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The COLONNADE Posterior Screw Fixation System is intended for posterior, noncervical pedicle fixation as an adjunct to fusion in skeletally mature patients using autograft and/or allograft for the following indications: degenerative disc disease (DDD) (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; pseudoarthrosis; and failed previous fusion. Fenestrated screws are not intended for use with cement.

The COLONNADE Posterior Screw Fixation System pedicle screw is an internal fixation device for spinal surgery. Various forms and sizes of these implants are available so that constructions can be utilized to account for the unique pathology and anatomy of each patient. The subject pedicle screws and set screw of COLONNADE Posterior Screw Fixation System are manufactured from Ti-6Al-4V ELI as per ASTM F136, and are anodized The subject rods are manufactured from Ti-6Al-4V ELI as per ASTM F136 and Co-28Cr-6Mo as per ASTM F1537.

This document, an FDA 510(k) clearance letter for the "COLONNADE Posterior Screw Fixation System," details the regulatory approval of a medical device intended for spinal surgery. However, it does not contain information about a study proving that an AI/software device meets acceptance criteria.

The 510(k) letter explicitly states, "Clinical Testing: Not Applicable" in the "Non-Clinical and/or Clinical Tests Summary & Conclusions" section on page 6. This indicates that no human clinical study was performed to assess the device's performance in a clinical setting against acceptance criteria for diagnostic or AI-driven tasks.

Instead, the provided text emphasizes the substantial equivalence of the "COLONNADE Posterior Screw Fixation System" to predicate devices based on:

• Identical Indications for Use: The intended applications of the new device are the same as previously cleared devices.
• Similar Technological Characteristics: The design, materials (Ti-6Al-4V ELI, Co-28Cr-6Mo), function, and fundamental technologies are comparable to predicates, with only "slight differences between the length and diameter of screws, and rod length."
• Non-Clinical Testing: Performance was evaluated through mechanical testing standards (ASTM F1717) related to spinal implant constructs (Static Compression Bending, Static Torsion, Dynamic Compression Bending).

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving an AI/software device meets them, as this information is not present in the provided FDA 510(k) clearance letter.

The letter pertains to a hardware device (a spinal fixation system), not a software or AI device for which performance metrics like those typically associated with diagnostic AI (e.g., sensitivity, specificity, AUC, human reader improvement) would be established and tested in a clinical trial.

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