(116 days)
Kirschner Wire - ankle fracture fixation femoral shaft fracture hand fracture scaphold fracturc skeletal tractlon wrist fracture patellar fracture
Steinman Pin - ankle arthrodesis tiblotibular syndesmosis fixallorı femoral shaft fracture acromloclavicular Jolnt repair skeletal traction
Stainless Stool Fixation Pins
I apologize, but the provided text is a 510(k) clearance letter from the FDA for medical devices (Bone Screws, Kirschner Wire, and Steinman Pin). This document confirms that the devices are substantially equivalent to previously marketed devices. However, this type of regulatory correspondence does NOT contain information about acceptance criteria for device performance or the specifics of a study proving the device meets those criteria.
Therefore, I cannot extract the requested information regarding:
- A table of acceptance criteria and reported device performance.
- Sample size and data provenance for the test set.
- Number and qualifications of experts for ground truth.
- Adjudication method for the test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study details.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
To obtain this information, you would typically need to refer to the preclinical and clinical study reports submitted as part of the 510(k) premarket notification, which are not included in this letter.
§ 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.