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The Arisstos™ Spinal System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in 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, spinal tumor and failed previous fusion (pseudarthrosis).

The Arisstos™ Spinal System is indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the LS-S1 vertebra in skeletally mature patients undergoing fusion by autogenous bone grafting having implants attached to the lumbar and sacral spine with removal of implants after the attainment of a solid fusion.

The Arisstos™ Spinal System is an internal fixation device for spinal surgery consisting of rods, screws, hooks and connectors available in various lengths, diameters, and configurations to enable close conformance to patient anatomy. A series of manual instruments intended to assist in the insertion and placement of the implants is provided in separate trays.

The provided text describes a 510(k) premarket notification for the Arisstos™ Spinal System. It outlines the device's indications for use, its classification, and comparison to predicate devices. However, this document does not contain information about acceptance criteria or a study proving the device meets the acceptance criteria in the context of an AI/ML medical device.

The "Performance Testing" section states: "Mechanical testing, including static compression bending, dynamic compression bending, and static torsion was performed per ASTM F1717 to establish that the mechanical properties of the subject devices are equivalent to the predicate devices." This is physical device testing for a spinal implant, not performance testing for an AI/ML algorithm that predicts or analyzes medical images or data.

Therefore, I cannot fulfill your request for the following information based on the provided text, as it pertains to a different type of medical device and regulatory submission:

• A table of acceptance criteria and the reported device performance (for an AI/ML device)
• Sample sized used for the test set and the data provenance
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts
• Adjudication method for the test set
• If a multi reader multi case (MRMC) comparative effectiveness study was done
• If a standalone performance study was done
• The type of ground truth used
• The sample size for the training set
• How the ground truth for the training set was established

The document is a regulatory letter for a spinal implant system, focusing on mechanical performance and substantial equivalence to existing predicate devices, not on the performance of a software-as-a-medical-device (SaMD) product or an AI/ML algorithm.

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