Search Results

The MIS Z-Pedicle Screw System is intended to provide immobilization and stabilization of the spinal segments for posterior, non-cervical pedicle fixation in skeletally mature patients as an adjunct to fusion for the following indications: · degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies): · spondy lolisthesis (grades 3 and 4) at L5-S1 - · trauma (i.e., fracture or dislocation) - · spinal stenosis - · curvatures (i.e.,scoliosis, kyphosis, and/or lordosis) - · tumor - · pseudoarthrosis - · failed previous fusion.

The MIS Z - Pedicle Screw System consists of a variety of Pedicle screws and rods in different sizes. The devices are intended to provide immobilization of the spinal segments for posterior, noncervical pedicle fixation in skeletally mature patients as an adjunct to fusion. The safety and effectiveness of this device has not been established when used in conjunction with bone cement or for use in patients with poor bone quality (e.g. osteoporosis, osteopenia). This device is intended only to be used with saline or radiopaque dye. Z-Pedicle Screws: Material: ASTM F136 (Ti-6Al-4V ELI) Length: 35mm to 55 mm Diameter: 5, 6, 7, 8 mm Z- Rods: Material: ASTM F136 (Ti-6Al-4V ELI) Length: 35mm to 300mm Diameter: 5,5 mm

I am sorry, but I cannot provide information on the acceptance criteria and study details for the device, as the provided text does not contain any details regarding acceptance criteria, device performance, sample sizes, data provenance, expert ground truth establishment, adjudication methods, MRMC comparative effectiveness studies, standalone performance, training set sample size, or how ground truth was established for the training set.

The document is a 510(k) premarket notification clearance letter from the FDA for a medical device (MIS Z-Pedicle Screw System). It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices based on indications for use, material, technology, design, and mechanical bench testing. While it mentions some testing performed (biocompatibility, sterilization, packaging/shelf life, and mechanical bench testing), it does not provide the specific performance metrics or acceptance criteria that would be relevant to the questions you've asked, particularly in the context of an AI-powered device or a study involving human readers.

The mechanical testing section (Item 6.4) states that "the results of the testing exceed the values we defined in our rational for the worst case scenario based on literature," but it doesn't quantify these values or specific acceptance criteria.

Ask a specific question about this device