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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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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 (L2-S1) in the treatment of degenerative 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 Ardis® Interbody System is an implant device for interbody fusion of the anterior column of the spine. It is available in various height, width and length options. The device has a textured "tooth" pattern on both the cranial and caudal sides of the device and teardrop holes on the medial and lateral sides of the device. The implant incorporates an internal cavity that allows for the placement of bone graft material.

The system includes the single-use spacer implant, as well as the associated reusable instruments used for site preparation, trialing, and placement/extraction of the device, such as rasps, tamps, shavers, bone funnel, bone tamp, slap-hammer, T-handle and trials.

The provided document pertains to the 510(k) summary for the Ardis® Interbody System, an implantable medical device, not an AI/ML powered device. As such, it does not contain information typically found in studies for AI/ML devices, such as acceptance criteria in terms of performance metrics (e.g., accuracy, sensitivity, specificity), sample sizes for test sets in an AI/ML context, data provenance, ground truth establishment by experts, adjudication methods, MRMC studies, standalone performance, or training set details.

The "Summary of Performance Testing" section describes a simulated surgical evaluation using a cadaver specimen. This type of test is for the physical and functional aspects of the surgical device and instruments, not for an AI/ML algorithm's performance.

Here's the relevant information that can be extracted, interpreted in the context of a non-AI medical device:

1. Table of acceptance criteria and the reported device performance:

   Acceptance Criteria	Reported Device Performance
   Meet documented user needs and intended use (of the Ardis Interbody System and associated instruments)	"All responses met the established acceptance criteria."
   Function (of the associated instruments)	Evaluated and met criteria.
   Performance (of the associated instruments)	Evaluated and met criteria.
   Conformance to user needs and intended use (of the associated instruments)	Validated and met criteria.

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

   • Sample Size: A "cadaver specimen" was used. The document does not specify the number of cadaver specimens.
   • Data Provenance: The cadaver specimen provides biological/anatomical data. The study involved "participating healthcare professionals" suggesting a U.S. or similar clinical setting for the evaluation. Prospectiveness is implied as it's a simulated surgical evaluation.

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

   • Number of Experts: "Participating healthcare professionals" were involved. The exact number is not specified.
   • Qualifications of Experts: Not explicitly stated, but "healthcare professionals" implies medical doctors or other qualified clinical staff who would typically perform or assist in spinal surgeries.

4. Adjudication method for the test set:

   • Not applicable in the context of this type of performance testing for a physical device. The "function, performance, and conformance to user needs and intended use" were "validated based on responses received from the participating healthcare professionals," indicating an expert review or feedback process. It doesn't describe a formal adjudication method as understood for diagnostic accuracy studies.

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:

   • No, an MRMC study was not done. This study is for a physical surgical implant system, not an AI tool.

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

   • No, this is not an AI/ML algorithm. The performance testing was for the physical device and instruments, involving human interaction (healthcare professionals performing a simulated surgery).

7. The type of ground truth used:

   • For this type of device, "ground truth" relates to the physical and functional suitability of the device and instruments during a simulated surgical procedure. The "ground truth" was established by the feedback and validation from participating healthcare professionals on whether the device and instruments met their needs and intended use in a cadaver model.

8. The sample size for the training set:

   • Not applicable. This is not an AI/ML device; therefore, there is no "training set." Device development would involve design, engineering, and iterative testing, but not in the sense of training a machine learning model.

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

   • Not applicable, as there is no training set for an AI/ML model.

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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 (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 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 Ardis® Interbody System is a device for interbody fusion of the anterior column of the spine. The Ardis implant may be used to replace the disc. These cages are hollow so that bone can grow through the device. fusing the adjacent bony surfaces.

