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The Insignia™ Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-T1) for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (kyphosis, lordosis or scoliosis), pseudarthrosis, failed previous fusions, spondylolisthesis, and spinal stenosis.

The Insignia Anterior Cervical Plate System is intended for anterior fixation to the cervical spine. The Insignia Anterior Cervical Plate System consists of a variety of sizes of plates and screws that are manufactured from titanium alloy conforming to ASTM F136 and are offered non-sterile. The instruments in this system are intended for use in surgical procedures.

The provided document, a 510(k) summary, describes a medical device called the "Insignia™ Anterior Cervical Plate System" and its substantial equivalence to predicate devices. However, this document does not contain the kind of information typically found in a study proving a device meets acceptance criteria for an AI/ML-based diagnostic or assistive technology.

The document is for a physical medical implant, a spinal fixation system, and the "performance data" section refers to nonclinical mechanical testing (e.g., static and dynamic compression, torsion testing) to demonstrate its physical performance and substantial equivalence to existing devices. It explicitly states: "Clinical Information: Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data."

Therefore, I cannot provide the requested information about acceptance criteria and a study proving the device meets those criteria in the context of AI/ML performance (e.g., accuracy, sensitivity, specificity, reader improvement, ground truth methodology) because the document describes a purely mechanical device, not a diagnostic or AI-driven one.

The prompt's requirements (e.g., "effect size of how much human readers improve with AI vs without AI assistance," "standalone (i.e. algorithm only without human-in-the loop performance)," "type of ground truth used") are specific to AI/ML device evaluations, which are not relevant to this 510(k) submission for a spinal plate system.

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