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The CBT Screw Fixation System is a posterior, noncervical pedicle fixation system intended to provide immobilization and stabilization of spinal segments in skeletally-mature patients as an adjunct to fusion by autogenous bone graft in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar and sacral spine:

• Spondylolisthesis
• Degenerative spondylolisthesis with objective evidence of neurological impairment
• Trauma (i.e., fracture or dislocation)
• Spinal stenosis
• Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
• Tumor
• Pseudoarthrosis
• Failed previous fusion

The Cortical Bone Trajectory(CBT) Screw Fixation System(hereinafter referred to as "CBT Screw Fixation System") is manufactured by U&I corporation. The Cortical Bone Trajectory(CBT) Screw Fixation System is modular, with the screw assembled intraoperatively, posterior spinal fixation system and less invasive surgery. The CBT Screw Fixation System allows surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The CBT Screw Fixation System components are supplied non-sterile, single use and are fabricated from medical grade titanium alloy (ASTM F136) and medical grade cobalt-chromium-molybdenum alloy (ASTM F1537). All bone screws have self-tapping function in CBT Screw Fixation System. The double lead thread is applied to the all bone screws to shorten the operation time. CBT Screw Fixation System with CoCr rods may be used to provide immobilization and stabilization of spinal segment when the rigid system is need. (Recommendation: trauma or deformities)

The provided text describes a 510(k) premarket notification for a medical device called the "CBT Screw Fixation System." This document primarily focuses on demonstrating substantial equivalence to a predicate device through mechanical performance testing.

Therefore, the information required to answer your specific questions about "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/algorithm-based medical device is not present in the provided text. The device being reviewed here is a physical orthopedic implant (a pedicle screw system), not an AI-powered diagnostic or therapeutic tool.

The document does not contain:

1. A table of acceptance criteria and reported device performance related to AI/algorithm performance. The "performance" discussed is purely mechanical.
2. Sample size used for a test set for an AI algorithm.
3. Data provenance for an AI test set.
4. Number of experts used to establish ground truth for an AI test set.
5. Adjudication method for an AI test set.
6. MRMC comparative effectiveness study related to AI assistance.
7. Standalone (algorithm only) performance data.
8. Type of ground truth used for an AI system.
9. Sample size for the training set for an AI algorithm.
10. How the ground truth for the training set was established for an AI algorithm.

What the document does describe in terms of "acceptance criteria" and "study":

For the CBT Screw Fixation System (a physical medical device):

• Acceptance Criteria & Performance: The document states, "The mechanical performance of the CBT Screw Fixation System met the acceptance criteria which have been established from the predicate devices." It also says, "All tests met all acceptance criteria and that verifies performance of the CBT Screw Fixation System is substantially equivalent to predicate devices." Specific numerical acceptance values are not provided in this summary.
• Study Type: Non-clinical (bench testing) was performed.
• Tests Conducted:
  • Static compression bending test according to ASTM F1717-15
  • Static torsion test according to ASTM F1717-15
  • Compression bending fatigue test according to ASTM F1717-15
  • Dissociation test
• Purpose of Studies: To assess that "no new safety and efficiency issues were raised with this device" and to demonstrate substantial equivalence to predicate devices in mechanical performance.

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