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The G Surgical Marksman MIS 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 following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, kyphosis and/or lordosis), tumor, pseudarthrosis, and/or failed previous fusion. The G Surgical Marksman MIS System can be used in an open approach or a percutaneous approach with MIS instrumentation.

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

The provided document is a 510(k) premarket notification for a medical device called the "G Surgical Marksman MIS System." This document primarily focuses on establishing "substantial equivalence" to predicate devices based on mechanical testing and technological characteristics. It does not contain information about acceptance criteria for an AI/CADe device, a study proving such a device meets acceptance criteria, or any of the detailed information regarding AI algorithm training or testing as requested.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as the input document does not pertain to an AI-powered device or its performance evaluation in the way you've outlined.

The document discusses:

• Device: G Surgical Marksman MIS System (a pedicle screw spinal system)
• Purpose: To provide immobilization and stabilization of the posterior non-cervical spine as an adjunct to fusion.
• Regulatory Focus: Demonstrating substantial equivalence to existing predicate devices (Firebird with Phoenix MIS Spinal Fixation System, Zodiac® Spinal Fixation System, Moss Miami™ Spinal System, Optima™ Spinal System).
• Performance Data: Mechanical testing of worst-case constructs according to ASTM F1717 (static and dynamic compression bending, static torsion) to show performance is "substantially equivalent to the predicate devices."

The questions posed (acceptance criteria, sample sizes, ground truth, experts, adjudication, MRMC, standalone performance, training set details) are relevant to the evaluation of an AI or CADe device, which is not what this document describes.

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