(169 days)
The ZEVO™ Anterior Cervical Plate System is intended for anterior interbody screw fixation from C2 to T1. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with: 1) degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) trauma (including fractures), 3) tumors, 4) deformity (defined as kyphosis, lordosis, or scoliosis, 5) pseudoathrosis, and/or 6) failed previous fusions.
The ZEVO™ Anterior Cervical Plate System consists of temporary implants (plates and bone screws) intended for anterior screw fixation of the cervical spine during the development of a cervical spinal fusion. Fixation is provided by bone screws inserted into the vertebral body of the cervical spine using an anterior approach. The device is intended for the anterior screw fixation from C2- T1 in the cervical spine. The ZEVO™ Anterior Cervical Plate System implants are available in a broad range of size offerings, and are supplied in both sterile and non-sterile form. The implant components are made from titanium alloy, with plates having subcomponents manufacturing from nitinol (NiTi).
The provided text describes a 510(k) premarket notification for the ZEVO™ Anterior Cervical Plate System. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel clinical effectiveness through extensive clinical trials with acceptance criteria based on patient outcomes or AI performance metrics.
Therefore, the information requested (acceptance criteria, device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types) is not applicable to this document.
The document describes non-clinical tests performed to demonstrate substantial equivalence. Here's a breakdown of that information:
1. A table of acceptance criteria and the reported device performance:
| Test Method | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| ASTM F1717-13 "Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model" | Pre-determined acceptance criteria for spinal implant constructs. (Specific criteria not detailed in this document but would be defined within the standard or by the manufacturer based on predicate device performance.) | The subject device met the pre-determined acceptance criteria for all tests. |
| ASTM F2129-08 "Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices" | Pre-determined acceptance criteria for corrosion susceptibility. (Specific criteria not detailed in this document but would be defined within the standard or by the manufacturer.) | The subject device met the pre-determined acceptance criteria for all tests. |
Reasoning for "Not Applicable" for other points:
- Sample sized used for the test set and the data provenance: This device is a physical implant. "Test set" in this context refers to the number of physical samples subjected to mechanical and corrosion testing, not a dataset of patient images or clinical data. The document does not specify the number of samples used for these non-clinical tests. Data provenance (country of origin, retrospective/prospective) is not relevant for in-vitro mechanical and corrosion testing.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: "Experts" and "ground truth" (in the medical AI sense) are not applicable here. The ground truth for mechanical and corrosion tests is established by the specifications of the ASTM standards and the physical properties of the materials and device design.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for non-clinical engineering tests. Test results are objective measurements based on established standards.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. This is a physical implant, not a diagnostic or AI-driven device that assists human readers.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical implant, not an algorithm.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. For the non-clinical tests described, the "ground truth" is defined by the physical test conditions, material properties, and the established ASTM standards.
- The sample size for the training set: Not applicable. There is no concept of a "training set" for a physical medical device undergoing mechanical and corrosion testing.
- How the ground truth for the training set was established: Not applicable.
In summary, this document pertains to the regulatory clearance of a physical medical device based on substantial equivalence demonstrated through non-clinical laboratory testing, not a clinical study or AI performance evaluation.
§ 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.