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CancelleX Porous Titanium Lumbar Interbody System devices are intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous non- fusion spinal surgery at the involved spinal level(s). The device is intended to be used with supplemental fixation systems that have been cleared for use in the lumbrosacral spine (e.g. posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). Hyperlordotic interbody devices (≥20° lordosis) must be used with at least anterior supplemental fixation. The device is intended to be used with autogenous bone graft. Patients must have undergone a regimen of at least six months of non-operative treatment prior to being treated with the CancelleX device.

CancelleX Porous Titanium Lumbar Interbody System devices are being added to the Lumbar Interbody System. The CancelleX Porous Titanium Interbody devices are generally box shaped with surface teeth and a central channel for packing autogenous bone. These implants are available in a range of shapes and sizes to accommodate variations in patient anatomy. The devices are manufactured from Commercially Pure (Unalloyed) Titanium (ASTM F1580). The system also includes instruments manufactured using polyacrylamide (PARA-IXEF-GY51) polymer and stainless steel per ASTM F899.

The provided text describes the regulatory clearance of the CancelleX Porous Titanium Lumbar Interbody Device. It does not contain information about the acceptance criteria or a study proving the device meets said criteria in the context of AI/ML device performance.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance data (bench testing and biocompatibility). It explicitly states that animal and clinical performance data were not required to determine substantial equivalence.

Therefore, I cannot provide a table of acceptance criteria and reported device performance related to AI/ML or answer most of the requested questions.

Here's what can be extracted based on the provided document:

1. Table of Acceptance Criteria and the Reported Device Performance (as much as applicable):

The following questions cannot be answered based on the provided document as they relate to AI/ML device performance, which is not discussed:

• 2. Sample sized used for the test set and the data provenance
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
• 4. Adjudication method for the test set
• 5. If a multi reader multi case (MRMC) comparative effectiveness study was done
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
• 7. The type of ground truth used
• 8. The sample size for the training set
• 9. How the ground truth for the training set was established

Summary of what the document does indicate:

The device's clearance was based on its substantial equivalence to previously cleared predicate devices, supported by non-clinical (biocompatibility and bench) testing. No AI/ML components or associated studies are mentioned.

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CancelleX Porous Titanium Lumbar Interbody System devices are intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous non- fusion spinal surgery at the involved spinal level(s). The device is intended to be used with supplemental fixation systems that have been cleared for use in the lumbrosacral spine (e.g. posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). Hyperlordoric interbody devices (≥20° lordosis) must be used with at least anterior supplemental fixation. The device is intended to be used with autogenous bone graft. Patients must have undergone a regimen of at least six months of non-operative treated with the CancelleX device.

CancelleX Porous Titanium Lumbar Interbody devices are being added to the Lumbar Interbody System. The CancelleX Porous Titanium Interbody devices are generally box shaped with surface teeth and a central channel for packing autogenous bone. These implants are available in a range of shapes and sizes to accommodate variations in patient anatomy. The devices are manufactured from Commercially Pure Titanium (ASTM F67). The system also includes instruments manufactured using polyacrylamide (PARA-IXEF-GY51) polymer and stainless steel per ASTM F899.

This document is a 510(k) Premarket Notification from Xenco Medical, LLC. for their CancelleX Porous Titanium Lumbar Interbody Device. It outlines the regulatory submission process and the data provided to demonstrate substantial equivalence to legally marketed predicate devices.

The document does not describe a study involving an AI/Machine Learning device or a study comparing device performance to human readers with or without AI assistance. It focuses on a medical implant (an intervertebral body fusion device) and demonstrates its substantial equivalence through biocompatibility testing and bench testing, as typically required for physical medical devices of this type.

Therefore, I cannot provide the information requested in your prompt because it is designed for studies of AI/ML-driven diagnostic or assistive devices, and this document pertains to a physical medical implant.

The document specifically states:

• "Animal performance data was not required to determine substantial equivalence."
• "Clinical performance data was not required to determine substantial equivalence."

It concludes that "Conclusions drawn from the non-clinical tests demonstrated that the subject device possessed at least equivalent performance characteristics as the predicate device, and that overall the subject device is substantially equivalent."

Since the information you requested (acceptance criteria, sample sizes, expert involvement, MRMC studies, standalone performance, ground truth types, and training set details for AI/ML) is not present in this document, I cannot generate a response that fulfills those specific points based on the provided text.

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