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The Easyspine System is a posterior, noncervical pedicle and non-pedicle system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities of the thoracic, lumbar and sacral spine:

• 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
• Deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis)
• Tumor
• Pseudoarthrosis
• Failed previous fusion

The Easyspine System is designed to aid in the surgical correction of several types of spinal conditions. This system is intended only to provide stabilization during the development of a solid fusion with a bone graft. These implants are intended to be removed after the development of a solid fusion mass. Easyspine® consists of sacral and pedicle screws, cross-connections, rods of different rigidities and hooks. Specialized associated instrumentation is designed for implantation of these devices and for the distraction, compression or reduction of the lumbar and thoracic spine.

The provided text describes a 510(k) premarket notification for the LDR Spine Easyspine® System. This is a medical device submission, and the content focuses on establishing substantial equivalence to a predicate device, primarily through mechanical performance data. It does not contain information about acceptance criteria, device performance metrics, or a study involving human readers or AI algorithms as requested in your prompt.

Specifically, the document states:

• "Mechanical test results demonstrate that the proposed Easyspine System is substantially equivalent to the predicate device." (pg. 2, Section 8, "Non-Clinical Performance Data")

This indicates that the primary method of demonstrating equivalence was through mechanical testing, not through a clinical study with human readers or AI.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance. The device described is a physical implant (spinal system), not a diagnostic device or AI software that would typically have such performance metrics.

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