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The Sterispine™ PS system is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct of fusion.

Sterispine™ PS system is intended for posterior, non-cervical pedicle and non-pedicle fixation 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; tumor; pseudoarthrosis and failed previous fusion.

The cleared range of Sterispine™ Ps system include multiaxial screws and cannulated multiaxial screws with or without extended head (Ø5.5, 6.5 and 7.5mm, lengths from 25 to 60mm) and straight and prebent rods (Ø5.5, 6.5 and 7.5mm, lengths from 30 to 380mm). Components of Sterispine™ PS range of products is supplied sterile with a sterile single-use set of surgical instruments.

This looks like a 510(k) summary for a medical device called "Sterispine™ PS", which is a thoracolumbosacral pedicle screw system. From the information provided, it's clear that this is not a software device or an AI/ML powered device, and therefore does not have acceptance criteria or a study related to software performance.

The document describes premarket notification for a traditional medical device (implants for spinal fusion) and focuses on demonstrating substantial equivalence to previously cleared predicate devices. The "Discussion of testing" section refers to mechanical and biocompatibility testing for the physical device components, not software performance.

Here's why the requested information about acceptance criteria and studies for device performance (in the context of AI/ML) cannot be found in this document:

• Device Type: This is a physical implant (pedicle screw system), not a diagnostic algorithm, image analysis tool, or any other type of software that would typically have performance metrics like sensitivity, specificity, or AUC.
• Regulatory Pathway: A 510(k) for a physical medical device like this often relies on demonstrating substantial equivalence to legally marketed predicate devices through material comparisons, mechanical testing, and functional similarities, rather than clinical performance studies of a software output.
• "Device Performance" Context: When the document refers to "testing," it's discussing the physical properties of the implant (e.g., static compression, torsion, bacterial endotoxin) to ensure it's safe and performs as intended mechanically, not the accuracy of an algorithm.

Therefore, since the request is based on the assumption of an AI/ML driven device, which this is not, I cannot extract the requested information.

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