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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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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 CoCr per ASTM F1537

This document is a 510(k) Summary for the CosmoLock Pedicle Screw System. It describes the device and its intended use and claims substantial equivalence to predicate devices. However, it does not contain the detailed information needed to answer many of your questions, as it explicitly states that no clinical studies were performed.

Here's an analysis based on the provided text:

1. A table of acceptance criteria and the reported device performance

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The studies mentioned are non-clinical (mechanical tests), and details about sample sizes for these tests are not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable/provided. No clinical studies were performed, and therefore no ground truth established by experts is relevant to the data presented.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable/provided. No clinical studies were performed.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This document states, "No clinical studies were performed."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable. The device is a mechanical pedicle screw system, not an AI or algorithm-based device. No standalone performance study in this context was performed.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

The ground truth for the non-clinical tests would be the established mechanical testing standards (ASTM F1717) and the performance of the predicate devices. There is no biological or expert-defined "ground truth" in the typical medical imaging/diagnosis sense, as this is a mechanical implant.

8. The sample size for the training set

This information is not applicable/provided. No clinical studies were performed, and there is no mention of an algorithm or AI requiring a training set.

9. How the ground truth for the training set was established

This information is not applicable/provided. No training set or associated ground truth was established, as no clinical studies or AI development are described. The focus is on demonstrating mechanical equivalence to predicate devices.

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