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The OPTIMA™ posterior spinal fixation device is a pedicle screw system indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

In addition, the OPTIMA™ is 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 or deformities of the thoracic, lumbar and sacral spine: degenerative Spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudoarthrosis).

When used as an anterior screw fixation system, the OPTIMA™ is indicated for patients with degenerative disc disease which is defined as back pain of the discogenic origin with degeneration of the disc confirmed by history and radiographic studies, Spondylolisthesis, fracture, spinal stenosis, spinal deformities such as scoliosis, kyphosis, lordosis, tumor, pseudoarthrosis, or revision of failed fusion attempts.

The OPTIMATM Spinal System is a top-loading multiple component, anterior / posterior spinal fixation system which consists of pedicle screws, rods, set screws, connectors, and a transverse (cross) linking mechanism.

The OPTIMA™ system will allow surqeons to build a spinal implant construct to stabilize and promote spinal fusion. The OPTIMA™ implant system components are supplied non-sterile are single use and are fabricated from titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F 136. Various sizes of these implants are available. Specialized instruments made from surgical grade stainless steel are available for the application and removal of the OPTIMA™ system

The provided text is a 510(k) summary for the OPTIMA™ Spinal System, which is a medical device for spinal fixation. This type of submission focuses on demonstrating substantial equivalence to legally marketed predicate devices, primarily through materials, design, indications for use, and operational principles, often supported by bench testing. It does not involve the kind of performance criteria and clinical study details related to AI or diagnostic device accuracy that your questions are designed to gather.

Therefore, I cannot provide the requested information in the format you've specified because the submission does not contain:

• Acceptance criteria and reported device performance (beyond general equivalence to predicates).
• Details on sample sizes or data provenance for test sets.
• Number/qualifications of experts for ground truth.
• Adjudication methods.
• MRMC comparative effectiveness studies or effect sizes.
• Standalone algorithm performance.
• Specific types of ground truth (expert consensus, pathology, outcomes data).
• Training set sample sizes or how their ground truth was established.

The "Performance Data" section explicitly states: "Bench testing as listed in Section XII which was conducted in accordance with ASTM F1717 demonstrates equivalence to the above listed predicate devices." This refers to mechanical testing, not clinical performance metrics or AI/diagnostic accuracy.

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