(42 days)
Ozark™ Cervical Plate System is indicated for use in anterior screw fixation to the cervical spine (C2-T1) for the following indications: degenerative disc disease (DDD) (defined as neck pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, tractures), spinal stenosis and tumors (primary and metastatic), failed previous fusions (pseudarthrosis) and deformity (defined as scoliosis, kyphosis or lordosis).
The Ozark Cervical Plate System consists of variable and fixed screws having self-tapping and self-starting tips, and one- through five-level plates. The implants are offered both sterile and non-sterile.
This document describes the Ozark™ Cervical Plate System, a Class II medical device used for anterior screw fixation to the cervical spine. The Food and Drug Administration (FDA) has determined that this device is substantially equivalent to legally marketed predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Test Standard) | Reported Device Performance (Ozark™ Cervical Plate System) |
|---|---|
| ASTM F1717 (Static Compression) | Met acceptance criteria |
| ASTM F1717 (Dynamic Compression) | Met acceptance criteria |
| ASTM F1717 (Static Torsion) | Met acceptance criteria |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes for the mechanical tests. It only mentions that "Mechanical testing of the Ozark Cervical Plate System constructs was performed according to ASTM F1717". The data provenance refers to laboratory testing of device constructs according to a recognized standard rather than clinical data from human subjects. Therefore, there is no information on country of origin or whether the data was retrospective or prospective in the context of patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The "ground truth" for this device is based on standardized mechanical testing according to ASTM F1717, not on expert clinical interpretation of images or patient data. The results of these tests are objective measurements of the device's physical properties.
4. Adjudication Method for the Test Set
Not applicable. As mechanical tests, the results do not require adjudication by human experts in the same way clinical diagnostic interpretations would. The tests generate quantitative data that are compared against predefined limits within the ASTM F1717 standard.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and 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 surgical implant (cervical plate system), not an AI-powered diagnostic or assistive technology for human readers. Therefore, an MRMC study related to AI assistance is not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not a software algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The ground truth for demonstrating the device's performance is established by validated mechanical testing standards, specifically ASTM F1717. This standard defines the methodologies and acceptable performance limits for spinal implant constructs under various mechanical loads (static and dynamic compression, static torsion).
8. The Sample Size for the Training Set
Not applicable. This device is a physical implant and does not involve machine learning or AI models that require a "training set" of data.
9. How the Ground Truth for the Training Set was Established
Not applicable. As explained above, no training set is relevant for this type of device.
§ 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.