(272 days)
The REDEMPTION™ Charcot Plating System bone plates and screws are indicated for use in bone fractures, osteotomies, and fixation of bones and bone fragments in the upper and lower extremities, primarily of the hand, wrist, foot, and digits. Specific examples include: medial column fusion (talus, navicular, cuboid, first metatarsal) for patients with osteopenic bone in neuropathic osteoarthropathy (Charcot).
The REDEMPTION™ Charcot Plating System contains bone plates, screws, and accompanying instruments to aid in the surgical procedures. The system is a multi-indication reconstruction solution providing polyaxial locking technology and low-profile design. The system is optimized for use in osteopenic bone, such as those of neuropathic osteoarthropathy (Charcot) patients.
The system contains poly-axial locking and non-locking 4.0mm and 5.5mm diameter screws with threads optimized for osteopenic bone purchase.
All implant components are manufactured from titanium (Ti-6AI-4V, ASTM F136).
Specific instrumentation including wires, drills, torx drivers, and drill guides are required for use with the system. The REDEMPTION™ instruments are manufactured from stainless steel, with a few Aluminum and Silicone components.
I am sorry, but the provided text from the FDA 510(k) K233816 document for the "REDEMPTION™ Charcot Plating System" does not contain any information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of an AI/ML medical device.
The document describes a traditional 510(k) submission for a metallic bone fixation system (plates and screws), not an AI/ML-driven diagnostic or therapeutic device. The "Performance Data" section details mechanical and material testing for the bone fixation system, such as:
- Static four-point bend testing per ASTM F382-17
- Screw Torsional Properties per ASTM F543-17 A1
- Screw Insertion and Removal Torque per ASTM F543-17 A2
- Screw Pullout Testing per ASTM F543-17 A3
- Cleaning and sterilization validations
These tests are standard for orthopedic implants to demonstrate structural integrity, and biocompatibility, and ensure the device can be properly cleaned and sterilized.
Therefore, I cannot provide the requested information regarding:
- A table of acceptance criteria and reported device performance for an AI/ML device.
- Sample size, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or ground truth types, as these are concepts applicable to AI/ML software validation, not the mechanical testing of orthopedic hardware described in this document.
§ 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.