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The PASS XS Spinal System is a pedicle screw fixation system intended for 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 the thoracic, lumbar, and sacral spine: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, tracture or dislocation), deformity or curvature (e.g., scoliosis, and/or lordosis), tumor, spinal stenosis, pseudoarthrosis, or failed previous fusion.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the PASS XS Spinal System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The PASS XS Spinal System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The PASS XS Spinal System is designed to contribute to the correction and surgical stabilization of the thoracic, lumbar and sacral spine.

The system consists of pedicle screws, connectors, rods, nuts, and crosslink components. It can be used for single or multiple level fixations. Components are manufactured from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136 and ISO5832-3 and cobaltchromium molybdenum alloy Co-Cr28Mo6 that conforms to ISO 5832-12 and ASTM F1537.

The PASS XS components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case.

The purpose of this submission is to introduce the PASS XS Spinal System which is, essentially, a smaller version of the PASS-LP system.

This document is a 510(k) summary for the Medicrea PASS XS Spinal System, a pedicle screw fixation system. It outlines the device's characteristics and its equivalence to predicate devices, but it does not include acceptance criteria or a study designed to prove the device meets specific acceptance criteria in the context of AI/ML performance.

The document primarily focuses on demonstrating substantial equivalence through:

• Comparison of technological characteristics with predicate devices.
• Performance data limited to biocompatibility and mechanical testing of the physical implant components.

Therefore, I cannot provide the requested information for acceptance criteria and a study to prove meeting those criteria, as it is not present in the provided text. The document specifically states:

• Clinical study: "No clinical studies were performed."
• Animal study: "No animal studies were performed."

The performance data mentioned ("static axial compression, static torsion and dynamic axial compression according to ASTM F1717, and axial gripping, torsional gripping and flexion-extension according to ASTM F1798") refers to mechanical testing of the hardware, not the performance of an AI/ML device.

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