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The ROMEO®2 PAD Posterior Axial Device is a posterior, non-pedicle supplemental fixation device, intended for use as an adjunct to fusion at a single level in the lumbar spine (L1-S1). It is intended for attachment to the spinous processes for the purpose of achieving stabilization as an adjunction to fusion in patients with degenerative disc disease - defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e.,fracture or dislocation) and /or tumor. The ROMEO®2 PAD Posterior Axial Device is not intended for standalone use.

The ROMEO®2 PAD is a Spinous Process Fixation device consisting of two titanium plates linked by a titanium cylinder that is used to perform immobilization of spinous processes of adjacent vertebras and thus provide supplemental stabilization of spinal segments to facilitate fusion. The device is locked and secure automatically at the same time. The plates include spikes on their opposing faces to provide attachment to bone. The mobile plate can translate along the titanium cylinder and includes some features that insure continuous locking at any position. The locking anti-back-out system maintains the plates in the desired position and pressed firmly against the spinous processes. The ROMEO®2 PAD is available in a range of sizes to fit the anatomical needs of a variety of patients. Components are provided pre-assembled and delivered sterile (gamma sterilization) with dedicated surgical instruments (reusable – provided non sterile).

I am sorry, but the provided text does not contain any information about acceptance criteria or a study that proves a device meets those criteria. The document is an FDA 510(k) clearance letter for a medical device called "ROMEO® 2 PAD Posterior Axial Device," which confirms its substantial equivalence to previously marketed devices. It outlines the device's indications for use, technological characteristics, and regulatory information, but it does not detail a study with specific acceptance criteria, sample sizes, ground truth establishment, or expert reviews.

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