(87 days)
Magly 4.0 and 5.5mm Locking screws are used for the interlocking of APEX Intramedullary Femoral and Tibial Nails
The screws are fully threaded from the distal tip to approximately 1mm to 2mm under the head. The distal end will embody a spherical shape at the tip and four cutting flutes used for tapping the thread profile.
The locking screws will be available in 2mm incremental lengths, measured from under the head to the distal tip, the 4.0mm from 16mm-80mm and the 5.5mm from 20mm-120mm.
Magly 4.0 and 5.5mm Locking Screws are manufactured from titanium alloy.
The provided text is a 510(k) premarket notification summary for the Magly 4.0 and 5.5mm Locking Screws. This type of submission is for medical devices and focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than a clinical study proving the device meets specific acceptance criteria related to performance metrics like sensitivity, specificity, accuracy, or human reader improvement for AI/CAD systems.
Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC comparative effectiveness studies is not applicable to this type of document because it describes a mechanical medical device (bone screws), not a diagnostic algorithm or an AI/CAD system.
The document states that the Magly 4.0 and 5.5mm Locking Screws are substantially equivalent to the Synthes 4.0 and 5.0mm Locking Screws based on "design, function, materials used, and indications for use." This is the core "acceptance criteria" for a 510(k) submission for this type of device – demonstrating equivalence to a predicate device that is already legally marketed. No formal study in the sense of a clinical trial with statistical endpoints for performance metrics is described because it's a mechanical device for fixation.
§ 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.