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CORBEL™ Spacers are integrated anterior lumbar interbody fusion devices indicated for use at one or more levels of the lumbosacral spine (L1-S1), as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc hemiation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). DDD is defined as discogenic back 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) months of non-operative treatment.

CORBEL™ Spacers are intended to be used with or without three screws and/or anchors which accompany the implants. These devices are intended for use with supplemental fixation (e.g. facet screws or posterior fixation). In addition, these devices are intended for stand-alone use in patients with DDD at one or two levels only when

CORBEL™ Spacers are integrated anterior lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectorny. The spacers are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. Protrusions on the superior and inferior surfaces of the device grip the endplates of the adjacent vertebrae to aid in expulsion resistance. Screws and/or anchors are inserted through the anterior portion of the implant into adjacent vertebral bodies for bony fixation.

CORBEL™ Spacers are manufactured from titanium alloy, as specified in ASTM F136. The mating screws and anchors are manufactured from titanium alloy, per ASTM F136 and F1295, and/or cobalt chrome alloy, per ASTM F1537. Titanium screws and anchors are available with or without hydroxyapatite (HA) coating, per ASTM F1185.

The provided document is a 510(k) summary for the CORBEL™ Spacers, an intervertebral body fusion device. It details the device's purpose, description, indications for use, and the basis for substantial equivalence to predicate devices. However, this document does not contain information about acceptance criteria or a study that proves the device meets those criteria in the context of an AI/ML medical device.

The "Performance Data" section briefly mentions mechanical testing and bacterial endotoxin testing, but these relate to the physical and material properties of the implant, not to the performance of a diagnostic or prognostic AI/ML algorithm.

Therefore, I cannot provide the requested information, particularly:

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

This document describes a traditional medical device (an implant), not an AI/ML-driven device.

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