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This product is a cordless motor handpiece system intended for tightening and loosening an abutment screw to fix and remove the abutment on a dental implant in prosthodontic treatment.

The Cordless Prosthodontic Screwdriver with Torque Calibration System consists of the cordless motor handpiece, the contra angle head, and the quick charger. The motor handpiece and the contra angle head are connected via a proprietary coupling. The dental professional can select various settings such as: ON/OFF; forward/reverse; speeds of 15, 20, or 25 rpms; and torque settings between 10 and 40 N·cm.

The provided text is a 510(k) summary for the Nakanishi iSD900 Cordless Prosthodontic Screwdriver with Torque Calibration System. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain the detailed information requested regarding specific acceptance criteria for performance, a study proving those criteria were met, sample sizes for test/training sets, expert qualifications, ground truth establishment, or comparative effectiveness studies.

The "Performance Testing" section states: "The iSD900 Prosthodontic Screwdriver was developed and is produced under consideration of all applicable technical standards and internal specifications. The product's conformance with the applicable technical standards and internal specifications was verified in the course of bench testing and software validation testing."

This statement indicates that performance testing was conducted, but it does not provide the specific results, acceptance criteria, or methodology that would allow for filling out the requested table and details. This document is a regulatory submission summary, not a detailed study report.

Therefore, I cannot provide the requested information based solely on the text provided. The document explicitly states that performance was "verified in the course of bench testing and software validation testing" with "applicable technical standards and internal specifications," but it doesn't detail what these standards or specifications were, nor the results of those tests.

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