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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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The Atlas Spine Expandable Interbody System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved levels. These patients may have had a previous non-fusion surgery at the involved level(s).

The Atlas Spine Expandable Interbody System is intended for use with autograft comprised of cancellous and/or corticocancellous bone graft; and supplemental fixation system (i.e. Firebird® Spinal Fixation System).

Patients must have undergone a regimen of at least six months of non-operative treatment prior to being treated with the Atlas Spine Expandable Interbody System.

The Atlas Spine Expandable Interbody System consists of various size and style options to address the clinical and anatomic needs of individual patients. The implant is rectangular in its general shape with the capability to expand in height infinitely within its design limitations. The implant incorporates bone graft cavities through the superior and inferior surfaces to allow fusion between adjacent vertebral bodies. The implants incorporate a textured bone contacting surface to resist migration/expulsion of the implant post operatively. Additionally, the implant incorporates an opening posteriorly to allow the addition of bone graft material post expansion.

The implants components are manufactured from implantable grade Ti6Al4V alloy and Peek Optima LT1 delivered in the pre-assembled, unexpanded state.

The provided text describes information about the Atlas Spine Expandable Interbody System, specifically regarding its 510(k) premarket notification to the FDA. However, it does not provide acceptance criteria for a device, nor does it detail a study proving a device meets specific acceptance criteria in the context of AI/ML performance.

The document discusses:

• Device Name: Atlas Spine Expandable Interbody System
• Regulation Number: 21 CFR 888.3080
• Regulation Name: Intervertebral Body Fusion Device
• Regulatory Class: Class II
• Product Code: MAX
• Indications for Use: Spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2-S1), with or without Grade 1 spondylolisthesis, after at least six months of non-operative treatment. Intended for use with autograft/allograft and supplemental fixation.
• Predicate Devices: Caliber™ Spacer (Primary), ProLift® Expandable System, FORZA® PTC Spacer System, Spinal Jaxx Interbody Fusion Device, L-Varlock Lumbar Cage, Atlas Spine Verterbral Body Replacement, Bluefin™ Interbody System, Dorado™ Intervertebral Body Cage.
• Device Description: Rectangular, height-expandable implant with bone graft cavities and a textured bone-contacting surface, manufactured from implantable grade Ti6Al4V alloy and Peek Optima LT1.
• Non-Clinical Testing: Bench testing was performed as recommended by FDA guidance (Class II Special controls guidance document: Intervertebral body Fusion Device, June 12, 2007). This included:
  • Static testing in load to failure mode (axial compression, shear, expulsion, subsidence).
  • Dynamic axial compression testing to estimate maximum run-out load.
  • Dynamic compression shear testing to estimate maximum run-out load.
• Conclusion of Testing: Test results demonstrated that the Atlas Spine Expandable Interbody System is found to be substantially equivalent to the predicate devices.
• Clinical Performance Data: "No clinical testing was required."

Therefore, I cannot provide the requested information about acceptance criteria and a study proving a device meets them, especially in the context of AI/ML, as this document pertains to a spinal implant and its mechanical substantial equivalence to predicate devices, with no mention of AI/ML components or performance metrics.

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