(46 days)
The Zimmer Natural Nail System is intended for temporary fracture fixation and stabilization of the bone. Indications for the Cephalomedullary nails include:
- Compound and simple shaft fractures
- Proximal, metaphyseal and distal shaft fractures
- Segmental fractures
- Comminuted fractures
- Fractures involving osteopenic and osteoporotic bone
- Pathological fractures
- Fractures with bone loss
- Pseudoarthrosis, non-union, mal-union and delayed union
- Periprosthetic fractures
- Surgically created defects such as osteotomies
- Intertrochanteric and subtrochanteric fractures
The Zimmer® Natural Nail® System Cephalomedullary Nails are temporary fixation intramedullary nails designed for fracture fixation and stabilization of the femur. They restore the shape of preinjured bone and are available in a variety of lengths and diameters to meet assorted anatomical needs. Nail caps are available to protect the nail threads from tissue ingrowth and extend the nail length if necessary. Each of the intramedullary nails is secured by a series of screws that pass through holes in the nail. A set screw (with a polyethylene peg) allows guided rotational stability of the lag screw. Nails, nail caps and screws are made from Tivanium Ti-6Al-4V Alloy. Set screws are made from Tivanium Ti-6Al-4V Alloy and Polyethylene (PE). Selected components of the Zimmer Natural Nail System are color coded to aid in identifying which components should be used together. The package label for each of the nails indicates which screw sizes should be used with that nail. A screw case that holds unused screws intended for resterilization is available and contains designated sections for each screw size. Each section contains the color name that matches the color/color name on the label of the appropriate screw size for that section. Refer to the color coding chart and/or surgical technique for more detailed instructions on the use of Zimmer Natural Nail System components.
The provided document, K192312, is a 510(k) premarket notification for a medical device: the Zimmer Natural Nail System Cephalomedullary Nails. It details the substantial equivalence of the device to existing predicate devices.
Based on the provided text, there is no information about an AI/algorithm-driven device or its performance criteria. The document exclusively discusses an intramedullary fixation rod for fracture fixation and stabilization of the bone.
Therefore, I cannot provide details on:
- A table of acceptance criteria and reported device performance for an AI/algorithm.
- Sample sizes for test sets or data provenance for an AI/algorithm.
- Number of experts or their qualifications for establishing ground truth for an AI/algorithm.
- Adjudication methods for an AI/algorithm's test set.
- Multi-reader multi-case (MRMC) comparative effectiveness studies for an AI/algorithm.
- Standalone AI/algorithm performance.
- Type of ground truth used for AI/algorithm.
- Sample size for training set or how ground truth was established for an AI/algorithm and its training set.
The document explicitly states under "Performance Data (Nonclinical and/or Clinical)":
- "Non-Clinical Performance and Conclusions: Class II: Amendment of Design Controls with verification of mechanical integrity and resistance."
- "Clinical Performance and Conclusions: Clinical data and conclusions were not needed for this device."
This indicates that the clearance was based on mechanical integrity testing and design control amendments, not on a clinical performance study involving AI or human interpretation of images.
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.