(171 days)
The DePuy Synthes MAXFRAME™ Multi-Axial Correction System is indicated for the following treatments in adults, and in both children (3-12) and adolescents (12-21) in which the growth plates have fused or will not be crossed with hardware: fracture fixation (open and closed) pseudoarthrosis of long bones limb lengthening (epiphyseal or metaphyseal distraction) joint arthrodesis infected fractures or nonunions correction of bony or soft tissue deformities correction of segmental defects.
The DePuy Synthes MAXFRAME™ Multi-Axial Correction System, with adult and pediatric indications, is an external ring fixation system that is combined with web-based software in treatment of soft tissue and bone deformities. In the MAXFRAME system, implanted transfixion wires, Schanz screws and pins are attached to the rings and plates surrounding the deformity using bolts, nuts and connecting plates. Upper and lower rings are then connected to one another using six telescoping struts, creating a "Stewart Platform" type device. Adjusting the strut length allows for correction of length, rotation, and angular deformity at the same time. The modular nature of a ring fixation frame allows multiple frame options. A ring fixation frame is assembled individually by the surgeon to address the different characteristics of each case. The materials of construction for this system include aluminum, elgiloy, stainless steel and various polymeric materials. This system has been validated as MR Conditional.
The provided text describes the DePuy Synthes MAXFRAME™ Multi-Axial Correction System, a medical device, and its FDA 510(k) summary. However, it does not contain information about acceptance criteria or a study proving that an AI device meets acceptance criteria. The device itself is a physical external ring fixation system combined with web-based software for treatment planning, not an AI diagnostic or predictive tool in the context of typical AI performance studies.
Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance related to AI, nor can I provide information on sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance for an AI component.
The document discusses performance in terms of:
- Construct testing: ASTM 1541-02 (2011)
- Component testing: Static & Dynamic Compression testing, Static Torsion, Static Cantilever, Static and Dynamic Fatigue, Wire Slip and Ring to Wire Interface Testing
- System Validation
- Software Verification: In accordance with Special Controls & EN IEC 62304:2006-05 Medical device Software life cycle processes
- MR Conditional Technical Data: In accordance with FDA Guidance and ASTM F2503-13
- Reprocessing of SUD in accordance with Special Controls
The conclusion states that "The objective evidence presented demonstrates that the mechanical performance of the proposed device is comparable to that of the predicate device(s) and supports substantial equivalence for safety and effectiveness."
No clinical evaluation was deemed necessary for the determination of substantial equivalence for this device.
§ 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.