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The JAZZ Spinal System is intended for posterior, non - cervical fixation as an adjunct to fusion for skeletally mature patients for the following indications: 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. In addition, when used as a pedicle screw fixation system, the JAZZ Spinal System is intended for skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral, L5-S1 vertebra, who are receiving fusion by autogenous bone graft only, who are having the device attached to the lumbar and sacral spine (levels may be from L3 to the sacrum/ilum), who are having the device removed after the attainment of a solid fusion.

The JAZZ Spinal System consists of a variety of shapes and rods that can be rigidly locked in a variety of configurations, with each construct being tailor-made for the individual case. Fixation is provided via a posterior approach. The components are made from titanium alloy or cobalt chrome alloy. Components of the system include straight and pre-bent rods, monoaxial and polyaxial screws (cannulated and non-cannulated), reduction screws, domino connectors, lateral connectors, crosslinks, dual headed screws and connectors, transverse and sagittal uniplanar screws, favored angle screws, modular screws, S2Al screws, along with associated set screws and class I instrumentation.

This document, a 510(k) summary for the JAZZ Spinal System, does not describe the acceptance criteria and study that proves a software device meets acceptance criteria. Instead, it focuses on the mechanical and material performance of a medical device (spinal system) and its substantial equivalence to predicate devices, which is typical for hardware devices.

Therefore, I cannot provide the requested information about acceptance criteria and study details for an AI/software device based on the provided text. The document discusses:

• Acceptance Criteria (Implicit for Hardware): The acceptance criteria are implicitly related to the performance standards set by ASTM F1717 and ASTM F1798 for spinal implants, ensuring the mechanical strength and stability of the system.
• Reported Device Performance: "Bench performance testing was performed including static axial compression, dynamic axial compression, and static torsion per ASTM F1717...; Static Axial grip, Static Nominal Dissociation, and Static Maximum Angle Dissociation per ASTM F1798..."
• Study Type: This is a bench performance testing study, not an AI/software performance study.
• Ground Truth: For this type of device, the "ground truth" is adherence to established engineering standards for mechanical properties.

The other points you raised (sample sizes for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types for AI, training set size, and ground truth establishment for training) are all specifically relevant to the evaluation of AI/software medical devices and are not applicable to the content of this 510(k) summary, which concerns a physical spinal implant system.

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