(338 days)
Smartcord is knitted retraction cord made from 100% cotton for the temporary gingival retraction.
Smartcord X is knitted retraction cord made from 100% cotton, impregnated with Aluminum Chloride for the temporary gingival retraction and hemostasis of the gingival margin.
Smartcord is non-impregnated knitted retraction cord made from 100% cotton. Smartcord X is knitted retraction cord made from 100% cotton, impregnated with Aluminum Chloride Hexahydrate.
The provided document is a 510(k) summary for the medical devices Smartcord and Smartcord X. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed acceptance criteria and a study proving the device meets those criteria.
Therefore, many of the requested sections about acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, multi-reader multi-case studies, and standalone performance results are not available in this type of document.
Here's an analysis based on the information available in the document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly define specific performance acceptance criteria (e.g., minimum tensile strength, specific retraction efficacy metrics) or report quantitative results for the device against such criteria. Instead, it relies on demonstrating equivalence in material composition, intended use, and general properties to the predicate device.
The "performance" described is in the context of biocompatibility testing, which confirmed the device is biocompatible as directed.
| Acceptance Criteria (Not Explicitly Stated, Inferred from Equivalence) | Reported Device Performance (Summary from Biocompatibility) |
|---|---|
| Biocompatible for gingival sulcus contact ( |
N/A