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The inViZia® Anterior Cervical Plate System is designed for anterior interbody screw fixation of the cervical spine at levels C2-T1. The inViZia® Anterior Cervical Plate System is in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis or scoliosis), pseudoarthrosis and/or failed previous fusions. WARNING: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

The SC-AcuFix® Ant-Cert Dynamic Anterior Cervical Plate System is in the temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion inpatients with instability caused by the following: degenerative disc disease (as defined by neck pain of discogenic origin with denegation of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumor, spondylolisthesis, deformity (i.e. scoliosis, kyphosis, lordosis), pseudarthrosis, and failed previous fusions.

The Spinal Concepts Inc. (SCI) Anterior Cervical Plate System is in the temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion inpatients with instability caused by the following: degenerative disc disease (as defined by neck pain of discogenic origin with denegation of the disc confirmed by patient history and radies), trauma (including fractures), tumor, spondylolisthesis, spinal stenosis, kyphosis, lordosis, lordosis), pseudarthrosis, and failed previous fusions.

The SC-AcuFix® Thinline Anterior Cervical Plate System is indicated for use in the temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion inpatients with instability caused by the following: degenerative disc disease (as defined by neck pain of discogenic origin with denegation of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumor, spondylolisthesis, spinal stenosis, deformity (i.e. scoliosis, lordosis), pseudarthrosis, and failed previous fusions.

The Trinica® Anterior Lumbar Plate System is interal or anterolateral surgical approach above the bifuration of the great vessels or via the anterior surgical approach, below the bifurcation of the great vessels. This system is indicated in the treatment of lumbar or lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), pseudoarthrosis, scoliosis, scoliosis, lordotic deformities of the spine, spinal stenosis, or a failed previous fusion.

The Trinica® and Trinica® Select Anterior Cervical Plate System is interior interbody screw fixation of the cervical spine at level C2-T1. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degeneratived by neck pain of discogenc origin confirmed by patient history and radiographic studies), trauma (including fractures), turnors, deformity (defined as kyphosis, or scoliosis), pseudoarthrosis and/or failed previous fusions. WARNING: These devices are not approved for screw attachments (pedicles) of the cervical, thoracic, or lumbar spine.

The V2F Anterior Fixation System is indicated for use via the lateral or anterolateral surgical in the treatment of thoracc and thoracolumbar (TI-L5) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, lordosis, spinal stenosis, or a failed previous spine surgery.

The Zimmer Spine Anterior Cervical and Lumbar Plate Systems are intended to provide stabilization of the spine during the development of a solid spinal fusion in patients per the system(s) indications at various spinal levels. The Zimmer Spine Anterior Cervical and Lumbar Plate Systems consist of plates, bone screws and instruments necessary to implant the specific system. Bone screws are secured to the plate through locking caps and/or a Secure Ring® mechanism. The plates are available in various sizes and lengths and the bone screws are available in various diameters and lengths. The subject devices are temporary implants to be implanted per the indications for use and/or the instructions of the surgical technique guide(s). These subject implants are intended to be removed after solid fusion has occurred. The Zimmer Spine Anterior Cervical and Lumbar Plate implants (plates and bone screws) are manufactured from medical grade Ti-6Al-4V ELI titanium alloy. The system's instrumentation is manufactured from one (or more) of the following medical/surgical grade materials: stainless steel, plastic, aluminum, and silicone. The subject implants are provided non-sterile and must be sterilized by the enduser/healthcare facility prior to use. The subject implants are designed for single-use only. The system's instrumentation is provided to the end-user/healthcare facility clean but not sterile. The end-user/healthcare facility ensures through cleaning and sterilization of instrumentation before use and the instrumentation may be reused. Selective plate systems contain drill bits and/or fixation pins that are provided to the end-user sterile and designed for single-use.

This document describes a 510(k) premarket notification for several Zimmer Spine Anterior Cervical and Lumbar Plate Systems. The purpose of this submission is not to introduce a new device or change the design/performance of existing devices, but solely to update the product-specific package inserts (Instructions for Use - IFU) with MRI Conditional language. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are related to MRI compatibility, rather than the primary biomechanical function of the implants.

Here's an analysis based on the provided text, addressing your points:

1. A table of acceptance criteria and the reported device performance

The acceptance criteria here are implicitly meeting the standards for MRI compatibility for passive implants. The reported performance is that the devices were tested according to these standards and found to be MRI Conditional.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: The document does not specify the exact number of devices (plates and screws) tested for each MRI compatibility standard. It refers to "Plate implants contained in the Zimmer Spine Anterior Cervical and Lumbar Plate Systems were assessed and tested." This suggests representative samples were used for each type of implant.
• Data Provenance: Not explicitly stated, but typically, such testing is conducted in controlled laboratory environments in the country of manufacturing or a certified testing facility. The context is a US FDA submission, so the testing would have been to US-recognized standards. The testing is prospective in nature, as it's a specific set of tests performed on the physical devices for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This question is not applicable to this submission. The "ground truth" here is the physical interaction of the medical devices with magnetic fields, measured by engineering and physics principles, not by expert interpretation of clinical data or images. The standards (ASTM) themselves define the methodology and acceptable limits, which are established by relevant technical experts in the field of MRI safety and medical devices.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is not a clinical study involving human assessment of outcomes or images. The results of the MRI compatibility tests are objective measurements against defined ASTM standards.

