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The PRE-IMPRESSION CONDITIONING SOLUTION is indicated as a preparation conditioning solution for uniform surface wetting prior to elastomeric impression procedures.
Indications for Use: Preparation conditioning solution for uniform surface wetting prior to elastomeric impression procedures

The PRE-IMPRESSION CONDITIONING Solution is a product to be used in the impressiontaking process. When applied to substrates such as sulcular tissue; tooth preparations; ceramic, composite, or metal core build-up material; or implant abutments or copings, it provides a uniform surface condition with reduced surface tension prior to the application of an elastomeric impression material. This standardized surface with reduced contact angle on all impressed substrates allows capture of fine preparation detail both supra and subgingiyally.

This 510(k) summary provides limited information about the device's technical characteristics and studies. Based on the provided text, here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state specific acceptance criteria or quantitative performance metrics for the PRE-IMPRESSION CONDITIONING SOLUTION. Instead, it relies on a comparison to legally marketed predicate devices and the safety of its components.

2. Sample Size Used for the Test Set and Data Provenance

The document does not describe a specific "test set" for the PRE-IMPRESSION CONDITIONING SOLUTION. The basis for clearance appears to be:

• The fact that "All of the components found in PRE-IMPRESSION CONDITIONING SOLUTION have been used in legally marketed devices and are safe for dental use."
• "Prior use of the components of PRE-IMPRESSION CONDITIONING SOLUTION in legally marketed devices and the data provided, support the safety and effectiveness of PRE-IMPRESSION CONDITIONING SOLUTION for the indicated use."

This suggests that the "data provided" likely refers to prior submissions or existing knowledge about the individual components, rather than a new, dedicated study on the final product with a specific test set. Therefore, information on sample size, country of origin, and retrospective/prospective nature is not available.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Given that no specific "test set" for performance evaluation of the final device is described, this information is not applicable/not available from the provided text.

4. Adjudication Method for the Test Set

As no specific "test set" or performance study is described, this information is not applicable/not available from the provided text.

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

The device is a "Pre-Impression Conditioning Solution," a dental material, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC comparative effectiveness study involving human readers or AI assistance is not applicable to this device.

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

The device is a chemical solution, not an algorithm. Therefore, a standalone algorithm performance study is not applicable to this device.

7. The Type of Ground Truth Used

Based on the submission, the "ground truth" for the device's safety and effectiveness seems to be derived from the known safety and efficacy of its individual components, which have been previously used in legally marketed dental devices. There's no mention of specific pathology, outcomes data, or expert consensus being established for the overall product's performance in a new study.

8. The Sample Size for the Training Set

The document does not describe a "training set" for an algorithm, as this is a chemical solution. If "training set" refers to data supporting the safety of individual components, that information is not provided in terms of sample size for this submission.

9. How the Ground Truth for the Training Set was Established

As this is not an AI algorithm and no specific "training set" is described, this information is not applicable from the provided text. The "ground truth" for component safety would have been established through prior regulatory clearances and extensive historical use in dentistry, but the specifics of how for those individual components are not detailed in this 510(k) summary.

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