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MNH - When used as a posterior pedicle system, the device is indicated for use in skeletally mature patients L3 & below who are:

• having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint;
• receiving fusions using autogenous bone graft only; .
• having the device fixed or attached to the lumbar and sacral spine; and
• . having the device removed after the development of a solid fusion mass.

MNI - Posterior pedicle systems are 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 (T-10 - S1/2):

• degenerative spondylolisthesis with objective evidence of neurologic impairment .
• fracture
• dislocation
• . scoliosis
• kyphosis
• . spinal tumor
• failed previous fusion (pseudarthrosis) .

The ORIA CLARIS includes implantable components that fit together to form a construct for use during spinal fusion surgery. The system contains components of various designs and sizes that allow the surgeon to build an implant system to fit the patient's individual anatomical and physiological requirements. Selection of the necessary components is addressed in the surgical protocol. The titanium components are made of surgical implant grade CP Titanium and titanium alloy (6al4Vti). The basic system components include: Connectors, Nuts & Locking Screws, Rods, Crosslinks, Pedicle Screws, Sacral Screws, Unique Instrumentation. The system consists of a series of alloy compatible parts from which various spinal assemblies or constructs may be fashioned. Specially designed connectors, interconnection mechanisms incorporating nuts, screws; longitudinal members (rods) and/or transverse connectors, sacral screws and pedicle screws are offered. The levels of attachment (depending on specific indication) are lumbar and thoracic spine, and the sacrum and may only be used posteriorly.

This appears to be a 510(k) premarket notification for a medical device (ORIA CLARIS Posterior spine system). The provided document describes the device, its indications for use, and regulatory compliance, but it does not contain information about acceptance criteria or a study proving the device meets those criteria in the way you've outlined for performance studies of AI/diagnostic devices.

The document primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device (Eurosurgical, S.A., K021679) for regulatory approval, rather than presenting a performance study with specific acceptance criteria and detailed methodology using a test set, ground truth, experts, etc.

Therefore, I cannot populate the table or provide the requested information because the provided text does not contain:

• Explicit acceptance criteria for performance metrics (e.g., sensitivity, specificity, accuracy).
• A "study" in the sense of a clinical trial or a performance evaluation against a defined ground truth on a test set. The closest it comes to "testing" is mentioning compliance with material, mechanical, and biocompatibility standards, and sterilization cycle validation, but these are not performance studies as typically described for AI/diagnostic devices.
• Sample size used for a test set or data provenance.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method.
• MRMC comparative effectiveness study.
• Standalone algorithm performance.
• Type of ground truth used (beyond general material/mechanical standards).
• Sample size for a training set.
• How ground truth for a training set was established.

The document's purpose is to satisfy regulatory requirements for market clearance based on substantial equivalence to an existing device, which often relies on demonstrating similar design, materials, and intended use, rather than novel performance benchmarks.

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