The Ardis implant is a hollow device with texture on two opposing convex sides, and is offered in various lengths, widths and heights. Zimmer Spine designed Ardis to be placed through a posterior or transforaminal approach and to address vertebrae in the lumbosacral region of the spine. The system contains implants of various sizes to accommodate different patient anatomy. and instruments for site preparation. trialing and insertion. The device is crafted from (polvetheretherketone) PEEK-OPTIMA (ASTM F2026). As PEEK-OPTIMA is radiolucent, radiographic markers are included in the distal and proximal ends of the PEEK implants. The markers consist of tantalum wires and beads (ASTM F560) that are press fit into small holes in the implant. Additionally. the Zimmer Spine Ardis® Interbody System includes the instrumentation to facilitate the implantation of the system is comprised of instruments and perforated instrument cases that are generally comprised of aluminum, stainless steel. and/or polvmeric materials.

The Ardis Inserter that is the subject of this premarket notification is an instrument intended for use with the Ardis® Interbody System. The instrument is designed specifically to implant the PEEK interbody device into a prepared disc space. The inserter threads into the posterior hole of the PEEK implant securing the implant in place with a secondary locking (anti-rotation) mechanism. The inserter design is specific to the width measurement of the PEEK implant. A 9mm width implant will be used in conjunction with the PEEK Ardis Inserter, 9mm, and an 1 Imm implant will be inserted using the PEEK Ardis Inserter, 1 I mm.

The provided text describes a 510(k) summary for the Zimmer Spine Ardis® Interbody System and Ardis Inserter. However, it does not include information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML-enabled medical device.

The document discusses:

• The device description (spinal intervertebral body fusion device and its inserter).
• Its classification (Class II, Spinal Intervertebral Body Fusion Device).
• The predicate device (Zimmer Spine Ardis® Spacer System, K073202).
• Indications for Use.
• Technological characteristics and comparison to the predicate device (stating substantial equivalence).
• Performance Data: It briefly mentions "Design Verification Testing and Design Validation studies conducted on the Ardis Interbody System implants and instruments demonstrated the performance of the subject device was substantially equivalent in design, function, material, biocompatibility and sterilization when compared to the predicate device."
• Substantial Equivalence: It reiterates that documentation was submitted to demonstrate substantial equivalence, and that the design modification (the inserter itself) does not present new issues of safety or effectiveness.

Based on the provided text, none of the requested information regarding acceptance criteria, device performance tables, sample sizes for test/training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance for an AI/ML-enabled medical device is available.

This document is a traditional 510(k) submission for a physical medical device (an intervertebral body fusion device and its inserter), focusing on demonstrating substantial equivalence to a predicate device through engineering design verification and validation, material testing, biocompatibility, and sterilization, rather than AI/ML performance metrics.

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The TM 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 (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 non-operative treatment.

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

The TM Ardis® Interbody System implant is a convex, straight TLIF or PLIF device for interbody fusion of the anterior column of the spine. TM Ardis is designed for fusing the adjacent bony surfaces and may be used to replace a disc at one or two contiguous levels in L2-S1. The superior and inferior surfaces of the device are textured to provide increased stability and convex to conform to the vertebral endplates. The device also has two slots on the posterior end to mate with the insertion instrument. The TM Ardis device is wholly comprised of Trabecular Metal Porous Tantalum. Surgical instrumentation for use with the proposed system is fabricated from surgical grade stainless steel and other applicable materials. TM Ardis Interbody System was cleared via 510(k) number K113561 on May 29, 2012.

The TM Ardis® Inserter instrument, that is the subject of this premarket notification, is intended for use with the TM Ardis® Interbody System. This instrument is designed specifically for use with the TM Ardis® Implants and is considered an accessory to the implants.

This 510(k) summary describes a modification to an accessory instrument (TM Ardis® Inserter instrument) for an already cleared intervertebral body fusion device (TM Ardis® Interbody System). The information provided focuses on the substantial equivalence of the modified instrument to the original, rather than the primary device's clinical performance. Therefore, many of the requested categories related to clinical studies and AI performance are not applicable.

Here's the breakdown of the available information:

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

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

• Sample size for test set: Not specified. The document refers to "Design Verification and Design Validation Testing," which would typically involve a sample of the modified inserter instruments. However, the specific number of units tested is not provided.
• Data provenance: Not explicitly stated, but it would be internal testing performed by Zimmer Trabecular Metal Technology, Inc. There is no mention of external data or patient data.

