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The AnyPlus Spinal Fixation System are non-cervical spinal fixation devices intended for use as posterior pedicle screw fixation systems (T1 – S2), a posterior hook fixation system (T1 – L5),or as an anterolateral fixation system (T8 – L5). All components are limited to skeletally mature patients. System components are to be used for immobilization and stabilization of the spine as an adjunct to fusion. These devices are indicated for all of the following indications regardless of the intended use: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis, Scheuermann's Disease), tumor, stenosis, pseudoarthrosis, and failed previous fusion.

AnyPlus Spinal Fixation System is made of devices for fixation of the noncervical spine. They include smooth rods, plates, screws, hooks, nut, screws, and transverse links. The purpose of this submission was to add components to the Anyplus Spinal Fixation System.

This document does not describe an AI/ML powered medical device. It pertains to a Spinal Fixation System, which is a physical implant used in spinal surgery.

Therefore, the requested information about acceptance criteria, study design for AI/ML performance, sample sizes, ground truth establishment, expert involvement, and MRMC studies is not applicable to this device.

The "Performance Data" section in the document indicates that the device underwent mechanical testing according to ASTM F1717 standards (static compression bending, static torsion, and dynamic compression bending) to demonstrate its safety and effectiveness. This is typical for physical orthopedic implants, not software algorithms.

The "Substantial Equivalence" section confirms that the device was deemed substantially equivalent to predicate physical devices based on intended use, indications, technological characteristics, principles of operation, and mechanical testing results.

In summary, this document describes the FDA clearance of a medical device (spinal fixation system) that is a physical product, not an AI/ML algorithm.

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