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Vista Rinse and Vista Rinse Plus are endodontic irrigating solutions that cleanse the root canal system by removing the smear layer after endodontic instrumentation.

Vista Rinse and Vista Rinse Plus are endodontic irrigating solutions that cleanse the root canal system by removing the smear layer after endodontic instrumentation. Both medical devices are packaged in bottles. Clinical use of the medical devices requires the irrigant to be expelled from syringes through irrigation tips, which are class I medical devices per EIC product code (syringe, periodontic, endodontic, irrigating) and CFR regulation number 872.4565 and are 510(k) exempt.

The provided document is a 510(k) summary for the Vista Rinse and Vista Rinse Plus endodontic irrigating solutions. This type of document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with specific acceptance criteria as one might find for a novel medical device. Therefore, much of the requested information regarding a study proving acceptance criteria and specific performance metrics in a clinical context is not explicitly available in this document.

However, I can extract information related to the non-clinical performance testing which served as the basis for demonstrating substantial equivalence.

Here's the breakdown based on the provided text:

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

The document does not define explicit "acceptance criteria" in a quantitative sense as might be found in a clinical trial protocol. Instead, it relies on demonstrating comparable performance to predicate devices through non-clinical testing. The reported device performance is presented as being "commensurate with" or "identical to or better than" the predicate devices.

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

The document does not specify the sample sizes (e.g., number of test specimens, number of wells for cytotoxicity) used for the non-clinical tests.

• Cytotoxicity Testing: No specific sample size is mentioned.
• SEM Evaluation & Calcium Chelation Testing: No specific sample size is mentioned for the SEM evaluations or calcium chelation.
• Data Provenance: The testing was conducted by Inter-Med/Vista Dental Products, the submitter, as part of their 510(k) submission. The exact country of origin or whether the data was retrospective or prospective (for non-clinical lab studies) is not detailed.

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

This information is not applicable. For non-clinical performance testing like cytotoxicity and smear layer removal, the "ground truth" is established by scientific methodologies and laboratory measurements, not by expert consensus. There were no human experts adjudicating test results in this context.

4. Adjudication method for the test set

Not applicable, as there was no human expert adjudication of test results for these laboratory studies.

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 device is an endodontic irrigating solution, not an AI-assisted diagnostic or therapeutic device that would involve human readers or MRMC studies.

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

Not applicable. This device is a medical solution, not a software algorithm.

7. The type of ground truth used

The "ground truth" for the non-clinical performance testing was based on:

• Laboratory measurements and analytical chemistry: For composition verification (analytical testing), pH, and chelation characteristics.
• Standardized biological assays: For cytotoxicity testing (ISO 10993-5:2009).
• Microscopic imaging and qualitative assessment: For smear layer removal (SEM evaluation). The effectiveness was compared to the known performance of predicate devices, which utilize 17% EDTA, considered the "gold standard."

8. The sample size for the training set

Not applicable. This document describes a traditional medical device (chemical solution), not a machine learning or AI-driven device that requires a training set.

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

Not applicable, as no training set was used.

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