(59 days)
The Trinica and Trinica® Select Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine at level 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 confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis or scoliosis), pseudoarthrosis and/or failed previous fusions.
WARNING: These devices are not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
The Trinica® and Trinica® Select Anterior Cervical Plate Systems both consist of cervical plates, locking caps, bone screws, and the instruments necessary to implant the specific system. All implant components are made from a titanium alloy (Ti-6Al-4V). Both, the Trinica® Select Anterior Cervical Plate Systems, are intended to provide stabilization of the cervical vertebra for various indications (see below). The fixation construct consists of a cervical plate that is attached to the vertebral body of the cervical spine with self-tapping and/or self-drilling bone screws using an anterior surgical approach. Bone screws are available for fixed angle or variable angle implantation. The Trinica® and Trinica® Select Anterior Cervical Plate Systems are provided non-sterile, are for single use only and are intended to be removed after solid fusion has occurred.
The only difference between the two systems is the Trinica® Select system has smaller width cervical plates to accommodate smaller anatomical structures. The locking cap for the Trinica® Select system required a reduction to diameter and height to accommodate reduced lateral profile cervical plate.
Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Zimmer Spine Trinica® and Trinica® Select Anterior Cervical Plate Systems:
1. A table of acceptance criteria and the reported device performance:
The document doesn't explicitly state "acceptance criteria" in a quantitative, pass/fail format typical for AI/software devices. Instead, it focuses on demonstrating substantial equivalence to predicate devices through various tests. The performance is reported in terms of meeting the intended use and being comparable to the predicates.
| Acceptance Criteria (Implied by Substantial Equivalence Goal) | Reported Device Performance |
|---|---|
| Mechanical Performance: Demonstrate equivalent mechanical properties to predicate devices for intended stabilization. | - Bench testing (static compression bending, dynamic compression bending, static torsion per ASTM F1717) was performed. |
- Conclusion: "confirmed the product performance of current Trinica and Trinica Select is suitable for its intended use: the same intended use as the predicate devices." |
| Functional Performance: Demonstrate that the system can be implanted and functions as intended. | - Cadaver lab testing of the implants and instruments was performed. - Conclusion: "demonstrates that the system meets the defined intended use(s) and functions as intended." |
| Biocompatibility: Ensure materials are biocompatible after manufacturing and minor design changes. | - Biocompatibility testing was performed. - Conclusion: "ensured the current Trinica and Trinica Select instrument materials are biocompatible after manufacturing based on the minor design changes made in comparison to the predicate devices." |
| Sterilization, Dry Time & Cleaning: Ensure steam sterilization, cleaning, and dry time instructions are substantially equivalent. | - Sterilization, Dry Time and Cleaning testing was performed. - Conclusion: "ensured the current Trinica and Trinica Select systems steam sterilization, cleaning and dry time instructions are substantially equivalent to the predicate devices." |
| Intended Use: Maintain the same indicated uses as the predicate devices. | - Stated: "The current Trinical and Trinical Select Anterior Cervical Plate Systems performance, intended use and fundamental scientific technology remain unchanged from their predicate devices." |
| Fundamental Scientific Technology: Maintain identical underlying technology for spinal intervertebral body fixation. | - Stated: "The current Trinical and Trinical Select Anterior Cervical Plate Systems performance, intended use and fundamental scientific technology remain unchanged from their predicate devices." |
| Device Design: Maintain equivalent design for anterior cervical plate stabilization. | - Stated: "The modifications do not change the stabilization fixation of the cervical vertebra when compared to the predicate devices." (Referring to the minor modification of Trinica Select's width and locking cap). |
| Materials: Use identical materials (Titanium Alloy Ti-6Al-4V) for implants and similar treatments for plates/locking caps. | - Confirmed: Identical "Titanium Alloy (Ti-6Al-4V)" for implants and "Treated: Titanium Anodization per AMS 2488 Type II" for plates and locking caps. |
| Packaging: Provided non-sterile for system, sterile for drill bits/fixation pins. | - Confirmed: Identical "Provided Non-Sterile" for implants and instruments, and "Provided Sterile" for drill bits and fixation pins. |
| Sterilization Parameters (for user): Establish appropriate steam sterilization cycle. (Note: A difference in cycle time was deemed acceptable for substantial equivalence). | - New Device: "Steam Sterilization Cycle Time: 4 Minutes Temp: 270°F (132°C)" - Predicate Device: "Steam Sterilization Cycle Time: 15 Minutes Temp: 270°F (132°C)"
- Comparison: "Similar" (implies the new cycle was validated and found acceptable). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not explicitly stated for specific test sets (e.g., how many plates were bent, how many cadavers were used). The document refers to "components" and "implants and instruments" being tested.
- Data Provenance: Not specified. This is a premarket notification for a medical device (spinal fixation system), not an AI/software device, so the concept of "country of origin of data" or "retrospective/prospective" in the context of clinical trials doesn't directly apply here. The testing is bench and cadaver-based, not patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable to the type of device and testing described. The "ground truth" for mechanical and functional performance is established through established engineering standards (ASTM F1717) and cadaveric testing, not through expert consensus on medical images or clinical outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not applicable. The tests performed are objective engineering and biological assessments, not subjective interpretations 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:
- This is not applicable. This document describes a spinal fixation system (physical implant), not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- This is not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- The "ground truth" for this device's performance is based on:
- Engineering Standards: ASTM F1717 for mechanical testing.
- Functional Assessment: Successful implantation and function in cadaveric models.
- Biological Compatibility Standards: Biocompatibility testing to established norms.
- Sterilization Validation Standards: Testing to confirm effective sterilization, cleaning, and dry times.
8. The sample size for the training set:
- This is not applicable. This is a physical medical device, not a machine learning model. There is no concept of a "training set."
9. How the ground truth for the training set was established:
- This is not applicable as there is no training set for this type of device.
In summary:
This 510(k) summary is for a physical medical device (anterior cervical plate system), not an AI/software device. Therefore, many of the requested points, especially those related to AI model evaluation (sample sizes for test/training sets, experts, adjudication, MRMC studies, standalone performance, types of ground truth for AI), are not relevant to this document. The "acceptance criteria" are implicitly met by demonstrating substantial equivalence to previously cleared predicate devices through direct comparison of specifications and various non-clinical (bench and cadaver) performance 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.