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Vista Clear is intended for sulcus retraction prior to impression making and to control bleeding and gingival oozing in restorative and operative dentistry used with gingival retraction cord. Vista Clear facilitates the insertion of the cord into the sulcus.

Vista Clear is used to facilitate sulcus retraction prior to taking a dental impression of a tooth. This entails placement of the device into the sulcus which provides physical displacement of the gingival tissue from the tooth. If using a gingival retraction cord, the subject device facilitates the insertion of the cord into the sulcus while also creating a physical barrier to prevent gingival bleeding and oozing from affecting restorative and tissue management procedures.

The provided text describes a 510(k) premarket notification for a medical device called "Vista Clear." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing extensive clinical trials or performance testing against specific acceptance criteria for efficacy in the same way a novel device might.

Therefore, the document does not contain information on "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of clinical performance or diagnostic accuracy. Instead, the "device performance" described relates to non-clinical testing demonstrating equivalence to a predicate device.

Here's an analysis based on the provided text, addressing your questions to the extent possible, and highlighting what's not present:

Key Takeaway: This 510(k) summary is for a device with a clear physical/chemical function (sulcus retraction, bleeding control) and claims substantial equivalence based on technological characteristics and non-clinical testing, not clinical performance or diagnostic accuracy with human interpretation.

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

The concept of "acceptance criteria" in this 510(k) largely revolves around demonstrating substantial equivalence to the predicate device and meeting relevant non-clinical performance standards. There are no explicit quantitative clinical performance acceptance criteria (e.g., sensitivity, specificity, AUC) stated in the document, as it's not a diagnostic device.

Reported Device Performance (from "Non-Clinical Performance Testing and Compliance"):

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

• Test Set (for non-clinical performance): The document does not specify a "test set" in the context of clinical or diagnostic performance data (e.g., number of patient cases, images). The testing refers to laboratory-based evaluations of the device's material properties, packaging, and stability.
  • Data Provenance: N/A. This is a submission for a new device, and the data provenance refers to materials/engineering tests, not patient data. No country of origin for patient data (as there isn't any provided in text) or retrospective/prospective study type is mentioned as no clinical studies were performed.

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

• N/A. This information is relevant for studies involving human interpretation or diagnostic accuracy. For this type of device and 510(k) submission, ground truth relates to the results of objective laboratory tests (e.g., is it cytotoxic?), not expert consensus on clinical findings.

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

• N/A. As no expert consensus or human interpretation of clinical cases was performed, no adjudication method is relevant or described.

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

• N/A. This device is a dental material, not an AI or diagnostic imaging device. Therefore, no MRMC study was conducted or is applicable.

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

• N/A. This is not an algorithm-based device.

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

• The "ground truth" for this device is based on objective laboratory test results (e.g., analytical chemistry, toxicology, microbiology, stability) that confirm the material properties, safety, and functionality of the device compared to established scientific principles and the predicate device's known characteristics. It's not clinical outcomes or expert labels.

8. The sample size for the training set

• N/A. This term is relevant for machine learning models. No training set is applicable for this type of medical device submission.

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

• N/A. As there is no training set, this question is not applicable.

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