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The Omnia Medical Rotary PLIF System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). This device is to be used with autogenous bone graft. The Omnia Medical Rotary PLIF System is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral body fusion device.

The Omnia Medical Rotary PLIF is manufactured from PEEK-OTIMA™ LT1 conforming to ASTM F2026 and tantalum markers conforming to ASTM F560. The Omnia Rotary PLIF is rectangular in shape and available in various sizes with heights ranging from 9mm to 17mm and 0° or 7° of lordosis. The leading end is tapered or bulleted for ease of insertion. All devices are 25mm in length. The device has six tantalum markers for radiographic confirmation of device position and orientation. The device is intended to be used with supplemental fixation.

This document is a 510(k) premarket notification decision letter and a summary for the Omnia Medical Rotary PLIF System. It does not contain the acceptance criteria or a study proving the device meets those criteria, nor does it provide details about a test set, expert involvement, or ground truth establishment.

The document mentions that "Engineering rationales were provided to leverage the mechanical testing of the predicates for this submission" and that "Mechanical testing on the predicate included static and dynamic compression per ASTM F2077, static and dynamic torsion per ASTM F2077, subsidence per ASTM F2267, and expulsion testing." It concludes that "These rationales and performance tests support substantial equivalence."

However, this is a summary of what was submitted for the predicate device, not the Omnia Medical Rotary PLIF System itself, and it does not detail the acceptance criteria or the specific results of those tests for the predicate or the new device.

Therefore, I cannot fulfill your request for the specific details you've asked for based solely on the provided text. The document acts as a regulatory approval notice based on the manufacturer's submission, not a detailed study report.

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