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When used as a nonpedicle posterior system, the SCS system is indicated for patients with:

• degenerative disk disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies
• spondvlolisthesis
• fracture
• spinal stenosis
• deformities (i.e., scoliosis, kyphosis, lordosis)
• tumors
• pseudarthrosis
• failed previous fusion (pseudarthrosis)

When used as an anterolaterallanterior system the SCS system is indicated for patients with:
degenerative disk disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies

• spondylolisthesis
• fracture
• spinal stenosis
• deformities (i.e., scoliosis, kyphosis, lordosis)
• tumors
• pseudarthrosis
• failed previous fusion (pseudarthrosis)

When used as a posterior pedicle system, the device is indicated for use in skeletally mature patients L3 & below who are:

• having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint
• receiving fusions using autogenous bone graft only
• having the device fixed or attached to the lumbar and sacral spine
• having the device removed after the development of a solid fusion mass.

Posterior pedicle systems are 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 the thoracic, lumbar, and sacral spine:

• degenerative spondylolisthesis with objective evidence of neurologic impairment
• fracture
• dislocation
• scoliosis
• kyphosis
• spinal turnor
• failed previous fusion (pseudarthrosis)

The 5.0mm Spinal Screws. The new diameter screws are made of titanium and stainless steel per the referenced specifications 316LVM ASTM F138 GR2 ISO 5832-1 TA6V ELI ASTM F136-92 ISO 5832-3. The product is manufactured in the same facility as the other components of the SCS Spinal System following identical manufacturing procedures in full compliance with cGMP regulations. The 5.0mm Spinal Screws facilitates screw insertion by providing an alternative to the larger 6, 6.5 or 7.0mm pedicle screws or vertebral screws available in the cleared system. This new screw diameter allows the surgeon to insert screws in cases where the spine deformity or the small size of the pedicle would not permit insertion of larger diameter screws. The smaller diameter of the 5.0mm Spinal Screws permits the surgeon to address the needs of a larger patient population. The 5.0mm Spinal Screws are to be a new "standard" screw for the SCS Spinal System with an identical coding for product reference in which "xx" represents the length of the screw. 2010. represents the reference for stainless steel products and 2T10 represents the reference for titanium products. The new screw will be used in all SCS Spinal System applications where a smaller screw would be of benefit. Therefore, the mechanical characteristics of mechanical and fatigue performance are important. The balance of the SCS Spinal System components will remain the same. Other than the major and minor diameter of the cancellous threads the new 5.0mm screws are identical to the existing screws. Rod attachment method and the use of all couplers are the same as were previously cleared for commercialization. Materials are identical.

This document describes the acceptance criteria and the study conducted for the ORTHOTEC, LLC. 5.0mm Spinal Screw (SCS Spinal System).

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the 5.0mm Spinal Screws are based on demonstrating equivalence to the existing larger diameter screws of the SCS Spinal System in terms of mechanical and fatigue performance. The study aimed to show that the new 5.0mm screws are suitable and equivalent to the cleared larger diameter screws.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document does not explicitly state the exact number of 5.0mm Spinal Screws tested. It mentions that "Samples were tested" for both static and fatigue performance.
• Data Provenance: The testing was conducted internally by OrthoTec, LLC. and its submission to the FDA. The provenance can be considered retrospective in the context of the 510(k) submission, as the tests were performed to demonstrate substantial equivalence to an already marketed predicate device. The country of origin of the data is USA, where OrthoTec, LLC. is located.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This document does not involve clinical data or "ground truth" established by medical experts in the traditional sense of diagnostic or therapeutic accuracy studies. The evaluation is focused on mechanical and biocompatibility performance of a medical device (spinal screw). The "ground truth" or reference for performance is the predicate device's established performance and recognized engineering standards (ASTM). The experts involved would be engineers and material scientists responsible for conducting and interpreting the mechanical and fatigue tests and ensuring compliance with material and design standards. Their specific qualifications are not detailed but are implied by their role in conducting such tests.

4. Adjudication Method for the Test Set

Not applicable. This is a mechanical performance study, not a clinical study involving human reader interpretation or adjudication. The results are based on objective measurements from instruments.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is a mechanical performance study for a spinal implant, not a study assessing the effectiveness of a diagnostic or therapeutic device that requires human interpretation, nor does it involve comparing human readers with and without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This device is a physical medical implant, not an algorithm or AI system. Its performance is evaluated through standardized mechanical testing, not algorithm performance.

7. Type of Ground Truth Used

The "ground truth" used for this study is primarily:

• Predicate Device Performance: The established mechanical and fatigue performance of the "larger diameter cleared spinal screws of SCS Spinal System (K983353)."
• Recognized Engineering Standards: Specifically, ASTM F-1717-96 guidance document for mechanical and fatigue testing. Other voluntary standards utilized include ASTM, ISO materials standards (ISO 5832-1, ISO 5832-3), and ISO 9000 series quality regulations. This provides an objective standard for performance.

8. Sample Size for the Training Set

Not applicable. This refers to a mechanical engineering study, not an AI or machine learning study, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device evaluation.

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