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The CosmoLock 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 and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, deformities or curvatures (i.e. scoliosis, and/or lordosis), spinal tumor. pseudarthrosis and failed previous fusion.

The CosmoLock Pedicle Screw System is also intended for non-cervical pedicle screw fixation for the following indications: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. It is also intended for the following indications: trauma (i.e. fracture or dislocation); spinal stenosis; deformities or curvatures (i.e. scoliosis, and/or lordosis), tumor; pseudoarthrosis; and failed previous fusion.

The CosmoLock Pedicle Screw System is a top loading, multiple component, posterior spinal fixation system which consists of pedicle screws, rods and cross links. All of the components are available in a variety of sizes to match more closely the patient's anatomy.

Materials:
Ti-6Al-4V per ASTM F136 Co-28Cr-6Mo per ASTM F1537 Commercially Pure Ti per ASTM F67

This document is a 510(k) Premarket Notification from the FDA regarding the "CosmoLock Pedicle Screw System." It explicitly states that no clinical studies were performed for this device. Therefore, it is impossible to provide the requested information regarding acceptance criteria and a study proving the device meets those criteria, as no such study was conducted or presented in this document.

The document focuses on demonstrating substantial equivalence to previously approved predicate devices based on non-clinical tests (static and dynamic compression, static torsion) and similarities in intended use, design, materials, and mechanical safety/performance.

To answer your specific questions:

1. A table of acceptance criteria and the reported device performance: Not applicable. No clinical performance criteria or results are reported, as no clinical study was performed. The non-clinical tests' results are stated as indicating equivalence to predicate devices, without specific performance metrics or acceptance criteria for those metrics.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for clinical testing. For non-clinical tests, "samples" refer to the physical devices tested, not patient data. The document does not specify the number of devices tested for static and dynamic compression/torsion. Data provenance is not relevant.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No clinical test set.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a medical device (pedicle screw system), not an AI/imaging device requiring human reader studies. No clinical study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. No clinical study was performed. The "ground truth" for the device's safety and effectiveness relies on its substantial equivalence to previously cleared devices, supported by non-clinical mechanical testing results.
8. The sample size for the training set: Not applicable. No AI/machine learning component. No clinical study for training.
9. How the ground truth for the training set was established: Not applicable. No AI/machine learning component. No clinical study for training.

In summary, this document is a regulatory submission demonstrating substantial equivalence for a physical medical implant based on non-clinical mechanical testing, not clinical performance data or studies involving human subjects.

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