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INDEPENDENCE® Spacers (including INDEPENDENCE MIS® and INDEPENDENCE MIS AGX™) are integrated anterior lumbar interbody fusion devices indicated for use at one or more levels of the lumbosacral spine (L1-S1) , as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis), spinal stenosis, and failed previous fusion (pseudarthrosis). 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 at least six (6) months of non-operative treatment. All INDEPENDENCE® TPS coated spacers are indicated for the same use as nor-coated PEEK versions.

INDEPENDENCE® Spacers are intended to be used with or without three screws which accompany the implants. INDEPENDENCE MIS® and INDEPENDENCE MIS AGX™ Integrated Spacers are intended to be used with or without three screws and/or anchors which accompany the implants. These devices are intended for use with supplemental fixation (e.g. facet screws or posterior fixation). In addition, these devices are intended for stand-alone use in patients with DDD at one or two levels only when

INDEPENDENCE® (including INDEPENDENCE MIS® and INDEPENDENCE MIS AGX™) Spacers are integrated anterior lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. The spacers are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to aid in expulsion resistance. These devices may be used with screws and/or anchors.

HEDRON IA™ Integrated Lumbar Spacers are integrated anterior lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. These devices may be used with screws and/or anchors.

MAGNIFY® Spacers are expandable anterior lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectorny. The devices are available in various height expansion ranges and geometric options to fit the anatomical needs of a wide variety of patients. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to aid in expulsion resistance. The MAGNIFY®-S Spacers are used with screws.

The MONUMENT® Spacer is an anterior lumbar interbody fusion device used to provide structural stability in skeletally mature individuals following discectomy. The MONUMENT® Spacer is intended to aid in reduction of a Grade 1 spondylolisthesis. The spacers are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to aid in expulsion resistance. Screws are inserted through the anterior titanium portion of the implant into adjacent vertebral bodies for bony fixation.

InterContinental® Plate-Spacers are lateral lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. InterContinental® Plate-Spacers are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. Protrusions on the superior and inferior surfaces grip the endplates of the adjacent vertebrae to aid in expulsion resistance. Bone screws and/or anchors may be used to attach to the lateral portion of the adjacent vertebral bodies for bony fixation.

ELSA® Spacers are expandable lateral lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. The devices are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to aid in expulsion resistance. Bone screws and/or anchors may be used to the lateral portion of the adjacent vertebral bodies for bony fixation.

This is a 510(k) premarket notification for a medical device (spinal interbody fusion devices), not an AI/ML device. Therefore, the requested information regarding acceptance criteria for AI/ML performance, study design with human readers, ground truth establishment, training set size, etc., is not applicable and cannot be extracted from this document. The document describes mechanical testing for the devices to demonstrate substantial equivalence to predicate devices, which is a different type of evaluation.

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FORTIFY® and FORTIFY® Integrated Corpectomy Spacers are vertebral body replacement devices intended for use in the thoracolumbar spine (T1-L5). FORTIFY® Spacers (titanium) are also intended for use in the cervical spine (C2-T1). All FORTIFY® TPS coated spacers are indicated for the same use as non-coated PEEK versions.

When used in the cervical spine (C2-T1), FORTIFY® devices (titanium) are intended for use in skeletally mature patients to replace a diseased or damaged vertebral body caused by tumor fracture or osteomyelitis, or for reconstruction following corpectomy performed to achieve decompression of the spinal tissues in cervical degenerative disorders. These spacers are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.

When used in the thoracolumbar spine (T1-L5), FORTIFY® Integrated devices are intended for use to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). These spacers are designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.

The interior of the spacers can be packed with autograft or allogenic bone graft comprising cancellous and/or corticocancellous bone graft as an adjunct to fusion.

These devices are intended to be used with FDA-cleared supplemental spinal fixation systems that have been labeled for use in the cervical, thoracic, and/or lumbar spine (i.e., posterior screw and rod systems, anterior plate systems, and anterior screw and rod systems). When used at more than two levels, supplemental fixation should include posterior fixation.

XPand® Corpectomy Spacers (including XPand®-R) are vertebral body replacement devices intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, or unstable vertebral body due to tumor or trauma (i.e., fracture). XPand® Corpectorny Spacers are intended to be used with supplemental spinal fixation systems that have been labeled for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate system, and anterior screw and rod systems). The interior of the spacer can be packed with bone grafting material. XPand® Corpectomy Spacers are designed to provide anterior spinal column support even in the absence of fusion for a prolonged period. All XPand® TPS coated spacers are indicated for the same use as non-coated PEEK versions.

