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The Pacific Implant Titanium Endodontic Point is intended for use during endodontic therapy to fill permanently the root canal of a tooth.

The product is a titanium endodontic point having the same intended use as endodontic silver points; i.e. to be used during endodontic therapy to fill permanently the root canal of a tooth. The device is fabricated in various endodontic point sizes of titanium CP meeting the ASTM F 67 standard specification for unalloyed titanium for surgical implant applications.

The provided text does not contain information about acceptance criteria or a study proving that a device meets such criteria. The document is a 510(k) summary for a dental device (Pacific Implant Titanium Endodontic Point) and a letter from the FDA determining its substantial equivalence to previously marketed devices. It focuses on regulatory approval and classification rather than performance studies or acceptance criteria for a specific device feature or function.

Therefore, I cannot provide the requested table or answer the questions regarding sample size, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth, or training set details. This information is simply not present in the given text.

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PULPDENT Endo-Prep II is a 17 % EDT A chelating agent used for debriding and clearing the root canal during endodontic procedures. EDTA aids in the filing process by chelating calcium from dentin.

PULPDENT Endo-Prep II is a 17 % EDT A chelating agent used for debriding and clearing the root canal during endodontic procedures. EDTA aids in the filing process by chelating calcium from dentin. PULPDENT Endo-Prep II will be offered in two viscosities, thin and thick, so that the dentist can apply the product either directly to the canal ovening or to the file.

This document does not contain information about acceptance criteria or a study proving that a device meets those criteria. The provided text is a "SUMMARY OF SAFETY AND EFFECTIVENESS DATA" for a dental product called PULPDENT Endo-Prep II, which is a chelating agent used in root canal procedures.

The document focuses on comparing PULPDENT Endo-Prep II to predicate devices, stating its substantial equivalence in composition and intended use. It references a publication by the American Dental Association regarding the general effectiveness of EDTA as a chelating agent.

Therefore, I cannot fulfill the request to describe acceptance criteria and a study based on the provided text, as this information is not present.

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