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The GS Medical AnyPlus II Spinal Fixation System is composed of a non-cervical spinal fixation devices. It is intended for use as posterior pedicle screw fixation system (T1-S2), a posterior hook fixation system (T1-L5), or as an anterolateral fixation system (T8-L5). All components in the system 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 following indications regardless of intended use: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, and/or lordosis, Scheuermann's Disease), tumor, stenosis, pseudoarthrosis, and failed previous fusion.

The AnyPlus II Spinal Fixation System consists of various screws (mono and polyaxial screws, reduction screw, canulated screws, long arm screws, cortical screws, and a set screw). The screws are available with diameters ranging from 4.5 to 10.5mm, and lengths ranging from 20-100mm in 5mm increments. They are available in noncannulated, cannulated, and longarm geometries with both mono and poly types for each geometry option. All AnyPlus II Spinal Fixation System implant components are manufactured from Ti6AI4V ELI according to ASTM F136.

These implants are supplied non-sterile and are not reusable. The instruments in this system are supplied non-sterile, are reusable, and patient contacting materials are fabricated from Precipitation Hardened Stainless Steels (STS630 and STS555) that complies with ASTM F899.

The provided text is a 510(k) summary for a medical device called the "AnyPlus II Spinal Fixation System." This document is focused on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria in a clinical or AI-driven study.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, training sets, and ground truth establishment for a study proving the device meets acceptance criteria cannot be extracted from this document.

The document details:

• The device's name, regulation, and classification.
• Indications for use.
• Description of the device components and materials.
• A comparison to a predicate device (AnyPlus Spinal Fixation System, K172546), claiming substantial equivalence.
• Performance data consisting of biomechanical testing (static and dynamic axial compression bending, static torsion testing) according to ASTM F1717. This testing aims to show equivalent biomechanical performance to the predicate device (K091717, which seems to be an earlier predicate referenced for biomechanical comparison, rather than the primary equivalence predicate K172546).

In summary, this document does not contain the type of clinical or AI performance study details requested. It is a regulatory submission for a physical medical implant, not a software or AI device requiring such detailed performance evaluation against clinical ground truth.

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