(73 days)
The Anterior Cervical Plate System is indicated for stabilization of the cervical spine from C2 to C7 employing unicortical screw fixation at the anterior face of the vertebral bodies. Specific clinical indications for anterior plating include: instability caused by trauma; instability associated with correction of cervical lordosis and kyphosis deformity; instability associated with pseudoarthrosis as a result of previously failed cervical spine surgery; instability associated with major reconstructive surgery for primary tumors or metatstatic malignant tumors of the cervical spine; instability associated with single or multiple level corpectomy in advanced degenerative disc disease, spinal canal stenosis and cervical myelopathy.
The Anterior Cervical Plate System is indicated for stabilization of the cervical spine from C2 to C7 employing unicortical screw fixation at the anterior face of the vertebral bodies. Specific clinical indications for anterior plating include: instability caused by trauma; instability associated with correction of cervical lordosis and kyphosis deformity; instability associated with pseudoarthrosis as a result of previously failed cervical spine surgery; instability associated with major reconstructive surgery for primary tumors or metatstatic malignant tumors of the cervical spine; instability associated with single or multiple level corpectomy in advanced degenerative disc disease, spinal canal stenosis and cervical myelopathy.
The plates with lowest profile are available several configurations, including different levels and lengths. It accommodates both semi-constrained constructs in which the variable screws are used for fixation, and constrained applications in which the fixed screws are rigidly locked to the plate attach to the anterior cervical spine with a minimum of four screws per plate.
The screws are also available in several configurations, including types (screw and self-tapping screw), locking methods (fixed locking and variable locking), diameters and various lengths.
All implants of Anterior Cervical Plate System are manufactured from Titanium alloy that meets the requirements of ASTM F136-11, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). The materials are wildly used in the industry with well-known biocompatibility. No new materials are used in the development of this implant.
This system is provided non-sterile.
The provided text describes a medical device submission (K123578) for an Anterior Cervical Plate System. The document focuses on establishing the substantial equivalence of the proposed device to a predicate device based on non-clinical bench tests. It does not contain information about studies involving human subjects, AI algorithms, or detailed performance metrics that would typically address the requested criteria.
Therefore, many of the requested items cannot be answered from the provided text.
Here's a breakdown of what can and cannot be answered:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Bench Tests) | Reported Device Performance |
|---|---|
| Mechanical Testing per ASTM F1717-04: | "met all design specifications" (stated in text) |
| - Static compression bending test | Complies with standard |
| - Dynamic compression bending test | Complies with standard |
| - Static torsion test | Complies with standard |
| Material Composition: | Manufactured from Titanium alloy that meets ASTM F136-11 |
| Biocompatibility: | "wildly used in the industry with well-known biocompatibility." |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified for the bench tests.
- Data Provenance: The tests are "bench tests," meaning they were conducted in a laboratory setting, not with patient data. The manufacturer is Weigao Orthopaedic Device Co., Ltd. in Weihai, Shandong, China.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not Applicable. This is a bench test study, not a clinical study involving experts establishing ground truth for patient outcomes or image interpretation.
4. Adjudication Method for the Test Set:
- Not Applicable. This is a bench test study.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done (with or without AI assistance):
- No. This is a mechanical device, and the study described is a bench test, not an MRMC study. There is no mention of AI.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done:
- No. This is a mechanical device, and there is no mention of an algorithm or AI.
7. The Type of Ground Truth Used:
- For the bench tests, the "ground truth" would be the specifications outlined in the ASTM F1717-04 standard and the material properties defined by ASTM F136-11. The device's performance was compared against these predefined physical and mechanical criteria.
8. The Sample Size for the Training Set:
- Not Applicable. This is a bench test for a physical medical device, not a machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set was Established:
- Not Applicable. As there is no training set, this question is not relevant.
§ 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.