(77 days)
The titanium alloy cortical bone screws presented in this submission are intended for long and small bone fracture fixation.
The subiect of this premarket notification are 4.0mm titanium alloy (partially threaded and fully threaded) bone screws and associated manual orthopedic instruments designed to assist screw fixation.
This 510(k) summary for the Aesculap Titanium Alloy Bone Screws does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria, as it pertains to AI/ML or diagnostic performance.
The document describes a medical device, specifically bone screws, and focuses on its substantial equivalence to previously marketed devices. The "Performance Data" section explicitly states: "No applicable performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices. However, fatigue testing was performed on the titanium alloy screws; this information is detailed in the application. The Titanium Alloy Bone Screws will be manufactured in accordance with ISO and German Din Standards."
This indicates that the performance data described here is related to mechanical testing (fatigue testing) of the physical screws, not a study evaluating diagnostic performance, AI algorithm performance, or human reader improvement with AI assistance.
Therefore, I cannot provide the requested table and details because the provided text does not describe:
- Acceptance criteria related to AI/ML performance.
- A study proving diagnostic or AI/ML performance.
- Details about sample sizes for test/training sets, experts, or ground truth relevant to AI/ML or diagnostic studies.
- Information about MRMC studies or standalone algorithm performance.
§ 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.