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The G Surgical Marksman Spinal Deformity System is intended to provide immobilization of the posterior non-cervical spine (T1-S2/Ilium) in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis and/or lordosis), tumor, pseudarthrosis, and/or failed previous fusion.

The G Surgical Marksman Spinal Deformity System consists of longitudinal members (rods), anchors (screws), connectors (crosslinks) and fasteners in a variety of sizes to accommodate differing anatomic requirements.

Unfortunately, I cannot fulfill your request to describe the acceptance criteria and study proving the device meets them, nor any of the other numbered items.

The provided document is a 510(k) clearance letter from the FDA for a medical device called the "G Surgical Marksman Spinal Deformity System." This type of document primarily confirms that the FDA has found the device to be "substantially equivalent" to predicate devices already on the market.

It explicitly states that the device is a "Thoracolumbosacral Pedicle Screw System" and is manufactured from specific titanium and cobalt chrome alloys.

The document details the device's indications for use (spinal immobilization and stabilization as an adjunct to fusion for various conditions), describes its components (rods, screws, connectors, fasteners), and mentions the materials used.

However, the provided text does not contain any information about acceptance criteria, clinical study results, performance data (beyond mechanical testing to ASTM F1717 and sterilization validations), sample sizes for testing, expert qualifications, ground truth establishment, or any details related to AI assistance or multi-reader multi-case studies.

Therefore, I cannot extract the information you've requested from this document. It appears to be a clearance for a physical orthopedic implant, not a diagnostic or AI-driven device that would typically involve the types of performance studies and metrics you've listed.

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