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Cut Screw - Percutaneous Compression Screw are single use devices indicated for fixing and stabilizing the bones of the mid foot, metatarsal and phalanges of the foot using an appropriate relation bone-screw size.

The Cut Screw - Percutaneous Compression Screw for bone synthesis, with a hole in the center in order to allow the passage of the guide wire, thus facilitating its placement, as the surgeon is able to verify the positioning of the screw through the radiological image of the guide wire before its placement. In addition, the Cut Screw -Percutaneous Compression Screw, provides anatomical reduction, stable fixation, and preservation of blood supply by using a percutaneous incision. The screws have a hexagonal connection for a wrench. They are found in a variety of diameters to meet the range of anatomies of the patients, are presented in Titanium Alloy according to the standard ASTM F136, it could be provided in sterile condition sterilized by Ethylene Oxide or non-sterile condition to end user and must be cleaned, and steam sterilized before use.

The provided document is a 510(k) Premarket Notification for a medical device called "Cut Screw - Percutaneous Compression Screw." This document focuses on demonstrating substantial equivalence to an already legally marketed device (predicate device) rather than clinical performance (e.g., diagnostic accuracy of an AI/ML algorithm). Therefore, the information requested in your prompt, which pertains to the acceptance criteria and study design for proving the performance of a device, particularly for AI/ML-based medical devices, is not present in this document.

Specifically, the document states:

• "No clinical data were included in this submission." (page 5)
• The performance data provided is limited to non-clinical mechanical testing (Torsional Properties, Driving Torque, Axial Pullout Strength per ASTM F543) to demonstrate safety and efficacy in terms of mechanical properties. (page 5 & 6)

Therefore, I cannot provide answers to the questions regarding acceptance criteria, study types (MRMC, standalone), ground truth, sample sizes for test/training sets, or expert qualifications as these are not relevant to this type of device submission as described in the provided text.

The document's purpose is to show similarity in design, materials, and mechanical performance to an already approved device, rather than proving a new diagnostic or therapeutic capability through clinical studies.

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