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The PASS LP Spinal System includes a 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 or deformities of thoracic, lumbar, and sacral spine: fracture, dislocation, failed previous fusion (pseudoarthrosis), spinal stenosis, degenerative spondylolisthesis with objective evidence of neurological impairment, spinal deformations such as scoliosis or kyphosis and loss of stability due to tumors.

The PASS LP Spinal System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebrae 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.

The Medicrea PASS LP Spinal System consists of pedicle screws, hooks, sacral plates, clamps, rods, nuts, rod plates and crosslink members. It can be used for single or multiple level fixations. All components are manufactured from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136.

The provided text describes a Special 510(k) submission for the PASS LP Spinal System, focusing on modifications to connectors. It does not contain information about acceptance criteria or a study that proves the device meets those criteria, as it is a mechanical device, not an AI/algorithm-based one.

Specifically, the document states:

• Performance Data: "When applicable, the tests performed on the additional components according to ASTM F1798, indicate that the products are as mechanically sound as other devices commercially available."

This statement confirms that some mechanical testing was done according to ASTM F1798, but it does not provide acceptance criteria or detailed study results. AI/algorithm-related criteria or studies are not relevant to this device.

Therefore, I cannot provide the requested information for acceptance criteria and a study proving device performance as the provided text pertains to a mechanical spinal system and not an AI-based device. The original request's parameters (e.g., sample size for test set, number of experts, adjudication method, AI assistance, ground truth) are designed for AI/algorithm-based devices and are not applicable here.

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