(91 days)
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.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.