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The CarboClear Vertebral Body Replacement (VBR) System is intended for use during open surgical procedures in the thoracolumbar spine (T1-L5) to replace a collapsed, or unstable vertebral body due to tumor or trauma (e.g., fracture).

The CarboClear Vertebral Body Replacement device is intended to be used with supplemental internal spinal fixation systems that have been labeled for use in the thoracic and lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems).

The use of allograft or autograft with the CarboClear Vertebral Body Replacement device is optional.

The CarboClear VBR System comprises implants (spacers) in different dimensions, and instruments. The CarboClear VBR spacers are made of carbon fiber reinforced polyetheretherketone (CFR-PEEK), with titanium alloy endplates.

The provided document is a 510(k) summary for the CarboClear® VBR System, a medical device for spinal intervertebral body fixation. It does not describe an AI/ML powered device, nor does it detail a study proving device performance against acceptance criteria in the manner requested (e.g., with specific metrics like sensitivity, specificity, or human reader improvement with AI assistance).

The document focuses on demonstrating substantial equivalence of the CarboClear® VBR System to predicate devices through an assessment of its intended use, design, materials, technological characteristics, principles of operation, and mechanical performance characteristics.

Therefore, I cannot extract the information required for an AI/ML powered device study from this document. The sections you requested (acceptance criteria table, sample size, expert ground truth, MRMC study, standalone performance, etc.) are deeply specific to the evaluation of AI/ML models, not for a physical implant device like the CarboClear® VBR System.

The closest relevant information concerning "performance" in this document refers to mechanical testing standards for an implant:

• Performance characteristics included static and dynamic axial compression and torsion testing per ASTM F 2077, expulsion testing, and endplate shear strength testing.
• Performance characteristics are comparable to those of predicate devices (as applicable), thus demonstrating that the device is substantially equivalent to the predicates.

This indicates that the "acceptance criteria" were likely defined by meeting or exceeding the mechanical performance standards established in ASTM F 2077 and demonstrating comparability to predicate devices for these physical attributes. However, specific numerical acceptance criteria (e.g., a minimum axial compression strength) and reported performance values are not provided in this summary for confidentiality reasons, as this is a 510(k) summary, not the full submission. Similarly, the "study" proving this performance would be the mechanical testing described, not a clinical study involving human outcomes or an AI algorithm's performance.

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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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