(72 days)
The Jet-X HA Coated Half Pin is intended to be used with an external fixation system for fracture fixation (open and closed); pseudoarthrosis or nonunion of long bones; limb lengthening by epiphyseal or metaphyseal distraction, correction of bony or soft tissue deformity; correction of segmental bony or soft tissue defects; and joint arthrodesis.
The Jet-X Half Pin is a modification of the Jet-X TiN Coated Half Pin that was cleared for market under K023134. This submission design modifications to the threads and provides for a hydroxylapatite (HA) coated stainless steel half pin.
The provided text describes a 510(k) submission for the "Jet-X HA Coated Half Pins," which is a rigid implant and does not involve AI or algorithms, nor does it present any studies involving device performance data against acceptance criteria in the manner typically seen for diagnostic or AI-driven medical devices.
Therefore, I cannot extract the requested information as it is not present in the provided document. The document focuses on establishing substantial equivalence to predicate devices based on design, materials, and intended use for regulatory clearance, rather than presenting a performance study with acceptance criteria.
Response:
The provided document describes a 510(k) submission for the "Jet-X HA Coated Half Pins," which is a medical device for bone fixation. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a performance study with specific acceptance criteria and reported device performance in the context of an AI or diagnostic device.
Therefore, the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance, as typically found in studies for AI-driven or diagnostic devices, is not available 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.