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The 3° Anterior Cervical Plating System is intended for anterior fixation to the cervical spine from C2 to C7. The specific clinical indications include:

1. Degenerative disc disease (defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies).
2. Spondylolisthesis
3. Fracture
4. Spinal stenosis
5. Deformities (i.e., scoliosis, kyphosis, and/or lordosis)
6. Tumor
7. Pseudoarthrosis
8. Revision of previous surgery

The Reliant Anterior Cervical Plating System is intended for anterior fixation to the cervical spine from C2 to C7. The specific clinical indications include:

1. Degenerative disc disease (defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies).
2. Spondylolisthesis
3. Fracture
4. Spinal stenosis
5. Deformities (i.e., scoliosis, kyphosis, and/or lordosis)
6. Tumor
7. Pseudoarthrosis
8. Revision of previous surgery

The Unity Lumbosacral Fixation Plate is indicated for use as an anteriorly placed supplemental fixation device for the lumbosacral (L5-S1) level below the bifurcation of the vascular structures. The Unity LX Lumbar Fixation Plate is indicated for use as an anteriorly or anterolaterally placed supplemental fixation device for the lumbar region of the spine above the bifurcation of the vascular structures. When properly used, the system will help provide temporary stabilization until a solid spinal fusion develops. Specific indications include:

1. Degenerative disc disease (defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies).
2. Pseudoarthrosis.
3. Spondylolysis.
4. Spondylolisthesis.
5. Fracture.
6. Neoplastic disease.
7. Unsuccessful previous fusion surgery.
8. Lordotic deformities of the spine.
9. Idiopathic thoracolumbar or lumbar scoliosis.
10. Deformities (i.e., scoliosis, kyphosis, and/or lordosis) associated with deficient posterior elements such as that resulting from laminectomy, spina bifida, or myelomenigocele.
11. Neuromuscular deformity (i.e., scoliosis, lordosis, and/or kyphosis) associated with pelvic obliquity.

The Hallmark Anterior Plate System is a temporary implant intended for anterior fixation to the cervical spine from C2 to C7. The specific clinical indications include:

1. Degenerative disc disease (defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies).
2. Spondylolisthesis
3. Fracture
4. Spinal stenosis
5. Deformities (i.e., scoliosis, kyphosis, and/or lordosis)
6. Tumor
7. Pseudoarthrosis
8. Revision of previous surgery

The NewBridge Laminoplasty Fixation System is indicated for use in the lower cervical and upper thoracic spine (C3-T3) after a laminoplasty has been performed. The system holds or buttresses the allograft in place in order to prevent expulsion of the allograft or impingement of the spinal cord.

The CETRA Anterior Cervical Plate System is a temporary implant intended for anterior fixation to the cervical spine from C2 to C7. The specific clinical indications include:

1. Degenerative disc disease (defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies).
2. Spondylolisthesis
3. Fracture
4. Spinal stenosis
5. Deformities (i.e., scoliosis, kyphosis, and/or lordosis)
6. Tumor
7. Pseudoarthrosis
8. Revision of previous surgery

3° Anterior Cervical Plating System - The 3° Anterior Cervical Plating System is a temporary titanium alloy (Ti6Al-4V ELI, per ASTM F136) system comprised of a variety of non-sterile, single use components that allow the surgeon to build an anterior cervical implant construct. The system's design is intended to stabilize the cervical spinal operative site during the fusion process of a bone graft in the disc space. The system is attached to the anterior aspect of the vertebral body by means of screws to the cervical spine. The system consists of an assortment of screws, plates and associated instrumentation which assists in the surgical implantation of the devices. The system is provided non-sterile and requires sterilization prior to use.

Reliant Anterior Cervical Plating System - The Reliant Anterior Cervical Plating System is temporary, titanium alloy system comprised of a variety of single-use components that allow the surgeon to build an anterior cervical implant construct. The system is attached to the anterior aspect of the vertebral body by means of screws to the cervical spine. The system consists of an assortment of screws, plates and associated instrumentation which assist in the surgical implantation of the devices. The system is provided non-sterile and requires sterilization prior to use.

Unity Lumbosacral Fixation System - The Unity Lumbosacral Fixation System consists of the Unity 51 Lumbosacral Fixation Plate for lumbosacral fixation and the Unity LX Lumbar Fixation Plate for anterior or anterolateral fixation above L5-S1.

The Unity 51 Lumbosacral Fixation Plate is designed specifically for supplemental fixation of anterior lumbar fusions at the L5-S1 level. The plate is contoured to the unique anatomy of the L5-S1 segment. The Unity 51 Plate is available in six heights: 17mm to 25mm in 2mm increments and one additional plate at 28mm.

