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When used as a vertebral body replacement device, the InFix System is intended for use in the thoracic and/or lumbar spine (T3-L5) to replace a collapsed, damaged or unstable vertebral body resected or excised (i.e., partial vertebrectorny procedures) due to tumor or trauma (i.e., fracture). The InFix System is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. The InFix intended to be used with bone graft.

When used as an intervertebral body fusion device, the InFix System is indicated for use with autogenous bone graft at one or two contiguous levels in the lumbosacral region (12-S1) in the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Patients with previous non-fusion spinal surgery at involved level may be treated with the device. Patients should be skeletally mature and six months of non-operative treatment. When used as an intervertebral body fusion device, the InFix implant is intended to be used with supplemental fixation.

For both of the indications listed above, the InFix implant is intended to be implanted via an open anterior approach.

The Ardis Interbody System is indicated for use with autogenous bone graft as an intervertebral body fusion device at one or two contiguous levels in the lumbosacral region (12-S1) in the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Patients with previous non-fusion spinal surgery at involved level may be treated with the device. Patients should be skeletally mature and have had six months of non- operative treatment.

The Ardis Interbody System is implanted using a posterior or transforaminal approach and is intended to be used singly or in pairs with supplemental fixation.

The BAK/C implant is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. BAK/C implants are used to facilitate fusion in the cervical spine and are placed via an anterior approach at the C-3 to C-7 disc levels using autograft bone.

The BAK device is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels form L2-S1. These DDD patients may also have up to Grade I spondylolisthesis at the involved levels(s). BAK devices are to be implanted via an open anterior or posterior approach. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.

Standard BAK devices and BAK/Proximity devices are to be implanted via an open anterior or posterior approach. BP/Lordotic devices are to be implanted via an open anterior approach.

All BAK devices are also indicated for lapantation at the L4-L5 and L5-S1 levels for the same clinical indications described above.

Cadence and TraXis are vertebral body replacement devices that are intended for use in the thoracic and/or thoracolumbar spine (T3-LS) to replace a collapsed, damaged or unstable vertebral body resected or excised (i.e., partial or total vertebres) due to tumor or trauma (i.e., fracture). These devices are designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. These devices are intended to be used with bone graff.

The Zimmer Spine Interbody Fusion and Vertebral Body Replacement Device Systems are intended for use in the cervical, thoracic and/or lumbar spine to mitigate and/or replace the disc space. The interbody fusion devices are intended for use with autogenous bone graft in patient with degenerative disc disease (DDD); defined as discogenic back pain and degeneration of the disc space. The vertebral body replacement (VBR) devices are intended to replace a collapsed, damaged or unstable vertebral body. VBR devices are designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column in the absence of fusion for a prolonged period.

The subject devices are to be implanted by either an anterior approach or a posterior approach or a transforaminal approach per the indications for use and/or the instructions of the surgical technique quide(s). The BAK devices are also indicated for laparoscopic implantation, per the device indications for use.

The Zimmer Spine Interbody Fusion and Vertebral Body Replacement Device System implants are manufactured from medical grade Ti-6AI-4V ELI titanium alloy or Polyether ether ketone (PEEK) OPTIMA with tantalum markers. The InFix system allows for the use of an optional Endcap made from Ultra High Molecular Weight Polyethylene (UHMWPE).

System(s) with instrumentation, the instruments are manufactured from one (or more) of the following materials: Surgical Grade Stainless Steel, Aluminum, Silicone Rubber, Radel, AITiN PVD coating, TiN PVD Coating, Nylon.

The subject implants are provided terminally sterilized with the exception of the InFix System, which is provided Non-Sterile. The InFix System must be sterilized by the end-user/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.

This document is a 510(k) premarket notification for several spinal implant devices, primarily focused on updating product specific package inserts with MRI Conditional language. Therefore, the "acceptance criteria" and "device performance" discussed relate to MRI compatibility, rather than clinical efficacy or diagnostic accuracy.

