Search Results

The KHEIRON® Spinal Fixation System is intended to provide immobilization 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 thoracic. lumbar, and sacral spine: degenerative disc disease (defined as back pain with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, deformities or curvatures (i.e. scoliosis, and/or lordosis), spinal stenosis, spinal tumor, pseudarthrosis and failed previous fusion.

When used for posterior, non-cervical, pedicle screw fixation in pediatric patients, the KHEIRON 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 KHEIRON Spinal Fixation System is intended to treat pediatic patients diagnosed with spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion.

This system is intended to be used with autograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The KHEIRON® Spinal Fixation System is used in a variety of conditions that affect the thoracic and lumbar spine. In cases in which the posterior elements are fractured, the pedicle screw offers an excellent means of stabilizing a specific spinal segment. The KHEIRON Spinal Fixation System includes screws, anchoring, connecting components, hooks, iliac extensions, and crosslinks in a range of sizes and shapes that can be locked in various configurations, with each assembly being tailor-made to the patient's anatomical condition. The KHEIRON pedicle screws must be used with 5.5mm and 6.0mm rods. KHEIRON spinal implants are made of Ti-6AI-4V ELI alloy that conforms to ASTM F136. The KHEIRON Spinal Fixation System is provided clean, non-sterile, and the implants are single-use only.

The provided document is a 510(k) premarket notification decision letter and summary for a medical device called the KHEIRON® Spinal Fixation System. It outlines the regulatory approval of this system, primarily by demonstrating its substantial equivalence to previously cleared predicate devices.

*Crucially, this document does not contain any information about an AI/ML-based device or a study proving its performance against acceptance criteria for such a device with ground truth established by experts. The KHEIRON® Spinal Fixation System is a physical implant (pedicle screw system) used in spinal surgery, and its approval is based on demonstrating mechanical strength, material compatibility, and similar indications for use compared to predicate devices. The "Performance Data" section explicitly refers to mechanical testing (Static and dynamic compression bending, Static torsion) of the physical device, not an AI/ML algorithm.

Therefore, I cannot fulfill your request to describe acceptance criteria and study proving device meets them for an AI/ML-based device using the provided text. The document is about a completely different type of medical device.

Ask a specific question about this device