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The ROMEO® 2 Posterior Osteosynthesis System is intended to provide 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 disease; spondylolisthesis; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). When used for posterior noncervical pedicle screw fixation in pediatric patients, the ROMEO® 2 Posterior Osteosynthesis System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The ROMEO® 2 Posterior Osteosynthesis System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The ROMEO 2 Posterior Osteosynthesis System comprises polyaxial screws, monoaxial screws, spondylolisthesis screws, setscrew, straight and pre-bent Titanium or CoCr rods, and various connectors available in several sizes and models to accommodate different patient anatomies. ROMEO implantable components are single-use device provided sterile (gamma radiation) and supplied with dedicated surgical instruments.

This document is a 510(k) premarket notification from the FDA for a medical device called the "ROMEO® 2 Posterior Osteosynthesis System." It provides information about the device, its intended use, and its equivalence to previously marketed predicate devices.

Based on the provided document, there is no information regarding acceptance criteria, device performance results, sample sizes for test/training sets, expert involvement, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment for an AI/ML-driven medical device.

This document pertains to a traditional spinal implant system, not a device that relies on artificial intelligence or machine learning for its functionality or medical decision-making. The "Discussion of Testing" section explicitly mentions "non-clinical tests" like "Axial Rotation" and "Axial Push Down" per ASTM F1798, which are mechanical performance tests for orthopedic implants.

Therefore, I cannot fulfill the request to describe the acceptance criteria and study proving device performance as there is no relevant information in the provided text for an AI/ML device.

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