(28 days)
The Ant-Cer Dynamic Anterior Cervical Plate System is indicated for use in the temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion in patients with instability caused by the following: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), turnor, spondylolisthesis, spinal stenosis, deformity (i.e., scoliosis, lordosis), pseudarthrosis, and failed previous fusions.
The Ant-Cer Dynamic Anterior Cervical Plate System consists of bone plates, screws and surgical instruments. The screws are used to secure the plates to the vertebral bodies of the cervical spine through an anterior approach. The plates have an integrated locking mechanism that captures the screw upon full insertion, preventing screw-backout. The Ant-Cer system is a dynamic plate system that provides for uni-directional axial movement to ensure postoperative load sharing between the plate and graft. Plates and screws are manufactured from titanium alloy (ASTM F-136) and may be supplied sterile or non-sterile.
The provided text is a 510(k) summary for the Ant-Cer Dynamic Anterior Cervical Plate System. It describes the device, its indications for use, and states that mechanical testing data was collected to verify design changes. However, it does not include specific acceptance criteria, detailed study results, or information about the type of study (comparative effectiveness, standalone, etc.) as requested.
Here's a breakdown of what can be extracted and what is missing based on your requested format:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in document | "Mechanical testing data, including data collected in accordance with ASTM 1717, was collected to verify that the design changes met established design requirements." (No specific performance data or numerical results are provided.) |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified. Mechanical testing typically uses a certain number of samples for each test condition, but these numbers are not present in the summary.
- Data Provenance: Not specified. As mechanical testing is usually performed in a lab setting, there isn't a "country of origin of the data" in the human clinical sense. It's not a prospective or retrospective study involving human subjects.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This question is not applicable. The device is a spinal implant, and the study mentioned is mechanical testing. "Ground truth" in this context would refer to the physical and mechanical properties of the device, which are measured directly rather than established by expert consensus. There are no human experts evaluating images or making diagnoses.
4. Adjudication method for the test set
- Not applicable. This concept applies to human-reviewed data, not mechanical testing.
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 device is a medical implant, not an AI-powered diagnostic tool. The document describes mechanical testing, not a clinical study involving human readers or AI.
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
- The "ground truth" for mechanical testing is established by direct physical measurement of the device's properties (e.g., strength, durability under load, fatigue life) against predefined engineering specifications and standards (like ASTM 1717).
8. The sample size for the training set
- Not applicable. This device is not an AI algorithm; there is no "training set."
9. How the ground truth for the training set was established
- Not applicable.
In summary: The provided document is a 510(k) summary for a medical device (spinal implant) and focuses on regulatory clearance through substantial equivalence, supported by references to mechanical testing. It does not contain the detailed clinical study data or AI performance metrics requested. The "study" mentioned is "Mechanical testing data, including data collected in accordance with ASTM 1717." This type of study demonstrates the physical performance of the device, not diagnostic accuracy or AI effectiveness.
§ 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.