(25 days)
The Medtronic Sofamor Danek PYRAMID™ ANTERIOR PLATE Fixation System is indicated for use as an anteriorly placed supplemental fixation device for the lumbosacral level below the bifurcation of the vascular structures.
When properly used, this system will help provide temporary stabilization until a solid spinal fusion develops. Specific indications include: 1) Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); 2) Pseudoarthrosis; 3) Spondylolysis; 4) Spondylolisthesis; 5)Fracture; 6) Neoplastic disease; 7) Unsuccessful previous fusion surgery; 8) Lordotic deformities of the spine; 9) Idiopathic thoracolumbar or lumbar scoliosis; 10) Deformity (i.e., scoliosis, lordosis, and/or kyphosis) associated with deficient posterior elements such as that resulting from laminectomy, spina bifida, or myelomenigocele; and/or 11) Neuromuscular deformity (i.e., scoliosis, lordosis, and / or kyphosis) associated with pelvic obliquity.
The PYRAMID™ ANTERIOR PLATE Fixation System is a supplemental fixation construct consisting of a variety of shapes and sizes of plates, and screws, as well as ancillary products and instrument sets. The PYRAMID™ ANTERIOR PLATE Fixation System implant components can be locked into a variety of configurations, with each construct being tailor-made for the individual case. The implant components are made of titanium alloy (Ti-6A1-4V) described by ASTM Standard F136 or ISO 5832-3. Stainless steel and titanium implant components must not be used together in a construct.
The provided text describes a 510(k) submission for the Medtronic Sofamor Danek PYRAMID™ ANTERIOR PLATE Fixation System. This document focuses on demonstrating substantial equivalence to a predicate device through mechanical testing, not a study involving human readers or AI. Therefore, most of the requested information regarding acceptance criteria for AI/human reader performance is not applicable.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device | Determined to be substantially equivalent to K013665 (PYRAMID™ ANTERIOR PLATE Fixation System). |
| Mechanical Functionality & Safety Tests | Mechanical testing was performed. |
| Compliance with Regulatory Standards | Implants made of titanium alloy (Ti-6A1-4V) described by ASTM Standard F136 or ISO 5832-3. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This submission is for a medical device (spinal fixation system) and its substantial equivalence is demonstrated through mechanical testing, not a clinical study with a test set of human subjects or data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. Ground truth in the context of expert consensus is not relevant for this type of mechanical device submission. The "ground truth" here would be the performance of the predicate device against which the new device is compared.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. This is not a study requiring adjudication of expert opinions.
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. This is not an AI-assisted diagnostic or interpretive device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is a physical medical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" or benchmark here is the performance of the predicate device (K013665, PYRAMID™ ANTERIOR PLATE Fixation System) as established by its clearance and subsequent safety and effectiveness. The new device's mechanical performance is compared to this established predicate.
8. The sample size for the training set
- Not Applicable. There is no "training set" in the context of mechanical testing for substantial equivalence.
9. How the ground truth for the training set was established
- Not Applicable. There is no "training set" or corresponding ground truth establishment in this context.
§ 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.