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The VEOS Spinal Fixation System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine (from T1 to S1).

The VEOS Spinal Fixation System is intended for noncervical pedicle fixation 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); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor: pseudoarthrosis; and failed previous fusion in skeletally mature patients.

When used in a posterior percutaneous approach with MIS instrumentation, the VEOS Spinal Fixation System is intended for noncervical pedicle fixation 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); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, The VEOS Spinal Fixation System is indicated as an adjunct to fusion to treat adolescent idiopathic scollosis. Pediatric pedicle screw fixation is limited to a posterior approach.

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

The Spineway VEOS Spinal Fixation System is composed of implant devices made from a titanium alloy Ti6Al4V-ELI per ISO 5832-3 and Cobalt-Chrome per ISO 5832-12. All implants are provided sterile or non-sterile. The implants are to be implanted from the posterior approach. The screws are available as monoaxial reduction screws in multiple diameters and length. Titanium rods are available in two diameters and multiple lengths. CoCr rods are available in one diameter and two length. CoCr rods are only available non-sterile. Transverse connectors are available in various sizes to attach to the two parallel rods. Associated instrumentation to complete the procedure is provided. Screws for MS applications are available as polyaxial cannulated screws in multiple diameters and lengths. Rods for MS applications are available as pre-bent rods and straight rods. Associated instrumentation to complete the procedure is provided.

The provided text is an FDA 510(k) clearance letter for a medical device called the "VEOS Spinal Fixation System." This document primarily focuses on demonstrating substantial equivalence to existing predicate devices based on design, materials, and intended use, rather than presenting a performance study of an AI/ML powered medical device against specific acceptance criteria.

Therefore, the requested information about acceptance criteria and a study proving a device meets acceptance criteria (especially in the context of AI/ML performance) is not present in the provided text. The document clearly states:

• "Clinical testing was not performed." (Page 5)

The tests summarized are non-clinical, mechanical tests (ASTM F1717 and ASTM F1798) to evaluate the structural competence of the spinal fixation system, which are physical properties of the implant, not performance metrics of an AI/ML algorithm.

Therefore, I cannot provide the requested table and details because the provided document does not contain information about:

1. A table of acceptance criteria and reported device performance (in the context of AI/ML).
2. Sample sizes for a test set or data provenance for AI/ML.
3. Number of experts, their qualifications, or adjudication methods for ground truth establishment.
4. MRMC studies or standalone AI performance.
5. Type of ground truth (expert consensus, pathology, outcomes data).
6. Sample size for a training set or how its ground truth was established.

This document describes the clearance of a physical medical implant, not an AI/ML-driven diagnostic or treatment device.

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