(28 days)
The SC-AcuFix Ant-Cer Dynamic Anterior Cervical Plate System is indicated for use in the cervical spine (C2-C7) during the development of solid spinal fusion in patients with instability caused by the following:
- Degenerative disc disease (DDD) - as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies;
- Trauma (including fractures);
- Tumor;
- Spondylolisthesis;
- Spinal stenosis;
- Deformity (i.e., scoliosis, kyphosis, lordosis);
- Pseudarthrosis; and
- Failed previous fusions.
The SC-AcuFix Ant-Cer Dynamic Anterior Cervical Plate System consists of bone plates, screws, and instrumentation intended for anterior fixation to the cervical spine. The plate system incorporates a mechanism that allows for uni-axial motion in compression to ensure postoperative load sharing between the plate and the graft.
The provided document is a 510(k) premarket notification for a spinal fixation system, not a study describing the acceptance criteria and performance of a device, particularly an AI/ML-enabled device. This document describes a traditional medical device (spinal plate system) and primarily relies on demonstrating substantial equivalence to a predicate device rather than clinical performance studies with acceptance criteria, ground truth, or human reader involvement.
Therefore, most of the requested information cannot be extracted from the provided text.
Here is what can be inferred/noted:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for the device. The "acceptance criteria" for a 510(k) of this nature primarily revolve around demonstrating substantial equivalence to a legally marketed predicate device. This typically involves showing comparable materials, design, intended use, and performance based on non-clinical (laboratory/bench) testing.
- Reported Device Performance:
- Non-Clinical Performance: "Laboratory and bench testing results demonstrate that the proposed Ant-Cer device is substantially equivalent to the predicate device."
- Clinical Performance: "Clinical data and conclusions were not needed for this device."
As such, a table of acceptance criteria and reported device performance, as typically understood for an AI/ML device (e.g., sensitivity, specificity, AUC values), is not available in this document. The "performance" assessment here is focused on substantial equivalence.
2. Sample size used for the test set and the data provenance: Not applicable. No clinical test set data is provided. Non-clinical bench testing was performed, but sample sizes for these tests are not detailed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical test set requiring expert ground truth is described.
4. Adjudication method for the test set: Not applicable. No clinical test set is described.
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 not an AI/ML device, and no MRMC study was conducted or is relevant to this traditional medical device submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an AI/ML device.
7. The type of ground truth used: For the non-clinical testing, the "ground truth" would be established by engineering and mechanical testing standards and specifications, comparing the device's physical properties and performance (e.g., strength, durability, dynamic motion) against those of the predicate device and relevant ASTM/ISO standards. No clinical ground truth (e.g., pathology, outcomes data) was used or required for this submission.
8. The sample size for the training set: Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.
§ 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.