicate and the prior testing of the predicate.

Here's an attempt to structure what's available, acknowledging its limitations for the requested format:

1. Table of Acceptance Criteria and Reported Device Performance (Biocompatibility related)

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

• The document does not specify sample sizes for these biocompatibility tests.
• Data provenance: The tests were reported in K943574, likely conducted by the manufacturer, but specific country of origin or retrospective/prospective nature isn't detailed for these tests. The results are from prior testing of a predicate device.

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

• Not applicable for these types of biocompatibility tests. Standardized laboratory procedures are followed.

4. Adjudication method for the test set

• Not applicable for these types of biocompatibility tests.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done

• No. This is a biocompatibility assessment of a material, not a diagnostic AI/ML device.

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

• No. This is a material; there is no algorithm.

7. The type of ground truth used

• For biocompatibility:
  • Cytotoxicity: Measured cellular response in vitro.
  • Mutagenicity: Ames test results (bacterial mutation rates).
  • Toxicity: Animal model response (dermal toxicity).
  • Irritation: Animal model response (hamster cheek pouch).
  • These are standard biological endpoints.

8. The sample size for the training set

• Not applicable. There is no AI/ML algorithm or training set for this device.

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

• Not applicable.

Summary of Device and its "Proof of Safety/Effectiveness" based on the document:

The device, AQUASIL™ EASY MIX PUTTY IMPRESSION MATERIAL, is a two-component elastomeric impression material. Its safety and effectiveness are supported primarily by its substantial equivalence to predicate devices, particularly "Aquasil Smart Wetting® Impression Material" (K943574). The justification relies on:

• Identical Components: All components have been used in legally marketed predicate devices or are considered safe for dental use.
• Formulation Similarity: Due to the similarity in formulation to the Aquasil Smart Wetting Impression Material (K943574), additional biocompatibility testing of the new material was deemed unnecessary.
• Predicate Device Biocompatibility Testing: The predicate device (K943574) underwent various biocompatibility tests:
  • Cytotoxicity: Base pastes showed moderate cytotoxicity, catalyst pastes were non-cytotoxic. The mixed product showed persistent but lower cytotoxicity than another predicate (Reprosil®).
  • Mutagenicity (Ames Test): Mixed product was non-mutagenic.
  • Acute Dermal Toxicity Test: Mixed product was non-toxic.
  • Hamster Cheek Pouch Irritation Study: Mixed product was non-irritant.
• Limited Exposure Time: The material is in the mouth for less than ten minutes, which is considered a factor supporting its safety with the established biocompatibility profile.

In essence, the document presents a biocompatibility assessment based on prior testing of a substantially equivalent predicate device, rather than a performance study of an AI/ML diagnostic or treatment planning system.

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