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ROMEO posterior osteosynthesis system is intended to provide immobilization and stabilization 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: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).

The modifications to ROMEO posterior osteosynthesis system (K081165, K093170, K101678) manufactured by SPINEART consist of addition of Extension of the length range of pre-bent Rod Ø5.4mm (35, 45 and 55 mm) Extension of the length range of straight Rod Ø5.4mm (55 mm) Extension of the length range of transverse Connectors (20, 30 and 40 mm) Addition of iliac Connectors (Length 15, 20, 30, 40, 50 and 60 mm) Addition of axial Rod Connector, Parallel Rod Connector, Addition of Percutaneous pre-bent and straight titanium Rod Ø5.4 (Length 30 to 200 mm) These components are supplied either sterile or not sterile

The provided document is a 510(k) summary for a medical device called the ROMEO posterior osteosynthesis system. This document focuses on demonstrating substantial equivalence to a predicate device, primarily through mechanical testing of the additional components. It does not describe a study about the performance of an AI/ML powered device, nor does it contain acceptance criteria or reported performance metrics typically associated with such devices.

Therefore, I cannot extract the information required in your request regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone performance for an AI-powered device.

The "Performance data" section refers to:

• Acceptance Criteria/Standards: Conformity to "special control established for Pedicle screw spinal system" and to "Spinal System 510(k)s - Guidance for Industry and FDA Staff Document" issued on May 3, 2004.
• Study: Mechanical testing including static axial compression, static torsion, and dynamic axial compression tests have been performed according to ASTM F1717-09.
• Reported Device Performance: "Results demonstrate that additional components perform as safely and effectively as their predicate devices."

This is, however, for the physical components of the spinal system, not for an AI/ML powered device.

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