NIKO® Corpectomy Spacers are vertebral body replacement devices intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). NIKO® Corpectomy Spacers are intended to be used with supplemental spinal fixation systems that have been labeled for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and rod systems, and anterior screw and rod systems). The interior of the spacers can be packed with bone grafting material. NIKO® Corpectomy Spacers are designed to provide anterior spinal column support even in the absence of fusion for a prolonged period. All NIKO® TPS coated spacers are indicated for the same use as non-coated PEEK versions.

When used as lumbar intervertebral body fusion devices, SUSTAIN® Spacers (including SUSTAIN® R, and SUSTAIN®-IR) are intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). 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 at least six (6) months of nonoperative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis at the involved level(s). SUSTAIN®, SUSTAIN® R and SUSTAIN®-IR Spacers are to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft as an adjunct to fusion. SUSTAIN® TPS Spacers are to be used with autogenous bone graft material. These devices are intended to be used with supplemental fixation, such as the CREO®, REVERE®, REVOLVE®, or BEACON® Stabilization Systems.

When used as cervical intervertebral body fusion devices, SUSTAIN® Spacers (including SUSTAIN® R) are intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) at one level. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and at least six (6) weeks of non-operative treatment. SUSTAIN® Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation, such as the ASSURE®, PROVIDENCE®, or XTEND® Anterior Cervical Plate Systems. All SUSTAIN® TPS coated spacers are indicated for the same use as non-coated PEEK versions.

When used as vertebral body replacement devices, SUSTAIN® Spacers (including SUSTAIN® R TPS) are intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, or unstable vertebral body due to tumor or trauma (i.e., fracture). The spacers are intended to be used with supplemental spinal frave been labeled for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). The interior of the spacers can be packed with bone grafting material. SUSTAIN® Spacers are designed to provide anterior spinal column support even in the absence of fusion for a prolonged period. All SUSTAIN® TPS coated spacers are indicated for the same use as non-coated PEEK versions.

COALITION® Spacers are interbody fusion devices intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) for one or two contiguous levels, depending on the system. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. These devices are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone, depending on the system.

The COALITION® Spacer is a stand-alone interbody fusion device intended for use at one or two levels of the cervical spine (C2-T1) and is to be used with two titanium alloy screws which accompany the implant. The spacer is to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone.

The COALITION MIS™ Spacer is an interbody fusion device and is to be used with two titanium alloy screws or anchors which accompany the implants. When used with screws, COALITION MIS™ Spacers are stand-alone interbody fusion devices intended for use at one or two levels of the cervical spine (C2-T1). When used with anchors, COALITION MIS™ Spacers are intended for use at one level of the cervical spine (C2-T1) with additional supplemental fixation such as posterior cervical screw fixation. The spacer is to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone.

The COALITION AGX™ Spacer is intended to be used with supplemental fixation, such as anterior cervical plates or posterior cervical screw fixation. When used with the COALITION AGX™ Plate, the plate-spacer assembly takes on the indications for use of the COALITION AGX™ Spacer, with the COALITION AGX™ Plate acting as the supplemental fixation. The COALITION AGX™ Plate and Spacer assembly is a stand-alone device intended for use at one level of the cervical spine (C2-T1) and is to be used with two titanium alloy screws which accompany the implant. The spacer is to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone.

The COALITION AGX™ Plate is intended for anterior screw fixation to the cervical spine (C2-C7) for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), turnors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudoarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis.

COALITION® TPS Spacers are stand-alone interbody fusion devices intended for use at one level of the cervical spine (C2-T1) and are to be used with two titanium alloy screws which accompany the implants. The spacers are to be filled with autogenous bone graft.

PATRIOT® Spacers (including Constitution®, Signature®, TransContinental®, and TransContinental® M) are interbody fusion devices intents with degenerative disc disease (DDD) at one or two continuous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc as confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis at the involved level(s). PATRIOT® Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine (e.g. posterior pedicle screw and rod systems, anterior plate systems, and rod systems). Hyperlordotic interbody devices (>20° lordosis) must be used with at least anterior supplemental fixation. All PATRIOT® TPS coated spacers are indicated for the same use as non-coated PEEK versions.

