(125 days)
Vista FS and Vista FS Liquid are 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 FS Liguid facilitate the insertion of the cord into the sulcus.
Vista FS and Vista FS Liquid are medical devices used to facilitate sulcus retraction prior to taking a dental impressions of a tooth. This entails placement of the sulcus which provides physical displacement of the gingival tissue from the tooth. If using a gingival retraction cord, the subject devices facilitate the insertion of the cord into the sulcus while also facilitating the creating of a physical barrier to prevent gingival bleeding and oozing from affecting restorative and tissue management procedures.
The provided text does not contain specific acceptance criteria for performance metrics (such as sensitivity, specificity, or F1 score) or detailed results from a clinical study that would allow a direct comparison to such criteria. Instead, the document focuses on demonstrating substantial equivalence to predicate devices through comparisons of technological characteristics, intended use, and non-clinical performance testing.
Therefore, many of the requested fields cannot be directly extracted from the provided text. However, based on the information available, here's what can be provided:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria in terms of clinical performance metrics. The evaluation is based on demonstrating substantial equivalence to predicate devices. The "reported device performance" in this context refers to the results of non-clinical testing confirming manufacturing, cytotoxicity, shelf-life, microbiological properties, and transit resilience.
| Acceptance Criteria (Implicit from Substantial Equivalence Goal) | Reported Device Performance |
|---|---|
| Manufacturing quality and consistency | Testing verified manufacturing, commensurate with predicate devices. |
| Biocompatibility (Cytotoxicity) | No differences in cytotoxicity compared to predicate device (ViscoStat Clear); same result at all dilutions. |
| Shelf-life stability (interim) | All test data for 18-month time point significantly within test acceptance criteria. |
| Microbiological safety (bactericidal properties) | Exhibit bactericidal properties, mitigating contamination risks and supporting shelf stability. |
| Packaging integrity during transit | Packaging configurations sufficient, product performed satisfactorily post-transit. |
| Clinical performance (equivalent to predicates) | Clinical performance is not deemed necessary given substantial equivalence demonstration based on other factors. |
2. Sample size used for the test set and the data provenance
The document describes non-clinical laboratory testing. It does not refer to a "test set" in the context of clinical data or a patient population. The samples for testing were likely materials from the manufactured devices themselves (e.g., aliquots for analytical testing, cell cultures for cytotoxicity). No information on the country of origin of data or whether it was retrospective or prospective is provided, as these are not relevant to the described non-clinical tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This information is relevant for studies relying on expert-derived ground truth, typically in image analysis or diagnostic scenarios. The provided document concerns non-clinical testing of a dental product.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are used in studies involving human interpretation or subjective assessments, which are not described in this document for the evaluation of this dental product.
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 a dental product (sulcus retraction material) and not an AI-assisted diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a dental product and not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the non-clinical tests described would be the established scientific standards and methods for analytical chemistry, cytotoxicity assessment, stability testing, and microbiological evaluation. For example, for cytotoxicity, the "ground truth" is typically determined by observing cell viability and growth inhibition according to standardized protocols (e.g., ISO 10993).
8. The sample size for the training set
Not applicable. There is no mention of a "training set" as this document describes non-clinical testing of a physical medical device, not a machine learning model.
9. How the ground truth for the training set was established
Not applicable. As there is no training set for a machine learning model, this question is not relevant to the provided document.
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