(31 days)
The CHARLOTTE™ CAROLINA™ Jones Fracture System is indicated for fixation of bone fractures or for bone reconstruction of the 5th Metatarsal. Examples include:
- · Fixation of malunions and nonunions
- · Acute fractures
- · Avulsion fractures
- · Repetitive stress fractures
- · Jones Fractures
- · Malleolar Fractures
- Talus Fractures
- Greater Tuberosity Fractures
The CHARLOTTE™ CAROLINA™ Jones Fracture System screw is a cortical bone screw intended to aid in achieving fixation of bone fragments or bone reconstruction.
The design features of the CHARLOTTE™ CAROLINA™ Jones Fracture System screw are substantially equivalent to the design features previously cleared under the 5th Metatarsal Fracture Screw and are highlighted below:
- o Manufactured from 316L Cold-Worked Stainless Steel (ASTM F138)
- o Offered in three diameters: 4.5mm, 5.5mm, and 6.5mm
- o Offered in lengths ranging from 40mm-70mm in 5mm increments
- o Threads run 35% of screw length
The subject screws in this Special 510(k) include a change in the screw head size as well as a change in the driver interface to increase ease of use. Additionally, screws that are provided sterile have been added.
The provided text describes a medical device, the CHARLOTTE™ CAROLINA™ Jones Fracture System Screw, and its substantial equivalence to a predicate device. However, it does not contain information related to acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/ML device.
The document is a 510(k) summary for a screw, which is a traditional medical device, not an AI/ML product. The "acceptance criteria" discussed in the document are about demonstrating substantial equivalence through mechanical testing and comparison of design characteristics, not performance metrics like sensitivity, specificity, or accuracy that would be relevant for an AI/ML system.
Therefore, I cannot extract the requested information, which is specific to AI/ML device evaluation, from this document. If you provide a document related to an AI/ML medical device, I would be happy to help.
§ 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.