Here's a breakdown of the requested information based on the provided text:

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

• Magnetically Induced Displacement Force (ASTM F2052)
• MR Image Artifacts (ASTM F2119)
• Radio Frequency Induced Heating Near Passive Implants (ASTM F2182)
• Magnetically Induced Torque (ASTM F2213)

While specific numerical acceptance criteria are not explicitly stated in this document (e.g., maximum displacement, artifact size limits, temperature rise limits), the implication is that the devices passed these tests to qualify for MRI Conditional labeling. The underlying acceptance would be that the forces, heating, and artifacts generated during an MRI scan at specified field strengths would not pose an unacceptable risk to the patient and would allow for diagnostically acceptable imaging if properly managed according to the labeling. | Summary of Performance Testing:
Magnetic Resonance Imaging (MRI) testing of interbody fusion and VBR devices contained in the Zimmer Spine Interbody Fusion and Vertebral Body Replacement Device Systems were assessed and tested appropriately to design controls and the following ASTM Standards:

• ASTM F2052: 2006 Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
• ASTM F2119: 2007 Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants
• ASTM F2182: 11a* Standard Test Method of Measurement of Radio Frequency Induced Heating Near Passive Implants During Magnetic Resonance Imaging
• ASTM F2213: 2006 Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment

The document asserts that these tests were conducted to support the update of product-specific package inserts (IFU) with MRI Conditional language. This indicates that the devices performed within the acceptable limits of these standards to be deemed "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)

The document does not specify the sample size for the MRI compatibility tests. It refers to "interbody fusion and VBR devices contained in the Zimmer Spine Interbody Fusion and Vertebral Body Replacement Device Systems," implying that representative samples of the various devices (Ardis, BAK, InFix, TraXis, etc.) were tested.

Data provenance (e.g., country of origin, retrospective/prospective) is not mentioned as this type of testing is typically controlled laboratory testing of the devices themselves, not patient data.

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 type of information is not applicable to the performance testing described. MRI compatibility testing involves standardized physical measurements in a laboratory setting, not expert interpretation of clinical data to establish a "ground truth."

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

Not applicable. This testing is based on objective physical measurements according to ASTM standards, not subjective assessments requiring adjudication.

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 document is a 510(k) submission for spinal implants, specifically addressing MRI compatibility, not an AI-based diagnostic tool.

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

Not applicable. This document does not describe an algorithm or AI.

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

Not applicable. For MRI compatibility testing, the "ground truth" is adherence to the physical and safety limits defined by the ASTM standards and regulatory requirements for MRI Conditional labeling.

8. The sample size for the training set

Not applicable. There is no training set mentioned as this is not an AI/machine learning device.

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

Not applicable. There is no training set.

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When used as a vertebral body replacement device, the InFix® System is intended for use in the thoracic and/or lumbar spine (T3-L5) to replace a collapsed, damaged or unstable vertebral body resected or excised (i.e., partial vertebrectomy procedures) due to tumor or trauma (i.e., fracture). The InFix is designed to restore the biomechanical integrity of the anterior and middle spinal column even in the absence of fusion for a prolonged period. The InFix implant is intended to be used with bone graft.

When used as an intervertebral body fusion device the InFix System is indicated for use with autogenous bone graft at one or two contiguous levels in the lumbosacral region (L2-S1) in the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Patients with previous non-fusion spinal surgery at involved level may be treated with the device. Patients should be skeletally mature and have had six months of nonoperative treatment. When used as an intervertebral body fusion device, the InFix implant is intended to be used with supplemental fixation.

For both of the indications listed above, the InFix implant is intended to be implanted via an open anterior approach.

The InFix System is comprised of implants and two configurations of instrumentation. The subject InFix implants are the same design and dimensions as those described in InFix System, VBR submission K031672.

The InFix implant is comprised of two endplates and two struts, which are to be utilized together: with an optional endcap. The InFix System is provided in a range of angles and heights. including the instrumentation (accessories and instruments) necessary to implant the specific system. The current instrumentation is retained in aluminum trays. The new proposed instrumentation is retained in stainless trays.

