Search Results

The COSY Cervicothoracic Occipital Rod-Screw System is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1-C7), and the thoracic spine from T1-T3: traumatic spinal fraumatic dislocations; instabilities or deformity; failed previous fe.g., pseudoarthrosis); tumors involving the cervical spine; degenerative disease, including intractable radioulopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability.

The COSY cervicothoracic occipital rod-screw system is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advance stage turnors involving the cervical spine in whom life expectancy is of limited duration to permit achievement of fusion.

In order to achieve additional levels of fixation, the COSY Cervicothoracic Occipital Rod-Screw System may be connected to the components of the DIPLOMAT System or MONOPOLY System using the rod-to-rod connectors or transition rods.

The COSY Cervicothoracic Occipital Rod-Screw is a multiple component, posterior spinal fixations system which consists of solid screws, cannulated screws, standard tulips, angulated tulips, curved rods, straight rods, hybrid rods, parallel connectors, inline connectors, occipital plates, occipital bone screws, hooks, and offset connectors. All implants, except of variations of the rods, are available in Ti-6AL-4V ELI per ASTM F136. Rods are available in Ti-6AL-4V ELI per ASTM F136 or Co-Cr28-Mo6 per ASTM F1537. The pedicle screws consist of a tulip and a pedicle screw shaft. The shaft has a prominent thread, to provide anchorage of the screw in the pedicle section of the vertebrae. Each tulip is securely attached to the rod via a set screw. The shafts of the pedicle screws are provided in different lengths, diameters, fully or partially threaded, and with a symmetric anqulation to provided adaptability to the patient's anatomy. The rods can be shortened on site by the surgeon. The occipital plate is available with four or five holes and areas to be bent for better fixation to the occipital part of the skull. The plate is fixed via bone screws and as two gliding tulips to provided anchoring of the rod. The gliding tulips are constructed similar to the tulips of the pedicle screws in the area of the rod- set screw -tulip intersection.

It seems there's a misunderstanding. The provided document is an FDA 510(k) clearance letter for a medical device called the "COSY Cervicothoracic Occipital Rod-Screw System." This document is related to spinal implants, not a diagnostic AI device.

Therefore, the requested information about "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/Machine Learning device (which would involve test sets, expert consensus, ground truth, etc.) is not applicable to this document.

The document describes mechanical testing performed to demonstrate the safety and effectiveness of the spinal implant system, compared to a predicate device. It addresses:

• Indications for Use: What the device is designed to treat.
• Device Description: What the components are made of and how they function.
• Comparison to Predicate Device: How it's similar to and different from devices already on the market.
• Mechanical Testing: Listing of ASTM standards used for dynamic and static testing related to compression, bending, and torsion.

There is no information within this document that aligns with the questions asked about AI/ML device validation.

If you have a document related to an AI/ML diagnostic or prognostic device, please provide that document, and I will do my best to answer your questions based on its content.

Ask a specific question about this device