(58 days)
The Synthes (USA) Pediatric LCP Hip Plate System is intended for fixation of fractures and osteotomies of the proximal femur in children, adolescents, and small statured adults.
Specific indications include:
- intertrochanteric rotational and/or varus osteotomies
- femoral neck and/or pertrochanteric fractures
- intertrochanteric valgus osteotomies and/or rotational osteotomies
The Synthes (USA) Pediatric LCP Hip Plate System is available in 3.5 and 5.0 mm versions which include 100, 110, 120, and 150 degree angles. The plates are designed with three conical locking screw holes located at the head in conjunction with 3 or 4 combination locked-compression screw holes at the shaft. The fixed angle construct is created by means of three standard locking screws inserted through the head of the plate. The shaft of the plate accepts locking or cortex screws, depending on the nature of the fracture or the quality of bone.
The Synthes (USA) Pediatric LCP Hip Plate System Modifications to include 3.5 mm Cortex screws to be utilized with the plates.
The screws are manufactured from 316L stainless steel and available both sterile and non-sterile.
The provided text describes a 510(k) premarket notification for a medical device: the "Synthes (USA) Pediatric LCP Hip Plate System Modifications." This document is a regulatory submission for a medical device and, as such, does not contain acceptance criteria or a study demonstrating device performance in the manner typically found for AI/software-as-a-medical-device (SaMD) products.
This 510(k) submission relates to a physical orthopedic implant (bone plates and screws) and primarily focuses on demonstrating substantial equivalence to a predicate device. The information provided is for a traditional hardware medical device, not a software or AI-driven diagnostic/therapeutic system. Therefore, the questions about acceptance criteria, test sets, ground truth establishment, expert consensus, MRMC studies, or standalone algorithm performance are not applicable to this type of submission.
The document discusses the device description, intended use, and substantial equivalence to a predicate device based on its design, materials (316L stainless steel), and mechanical function for bone fixation.
To directly answer your request based on the provided text, I must state that the requested information (acceptance criteria, details of a performance study, sample sizes, expert qualifications, etc.) is not present because it's not relevant to this type of device submission.
§ 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.