The Unity LX Lumbar Fixation Plate is designed for lumbar levels above L5-S1 in 2 configurations - anterior and anterolateral. In the anterolateral configuration, the plate allows surgeons lateral-to-medial placement of the self-neuro foramen. The Unity LX Plate is available in six heights: 19mm to 25mm in 2mm increments and two additional plates at 28mm and 31mm.

Hallmark Anterior Plate System – The Hallmark Anterior Plate System is comprised of a variety of non-sterile, single use, titanium alloy (6AL-4V-ELI, per ASTM F136) components that allow a surgeon to build an anterior cervical implant construct. The system is attached to the anterior aspect of the vertebral body by means of screws to the cervical spine. The system consists of an assortment of screws, plates and associated instrumentation, which assists in the surgical implantation of the devices.

NewBridge Laminoplasty Fixation System – The NewBridge Laminoplasty Fixation System is a device comprised of non-sterile, single use, titanium alloy components. The specially shaped plates, made of commercially pure (CP) titanium conforming to ASTM F67, are designed to fit the anatomy of a dorsally elevated lamina. The plates have screw holes on both ends, which allow for attachment to the vertebral body, and a screw hole in the center for attachment to the allograft.

The screws, made of titanium alloy (Ti-6AI-4V ELI, per ASTM F136) are available in a variety of lengths and diameters in order to meet individual anatomical requirements.

The NewBridge Laminoplasty Fixation System must always be used with an allograft.

CETRA Anterior Cervical Plate System – The CETRA Anterior Cervical Plate System is comprised of an assortment of non-sterile, single use, titanium alloy (Ti-6AI-4V ELI per ASTM F136) plates and screws that allow a surgeon to build a temporary anterior cervical implant construct. The plate is attached to the anterior aspect of the vertebral body, by means of screws to the cervical spine. The system includes the necessary instrumentation to assist in the surgical implantation of the devices.

The provided document describes the addition of MR Conditional labeling to several spinal fixation systems and details the non-clinical tests performed to support this claim. It does not contain information about a study proving the device meets clinical acceptance criteria or comparative effectiveness with human readers. The information below is based only on the provided text, focusing on the MR Conditional aspect.

Here's the breakdown of the acceptance criteria and the study that proves the device meets the acceptance criteria for MR Conditional labeling:

1. Table of Acceptance Criteria and Reported Device Performance (for MR Conditional Labeling)

Note: The document states that the devices "met requirements necessary for MRI Conditional labeling", implying that the performance in each test fell within the acceptable limits defined by the respective ASTM standards for MR Conditional compatibility. Specific quantitative values for displacement force, torque, artifact size, or temperature rise are not provided in this summary.

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

• Sample Size: Not explicitly stated for each test. The testing was conducted on the "subject devices," referring to the various components of the 3° Anterior Cervical Plating System, Reliant Anterior Cervical Plating System, Unity Lumbosacral Fixation System, Hallmark Anterior Plate System, NewBridge Laminoplasty Fixation System, and CETRA Anterior Cervical Plate System. Typically, MR safety testing involves multiple samples of the actual devices or representative worst-case configurations.
• Data Provenance: The tests conducted are non-clinical, controlled laboratory experiments. No human patient data (retrospective or prospective) or country of origin for such data is relevant for these specific MR safety tests.

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

• Not applicable. The ground truth for MR Conditional testing is established by recognized international standards (ASTM). The tests are performed by qualified testing laboratories or personnel following these standardized protocols, not by clinical experts establishing a ground truth based on patient cases.

4. Adjudication Method for the Test Set

• Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for clinical study endpoints, especially when expert consensus is needed to establish ground truth or resolve discrepancies in interpretations of medical images or patient outcomes. For non-clinical, standardized engineering tests, the results are objectively measured against the criteria defined in the ASTM standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This submission is for the addition of MR Conditional labeling, which relies on non-clinical engineering tests to ensure device safety in the MR environment. It does not involve AI or human-in-the-loop performance evaluation.

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

• No, a standalone study in the context of an algorithm or AI performance was not done. The tests performed are engineering-based evaluations of physical device properties in an MR environment.

7. The Type of Ground Truth Used

• The ground truth used for this determination is explicit, objective criteria defined by internationally recognized consensus standards for MR safety: ASTM F2052-15, ASTM F2213-17, ASTM F2119-07, ASTM F2182-19E2, and ASTM F2503. These standards specify the methods and acceptable limits for magnetically induced displacement, torque, image artifacts, and radiofrequency induced heating.

8. The Sample Size for the Training Set

• Not applicable. This is not an AI or machine learning device. Therefore, there is no "training set" in the conventional sense.

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

• Not applicable. Since there is no training set, the establishment of its ground truth is not relevant.

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