The InFix implant is manufactured from implantable grade Ti-6AL-4V alloy that conforms to ASTM F-136. The implant is comprised to two opposing Endplates (provided in 0°, 3°, 6° and 9° angles) supported by two vertical Struts available in a range of heights, allowing the surgeon to fix the vertebrae in proper anatomical alignment and lordosis. Each of the Struts includes a load-sharing mechanism that allows a limited amount of strain across the fusion mass while supporting the load bearing surfaces. An Ultra High Molecular Weight Polyethylene (UHMWPE) Endcap may be placed inside the implant prior to packing it with bone graft. The Endcap serves as an optional block of the posterior opening in the implant construct to assist in containing the material inside. Holes in the Endplates provide space for bone in-growth while angled spikes penetrate the vertebral endplates and provide resistance to rotation and migration.

The InFix implant is designed for direct placement between two vertebral bodies. Component sizes and dimensions and the InFix implant depth, width and height are shown below. All dimensions are in millimeters. Strut heights are in 2mm increments.

The InFix implant is assembled and locked in-sity; bone graft is then inserted within the device and up to the anterior rim of the vertebral body.

InFix is implanted using a set of specialized instruments. The subject InFix System specialized instruments (stainless steel trays) are listed in the InFix Anterior Lumbar System Surgical Technique Guide. The current InFix System instruments (aluminum trays) are listed in the InFix Anterior Lumbar Device Surgical Technique Guide. Both instrumentation sets facilitate the insertion and removal of the InFix implants. The InFix implant is provided for single use only.

The InFix® Anterior Lumbar System is an intervertebral body fusion device and vertebral body replacement. The acceptance criteria and the study proving the device meets these criteria are detailed below.

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document describes non-clinical testing, primarily bench testing and cadaver testing. It does not specify a "test set" in terms of patient data or clinical trials.

• Bench Testing: The sample sizes for the various mechanical tests (Static and Dynamic Torsion, Compression Bending, Compression Shear, Subsidence) are not explicitly stated, but are implied by adherence to ASTM standards (ASTM F2077, ASTM F2267). These standards typically involve a defined number of test specimens to achieve statistical significance.
• Cadaver Testing: The sample size for cadaver testing is not specified.
• Data Provenance: The data is generated from laboratory testing and cadaveric studies, not from human patients. Therefore, terms like "country of origin" or "retrospective/prospective" are not applicable in the usual sense for clinical data. This is pre-clinical data.

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

This section is not applicable as the study described is non-clinical (bench and cadaver testing), not involving human patient data where expert review would establish ground truth for a diagnostic or treatment outcome. The "ground truth" for these tests is defined by the ASTM standards and the engineering principles they embody, which dictate acceptable performance limits and measurement methodologies.

4. Adjudication Method for the Test Set

This section is not applicable. Since the testing involves mechanical and cadaveric performance, there is no need for expert adjudication of results in the way it would be done for clinical imaging or diagnostic studies. The results are quantitative measurements against predefined criteria in ASTM standards.

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

No, an MRMC comparative effectiveness study was not done. The submission focuses on demonstrating substantial equivalence through non-clinical testing (bench and cadaver studies) against existing predicate devices, not on comparing the effectiveness of the device with and without AI assistance for human readers.

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

This section is not applicable. The device is a physical implant (intervertebral body fusion device/vertebral body replacement), not an AI algorithm. Therefore, "standalone algorithm performance" is not relevant.

7. The Type of Ground Truth Used

The ground truth for this device's performance evaluation is based on:

• ASTM Standards: Defined mechanical performance requirements and testing methodologies for spinal implants (e.g., ASTM F2077 for VBR, ASTM F2267 for IBFD). These standards define what constitutes acceptable mechanical behavior.
• Predicate Device Performance: The "ground truth" for substantial equivalence is the established performance and safety profile of the legally marketed predicate devices (InFix K031672 and Ardis K073202). The new device must perform comparably.
• Biocompatibility Standards: ISO 10993-1 provides the criteria for biocompatibility.
• Sterilization Standards: ISO 17665 and AAMI TIR12 dictate the requirements for sterilization.

This is primarily engineering and material science-based ground truth, not clinical outcomes or expert consensus on human patient data.

8. The Sample Size for the Training Set

This section is not applicable. As the device is a physical implant and not an AI algorithm, there is no "training set" in the context of machine learning.

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

This section is not applicable for the same reason as point 8.

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