(44 days)
The system is intended for use in internal fixation of small bones including the foot, hand, craniofacial skeleton and midface.
The Forefoot Reconstruction System is a series of Ti6A14V titanium alloy screws 2.3-3.0 mm in diameter and 8-22 mm in length. All screws are fully threaded and self-tapping with internal hex-drive heads.
The provided text is a 510(k) summary for a medical device (Forefoot Reconstruction System) and does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically found in AI/ML medical device submissions.
The information requested in your prompt (e.g., sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types) is specific to the evaluation and validation of an AI/Machine Learning device. The provided 510(k) summary describes a traditional, non-software implantable device (bone screws) and therefore does not have these types of studies or criteria.
To elaborate:
- Acceptance Criteria and Reported Device Performance: This 510(k) focuses on demonstrating substantial equivalence to predicate devices based on design, materials, and intended use, rather than performance metrics measured against specific acceptance criteria as you would find for an AI algorithm.
- Sample Size, Ground Truth, Experts, Adjudication, MRMC, Standalone Performance, Training Set: These concepts are entirely absent because the device is a physical hardware product (screws) and not an AI/ML algorithm.
Therefore, I cannot fulfill your request using the provided input, as the input does not describe an AI/ML medical device or its associated validation studies.
§ 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.