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

• Not applicable. This relates to clinical studies and ground truth establishment, which are not detailed for this instrument modification. The evaluation is based on mechanical performance testing and comparison to a predicate device.

4. Adjudication method for the test set

• Not applicable. This relates to clinical studies and expert review, which are not described for this instrument modification.

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 an interbody system's inserter instrument, not an AI-powered diagnostic or assistive device. Therefore, no MRMC study or AI-related effectiveness analysis was conducted or reported.

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

• Not applicable. As mentioned above, this is not an AI device.

7. The type of ground truth used

• Not explicitly defined as "ground truth" in the context of clinical outcomes. For the mechanical testing, the "ground truth" would be the pre-defined engineering specifications and performance benchmarks for the inserter instrument, likely based on industry standards and internal design requirements.

8. The sample size for the training set

• Not applicable. This is not an AI device, so there is no "training set."

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

• Not applicable. As this is not an AI device, there is no "training set" or ground truth for such a set.

Summary of the Study:

The study referenced is an internal design verification and validation testing of the modified TM Ardis® Inserter instrument. The purpose was to demonstrate that the changes (design change to the Inserter Locking Nut and a dimensional change of the Inserter Body Housing) did not negatively impact the instrument's performance and that it remained substantially equivalent to the original, already-cleared predicate device.

The study involved mechanical performance testing to ensure the modified inserter met its design specifications, particularly regarding its ability to release the implant and axial clearance. The results indicated that the acceptance criteria were met, confirming that the modified inserter performs as intended and is substantially equivalent to the predicate device in terms of safety and effectiveness.

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The TM 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 (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 non-operative treatment.

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

The TM Ardis® Interbody System implant is a convex, straight TLIF or PLIF device for interbody fusion of the anterior column of the spine. TM Ardis is designed for fusing the adjacent bony surfaces and may be used to replace a disc at one or two contiguous levels in L2-SI. The superior and inferior surfaces of the device are textured to provide increased stability and convex to conform to the vertebral endplates. The device also has two slots on the posterior end to mate with the insertion instrument. The TM Ardis device is wholly comprised of Trabecular Metal Porous Tantalum. Surgical instrumentation for use with the proposed system will be fabricated from surgical grade stainless steel and other applicable materials.

The provided text describes a 510(k) premarket notification for the "TM Ardis® Interbody System." This document focuses on demonstrating substantial equivalence to predicate devices through mechanical testing, rather than a clinical study evaluating diagnostic accuracy or a human-AI comparison. Therefore, many of the requested categories related to clinical studies, ground truth, expert involvement, and AI performance metrics are not applicable or cannot be extracted from this specific document.

Here's the breakdown of the information that can be extracted and a clear indication of what cannot be determined:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally established by the referenced ASTM standards and FDA guidance documents for mechanical performance. The reported performance is a qualitative statement of compliance.

Study Details

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

   • Sample Size: Not applicable. This document refers to mechanical testing of the device itself, not a clinical study involving human patients or a test set of data. The "sample size" would refer to the number of devices tested, which is not specified but would be aligned with standard mechanical test protocols.
   • Data Provenance: Not applicable, as it's mechanical testing, not patient data.

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):

   • Not applicable. Ground truth, in this context, would be the physical properties and performance metrics measured during mechanical testing, established by engineering and testing standards, not by human experts interpreting clinical data.

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

   • Not applicable. This is not a clinical study requiring adjudication of expert interpretations.

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:

   • Not applicable. This document describes mechanical testing of an intervertebral body fusion device, not an AI-powered diagnostic tool. Therefore, no MRMC study or AI-assistance evaluation was performed.

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

   • Not applicable. This is not an algorithm or AI device.

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

   • Ground Truth: The "ground truth" for this device is its physical and mechanical performance characteristics as measured against established engineering standards (ASTM F2077-03, ASTM F2267-04) and FDA guidance documents for intervertebral body fusion devices. This is a physical/mechanical ground truth, not a clinical or diagnostic ground truth.

7. The sample size for the training set:

   • Not applicable. 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:

   • Not applicable. There is no training set for this type of device submission.

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