(17 days)
The Extended HA Half Pins are intended to be used with an external fixation system for fixation of fractures of long bones, joint fusions, and limb lengthening or deformity corrections that involve cutting of the bone and temporary stabilization for the indications listed below.
- Fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction
- Open and closed fracture fixation
- Pseudarthrosis of long bones
- Limb lengthening by distraction
- Correction of bony or soft tissue deformities
- Joint arthrodesis
- Infected fractures
- Nonunions
Subject of this premarket notification is the Extended HA Half Pins. The proposed devices are design modifications of the Jet-X HA Coated Half Pins to extend the HA coating to the shank of the Half Pins.
I am sorry, but the provided text describes the regulatory clearance of a medical device, specifically Extended HA Half Pins from Smith & Nephew, Inc., and does not contain any information regarding acceptance criteria or a study that proves the device meets specific performance criteria related to AI or image analysis.
The document is a 510(k) premarket notification clearance letter from the FDA, along with the Indications for Use and a summary of the device. It focuses on demonstrating substantial equivalence to predicate devices for a physical medical device (bone fixation pins), not a software or AI-powered diagnostic tool.
Therefore, I cannot extract the requested information as it is not present in the provided text.
§ 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.