(106 days)
Knit-Pak+, a prescription-only, Aluminum Chloride Hexahydrate impregnated cord is used for temporary chemo-mcchanical retraction of gingival tissues and hemostasis of the gingival margin around the tooth. It is intended for accurate and enhanced results when acquiring dental impressions, for cavity preparation or wherever hemostasis and retraction is required.
Knit-Pak+, a prescription-only, Aluminum Chloride Hexahydrate impregnated cord
The provided text is a 510(k) premarket notification letter from the FDA regarding a dental product named "Knit-Pak+". This document is a regulatory approval letter and does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.
The letter confirms that the device is substantially equivalent to legally marketed predicate devices and can be marketed subject to general controls. It also outlines regulatory responsibilities for the company.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the provided text. The requested information regarding sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set information is not present in this document.
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