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The MECRON™ Cannulated Screw System is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, ligament fixation, fracture repair and fracture fixation, appropriate for the device.

The MECRON™ Cannulated Screw System consists of headed and headless bone screws and corresponding washers. The screws are offered in diameters from 2.0mm thru 7.0mm (in 0.5 mm increments) and overall lengths from 8 mm (for smaller diameters) thru 120 mm (for larger diameters). The cannulated screws have self-tapping and self-drilling features and are manufactured from medical grade titanium alloy (per DIN EN ISO 5832-3 and ASTM F136).

This document is a 510(k) premarket notification for a medical device (MECRON™ Cannulated Screw System). It does not describe acceptance criteria and a study proving a device meets those criteria in the context of an AI/ML or diagnostic device. Instead, it focuses on demonstrating substantial equivalence to a predicate device through mechanical testing for a physical orthopedic implant.

Therefore, I cannot extract the information required by your request about acceptance criteria, device performance, sample sizes, expert involvement, ground truth, or MRMC studies, as these concepts are not applicable or detailed in this specific type of regulatory submission for this device.

The document states:

• "Clinical Data were not needed for these devices to show substantial equivalence."
• "Merete has conducted mechanical analysis and functional worst case tests to demonstrate that the MECRON™ Cannulated Screw System has the mechanical properties necessary to perform as well or better than the predicate device... These tests have been performed in accordance with ASTM F543-13."

This indicates that the "study" proving the device met its criteria was a series of mechanical and functional worst-case tests, not a clinical study involving human data, AI models, or expert human readers. The "acceptance criteria" were likely performance benchmarks derived from the predicate device and established standards like ASTM F543-13.

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