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The NEXXT MATRIXX® corpectomy devices are indicated for use in the cervical spine (C2-T1) and thoracolumbar spine (T1-L5) in skeletally mature patients to replace a diseased, collapsed, damaged, or unstable vertebral body due to tumor, osteomyelitis, trauma (i.e. fracture), or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in degenerative disorders. The NEXXT MATRIXX® corpectomy devices are also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical, thoracic, and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion. The NEXXT MATRIXX® corpectomy devices are intended for use with autograft or allogenic bone graft comprised of cancellous and/ or corticocancellous bone graft, as an adjunct to fusion and with FDA-cleared supplemental internal fixation.

The NEXXT MATRIXX® System is a collection of additively manufactured spacers for cervical, lumbar/lumbosacral and thoracolumbar implantation. The basic shape of these implants is a structural column to provide surgical stabilization of the spine. Each device comprises an external structural frame having a roughened surface (~7μm). The intervening geometric lattices have pores 300-700µm. The inferior/superior aspects of the NEXXT MATRIXX® open devices incorporate a large vertical cavity which can be packed with bone graft material. The inferior/superior aspects of the NEXXT MATRIXX® solid devices are closed and do not permit the packing of bone graft within the implant. The solid devices are only to be used for partial vertebral body replacement. The open and solid devices are available in an assortment of height, length, width and lordotic angulation combinations to accommodate the individual anatomic and clinical circumstances of each patient.

This looks like a 510(k) summary for a medical device called the NEXXT MATRIXX® System, specifically for its corpectomy devices. Unfortunately, the provided document does not contain acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of AI or algorithm performance.

The "Performance Data" section explicitly states: "The modified corpectomy device was evaluated via mechanical testing including included static and dynamic compression and static and dynamic torsion (ASTM F2077), subsidence (ASTM F2267) and expulsion. The results demonstrated the performance of the modified corpectomy is substantially equivalent to the predicate."

This describes physical and mechanical performance testing of the device itself (an implant used in spinal surgery), not the performance of an AI or algorithm. Therefore, I cannot extract the information requested regarding:

1. A table of acceptance criteria and reported device performance (for AI/algorithm)
2. Sample size and data provenance for a test set (for AI/algorithm)
3. Number and qualifications of experts for ground truth (for AI/algorithm)
4. Adjudication method (for AI/algorithm)
5. MRMC comparative effectiveness study (for AI/algorithm)
6. Standalone performance (for AI/algorithm)
7. Type of ground truth used (for AI/algorithm)
8. Sample size for the training set (for AI/algorithm)
9. How ground truth for the training set was established (for AI/algorithm)

The document is about the physical testing and substantial equivalence of a spinal implant device.

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