(30 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 consists of a variety 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) premarket notification for the PYRAMID® ANTERIOR PLATE Fixation System, specifically to include modified screws.
Based on the provided text, there is no study described that demonstrates the device meets specific acceptance criteria in terms of performance metrics like accuracy, sensitivity, or specificity for an AI/ML powered device.
This document is a regulatory submission for a medical device (a spinal fixation system), not a study report for an AI/ML algorithm. The "acceptance criteria" and "device performance" in this context refer to manufacturing, material specifications, and substantial equivalence to a previously cleared predicate device, rather than the performance of an AI model.
Therefore, many of the requested categories for AI/ML device studies (like sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.) are not applicable to this document.
However, I can extract information relevant to the regulatory approval process and the broader context of device "performance" in a non-AI sense.
Here's the breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied by 510(k) Process) | Reported Device Performance (Implied by 510(k) Clearance) |
|---|---|
| Substantial Equivalence: Device (including modified screws) is as safe and effective as a legally marketed predicate device. | The FDA reviewed the 510(k) and determined the device is substantially equivalent to legally marketed predicate devices. |
| Material Compatibility/Safety: Components made of suitable biocompatible materials. | Implied by the use of titanium alloy (Ti-6A1-4V) described by ASTM Standard F136 or ISO 5832-3. |
| Intended Use Compatibility: Device's design and materials support its specified indications for use. | The system is indicated for use as an anteriorly placed supplemental fixation device for the lumbosacral level and helps provide temporary stabilization until solid spinal fusion develops. |
| Manufacturing Quality: Adherence to General Controls provisions (e.g., GMP requirements, labeling). | FDA states the device is subject to general controls provisions of the Act, including requirements for annual registration, listing, good manufacturing practice, and labeling. |
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 document is not about a study involving a test set for an AI/ML algorithm. The 510(k) process relies on demonstrating substantial equivalence to a predicate device, which typically involves engineering testing, material testing, and potentially clinical literature review, rather than a "test set" in the AI sense.
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. No explicit "ground truth" establishment for a test set is described in the context of an AI/ML device. The "experts" involved would be regulatory reviewers at the FDA (Celia M. Witten, Ph.D., M.D., Director, Division of General, Restorative and Neurological Devices Office of Device Evaluation) assessing the submission.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable. No test set or adjudication method for AI/ML performance 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
- No. An MRMC study is not mentioned as this relates to an AI/ML device.
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 (expert consensus, pathology, outcomes data, etc.)
- Not Applicable in the AI/ML sense. The "ground truth" for this regulatory submission is the established safety and effectiveness of the predicate device (K013665), to which the current device is deemed substantially equivalent.
8. The sample size for the training set
- Not Applicable. No training set is involved for an AI/ML algorithm.
9. How the ground truth for the training set was established
- Not Applicable. No training set is involved for an AI/ML algorithm.
In summary, this document is a regulatory clearance for a physical medical device (spinal fixation system) based on substantial equivalence, not a performance study of an AI/ML powered 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.