(85 days)
Synthes 3.5 mm and 4.0 mm Cannulated Screws are intended for fracture fixation of small bones and small bone fragments.
Synthes 3.5 mm and 4.0 mm Cannulated Screws are available in multiple thread length configurations (partially or fully threaded). The 3.5 mm Cannulated Screws feature reverse cutting flutes and cortical threads. The 4.0 mm Cannulated Screws feature self-drilling/self-tapping tips, reverse cutting flutes and cancellous threads. Both screws are used in conjunction with a guide wire for precise placement in bone. Synthes 3.5 mm and 4.0 mm Cannulated Screws will be provided sterile; gamma radiation will be used to sterilize the device.
This document is a 510(k) premarket notification for a medical device (Synthes 3.5 mm and 4.0 mm Cannulated Screws) and describes a comparison to a predicate device (Synthes 2.7 mm Cortex Screws) and other commercially available devices. It focuses on device equivalence based on mechanical testing and does not describe a study involving an AI/ML algorithm or software as a medical device (SaMD).
Therefore, I cannot provide the requested information regarding acceptance criteria and studies that prove an AI device meets those criteria, as there is no AI device and no such study described in the provided text.
The information provided only covers:
- Device description: Synthes 3.5 mm and 4.0 mm Cannulated Screws, their features, and intended use for fracture fixation of small bones and fragments.
- Comparison devices: Synthes 2.7 mm Cortex Screws (predicate), Richards 4.0 mm Cannulated Screw, and Alphatec Titanium Cannulated Mini Lag Screw System.
- Sterilization method: Gamma radiation.
- Basis for equivalence: Mechanical testing, concluding the new screws are at least equivalent to the predicate.
None of the requested categories for AI/ML device studies (acceptance criteria table, sample size, data provenance, expert qualifications, adjudication method, MRMC study, standalone performance, ground truth type, training set size, training set ground truth establishment) are applicable to this document.
§ 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.