(84 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, 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-6A 1- 4V) described by ASTM Standard F136 or ISO 5832-3. Stainless steel and titanium implant components must not be used together in a construct.
This document is a 510(k) summary for a medical device called the Medtronic Sofamor Danek PYRAMID™ ANTERIOR PLATE Fixation System. It describes the device, its intended use, and its substantial equivalence to previously cleared predicate devices.
Here's an analysis of the provided information, specifically addressing the acceptance criteria and study aspects you've requested.
It's important to note that this document is a 510(k) summary, which is a premarket notification for devices demonstrating substantial equivalence to a predicate device. It typically does not contain detailed clinical trial data or performance metrics in the same way a PMA (Premarket Approval) application would for novel, high-risk devices. The "study" here refers to mechanical testing for equivalence, not a clinical study on human subjects.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate devices (K922543, K010632) for intended use and safety/functionality. | "Mechanical testing was performed on the PYRAMID™ ANTERIOR PLATE Fixation System, which determined it to be substantially equivalent to the ZPLATE-ATL™ Anterior Fixation System and the BUTTERFLY™ PLATE Fixation System." |
| Meeting relevant ASTM/ISO standards for materials. | "The implant components are made of titanium alloy (Ti-6Al-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)
- Sample Size for Test Set: Not explicitly stated in terms of number of physical components tested, but implies sufficient samples were used for mechanical testing to establish equivalence. This is not a clinical "test set" in the traditional sense of patient data.
- Data Provenance: The origin of the mechanical testing data (e.g., specific lab, country) is not specified. Given Medtronic's location in Memphis, TN, it's likely U.S.-based or from a reputable international testing facility. This would be considered "prospective" testing as it was conducted specifically for this submission.
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)
This section is not applicable to this type of submission. Ground truth established by medical experts (e.g., radiologists) is relevant for diagnostic devices or AI algorithms interpreting medical images. For a spinal fixation system, "ground truth" for mechanical performance is established by engineering standards and comparative testing to predicate devices, typically assessed by engineers and regulatory bodies.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. Adjudication methods like 2+1 (two readers agree, third resolves discrepancy) are used for clinical studies involving human interpretation (e.g., image reading). Mechanical testing relies on objective measurements against defined criteria.
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
This is not applicable. This device is a passive implantable medical device, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance would not be performed for this product.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This device does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the mechanical testing performed, the "ground truth" would be the established performance characteristics and safety profiles of the predicate devices based on their own clearances and recognized engineering standards (e.g., ASTM/ISO). The new device's performance is compared to these benchmarks to demonstrate substantial equivalence.
8. The sample size for the training set
This is not applicable. This device is a physical implant, not a machine learning algorithm requiring a training set.
9. How the ground truth for the training set was established
This is not applicable as it applies to machine learning algorithms.
Summary of the "Study" mentioned:
The study referred to in this 510(k) summary is mechanical testing.
- Objective: To demonstrate that the PYRAMID™ ANTERIOR PLATE Fixation System is "substantially equivalent" in terms of functionality and safety to the predicate devices (ZPLATE-ATL™ Anterior Fixation System and BUTTERFLY™ PLATE Fixation System).
- Methodology: Mechanical tests were performed. While specifics of the tests (e.g., fatigue testing, static testing, torsional testing) are not detailed in this summary, they would typically involve applying forces and stresses to the device and comparing its performance (e.g., strength, durability, screw pull-out resistance, plate bending strength) against those of the predicate devices.
- Proof of Meeting Acceptance Criteria: The statement "Mechanical testing was performed... which determined it to be substantially equivalent..." serves as the proof that the device meets the (implied) acceptance criteria of performance comparable to the cleared predicate devices. This equivalence demonstrates that it is as safe and effective as the devices already on the market.
§ 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.