(127 days)
The Pediatric Plating Platform | Hip is intended for temporary internal fixation and stabilization of proximal femur fractures and osteotomies, mal-unions and non-unions, in pediatric and small stature adults.
The Pediatric Plating Platform | Hip consists of plates, screws and connector bolts in a variety of sizes and shapes to accommodate different anatomic requirements. The Pediatric Plating Platform | Hip also includes surgical instruments.
The Pediatric Plating Platform | Hip offers a selection of plates and screws specifically designed for deformity correction and trauma of the proximal femur. Plates are offered in a variety of angles and offsets to accommodate the anatomy following planned osteotomies or fixation of traumatic fractures. The plate is fixed to the bone via the choice of beam, locking and non-locking screws to ensure stable fixation and healing. The Pediatric Plating Platform | Hip is available in infant, child and adolescent families providing a suitable range of screw and plate sizes.
The implants of the Pediatric Plating Platform | Hip are manufactured from implant grade 316LVM Stainless Steel (ASTM F138 and/or F139).
The provided FDA 510(k) clearance letter for the Pediatric Plating Platform | Hip is for a physical medical device (bone plates and screws), not an AI/Software as a Medical Device (SaMD).
Therefore, the requested information regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of AI/SaMD (which typically involves metrics like sensitivity, specificity, AUC, human reader studies, etc.) is not applicable to this submission.
The FDA clearance relies on traditional medical device testing and comparisons for physical implants, such as:
- Biocompatibility: Based on the prior use of the OrthoPediatric Corp's Locking Proximal Femur System which shares the same materials, manufacturing, and cleaning processes.
- MR Safety: Evaluated using ASTM F2052, ASTM F2213, ASTM F2182, and ASTM F2119, determined to be MR Conditional.
- Mechanical Performance: Included Torsional Properties, Insertion and Removal Torque, Axial Pullout Strength (per ASTM F543), and Static Compression Bending and Fatigue Compression Bending (per ASTM F384). The results demonstrated substantially equivalent mechanical performance to the predicate device.
There is no mention of:
- AI algorithm performance metrics.
- Test sets, training sets, or data provenance for AI models.
- Ground truth established by experts for AI.*
- Multi-reader multi-case (MRMC) studies for AI assistance.
- Standalone AI performance.
In summary, a table of acceptance criteria and reported device performance, sample size, expert qualifications, and adjudication methods for AI/SaMD are not part of this 510(k) submission as it is for a physical orthopedic implant, not an AI software product.
§ 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.