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The LAGUNA™ Monoaxial Pedicle Screw System is intended for posterior, non-cervical fixation for the following conditions: 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.

The Laguna™ Monoaxial Pedicle Screw System is intended to help provide correction, immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and/or sacral space.

The Laguna Spinal System consists of a variety of rods and screws, which can be rigidly locked into a variety of configurations, with each construct being tailor made for the individual case. The additional monoaxial screws are supplied in winged and non-winged configurations from 30 to 80 mm length and in 5mm, 6mm, 7mm and 8mm diameter sizes. All sizes are able to receive 5.5mm connecting rods only.

The Laguna Spinal System implant components are fabricated from medical grade titanium alloy described by such standards as ASTM F136 or ISO 5832-3 or 5832-2.

The provided text focuses on the 510(k) summary for the Allez Spine Laguna Monoaxial Pedicle Screw System. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain details about acceptance criteria, a specific study proving those criteria, or information on AI/standalone algorithm performance, ground truth establishment, or multi-reader multi-case studies.

The document primarily states that:

• Performance Data: "Biomechanical tests have been performed. The test results were equivalent to other similar implants and are sufficient for in vivo loading."

This single statement is the extent of the performance data provided in this specific 510(k) summary. It does not elaborate on specific acceptance criteria, study methodologies, sample sizes, expert involvement, or AI aspects.

Therefore, I cannot fulfill the request for information on acceptance criteria and study details as they are not present in the provided text.

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