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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 Trinica® Anterior Lumbar Plate System is indicated for use via the lateral or anterolateral surgical approach above the bifurcation 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, spondylolisthesis, scoliosis, lordotic deformities of the spine, spinal stenosis, or a failed previous fusion.

The Trinica® Anterior Lumbar Plate (ALP) System is a temporary supplemental fixation device consisting of a variety of shapes and sizes of plates and screws. The Trinica Anterior Lumbar Plate 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 Trinica Anterior Lumbar Plate System components can be locked into a variety of configurations and each construct may be customized to individual cases. The plates are low profile and anatomically designed to provide optimal fit from either anterior or anterior-lateral approach. This system also features anti-migration locking caps to help secure the fixation screws. All Trinica Anterior Lumbar Plate System implant components are made from titanium alloy (Ti-6AI-4V ELI).

The Trinica Anterior Lumbar Plate System is supplied with the instrumentation necessary for implantation of the system. The Trinica" Anterior Lumbar Plate System is for single use only.

The provided documentation focuses on a 510(k) summary for the Zimmer Spine Trinica® Anterior Lumbar Plate System, which is a medical device for spinal fixation. This type of submission typically demonstrates substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria in the way a diagnostic AI/ML device would.

Therefore, the requested information regarding acceptance criteria, study details (sample size, data provenance, expert adjudication, MRMC study, standalone performance), and ground truth establishment is not applicable to this document. The document describes a sterilization validation as the primary "performance testing" conducted.

Here's a breakdown of the applicable information:

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

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

• Not Applicable. The submission does not detail a "test set" for a performance study in the context of diagnostic accuracy. The performance testing was related to sterilization validation.

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):

• Not Applicable. Ground truth, in the context of expert review, is not relevant to sterilization validation.

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

• Not Applicable.

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 device is a spinal implant, not an AI-powered diagnostic tool.

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

• Not Applicable. This device is a spinal implant.

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

• Not Applicable. For sterilization validation, the "ground truth" would be the successful killing of microorganisms, which is assessed through specific microbiological testing methods and standards (ISO 17665, AAMI TIR12).

8. The sample size for the training set:

• Not Applicable. There is no "training set" for this type of medical device submission.

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

• Not Applicable.

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The Trinica Anterior Lumbar Plate System is indicated for use via the lateral or anterolateral surgical approach above the bifurcation 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 instabliity 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, spondylolisthesis, scoliosis, lordotic deformities of the spine, spinal stenosis, or a failed previous fusion.

The Trinica Anterior Lumbar Plate System is a temporary supplemental fixation device consisting of a variety of shapes and sizes of plates and screws. The Trinica Anterior Lumbar Plate 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 Trinica Anterior Lumbar Plate System components can be locked into a variety of configurations and each construct may be customized to individual cases. The plates are low profile and anatomically designed to provide optimal fit from either anterior or anterior-lateral approach. This system also features anti-migration locking caps to help secure the fixation screws. All Trinica Anterior Lumbar Plate System implant components are made from titanium alloy (Ti-6Al-4V).

This document describes a 510(k) summary for the Zimmer Spine Trinica Anterior Lumbar Plate System. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and performance study results as one might find for a novel AI/software medical device.

Therefore, many of the requested categories for a study proving device meets acceptance criteria are not applicable or cannot be extracted from this specific document.

Here's an analysis based on the provided text:

Acceptance Criteria and Device Performance (Not Applicable - Substantial Equivalence Claim)

This 510(k) submission does not establish or report performance against specific quantitative acceptance criteria for a novel device. Instead, it claims substantial equivalence to existing predicate devices. The "acceptance criteria" in this context are implicitly that the device's technological characteristics and intended use are similar enough to existing legally marketed devices, such as the Synthes Anterior Tension Band (ATB) System and DePuy Spine AEGIS Anterior Lumbar Plate System.

The "device performance" is therefore not demonstrated through a study with outcome metrics but rather by stating that its characteristics (materials, range of sizes, intended use) are similar to the predicates.

Detailed information based on the request, where applicable:

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

   • Refer to the table above. The acceptance criteria are implicitly met by demonstrating technological equivalence to predicate devices, rather than through specific performance metrics.

2. Sample size used for the test set and the data provenance:

   • N/A. This document does not describe a clinical trial or performance study with a test set of data. It is a 510(k) submission based on technological comparison.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • N/A. No test set or ground truth establishment by experts is described as this is a device based on mechanical design and materials, not an AI/diagnostic device.

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

   • N/A. No test set with adjudication is described.

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:

   • N/A. This is a hardware medical device (spinal implant), not an AI/software device. MRMC studies are not relevant.

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

   • N/A. This is a hardware device; "standalone algorithm performance" is not applicable.

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

   • N/A. For this type of device, ground truth would typically relate to mechanical testing standards or clinical outcomes from previous studies of similar devices, none of which are detailed in this 510(k) summary provided. The "ground truth" for this submission is the established safety and effectiveness of the predicate devices.

8. The sample size for the training set:

   • N/A. Not applicable for a hardware medical device submission of this nature.

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

   • N/A. Not applicable for a hardware medical device submission of this nature.

Summary of the K061353 Filing:

The Zimmer Spine Trinica Anterior Lumbar Plate System is a temporary supplemental fixation device for the spine. The 510(k) submission (K061353) asserts its substantial equivalence to two predicate devices: the Synthes Anterior Tension Band (ATB) System and the DePuy Spine AEGIS Anterior Lumbar Plate System. The basis for this claim is the similarity in design, materials (Titanium alloy Ti-6Al-4V), functional aspects ("locked into a variety of configurations," "anti-migration locking caps"), range of sizes, and intended use as a spinal fixation system to treat L1-S1 instability resulting from conditions like fracture, tumor, degenerative disc disease, etc. The FDA's review led to a determination of substantial equivalence, allowing the device to be marketed. This type of submission relies on demonstrating that the new device does not raise new questions of safety and effectiveness compared to a legally marketed predicate.

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