(46 days)
The G3™ Acive Plate® Small Fragment system is intended for use in adult and pediatric (subpopulation: transitional adolescent B (18 years to
The G3TM Active Plate® Small Fragment System is a straight plate and locking screw system comprised of a variety of sizes to accommodate various patient anatomy and pathology. The plate and screw are intended to be used for fracture fixation. All implantable components are manufactured from medical grade stainless steel and silicone elastomer the same as the subject device. The screws are 3.5 mm diameter and come in lengths ranging from 10 to 90 mm. The plates range in size from 6 hole to 18 hole. The plates incorporate sliding elements, which are constrained within the plate and embedded in an elastomer sheath that is bonded to the sliding element. Once locking screws are inserted, the active elements allow for independent controlled axial translation of the screws. All instruments are made from stainless steel.
The provided text is a summary of a 510(k) premarket notification for a medical device called the G3™ Active Plate® Small Fragment System. It details the device's intended use, classification, and claims of substantial equivalence to previously cleared devices based on various performance tests. However, it does not include information about acceptance criteria for a study proving the device meets those criteria, specifically in the context of an AI/algorithm-driven device for diagnostic or prognostic purposes, which seems to be the focus of the request.
The request asks for information related to the acceptance criteria and a study that proves a device meets acceptance criteria, particularly for a device that seems to involve AI or algorithmic performance (given the questions about sample size for test/training sets, ground truth, experts, MRMC studies, and standalone performance). The provided document describes a metallic bone fixation appliance, not an AI-driven device.
Therefore, I cannot fulfill the request as it is posed because the provided document does not contain the type of information required for an AI/algorithm performance study.
Here's why the provided text doesn't contain the requested information:
- Type of Device: The G3™ Active Plate® Small Fragment System is a physical implant for fracture fixation, not a digital diagnostic or prognostic tool.
- "Acceptance Criteria" in this context: For this implant, "acceptance criteria" generally refer to design specifications, material properties, biocompatibility, and mechanical performance (stiffness, fatigue, pullout, torsion, torque) of the physical product, as demonstrated through bench testing (e.g., ASTM F543, ASTM F382). It does not involve diagnostic accuracy metrics like sensitivity, specificity, or AUC, which are common for AI devices.
- "Study" Information: The document refers to "Performance Testing" which included mechanical tests (stiffness, fatigue, pullout, torsion, torque, and construct fatigue). These are bench tests on the physical device components, not clinical studies involving human readers, ground truth established by experts, or AI algorithm performance.
- Missing Information Categories: All categories in your request (Table of acceptance criteria/performance, sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set sample size, ground truth for training set) are entirely irrelevant to the type of device and testing described in the provided document.
To summarize, the document details the regulatory clearance of a surgical implant based on its physical properties and mechanical performance, demonstrating substantial equivalence to predicate devices through bench testing. It does not describe an AI/algorithmic device or a study involving human readers, clinical data interpretation, or ground truth establishment relevant to AI performance.
§ 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.