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REVEL™ Spacers (REVEL™ and REVEL™-S) are interbody fusion devices intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) for one or two contiguous levels, depending on the system. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. Hyperlordotic implants (≥20°) must be used with supplemental fixation in addition to the two screws or anchors. These devices are to be filled with autograft bone and/or allogenic bone graft composed of cortical, cancellous, and/or corticocancellous bone.

The REVEL™ Spacer is an interbody fusion device intended to be used with supplemental fixation, such as anterior cervical plates or posterior cervical screw fixation, for one or two levels of the cervical spine.

The REVEL™-S Spacer is an integrated interbody fusion device intended to be used with two titanium alloy screws and/or anchors which accompany the implant. When used with two screws, the REVEL™-S Spacer is a stand-alone interbody fusion device intended for use at one or two levels of the cervical spine. When used with any anchors, the REVEL™-S Spacer is intended for use at one level of the cervical spine with additional supplemental fixation such as posterior cervical screw fixation.

REVEL™ Spacers are expandable, anterior cervical interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. The devices are available in various height expansion ranges and footprints to fit the anatomical needs of a wide variety of patients. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion.

The REVEL™-S Spacer is to be used with two screws and/or anchors that are inserted through the anterior portion of the implant into adjacent vertebral bodies.

This document is a 510(k) summary for the REVEL™ Spacers, an intervertebral body fusion device. The purpose of the submission is to request clearance for these spacers. The document describes the device, its indications for use, and technological characteristics. It also outlines the performance data used to demonstrate substantial equivalence to predicate devices, but it does not contain specific acceptance criteria or a study that directly proves the device meets those criteria with numerical results.

Therefore, the requested tables and details related to acceptance criteria, reported device performance, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies cannot be extracted from the provided text. The document focuses on demonstrating substantial equivalence through mechanical testing according to established standards and guidelines, rather than presenting a standalone study with specific performance metrics against pre-defined acceptance criteria.

However, I can extract the information provided about the performance data collected to support substantial equivalence:

Performance Data Collected:

• Mechanical Testing:
  • Static and dynamic compression
  • Static and dynamic compression-shear
  • Static and dynamic torsion
  • Subsidence
  • Weight loss analysis
  • Expulsion
• Bacterial Endotoxin Testing (BET): Conducted in accordance with ANSI/AAMI ST-72:2011.
• Biocompatibility: Demonstrated by using materials that meet applicable standards or are used in 510(k) cleared devices.
• MRI Testing: Assessed per ASTM F2052, F2119, and F2182.

Standards and Guidance Used for Mechanical Testing:

• "Guidance for Industry and FDA Staff, Class II Special Controls Guidance Document: Intervertebral Fusion Device," June 12, 2007
• ASTM F2025
• ASTM F2077
• ASTM F2267

The document states that these tests were conducted "to demonstrate substantial equivalence to the predicate devices." It does not provide the specific numerical results of these tests or explicit acceptance criteria that were met.

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The Leva® Anterior Expandable Spacer System is indicated for intervertebral body fission procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade I spondylolisthesis at the involved level(s). The Leva® Anterior Expandable Spacer System is to be used with autogenous bone graft and with supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral body fusion device.

The Leva® Anterior Expandable Spacer is an expandable lumbar intervertebral body fusion device manufactured from unalloyed commercially pure titanium per ASTM F67. The Leva® Anterior Expandable Inserter, a reusable surgical instrument, expands the spacer (which is provided in a collapsed form) in situ to a predefined height. To accommodate the anatomical needs of a variety of patients, the spacer is available in a range of sizes. The superior and inferior surfaces of the spacer are convex with a lordotic angle to conform to the vertebral endplates, and ridges on both surfaces help resist expulsion. The spacer is designed to accommodate autogenous bone graft material.

I am sorry, but the provided text describes a 510(k) premarket notification for a medical device (Leva® Anterior Expandable Spacer System), which is an intervertebral body fusion device. This documentation focuses on demonstrating substantial equivalence to predicate devices based on mechanical testing and material properties, rather than the performance of an AI or diagnostic device that would involve an AI algorithm.

Therefore, the document does not contain the information requested regarding acceptance criteria related to AI device performance, sample sizes for test/training sets, expert adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment for such studies.

The acceptance criteria in this document relate to the physical and mechanical properties of the implant, such as:

• Static and dynamic axial compression (per ASTM F2077)
• Static and dynamic compression shear (per ASTM F2077)
• Subsidence (per ASTM F2267)
• Cadaveric validation

Since the input doesn't provide data for an AI-related medical device study, I cannot generate the requested table and information.

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