(186 days)
The ZEPHIR™ Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, and/or failed previous fusions.
The ZEPHIR™ Anterior Cervical Plate System consists of a variety of shapes and sizes of bone plates (locking mechanism is pre-assembled to plates), screws and associated instruments. Fixation is provided by bone screws inserted into the vertebral body of the cervical spine using an anterior approach. The implant components will be made from titanium alloy as described by ASTM F-136 and may be supplied either sterile or non-sterile.
The provided text is a 510(k) summary for the ZEPHIR™ Anterior Cervical Plate System, a medical device. It details the device's identification, intended use, and claims of substantial equivalence to previously marketed devices. However, the document does not contain information about acceptance criteria or a specific study designed to prove the device meets such criteria in terms of analytical or clinical performance.
Instead, the submission primarily focuses on mechanical test data being provided to support the notification for substantial equivalence. This type of submission relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, often through engineering performance testing (e.g., strength, fatigue) rather than clinical studies with human participants.
Therefore, I cannot complete the requested tables and descriptions as the information is not present in the provided text.
Specifically, the following points from your request cannot be addressed based on the provided document:
- A table of acceptance criteria and the reported device performance: The document does not define specific acceptance criteria (e.g., sensitivity, specificity, accuracy) for clinical or analytical performance, nor does it report such performance values.
- Sample sized used for the test set and the data provenance: No information about a "test set" for clinical evaluation is provided. The "mechanical test data" mentioned likely refers to engineering tests, not clinical data from patients.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as there is no mention of a test set requiring expert ground truth.
- Adjudication method for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a physical implant, not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable, as there's no mention of a "training set" in the context of an AI/algorithm.
- How the ground truth for the training set was established: Not applicable.
The 510(k) summary states: "Mechanical test data were provided in support of this notification." This indicates that the primary evidence for substantial equivalence for this type of device (a spinal implant) typically comes from engineering and biomechanical testing, rather than clinical studies demonstrating diagnostic accuracy or efficacy in the way an AI diagnostic tool would.
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.