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The PressON Spinal Fixation System is a posterior, non-cervical pedicle screw system intended to provide immobilization and stabilization of spinal segments in skeletally 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 (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, scoliosis, lordosis, spinal tumor, and failed previous fusion (pseudarthrosis).

The PressON Spinal Fixation System is composed of pedicle screws and rods. These components can be assembled and implanted using associated instruments via a posterior approach into the pedicles of the noncervical vertebral bodies. The system is composed of pedicle screws, cortical screws, and a variety of couplers. All components of the PressON Spinal Fixation System are made from Ti-6Al-4V ELI (ASTM F-136).

I am sorry, but the provided text does not contain any information about acceptance criteria for a device's performance, nor does it describe a study proving a device meets such criteria. The document is an FDA 510(k) clearance letter for the "PressON Spinal Fixation System," stating it is substantially equivalent to a previously cleared predicate device.

The information primarily concerns:

• The device's name and classification.
• Its intended use (indications for use).
• Details about the manufacturer and regulatory contacts.
• A list of mechanical performance tests performed (ASTM F1717 and ASTM F1798), but without reporting any specific results, acceptance criteria, or details of a study setup (like sample size, ground truth establishment, expert qualifications, etc.). The document only states that "Performance testing was performed, and results demonstrated that the subject device is substantially equivalent to the predicate device."

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Number or qualifications of experts for ground truth.
4. Adjudication methods.
5. MRMC study details or effect size.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Training set sample size.
9. How ground truth for the training set was established.

This document pertains to the regulatory clearance of a physical medical device (spinal fixation system), not a software or AI/ML device that would typically involve the type of performance studies you are asking about (e.g., studies involving "human readers improve with AI vs without AI assistance").

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