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The ReForm Pedicle Screw 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 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 ReForm Pedicle Screw System is also intended for non-cervical pedicle screw fixation for the following indications: severe spondylolisthesis (grades 3and 4of 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; curvatures (i.e. scoliosis, kyphosis; and/or lordosis) spinal tumor; pseudloarthrosis; and failed previous fusion.

The Reform System is a top-loading, multiple component, posterior spinal fixation system which consists of pedicle screws, rods, cross-connectors, locking cap screws, hooks, domino connectors, and lateral offset connectors. All of the components are available in a variety of sizes to match more closely to the patient's anatomy. All components are made from medical grade stainless steel, cobalt chromium alloys, titanium or titanium alloy described by such standards as ASTM F138, ASTM F1537, ISO 5832-12, ASTM F136 or ISO 5832-3.

The provided text describes a 510(k) premarket notification for the ReForm Pedicle Screw System, specifically focusing on modifications and additions to its components. This type of submission is for medical devices, not AI/ML algorithms, and therefore the concepts of acceptance criteria, study design for performance evaluation, sample sizes, expert ground truth, adjudication methods, MRMC studies, or training sets do not apply in the way they would for a software-as-a-medical-device (SaMD) or AI-driven diagnostic tool.

The study described is a mechanical performance test for physical implant components, not a clinical or AI performance study.

Here's a breakdown of the relevant information from the provided text, adapted as much as possible to the requested format, to highlight why most of the questions are not applicable:

Acceptance Criteria and Device Performance

Study Details (Mechanical Performance Testing)

1. Sample size used for the test set and the data provenance: This refers to the number of physical components tested in dynamic axial compression. The specific number of components/constructs tested is not explicitly stated in the provided text. The data provenance is mechanical testing conducted according to ASTM F1717-12 standards, likely in a laboratory setting.

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 testing is based on engineering standards and measurements, not expert consensus as in diagnostic imaging.

3. Adjudication method for the test set: Not applicable. Mechanical testing involves objective measurements against predefined standards.

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 study is for a physical orthopedic implant system, not a diagnostic AI/ML system.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.

6. The type of ground truth used: For mechanical performance, the "ground truth" is defined by the objective measurements obtained through the specified test method (dynamic axial compression) and the compliance with the ASTM F1717-12 standard, particularly its requirements for not creating a "new worst-case construct" compared to predicate devices.

7. The sample size for the training set: Not applicable. There is no concept of a "training set" for this type of mechanical device testing.

8. How the ground truth for the training set was established: Not applicable. There is no training set.

Conclusion from the text: The study indicates that the modified ReForm Pedicle Screw System maintains substantial equivalence to its predicate devices based on its mechanical performance. The performance data, specifically the dynamic axial compression testing per ASTM F1717-12, showed that the changes did not introduce a new worst-case construct, thus meeting the required standard for this type of device modification.

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