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The Orthopeasia Spinal Fixation System is intended to provide immobilization of the posterior non-cervical spine (T1-S2/Illium) in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities:

• Degenerative disc disease (defied as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies):

• Degenerative spondylolisthesis with objective evidence of neurologic impairment;

• Trauma (i.e., fracture or dislocation);

• Deformities or curvatures (i.e., scoliosis, kyphosis and/or lordosis);

• Tumor;

• Stenosis;

• Failed previous fusion (pseudarthrosis)
  The Orthopeasia Spinal Fixation System is also indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebral joint in skeletally mature patients receiving fusion by autogenous bone graft having the device fixed or attached to the lumbar and sacral spine (L3 to sacrum), with removal of the implants after the attainment of a solid fusion.

The Orthopeasia Spinal Fixation System is a temporary, multiple component system comprised of a variety of non-sterile, single use components, made of titanium alloy or cobalt chrome alloy, that allow the surgeon to build a spinal implant construct. The system is attached to the vertebral body by means of screw fixation to the non-cervical spine. The system consists of a variety of shapes and sizes of screws, rods, crosslinks and connectors to create a rigid construct as an adjunct to fusion for temporary internal fixation and stabilization of the thoracic, lumbar and sacral spine.

The Orthopeasia Spinal Fixation System is this submission comprises of the following components,

A. Pedicle screws (Mono-axial and Poly-axial), standard, cannulated, with:

• a. Monoaxial screw diameters from 5.5mm to 8.5mm
• b. Polyaxial screw diameters from 5.5mm to 8.5mm
• c. Monoaxial length range from 20mm to 55mm
• d. Polyaxial length range from 20mm to 100mm
• e. Made up of titanium alloy (ASTM F136).
• B. Straight rods of diameter of 5.0 mm made up of cobalt chrome alloy (ASTM F1537)
• C. Crosslinks and connectors made up of titanium alloy (ASTM F136).

The provided FDA 510(k) summary for the Orthopeasia Spinal Fixation System does not contain information about the acceptance criteria and study details for an AI/ML powered device. The document describes a spinal fixation system, which is a physical implant, not a software device that utilizes AI/ML.

Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details, as these are typically applicable to AI/ML device submissions and are not present in this document.

The document focuses on the substantial equivalence of the spinal fixation system to predicate devices based on its mechanical properties, intended use, materials, and components.

However, I can extract the performance testing and results that are present for this physical device:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance: Not applicable to this physical device. The testing described is mechanical performance testing on physical components, not a test set of data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable to this physical device. Ground truth and expert review are not relevant for the mechanical testing described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable to this physical device.

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 to this physical device. This is relevant for AI/ML diagnostic or assistive devices, not physical implants.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable to this physical device. This is relevant for AI/ML devices.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to this physical device. The "ground truth" for mechanical testing is based on established engineering standards (ASTM F1717, ASTM F1798) and comparison to predicate device performance.

8. The sample size for the training set: Not applicable to this physical device. This is relevant for AI/ML devices.

9. How the ground truth for the training set was established: Not applicable to this physical device. This is relevant for AI/ML devices.

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