(71 days)
The Additive Orthopaedics Patient Specific 3D Printed Locking Lattice Plate is indicated for alignment, stabilization and fusion of fractures, osteotomies and arthrodesis of small bones such as the foot and ankle. It is a patient specific device.
The Additive Orthopaedics Patient Specific 3D Printed Locking Lattice Plate is indicated for alignment, stabilization and fusion of fractures, osteotomies and arthrodesis of small bones such as the foot and ankle. This is a patient specific device which utilizes the CT scanning protocol previously cleared in K180239 by Additive Orthopaedics. These patient specific devices are manufactured within a size range of 30-80mm and are supplied non-sterile.
The subject device is manufactured from medical grade titanium alloy Ti6Al4V ELI and allows the surgeon to align and stabilize small bone osteotomies such as MPJ fusions, calcaneal osteotomies, Evans Osteotomies, opening wedge osteotomies and others. The plate is fixated using both locking and non-locking screws which were cleared in K 163593 (Additive Orthopaedics) and compatible with Additive Orthopaedics wedges (K153207 and K180239).
The provided text is a 510(k) summary for the Additive Orthopaedics Patient Specific 3D Locking Lattice Plates. This document is a premarket notification to the FDA to demonstrate substantial equivalence to a predicate device. It does not contain information about a study proving the device meets acceptance criteria in the context of an AI/ML-based medical device performance evaluation.
Instead, this document focuses on demonstrating substantial equivalence based on:
- Device Description: The device is patient-specific plates made from Ti6Al4V ELI, indicated for alignment, stabilization, and fusion of small bones (foot and ankle).
- Comparison to Predicate Devices: The key argument is that the subject device, while patient-specific, has similar indications, geometry, materials, and manufacturing processes to its predicate devices (Additive Orthopaedics Locking Lattice Plates K170214, BIOPRO, INC. BioPro Foot Plating System K162674).
- Non-Clinical Evidence: It refers to mechanical testing (4-point bending, static torsion, static driving torque, removal torque, static axial pullout) performed on the predicate device (K170214) per ASTM standards. The rationale is that since the new device uses similar materials and manufacturing methods, and the differences are primarily patient-specific geometry based on a previously cleared CT scanning protocol (K180239), the prior testing on the predicate device is sufficient.
Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth establishment, MRMC studies, or standalone algorithm performance, as these concepts are not applicable to the type of device and submission described in the provided text.
The device is a physical implant, not an AI/ML diagnostic or therapeutic system which would typically involve the type of performance evaluation outlined in your request.
§ 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.