(27 days)
The Zavation Buttress Plate System is intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts. The device is not intended for load bearing indications.
The Zavation Buttress Plate System consists of screws and plates. Screws are available in a variety of diameter and length combinations. Plates are available in a variety of lengths.
The provided text is a 510(k) summary for the Zavation Buttress Plate System. This document does NOT contain information about acceptance criteria for a medical device's performance as typically assessed in clinical studies, nor does it detail a study proving such performance against specific metrics.
Instead, this document focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, which is the regulatory pathway for Class II medical devices in the United States. The "performance data" mentioned refers to biomechanical testing to show the device itself is safe and effective in its engineering properties, not AI or a diagnostic algorithm's accuracy.
Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert ground truth, MRMC studies, or standalone algorithm performance cannot be extracted from this document.
Here's what can be gathered, reinterpreting "acceptance criteria" and "device performance" in the context of this 510(k) for a physical medical device:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (in context of 510(k)) | Reported Device Performance (as demonstrated by tests) |
|---|---|
| Biomechanical performance similar to predicate devices for spinal fixation. | Biomechanical testing, including static and fatigue cantilever beam loading, was conducted. |
| Made from appropriate materials for medical implants. | Components manufactured from titanium alloy (Ti-6Al-4V) as described by ASTM F136. |
| Basic design, sizes, and intended use are comparable to predicate devices. | Possesses the same technological characteristics as predicates: basic design (plate designed system having various screw diameters and lengths), material (titanium alloy), sizes (variety of plate and screw sizes), and intended use. |
2. Sample size used for the test set and the data provenance
- Test set sample size: Not applicable/Not provided. The document refers to biomechanical testing, not an algorithmic test set or patient data.
- Data provenance: Not applicable/Not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This information pertains to studies validating diagnostic or AI-driven devices, not the biomechanical testing of an implantable medical device.
4. Adjudication method for the test set
- Not applicable.
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
- No, an MRMC study was not done, and this type of study is not relevant for the type of device (spinal buttress plate) described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical implant, not an algorithm.
7. The type of ground truth used
- Ground truth concept (for biomechanical testing): The "ground truth" for this type of device would be established engineering standards (e.g., ASTM F136 for material, industry standards for static and fatigue loading) and the performance characteristics of the predicate devices. The device's performance is compared to these established benchmarks to demonstrate safety and effectiveness.
8. The sample size for the training set
- Not applicable. This device does not involve a "training set" in the context of AI or machine learning.
9. How the ground truth for the training set was established
- Not applicable.
In summary: This document is a regulatory submission for a physical medical device (a buttress plate system for spinal fusion). The "study" mentioned is biomechanical testing to demonstrate that the device functions as intended and is comparable to existing devices, satisfying the requirements for 510(k) submission for substantial equivalence. It does not provide information related to the performance evaluation of a diagnostic algorithm or AI-powered device, which is what your questions are primarily structured for.
§ 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.