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The Curiteva Pedicle Screw System is intended for posterior, non-cervical pedicle screw fixation (T1-S2/ilium) and hook fixation (T1-L5) in skeletally mature patients as an adjunct to fusion for all of the following indications: 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), tumor, stenosis, pseudarthrosis and/or failed previous fusion. The Curiteva Pedicle Screw System is intended to be used with autograft and/or allograft.

The Curiteva Pedicle Screw System is a thoracolumbar and/or sacral spine fixation system for spinal surgery that consists of a variety of screws, rods, set screws, crosslink connectors, rod connectors, and hooks. These implants are available in different sizes so that adaptations can be made to take into account pathology and individual patient anatomy.

The Curiteva Pedicle Screw System implants are manufactured from Titanium alloy (Ti-6Al-4V) that conforms to ASTM F136. Select rods are also available in medical grade Cobalt Chromium alloy (per ASTM F1537). All implants are intended for single use only and should not be reused under any circumstances.

This document is a 510(k) premarket notification from the FDA, which focuses on demonstrating substantial equivalence of a new medical device to existing predicate devices. It primarily details the device's design, materials, indications for use, and mechanical performance testing.

Crucially, this document does not describe the acceptance criteria or a study that proves a device meets acceptance criteria in the context of an AI/ML medical device. The "Curiteva Pedicle Screw System" is a physical medical implant (a pedicle screw system for spinal fixation), not an AI/ML-powered diagnostic or therapeutic device.

The performance data mentioned ("static and dynamic axial compression bend per ASTM F1717 and static torsion per ASTM F1717") refers to mechanical strength and durability testing of the physical hardware, not the performance of an algorithm.

Therefore, I cannot provide the requested information regarding AI/ML acceptance criteria, sample sizes for test/training sets, ground truth establishment, expert qualifications, or MRMC studies, as these concepts are not applicable to the type of device described in this document.

The "acceptance criteria" for this implant would be its ability to withstand certain mechanical forces as defined by ASTM standards and demonstrate equivalence to predicate devices in those tests. The "study" is the mechanical testing itself.

If the request was intended for an AI/ML medical device, the provided document does not contain that information.

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