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The Cortera" Spinal Fixation System is intended for posterior, non-cervical fixation in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondy lolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Cortera" Spinal Fixation System implants are indicated as an adjunct to treat progressive spinal deformities (i.e. scoliosis, kyphosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the Cortera" Spinal Fixation System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/ spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. Pediatric pedicle screw fixation is limited to a posterior approach.

The Cortera™ Spinal Fixation System is intended to be used with an autograft and/or allograft.

The Cortera™ Spinal Fixation System is a Thoracolumbosacral pedicle screw system intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and/or the sacral spine. The System consists of screws, rods, locking set screws and associated manual surgical instruments for an open or minimally invasive surgical approach. The screws and set screws are manufacturered from titanium alloy (Ti6Al4V per ASTM F136). The rods are available in titanium alloy or cobalt chromium alloy (Co-28Cr-6Mo per ASTM F1537). The implants are available in a variety of sizes to accommodate individual patient anatomy and are provided non-sterile.

The Cortera™ Spinal Fixation System rods may be used in connection with Streamline Cross Connectors, covered in K192800. The Streamline Cross Connectors accept various rod diameters and are appropriate for use with Cortera™ Spinal Fixation System 5.5 mm diameter rod-based systems. These cross connectors will keep their original cleared trade name.

The provided document is an FDA 510(k) clearance letter for the Cortera™ Spinal Fixation System. This is a document used to demonstrate the substantial equivalence of a new medical device to a legally marketed predicate device.

Crucially, this document does NOT describe the acceptance criteria or a study that proves a device meets specific performance criteria for an AI/ML algorithm within the context of medical imaging or diagnostics.

The "Performance Data" section (VII) refers to mechanical and physical testing of the spinal fixation system (e.g., static and dynamic compression, torsion, pull-off testing of the screws and rods per ASTM standards). This is typical for orthopedic implant devices to ensure their structural integrity and durability. It does not relate to the performance of an AI model.

Therefore, I cannot extract the information required by your prompt regarding Acceptance Criteria and a study proving an AI/ML device meets them, because this document is about a surgical implant, not an AI/ML medical device.

To answer your prompt, I would need a document detailing the 510(k) or de novo submission for an AI/ML powered medical device, which would include information on its clinical performance studies, ground truth establishment, sample sizes for training and testing, and acceptance criteria for its analytical and clinical validity.

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