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The Sterile Posterior Spinal Fixation System is intended for posterior, non-cervical fixation as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenc 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 Sterile Posterior Spinal Fixation System is a single-use system for surgical fixation of the spine. It is made up of pedicle screws, rods, and interconnecting devices. The implanted parts confer stabilization and fusion of two or more spinal segments and are to be removed once their stabilizing function is no longer required. The implantable devices are manufactured from titanium alloy and are provided sterile. The Sterile Posterior Spinal Fixation System includes the following sets: RS8 LEGEND (designed for open surgery) and RS8 LONG (designed for minimally invasive surgery). Each set comprises of different rods, screws, set screws, and accessory parts, including various lengths and diameters of reduction screws. Both sets are designed for internal posterior thoracolumbar fixation of the spine. Surgical instruments are provided with the subject device and predicate device. The subject of this submission is a design change to Posterior Spinal Fixation System(K201737). The Posterior Spinal Fixation System(K201737) is provided non-sterile and the subject device is provided sterile.

The provided text is a 510(k) summary for a medical device called "Sterile Posterior Spinal Fixation System." This document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria related to AI/ML algorithm performance, nor does it describe an AI/ML device.

The document discusses the substantial equivalence of a physical medical device (spinal fixation system) to a legally marketed predicate device. The only change described is the sterilization method of the implants.

Therefore, I cannot extract the requested information about AI/ML algorithm performance, acceptance criteria, ground truth establishment, sample sizes for test/training sets, expert qualifications, or MRMC studies from this document. The document explicitly states:

"No additional pre-clinical or clinical data is required to support the substantial equivalence determination for this change." (Page 5, "Performance data" section)

This indicates that extensive performance studies, as would be expected for an AI/ML device, were not conducted or required for this particular change to a physical implant.

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