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The ProMIS™ Fixation System is intended to provide immobilization of spinal segments in sketally mature patients as an adjunct to fusion in the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: 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; deformities (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

The ProMIS™ Fixation System can be used in an open approach or a posterior, percutaneous approach with minimal invasive (MIS) instrumentation.

The ProMIS™ Fixation System consists of 3 main single use implanted parts:

1. ProMIS™ Fusion Rods: a straight or bent rod of various lengths.
2. Polyaxial Pedicle Screws: cannulated and non- cannulated screw bodies with self-tapping flutes and rounded or self-drilling tips, available in three diameters (5.5mm, 6.5mm, with length ranging from 25 to 60, in increments of 5mm.
3. Setscrew.

All components are manufactured from Ti6Al4V per ASTM F136

Rods up to 100mm in length and the Pedicle Screws are provided sterile (gamma irradiated).

Rods exceeding 100mm are supplied non-sterile (steam/autoclave sterilization by the end user).

The provided text is a 510(k) summary for the Premia Spine Ltd.'s ProMIS™ Fixation System. It details a "Special 510(k) notice" for a modification to a previously cleared device (K150380).

Based on the information provided, this submission does not describe:

• Acceptance criteria for an AI/ML-driven device. The device is a "Thoracolumosacral Pedicle Screw System," which is a physical implant used in spinal surgery, not an AI/ML software device.
• A study proving device meets acceptance criteria related to AI/ML performance. The "Performance Data" section explicitly states, "The ProMIS™ Fixation System was subjected to static torsion and dynamic compression testing per ASTM F1717." This refers to mechanical testing of the physical implant, not a clinical study involving AI or human interpretation of images.
• Sample sizes for test sets, data provenance, expert numbers, adjudication methods, MRMC studies, standalone AI performance, or ground truth establishment for AI/ML models. These concepts are entirely absent from the document as they are not relevant to the type of device being described.

Therefore, it is not possible to extract the requested information regarding AI/ML device acceptance criteria and study details from the provided text. The document focuses on demonstrating substantial equivalence for design modifications to a physical medical implant, primarily through mechanical performance testing.

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