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. This submission is for MRI conditional labeling updates for orthopedic spinal implants, not for an AI/CAD device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This submission is for MRI conditional labeling updates for orthopedic spinal implants, not for an AI/CAD device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" used for this submission is based on scientific and engineering principles outlined in the referenced ASTM standards for MRI compatibility testing. These standards define the acceptable limits for magnetically induced displacement, torque, heating, and image artifact generation for passive medical implants.

8. The sample size for the training set

Not applicable. This submission is for MRI conditional labeling updates for existing devices, not for a device developed using a training/test set methodology (e.g., AI/ML).

9. How the ground truth for the training set was established

Not applicable. See point 8.

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The V2F™ Anterior Fixation System is indicated for use via the lateral or anterolateral surgical approach in the treatment of thoracic and thoracolumbar (T1-L5) spine instability as a result of fracture (including dislocation and subluxation), turnor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, spinal stenosis or a failed previous spine surgery.

The V2F™ Anterior Fixation System is a temporary supplemental fixation device consisting of: thoracolumbar plates, cap screws, bone screws and instrumentation necessary for implantation of the system.

The V2FTM Anterior Fixation System is used as an implant for the correction and stabilization of the spine. This system provides temporary stabilization and augments the development of a solid spinal fusion. Additionally, this system provides the surgeon with the ability to supplement an interbody device with anterior plate fixation. The plates are low profile and anatomically designed to provide optimal fit from either anterior or anteriorlateral approach. All implant components are manufactured from titanium alloy as specified in ASTM F136.

Here's an analysis of the provided text regarding the V2F™ Anterior Fixation System, focusing on acceptance criteria and supporting studies:

This submission is for a medical device (spinal fixation system), and the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are generally related to mechanical performance and substantial equivalence to predicate devices, rather than diagnostic performance or algorithm efficacy which would involve the concepts of sensitivity, specificity, human readers, ground truth consensus, etc.

Therefore, many of the questions related to AI/algorithm performance (e.g., sample size for test set, experts, MRMC studies, standalone performance, training set) are not applicable to this type of device submission.

Acceptance Criteria and Reported Device Performance

Study Proving Acceptance Criteria:

The study referenced is based on mechanical testing according to ASTM F1717 standards. The specific tests performed were:

• Static compression bending
• Static torsion
• Dynamic compression bending

The conclusion drawn from these tests is that the V2F™ Anterior Fixation System functioned as intended and performed in a manner substantially equivalent to that of the predicate(s). The predicate devices used for comparison are:

• InCompass Spinal Fixation System (K021564)
• Synthes Thoracolumbar Spine Locking Plate (TSLP) System (K020244)

Additional Information (Where Applicable)

1. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

   • Not Applicable (N/A): This is a mechanical device. The "test set" would refer to the number of physical samples of the device components subjected to the ASTM F1717 tests. This information (specific number of samples tested) is not detailed in the summary but would be part of the full test report. Data provenance (country, retrospective/prospective) is not relevant for mechanical testing of this nature.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

   • N/A: Ground truth in the context of diagnostic or AI performance is not relevant for the mechanical testing of a spinal fixation system. The "ground truth" for mechanical testing is defined by the ASTM standards themselves and the physical laws governing material properties and structural integrity.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • N/A: Adjudication methods are used to resolve discrepancies in human interpretations or classifications, typically in the context of diagnostic performance studies. This is not applicable to standardized mechanical engineering tests.

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:

   • N/A: MRMC studies are used for evaluating diagnostic imaging systems or AI algorithms with human readers. This device is a surgical implant.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • N/A: This submission is for a physical medical device, not an algorithm or AI system.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • N/A: As mentioned, ground truth in this context refers to the adherence to established mechanical testing standards (ASTM F1717) and the physical properties of the materials and design compared to predicates.

7. The sample size for the training set:

   • N/A: There is no "training set" as this is not an AI/machine learning device.

8. How the ground truth for the training set was established:

   • N/A: No training set exists.

Summary of Device Performance Determination:

The V2F™ Anterior Fixation System's acceptance criteria are centered on its mechanical properties and performance. The device is deemed to meet these criteria by demonstrating substantial equivalence to predicate devices through conformity to the ASTM F1717 standard for static compression bending, static torsion, and dynamic compression bending. The "study" is the mechanical testing conducted according to this recognized standard.

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