(20 days)
The EBI SpineLink™ System is a spinal fixation device for pedicle screw fixation and a nonpedicle hook and sacral/iliac screw fixation system of the noncervical spine.
When used as a pedicle screw fixation system, in the non-cervical spine of skeletally mature patients, the System is intended to provide immobilization and stabilization of spinal segments, as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: Degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocations, scoliosis, kyphosis, spinal tumor, and failed previous fusion (psuedarthrosis).
In addition, when used as a pedicle screw fixation system in skeletally mature patients, it is intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar - first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (d) who are having the device removed after the development of a solid fusion mass.
When used as a posterior hook and sacral/iliac screw fixation system, the levels of attachment are the lumbar and thoracic spine, and screw fixation limited to the sacrum and ilium. The System is intended for the treatment of degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). Psuedarthrosis; stenosis; scoliosis; spondylolisthesis, fracture; previous failed fusion; or tumor resection.
When used as an anterior fixation system, the levels of attachment are the anterolateral vertebral bodies of the lumbar and thoracic spine. The System is intended for the treatment of degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). Psuedarthrosis; stenosis; scoliosis; spondylolisthesis, fracture; previous failed fusion; or tumor resection.
The EBI SpineLink™ System is a spinal fixation device that uses interconnecting links. This submission is for the addition of a modified polydirectional spondylolisthesis screw. The components of the system are manufactured from Ti-6AI-4V ELI per ASTM F136. The components will be available with and without TiN coating.
This document is a 510(k) summary for a medical device (EBI SpineLink™ System), not a study demonstrating device performance against acceptance criteria for an AI/ML product. Therefore, it does not contain the information required to answer your specific questions about acceptance criteria, study design, expert involvement, or AI/ML performance metrics.
The document describes:
- The device (EBI SpineLink™ System), which is a spinal fixation device.
- Its intended use and indications.
- The materials used.
- A comparison to predicate devices, stating that there are "no significant differences" and that it is "substantially equivalent."
- An FDA letter confirming substantial equivalence and allowing the device to be marketed.
Based on the provided text, I cannot extract the information required to populate your table and answer your questions.
Specifically:
- Acceptance Criteria & Device Performance: This document does not detail specific quantitative acceptance criteria or performance metrics derived from a study that would be relevant to an AI/ML device (e.g., sensitivity, specificity, accuracy). It only states that "Testing comparing the modifications to the previous system demonstrated that the device complies with applicable standards and meets all of its functional requirements," but no specific data or criteria are provided.
- Sample Size, Ground Truth, Experts, Adjudication, MRMC, Standalone Performance, Training Set: These are all concepts related to the evaluation of AI/ML or diagnostic devices, which are not discussed in this 510(k) summary for a spinal fixation hardware system.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.