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The Intelligent Implant Systems Mediant™ Anterior Cervical Plating System is intended for anterior cervical fixation for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

The Intelligent Implant Systems' Mediant™ Anterior Cervical Plating System consists of bone screws (4.0 and 4.5 mm diameter) of various lengths and a series of plates for fusion of 1-. 2-. or 3- levels of the cervical spine (C2-T1). The device functions as follows: An appropriately sized plate is placed on the anterior aspect of the vertebral body of the cervical spine by inserting either a 4.0 mm or a 4.5 mm diameter bone screw through the cephalad and caudad holes and into the vertebral body. The device improves stability of the spine while supporting fusion. The Mediant™ cervical plates are provided in multiple lengths from 19 mm (one-level) through 78 mm (three-level) for one-, two- and three-level fusions. The thickness of all plates is 2.2 mm and the width is 19.0 mm. All plates interface with the same cervical bone screws. which are either 4.0 mm diameter or 4.5 mm diameter. The bone screws can best be described as semi-constrained, but can be inserted at any angle (within a ±18° angular variation) to the plate. A slider mechanism then locks the bone screws to the plate at the angle of insertion using the supplied locking pliers. The bone screw will remain fixed at the angle of insertion unless bone resorption results in high loading levels on the bone screws. If this occurs, due to the polyaxiality of the screw, the screw will re-position itself and re-lock at the new angle. All implant components of the Mediant™ Anterior Cervical Plating system are manufactured from Ti-6Al-4V ELI alloy, conforming to ASTM F136.

This document is a 510(k) summary for the Mediant™ Anterior Cervical Plating System. It focuses on demonstrating substantial equivalence to predicate devices, primarily through mechanical testing. It does not describe the acceptance criteria for a device, nor does it detail a study proving a device meets specific acceptance criteria in the way you've outlined for diagnostic AI/medical imaging systems.

Here's why the requested information cannot be extracted from this document:

• Device Type: This is a physical orthopedic implant (spinal plating system), not a diagnostic device or software (like an AI algorithm for medical imaging). The regulatory pathway and substantiation methods differ significantly.
• Performance Metrics: The performance data provided is mechanical testing (Static Compression Bending, Static Torsional Bending, Dynamic Compression Bending) to assess the strength and safety of the implant, not diagnostic accuracy metrics (sensitivity, specificity, AUC) or human reader performance.
• Clinical Study Absence: There is no mention of a human clinical study in the context you described (e.g., test set, ground truth, experts, MRMC studies) because it's not relevant to demonstrating substantial equivalence for this type of device based on mechanical properties.

Therefore, I cannot populate the table or answer the specific questions because the provided text pertains to a different type of medical device and a different kind of performance evaluation.

If you have a document related to a diagnostic AI or medical imaging device, I would be happy to analyze it according to your requested format.

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