(118 days)
OrthoPediatrics Wrist Fusion Plates are intended for wrist arthrodesis and fractures of other small bones in children, adolescents, and small stature adults. Specific indications include post-traumatic arthritis of the wrist; rheumatoid wrist deformities requiring restoration; complex carpal instability; post-septic arthritis of the wrist; severe unremitting pain related to motion; brachial plexus nerve palsies; tumor resection; and spastic deformities.
OrthoPediatrics Wrist Fusion Plates are provided non-sterile, are available in two lengths, 99mm and 112mm, to accommodate a patient with or without a Proximal Row Carpectomy (PRC). The Wrist Fusion Plates accept 2.7mm screws both distally and in the capitate, and 3.5mm screws proximally. These screws were previously cleared in the PediLoc Fragment System 510(k), K140431. In additional to the two wrist fusion plates, bending templates are included to assist with intra-operative contouring of the plate into either dorsiflexion or palmar flexion.
This document describes the premarket notification (510(k)) for the OrthoPediatrics Wrist Fusion Plate. However, it does not describe:
- A device that relies on AI or an algorithm.
- A study that establishes acceptance criteria for "device performance" in terms of sensitivity, specificity, accuracy, or similar metrics for diagnostic or AI-driven devices.
- Ground truth establishment, expert consensus, or multi-reader multi-case (MRMC) studies.
Instead, this document pertains to a Class II surgical implant (bone fixation appliance) and its substantial equivalence to predicate devices. The "performance data" discussed is primarily non-clinical mechanical testing (four-point bend testing) to show equivalence in terms of physical properties and function.
Therefore, I cannot extract the information requested as it is not present in the provided document. The questions you've asked are typically relevant for diagnostic devices, imaging systems, or AI/ML-driven medical software, not for a mechanical bone fixation plate.
To summarize why the requested information is absent:
- No AI/Algorithm: The device is a physical wrist fusion plate, not an algorithm or AI.
- No "Performance" in the Diagnostic Sense: The "performance" for this type of device relates to mechanical strength, material compatibility, and similar physical attributes, not diagnostic accuracy or human reader improvement.
- No Clinical Study for Equivalence: The document explicitly states "Clinical Tests: None provided as a basis for substantial equivalence." The equivalence is based on similar intended use, indications, materials, design features, and function, supported by non-clinical bench testing.
If you have a document describing a diagnostic device or an AI-driven medical device, I would be happy to analyze it for the criteria you provided.
§ 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.