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KHEIRON® Spinal Fixation System including patient specific K-ROD is 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 thoracic, lumbar, and sacral spine: degenerative disc disease (defined as back pain of discogenic origin 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, kyphosis, and/or lordosis), spinal stenosis, spinal tumor, pseudarthrosis and failed previous fusion.

When used for posterior, non-cervical, pedicle screw fixation in pediatric patients, KHEIRON® Spinal Fixation System including patient specific K-ROD is indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, KHEIRON® Spinal Fixation System including patient specific K-ROD is intended to treat pediatric patients diagnosed with spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion.

This system is intended to be used with autograft and/or allograft.

Pediatric pedicle screw fixation is limited to a posterior approach.

Patient specific K-ROD devices are compatible with NuVasive Reline System components and Seaspine Mariner System components that are compatible with ø5.5mm and/or ø6.0mm rods as well as screws ø4.5mm or larger and at least 25mm in length.

S.M.A.I.O.'s patient specific K-ROD is part of the 510(k) cleared KHEIRON® Spinal Fixation system (K211981, K232650) designed for stabilization and correction of chronic instability or deformity of the thoracic, lumbar, and sacral spine. The patient specific K-ROD is manufactured from Ti-6Al-4V ELI per ASTM F136 and is available in diameters of 5.5 and 6.0 mm.

The Seaspine Mariner System is a 510(k) cleared pedicle screw system (K222110) that consists of a variety of screws, hooks, rods, lock screws, transverse connectors, rod-to-rod connectors, iliac connectors, and general instruments. Implant components are available in a variety of sizes and can be rigidly locked into a variety of different configurations to suit the individual pathology and anatomical conditions of the patient. The Seaspine Mariner System is designed to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the posterior thoracic, lumbar, and sacral spine. The Seaspine Mariner System is also used to treat severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebral joint in skeletally mature patients receiving fusion by autogenous bone graft.

The purpose of this Special 510(k) Device Modification is to extend indication of S.M.A.I.O.'s patient specific K-ROD (K211981, K232650) for use with the Seaspine Mariner System (K222110).

This FDA 510(k) clearance letter pertains to a spinal fixation system, which is a medical device, not an AI/software device. Therefore, the provided text does not contain the information needed to answer the questions about AI/software device acceptance criteria and study details (such as sample size, ground truth expert qualifications, MRMC studies, standalone performance, training set details, etc.).

The letter explicitly states:
"We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent...".
It refers to the device as "KHEIRON® Spinal Fixation System, including patient specific K-ROD".

The performance data mentioned (Dynamic compression bending – ASTM F1717, Static torsion – ASTM F1717, Static axial gripping capacity – ASTM F1798, Static torsional gripping capacity – ASTM F1798) are mechanical tests performed to verify the physical properties and compatibility of the spinal fixation system components. These are not related to AI model performance or clinical accuracy studies typically seen with software as a medical device (SaMD).

Therefore, I cannot fulfill the request as the provided document does not contain the type of information required for an AI/software device.

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