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The GLOBAL SPINAL FIXATION SYSTEM™ posterior spinal fixation device is a pedicle screw system indicated for the treatment of severe Spondylolisthesis (Grade 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.

In addition, the GLOBAL SPINAL FIXATION SYSTEM™ is intended to provide immobilization and stabilization 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 the thoracic, lumbar and sacral spine: degenerative Spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis).

The GLOBAL SPINAL FIXATION SYSTEM™ Spinal System is a multiple component spinal fixation system comprised of variety of single-use, non-sterile devices that allow Spirial industry of the mant construct in order to provide stabilization and promote spinal fusion. The implants are manufactured from titanium alloy, Ti-6Al-4V ELI that conforms to ASTM 136 98 and include pedicle screws, set screws, rods, c.en that ochlorne to no se se (cross) linking mechanism. Various sizes of these implants are available.

The provided text describes a 510(k) submission for the GLOBAL SPINAL FIXATION SYSTEM™. This is a spinal implant system and the performance data provided is related to bench testing, not an AI/ML powered medical device. Therefore, many of the requested fields regarding AI/ML device performance are not applicable.

Here's the information that can be extracted from the provided text:

• Acceptance Criteria and Reported Device Performance: This information is related to the mechanical performance of the spinal fixation system.
• Sample size for the test set and data provenance: Not applicable for a spinal implant system's mechanical bench testing.
• Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable for mechanical bench testing. The "ground truth" for mechanical testing is typically established by engineering standards.
• Adjudication method for the test set: Not applicable.
• Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable as this is not an AI-powered device.
• Standalone (algorithm only without human-in-the-loop) performance: Not applicable.
• Type of ground truth used: For mechanical bench testing, the "ground truth" is typically defined by established engineering standards and specifications (e.g., ASTM F1717).
• Sample size for the training set: Not applicable as this is not an AI-powered device.
• How the ground truth for the training set was established: Not applicable.

Here's a table summarizing the relevant information:

Acceptance Criteria and Device Performance

Additional Information (from the prompt's request but mostly N/A for this device):

1. Sample size used for the test set and the data provenance: Not specified, as "test set" in this context refers to the samples used for bench testing. The data provenance would be the laboratory where the bench tests were performed.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical performance is based on engineering standards.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
4. 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 not an AI/ML device.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.
6. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Engineering standards and specifications (specifically ASTM F1717).
7. The sample size for the training set: Not applicable. This is not an AI/ML device.
8. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.

In summary, the provided document describes a traditional spinal implant system and its mechanical performance testing, not an AI/ML driven medical device. Therefore, most of the questions relating to AI/ML device performance are not relevant to this submission.

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The Global Spinal Fixation System is a pedicle screw indicated for the treatment of severe spondylolisthesis (Grade 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.

In addition, the GSFS is intended to provide immobilization and stabilization 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 the thoracic, lumbar and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairement, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

The Global Spinal Fixation System (GSFS) is a multiple component system comprised of a variety of single-use, non-sterile devices that allow the surgeon to build a spinal implant construct in order to provide stabilization and promote spinal fusion. The implants are manufactured from titanium allov. Ti6A14V that conforms to ASTM 136 98 and include pedicle screws, hooks, rods, cross link, and connector. Various sizes of these implants are available. Specialized instrument made from surgical instrument grade stainless steel is available for the application and removal of the GSFS implants.

I am sorry, but the provided text does not contain any information regarding acceptance criteria, device performance, sample sizes, data provenance, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, or ground truth establishment for a medical device.

The text is a summary of safety and effectiveness information for the "Global Spinal Fixation System," a spinal implant. It describes the device, its indications for use, and confirms its substantial equivalence to a predicate device. It also includes the FDA's clearance letter for the device.

Therefore, I cannot fulfill your request to create a table of acceptance criteria and device performance, or provide details about the studies you've specified, as this information is not present in the provided document.

Ask a specific question about this device