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The Coral™ Spinal System is a non-cervical spinal fixation device intended for use as a posterior pedicle screw fixation system, a posterior non-pedicle screw fixation system, or as an anterolateral fixation system. Pedicle screw fixation is limited to skeletally mature patients. The device is indicated as an adjunct to fusion for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

The purpose of this submission is the addition of cobalt chrome rods to the Coral™ Spinal System. The Coral™ Spinal System components can be rigidly locked together in a variety of configurations to promote fusion for a wide variety of patient anatomies.

I am sorry, but the provided text from K091266 does not contain information about acceptance criteria, device performance, sample sizes, expert qualifications, or study methodologies that are typically found in a clinical study report.

The document is a 510(k) summary for the Coral™ Spinal System, which focuses on demonstrating substantial equivalence to previously cleared predicate devices for the addition of cobalt chrome rods to the system. It primarily discusses:

• Device Description: The components and their materials.
• Intended Use: The medical conditions the device is designed to treat.
• Predicate Devices: Previously cleared devices it is similar to.
• Substantial Equivalence Argument: How the new components are similar to existing ones in terms of indications for use, operating principle, biocompatible materials, surgical techniques, manufacturing, sterilization, and packaging.
• Regulatory Information: Classification and product codes.

The key phrase "sufficient evidence exists to reasonably conclude that the additional components are substantially equivalent to the predicate device...This is based on the design concept, the use of established, known materials, feature comparisons, mechanical testing, indications for use, preproduction quality assurance planning and engineering analysis" indicates that the evaluation was based on bench testing (mechanical testing) and a comparison of design and materials, rather than clinical efficacy studies with patient data.

Therefore, I cannot provide the requested table or answer the questions related to clinical study design, acceptance criteria, sample sizes, ground truth establishment, or human reader performance. This type of information is not typically part of a 510(k) submission focused on substantial equivalence for a device modification where prior clinical data on the predicate device is assumed to be sufficient.

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