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PINE Pedicle Screw System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute or chronic spinal instabilities or deformities in the thoracic, lumbar, and sacral spine:

• Degenerative disc disease (DDD) as defined by back pain of discogenc origin with degeneration of the disc confirmed by patient history and radiographic studies
• Spondylolisthesis
• Trauma (i.e., fracture or dislocation)
• Spinal stenosis
• Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
• Tumor
• Pseudoarthrosis
• Failed previous fusion

The PINE Pedicle Screw System is a top-loading multiple component, posterior spinal fixation system which consist of pedicle screws, rods, set screws, connectors, and transverse (cross) linking mechanisms. The implant components are supplied non-sterile, single use and fabricated from titanium alloy (Ti-6Al-4V ELI) as specified in ASTM F136. Various sizes of these implants are available.

The provided text is a 510(k) summary for the "PINE Pedicle Screw System," a medical device. It does not describe acceptance criteria for an AI/ML device or a study involving such a device. Instead, it details the regulatory process for a spinal implant system.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving device performance for an AI/ML device based on this input. The document focuses on mechanical testing for a physical implant, not on the performance of a software algorithm.

Here's why the provided text isn't suitable for your request:

• Device Type: The device described is the "PINE Pedicle Screw System," which is a "top-loading multiple component, posterior spinal fixation system" made of "pedicle screws, rods, set screws, connectors, and transverse (cross) linking mechanisms." This is a physical, mechanical implant, not an AI/ML device.
• Performance Data: The "Performance Data" section explicitly states: "Non-clinical testing was performed to demonstrate that the subject PINE Pedicle Screw System is substantially equivalent to the predicate device. The following testing was performed in accordance with the ASTM F1717: - Static compression - Dynamic compression - Static Torsion." These are mechanical tests for structural integrity, not performance metrics like sensitivity, specificity, or AUC typically used for AI/ML algorithms.

To answer your request, I would need a document related to an AI or Machine Learning device.

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