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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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The Reform Pedicle Screw 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: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).

The Reform Pedicle Screw System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. The Reform Pedicle Screw System is also intended for non-cervical pedicle screw fixation (T1-S1/ilium) for the following indications: degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies); trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis, kyphosis; and/or lordosis); spinal tumor; pseudoarthrosis; and failed previous fusion.

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

The Reform System is a top-loading, multiple component, posterior spinal fixation system which consists of pedicle screws, rods, cross-connectors, locking cap screws, hooks, domino connectors, and lateral offset connectors. All of the components are available in a variety of sizes to match more closely to the patient's anatomy. All components are made from medical grade stainless steel, cobalt chromium alloys, titanium or titanium alloy described by such standards as ASTM F138, ASTM F1537, ISO 5832-12, ASTM F136 or ISO 5832-3.

The provided text is a 510(k) summary for a medical device (Reform Pedicle Screw System) and does not describe acceptance criteria or a study proving that an AI/device meets acceptance criteria. Instead, it details the indications for use, technical characteristics, and a performance testing summary related to demonstrating substantial equivalence to a predicate device.

Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving device performance in the context of an AI device. The document describes a physical medical device (pedicle screw system) and its regulatory clearance process based on substantial equivalence, not the performance of an AI algorithm against defined acceptance criteria.

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