(84 days)
When used as a posterior, non-pedicle system of the noncervical spine, the PLUS™ Pivot Link Universal System is indicated for:
- degenerative disc disease (discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)
- spondylolisthesis
- fracture
- spinal stenosis
- deformities (i.e. scoliosis, kyphosis, lordosis)
- tumors
- failed previous fusion (pseudoarthrosis)
The PLUS Pivot Link Universal System is also a pedicle screw system indicated for skeletally mature patients who:
- have severe spondylolisthesis (Grades 3 and 4) at the L5-S1 vertebra;
- receive fusions using autogenous bone graft only;
- have the device fixed or attached to the lumbar and sacral spine (L3 to sacrum); and
- have the device removed after the development of a solid fusion.
In addition, the PLUS Pivot Link Universal System is a pedicle screw system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients 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
- dislocation
- scoliosis
- kyphosis
- spinal tumor
- failed previous fusion (pseudoarthrosis)
The PLUS Pivot Link Universal System spinal instrumentation consists of hooks, screws, rods, and connectors that can be assembled in a variety of constructs. The instrumentation is combined and placed to treat a variety of spinal disorders, with the constructs varying according to the nature of the spinal pathology. The PLUS System components are available in stainless steel according to ASTMs F138 and F1586, from titanium alloy complying with ASTM-F136, and from commercially pure Titanium complying with ASTM F67.
The provided text describes a medical device submission (510(k)) for the PLUS™ Pivot Link Universal System. However, it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in terms of an AI algorithm or diagnostic performance.
The document is a regulatory submission for a spinal instrumentation system, focusing on its design, materials, indications for use, and a claim of substantial equivalence to previously cleared devices based on mechanical testing. It's a traditional medical device submission, not one related to an AI/ML powered device.
Therefore, I cannot provide the requested information for the following reasons:
- No AI/ML Component: The device described in the document is a physical spinal instrumentation system (rods, hooks, screws), not an AI algorithm or a diagnostic imaging device. As such, concepts like "acceptance criteria for device performance" in the context of sensitivity, specificity, AUC, human reader improvement, and ground truth establishment (other than for materials testing) are not applicable to this submission.
- No Performance Study as Described: The document mentions "Mechanical testing was performed to demonstrate the equivalence of the construct design to currently marketed spinal systems." This mechanical testing is done to ensure the structural integrity and functionality of the physical components, not to assess diagnostic accuracy or an AI's performance.
If you have a document describing an AI/ML medical device, I would be happy to analyze it for the requested information.
§ 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.