(76 days)
The KMI Wrist Fusion System is comprised of the total wrist fusion plate which is intended for wrist arthrodesis, providing fixation of small bones such as the radius and carpal bones and indicated for use in patients suffering pain and/or loss of function due to osteoarthritis, post-traumatic arthritis, fractures, revision of failed wrist fusions, segmental bone loss, or rheumatoid arthritis, and the KMI limited wrist fusion plate is intended for use in patients suffering pain and/or loss of function due to osteoarthritis, post-traumatic arthritis, fractures, revision of failed partial wrist fusions, carpal instability, or rheumatoid arthritis.
The KMI Wrist Fusion System consists of metal plates with holes to accommodate specific screws and the screws, all manufactured of 316L stainless steel.
The provided text does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria. It is a 510(k) summary for a medical device (KMI Wrist Fusion System) seeking clearance based on substantial equivalence to predicate devices, not on performance against specific acceptance criteria.
Therefore, I cannot populate the requested table or answer the questions related to studies, sample sizes, experts, adjudication, or ground truth.
The document explicitly states:
- "Summary of Performance Date: Not applicable." (Page 2)
- "Conclusions Drawn from Nonclinical and Clinical Tests: Not applicable." (Page 2)
This indicates that a performance study as typically understood for new device claims was not conducted or required for this 510(k) submission, which relies on predicates.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.