(26 days)
The XANTUSTM Anterior Lateral Supplemental Fixation System is intended for screw/bolt fixation/attachment to the anterolateral intervertebral bodies from T1 to L5 only. This system is to be used only on one side and placed in such a manner as to be as far away from blood vessels such as the aorta and nerve roots as possible.
When properly used, this system will provide temporary stabilization until a solid spinal fusion develops. Specific indications include:
- Degenerative Disc Disease (DDD as defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies).
- Pseudoarthrosis.
- Spondylolysis.
- Spondylolisthesis.
- Fracture.
- Neoplastic disease.
- Unsuccessful previous fusion surgery.
- Lordotic deformities of the spine.
- Idiopathic thoracolumbar or lumbar scoliosis.
- Deformity (i.e., scoliosis, lordosis, and/or kyphosis) associated with deficient posterior elements such as that resulting from laminectomy, spina bifida, or myelomenigocele.
- Neuromuscular deformity (i.e., scoliosis, and/or kyphosis) associated with pelvic obliquity.
The XANTUSTM Anterior Lateral Supplemental Fixation System consists of a variety of shapes and sizes of plates, screws, bolts, and nuts, as well as ancillary products and instrument sets. XANTUSTM Anterior Lateral Supplemental Fixation System anterior implant components can be locked into a variety of configurations, with each construct being tailor-made for the individual case. Implant components from other previously cleared Medtronic Sofamor Danek Spinal Systems can be used in conjunction with XANTUSTM Anterior Lateral Supplemental Fixation System. These components include the ZPLATE-ATL™ Anterior Fixation System screws and the DYNA-LOK® Spinal System nut. Refer to those package inserts for proper specific instructions for use.
This document describes a medical device, the Medtronic Sofamor Danek XANTUS™ Anterior Lateral Supplemental Fixation System, and its clearance process. However, it does not contain a study that provides specific acceptance criteria for performance metrics or data on how the device meets those criteria, as you've requested for AI/software-based devices.
The clearance outlined in the document (K022070) is based on substantial equivalence to a predicate device (K014267), meaning it was determined to be as safe and effective as a previously cleared device. The "study" mentioned is primarily focused on Functionality & Mechanical testing to demonstrate this equivalence for a physical medical device.
Therefore, I cannot provide the detailed information requested in your prompt regarding acceptance criteria and a study proving device performance in the context of an AI/software device. The document pertains to a physical implantable device.
If this were a software/AI-based device and such a study were present, here's how I would interpret and populate the requested information based on your prompt's structure:
Based on the provided text, the device is a physical implant (XANTUS™ Anterior Lateral Supplemental Fixation System), not an AI/software device. Therefore, the detailed acceptance criteria and study design elements typically associated with AI/software performance (such as sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.) are not applicable or provided in this regulatory submission.
The document states that demonstrating substantial equivalence to an already cleared predicate device (K014267) is the primary "acceptance criterion" for this type of physical device's regulatory clearance.
Here's what the document does provide regarding "acceptance criteria" and "device performance" in the context of a physical device:
-
Table of Acceptance Criteria and Reported Device Performance:
Acceptance Criteria (for Substantial Equivalence) Reported Device Performance Device Description Match: Be substantially similar in components, configuration, and use as the predicate device. The XANTUS™ Anterior Lateral Supplemental Fixation System consists of "variety of shapes and sizes of plates, screws, bolts, and nuts, as well as ancillary products and instrument sets." It's stated that "Implant components from other previously cleared Medtronic Sofamor Danek Spinal Systems can be used in conjunction with XANTUS™ Anterior Lateral Supplemental Fixation System." This description is implicitly deemed substantially similar to the predicate for regulatory purposes. Intended Use Match: Have the same intended use as the predicate device. The intended use is "for screw/bolt fixation/attachment to the anterolateral intervertebral bodies from T1 to L5 only. This system is to be used only on one side and placed in such a manner as to be as far away from blood vessels such as the aorta and nerve roots as possible." This is deemed substantially equivalent to the predicate's intended use. Indications for Use Match: Have the same indications for use as the predicate device. Specific indications are listed, including Degenerative Disc Disease, Pseudoarthrosis, Spondylolysis, Spondylolisthesis, Fracture, Neoplastic disease, Unsuccessful previous fusion surgery, Lordotic deformities of the spine, Idiopathic thoracolumbar or lumbar scoliosis, Deformity associated with deficient posterior elements, and Neuromuscular deformity associated with pelvic obliquity. These indications are deemed substantially equivalent to the predicate's indications. Safety and Functionality (Mechanical Testing): "Functionality & Mechanical testing" must demonstrate substantial equivalence to the predicate device in terms of safety and performance for its intended use. "Functionality & Mechanical testing was performed on the Subject XANTUS™ Anterior Lateral Supplemental Fixation System which determined it to be substantially equivalent to the predicate XANTUS™ Anterior Lateral Supplemental Fixation System." The specific metrics, thresholds, or detailed results of this mechanical testing are NOT provided in this summary document, only the conclusion of substantial equivalence. The system is designed to "provide temporary stabilization until a solid spinal fusion develops." -
Sample sizes used for the test set and the data provenance: Not applicable or provided for an AI/software study. The "test set" here refers to the physical samples subjected to mechanical testing. No details on the number of devices or components tested are given.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for a physical device's mechanical testing in this context. Substantial equivalence for mechanical testing is typically based on engineering standards and comparative data, not expert consensus on ground truth in a clinical imaging sense.
-
Adjudication method: Not applicable for mechanical testing as described.
-
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, this is not relevant for the clearance of a physical orthopedic implant system based on substantial equivalence and mechanical testing.
-
If a standalone (i.e., algorithm only without human-in-the loop performance) was done: No, not applicable.
-
The type of ground truth used: Not applicable in the context of AI/software. For mechanical testing, the "ground truth" would be established engineering standards, material properties, and performance benchmarks, against which the measured functionality of the device is compared.
-
The sample size for the training set: Not applicable.
-
How the ground truth for the training set was established: Not applicable.
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.