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The Genesys Spine Binary Lumbar Plate System is indicated as additional support during fusion via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracolumbar (T1 -L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor. degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, lordosis, spinal stenosis, or a failed previous spine surgery.

The Genesys Spine Binary Lumbar Plate System consists of an assortment of plates and screws. The Binary Lumbar Plate System also contains Class 1 manual surgical instruments and cases that are considered exempt from premarket notification. Implant components are available in a variety of sizes to suit the individual pathology and anatomical conditions. The Genesys Spine Binary Lumbar Plate System implants are manufactured from medical grade Ti-6A1-4V ELI titanium alloy per ASTM F136.

The provided text describes a 510(k) premarket notification for a medical device, the Genesys Spine Binary® Lumbar Plate System. It details the device's purpose, components, indications for use, and a comparison to a predicate device.

However, the document does not contain information about an Artificial Intelligence (AI) / Machine Learning (ML) enabled device, nor does it discuss clinical studies with acceptance criteria, human reader performance, ground truth establishment, or training/test set details related to AI/ML device performance.

This document pertains to a physical medical device (spinal plates and screws) and its regulatory clearance based on substantial equivalence to an existing predicate device, primarily through engineering analysis, not through the performance or evaluation of an AI algorithm.

Therefore, I cannot provide the requested information about acceptance criteria and study data for an AI/ML device, as such information is not present in the provided text.

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