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The EXPEDIUM SFX Cross Connector System is designed to transversely connect two rods used in spinal instrumentation constructs. The EXPEDIUM SFX Cross Connector System devices are intended for use with components of the commercially available EXPEDIUM 5.5mm and 6.35mm Spine Systems.

The uses of the legally marketed EXPEDIUM 5.5mm and 6.35mm Spine System are as follows:

The EXPEDIUM Spine System is intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.

The EXPEDIUM SFX Cross Connector System is designed to transversely connect two rods used in spinal instrumentation constructs. The EXPEDIUM SFX Cross Connector System devices are intended for use with components of the commercially available VSP Spine System.

The uses of the legally marketed VSP Spine System are as follows:

The VSP System is indicated for degenerative spondylolisthesis, in skeletally mature patients, with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal turnor, and failed previous fusion (pseudoarthrosis). Levels of fixation are for the thoracic, lumbar and sacral spine.

The VSP Spine System is also indicated for pedicle screw fixation for severe spondylolisthesis (Grade 3 and 4) at L5-S1, in skeletally mature patients, when autogeous bone graft is used, when affixed to the posterior lumbosacral spin, and intended to be removed after solid fusion is attained. Levels of fixation are from L3-S1.

The EXPEDIUM SFX Cross Connector System is designed to transversely connect two rods used in spinal instrumentation constructs. The EXPEDIUM SFX Cross Connector System devices are intended for use with components of the commercially available ISOLA 6.35mm Spine System.

The uses of the legally marketed ISOLA 6.35mm Spine System are as follows:

The ISOLA Spine Systems is a pedicle screw system 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, spinal tumor, and failed previous fusion (pseudarthrosis).

The ISOLA Spine Systems is also indicated for pedicle screw fixation for the treatment of 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.

The ISOLA Spine Systems is also a hook and sacral/iliac screw fixation system of the noncervical spine indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis).

The ISOLA Spinal System when used with pedicle screws is indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies). Levels of fixation are for the thoracic, lumbar and sacral spine.

The EXPEDIUM SFX Cross Connector System is designed to transversely connect two rods used in spinal instrumentation constructs. The EXPEDIUM SFX Cross Connector System devices are intended for use with components of the commercially available MOSS Miami 6.35mm Spine System.

The uses of the legally marketed MOSS Miami 6.35mm Spine System are as follows:

When used as a posterior, noncervical hook, and/or sacral/iliac screw fixation system, or as an anterior, thoracic/lumbar screw fixation system, the MOSS Miami 6.35mm Spinal System is intended to treat scoliosis, kyphosis and lordosis, fracture, loss of stability due to tumor, spinal stenosis, spondylolisthesis, a previously failed fusion surgery or degenerative disc disease (i.e., discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies).

When used as a pedicle screw fixation system of the noncervical spine in skeletally mature patients, the MOSS Miami 6.35mm Spinal System is indicated for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudoarthrosis).

The MOSS Miami 6.35mm Spine Systems is also indicated for pedicle screw fixation in skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebral joint, having fusions with autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation are L3-S1) and for whom the device system is intended to be removed after solid fusion is attained.

The EXPEDIUM SFX Cross Connector System is designed to transversely connect two rods used in spinal instrumentation constructs. The connector minimizes the torsional forces on the construct, thus reducing the micromotion and the probability of the construct shifting after placement. It is designed to accommodate the 5.5mm and 6.35mm spinal rods of the EXPEDIUM Spine System.

The EXPEDIUM SFX Cross Connector System is designed to transversely connect two rods used in spinal instrumentation constructs. The connector minimizes the torsional forces on the construct, thus reducing the micromotion and the probability of the construct shifting after placement. It is designed to accommodate the 6.35mm spinal rods of the VSP Spine System.

The EXPEDIUM SFX Cross Connector System is designed to transversely connect two rods used in spinal instrumentation constructs. The connector minimizes the torsional forces on the construct, thus reducing the micromotion and the probability of the construct shifting after placement. It is designed to accommodate the 6.35mm spinal rods of the ISOLA Spine System.

The EXPEDIUM SFX Cross Connector System is designed to transversely connect two rods used in spinal instrumentation constructs. The connector minimizes the torsional forces on the construct, thus reducing the micromotion and the probability of the construct shifting after placement. It is designed to accommodate the 6.35mm spinal rods of the MOSS Miami Spine System.

The provided text describes a Special 510(k) Submission for additions to the EXPEDIUM™ SFX Cross Connector System. This submission focuses on the mechanical performance and material compatibility of the device, rather than artificial intelligence or diagnostic algorithms. Therefore, many of the requested categories related to AI performance, expert consensus, and ground truth establishment are not applicable.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria: The acceptance criterion for the EXPEDIUM™ SFX Cross Connector System is that its performance, when transversely connecting two rods, must be equivalent or superior to the predicate devices. Specifically, it must minimize torsional forces on the construct, thereby reducing micromotion and the probability of construct shifting after placement. This is assessed through Performance data per ASTM F 1717.

Reported Device Performance:

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

• Sample Size for Test Set: Not explicitly stated as a numerical value within the provided text. The performance data is "per ASTM F 1717," which is a standard for in vitro mechanical testing of spinal implant constructs. The sample size would be determined by the requirements of this ASTM standard for various tests (e.g., static, fatigue, torsional).
• Data Provenance: The data is based on in vitro mechanical testing conducted according to ASTM F 1717. This is laboratory-based testing, not human-patient data. Therefore, country of origin or retrospective/prospective does not apply in the typical sense.

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

This question is not applicable as the study is a mechanical performance study of a medical device, not an AI or diagnostic imaging study that requires expert review for ground truth establishment.

4. Adjudication Method for the Test Set

This question is not applicable as the study is a mechanical performance study. Adjudication methods like 2+1 or 3+1 refer to human expert consensus, which is not relevant here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size of Human Improvement with AI vs. without AI Assistance

This question is not applicable. This submission concerns the mechanical properties of a spinal implant, not an AI-assisted diagnostic or treatment system.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was Done

This question is not applicable. This is a device related to mechanical stability in spinal instrumentation, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by engineering and material science standards, specifically ASTM F 1717, which dictates test methodologies and expected performance characteristics for spinal implant components. The "truth" is that the device must meet or exceed the mechanical performance characteristics of the predicate devices under standardized testing conditions.

8. The Sample Size for the Training Set

This question is not applicable as this is not an AI/machine learning study.

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

This question is not applicable as this is not an AI/machine learning study.

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