(30 days)
The Trinica™ Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine at levels C2-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 degenerative disc disease (as defined by neck pain of discogenic origin of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudoarthrosis, and/or failed previous fusions.
The Trinica Anterior Cervical Plate System is a fixation device consisting of cervical plates, locking caps, fixed bone screws and variable angle bone screws made from titanium alloy in conformance with ASTM F136. The locking cap is preassembled onto the plate and is designed with tabs that prevent bone screws from backing out. The plates and locking caps are treated with titanium anodization per AMS (Aerospace Material Specification) 2488 Type II. Bone screws are subjected to a color anodizing process to differentiate the screw type and diameter. Plates are offered in one-level, two-level, three-level, and four-level fusion configurations (24 mm through 92 mm). Bone screws are available in lengths from 10mm through 18mm in 1mm increments. The screws have either a 4.2 inch 4.6 inch diameter. Fixed angle and variable angle screws are available.
The provided text describes a 510(k) submission for the Trinica™ Anterior Cervical Plate System, focusing on its substantial equivalence to a predicate device rather than presenting a standalone study of the device's performance against specific acceptance criteria.
Therefore, many of the requested sections about study design, sample sizes, ground truth establishment, and expert involvement cannot be extracted directly from this document.
However, I can provide the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria for performance; instead, it relies on demonstrating substantial equivalence to a predicate device. The "performance" assessment is based on non-clinical tests.
| Characteristic | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Intended Use | Identical to predicate device (Michelson Anterior Cervical Plate System K974435) | Identical |
| Anatomical Sites | Identical to predicate device | Identical |
| Target Population | Identical to predicate device | Identical |
| Sterilization | Identical to predicate device | Identical |
| Packaging | Identical to predicate device | Identical |
| Operating Principle | Identical to predicate device | Identical |
| Materials | Identical to predicate device (ASTM F136 titanium alloy, AMS 2488 Type II anodization) | Identical |
| Labeling | Substantially Equivalent to predicate device | Substantially Equivalent |
| Physical Characteristics (Design) | Substantially Equivalent to predicate device | Substantially Equivalent |
| Performance Testing | Meets established criteria based on risk analysis; substantially equivalent to predicate device | Meets established criteria and is substantially equivalent |
| Safety Characteristics | Substantially Equivalent to predicate device; design modifications do not affect safety | Substantially Equivalent; design modifications do not affect safety |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This document refers to non-clinical tests which are typically bench tests (e.g., mechanical testing) and do not involve patient data or test sets in the context of clinical performance. The data provenance would be laboratory testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. Ground truth in this context would generally refer to a clinical diagnosis or outcome, which is not part of this non-clinical testing summary. Expert involvement would be in the design and interpretation of the non-clinical tests themselves, but this information is not provided.
4. Adjudication Method for the Test Set
Not applicable. There is no mention of a "test set" in the sense of clinical data requiring adjudication.
5. 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 is a medical device (spinal plate system), not an AI imaging or diagnostic algorithm.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a medical device, not an algorithm. Performance assessment is based on the physical device itself.
7. The Type of Ground Truth Used
For non-clinical performance testing, the "ground truth" would be established engineering standards, material specifications (e.g., ASTM F136), and biomechanical performance criteria. The document states "appropriate testing was conducted to evaluate the impact of the changes to ensure that the modified device meets established criteria."
8. The Sample Size for the Training Set
Not applicable. This is not a study involving a training set for an algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is not a study involving a training set for an algorithm.
Summary from the document:
The 510(k) submission for the Trinica™ Anterior Cervical Plate System relies on demonstrating substantial equivalence to a predicate device (Michelson Anterior Cervical Plate System K974435). The "study" referenced is a series of non-clinical tests (likely mechanical, material, and design verification tests) that assessed the impact of design changes. The document explicitly states:
- "Results of the testing demonstrated that the modified device meets established criteria."
- "Testing of the Trinica Anterior Cervical Plate System demonstrates that the device is substantially equivalent to the predicate Michelson Anterior Cervical Plate System (K974435) and that the design modifications do not affect device safety and effectiveness."
The primary "acceptance criterion" articulated in the document is satisfying the FDA's requirement for substantial equivalence to a legally marketed predicate device, especially regarding safety and effectiveness, which was confirmed through these non-clinical tests.
§ 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.