(185 days)
The CoLink® PCR Plating System is indication and fixation of fractures, revision procedures, joint fusion, osteotomies and reconstruction of the small bones in the hand, wrist, foot and ankle.
The In2Bones CoLink® PCR Plating System includes plates and screws and surgical instruments intended for treating fusions and fractures of the extremities. These subject devices are part of the overarching CoLink® Plating System and will be commonly referred to as the CoLink® PCR Plating System. The CoLink® PCR Plating System consists of the MTP Narrow NX and Universal style plates available in Carbon Fiber Reinforced PEEK-OPTIMA™ with Barium Sulfate. The plates are used with previously cleared 3.0mm and 3.5mm titanium alloy locking and non-locking screws.
The provided document ({0} - {4}) is a 510(k) Summary for the CoLink® PCR Plating System, a medical device for bone fixation. It describes the device, its indications for use, and how it demonstrates substantial equivalence to previously cleared predicate devices.
However, the document does not contain the information requested in the prompt regarding acceptance criteria and a study proving a digital health or AI/ML device meets those criteria. Specifically, it lacks:
- A table of acceptance criteria and reported device performance for a digital health/AI device. The document focuses on performance testing for mechanical properties (static and dynamic four-point bending per ASTM F382) and biocompatibility, sterilization, and packaging standards for a physical bone plating system.
- Sample size and data provenance for a test set (clinical data for AI/ML).
- Number and qualifications of experts for ground truth establishment.
- Adjudication method for a test set.
- Information on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance.
- Type of ground truth used (e.g., expert consensus, pathology, outcomes data).
- Sample size for a training set (for AI/ML models).
- How ground truth for a training set was established.
The document details the substantial equivalence of a physical medical device (bone plates and screws) by comparing its materials, geometry, and mechanical performance to legally marketed predicate devices. It is not an AI/ML or digital health device, and therefore the type of information requested in the prompt (related to AI model validation, clinical test sets, human-in-the-loop studies, etc.) is not present in this document.
§ 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.