PATRIOT® Spacers (including COLONIAL®) are interbody fusion devices intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) at one level. DDD is defined as discogenic pain with degeneration of the disc as confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. All PATRIOT® TPS coated spacers are indicated for the same use as non-coated PEEK versions.

PATRIOT® Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation, such as the ASSURE® or PROVIDENCE® Anterior Cervical Plate Systems.

The ALTERA™ Spacer is an interbody fusion device intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). 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 at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).

The ALTERA™ Spacer is to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation.

The RISE® Spacer is a lumbar interbody fusion device intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). 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 at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).

The RISE® Spacer is to be filled with autogenous bone graft material. This device is intended to be used with supplemental fixation, such as the REVERE® or REVOLVE® Stabilization Systems.

CALIBER® Spacers are interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). 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 at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). All CALIBER® TPS coated spacers are indicated for the same use as non-coated PEEK versions.

CALIBER® Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation, such as the CREO®, REVERE® or REVOLVE® Stabilization Systems.

The ELSA™ Spacer is an interbody fusion device intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). 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 at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The ELSA™ Spacer is to be filled with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone, may be used with two bone screws, and is to be used with supplemental fixation. Hyperlordotic (≥20°) implants must be used with the two bone screws and supplemental fixation in addition to the bone screws.

LATIS® Spacers are interbody for intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). 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 at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).

LATIS® Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation.

The MONUMENT™ Spacer is an interbody fusion device intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). 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 at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The MONUMENT™ Spacer is to be filled with autogenous bone graft material, and is to be used with four titanium alloy screws that accompany the implant. The device is intended to be used with supplemental fixation (i.e. pedicle screws, facet fixation).

InterContinental® Plate-Spacers are lateral lumbar interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be sketally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). InterContinental® Plate-Spacers are to be filled with autogenous bone graff material, and are to be used with two titanium alloy screws which accompany the implant. These devices are intended to be used with supplemental fixation (e.g. pedicle or facet screw systems) in addition to the integrated screws. All InterContinental® TPS coated spacers are indicated for the same use as noncoated PEEK versions.

The MAGNIFY™ Spacer is an interbody fusion device intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). 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 at least six (6) months of nonoperative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The MAGNIFY™ Spacer is to be filled with autogenous bone graft material, and is to be used with supplemental fixation, such as the CREO®, REVERE® or REVOLVE® Stabilization Systems.

The MAGNIFY™-S Spacer is a stand-alone interbody fusion device in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). 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 at least six (6) months of nonoperative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The MAGNIFY™-S Spacer is to be filled with autogenous bone graft material, and is to be used with three titanium alloy screws that accompany each implant.

INDEPENDENCE® (including INDEPENDENCE MIS™, and INDEPENDENCE MIS AGX™ Spacers) are interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1), 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 at least six (6) months of nonoperative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis at the involved level(s). INDEPENDENCE® Spacers are to be filled with autograft bone graft composed of cancellous and/ or corticocancellous bone. All INDEPENDENCE® TPS coated spacers are indicated for the same use as non-coated PEEK versions.

INDEPENDENCE® are stand-alone interbody fusion devices intended to be used with three titanium alloy screws which accompany the implants.

INDEPENDENCE MIS™ are interbody fusion devices intended to be used with three titanium alloy screws or anchors which accompany the implants. When used with screws, these devices are stand-alone interbody fusion devices. When used with anchors, these devices are intended for use with supplemental fixation (e.g. facet screws or posterior fixation), Hyperlordotic implants (≥25° lordosis) are intended for use with supplemental fixation (e.g. facet screws or posterior fixation).

INDEPENDENCE MIS AGX™ Integrated Spacer and INDEPENDENCE MIS AGX™ Integrated Ti Spacer are interbody fusion devices that may be used with three titanium alloy screws or anchors which accompany the implants. When used with screws, these devices are stand-alone interbody fusion devices. When used with anchors, these devices are intended for use with supplemental fixation (e.g. facet screws or posterior fixation). Hyperlordotic implants (≥25° lordosis) are intended for use with supplemental fixation (e.g. facet screws or posterior fixation).

INDEPENDENCE MIS AGX™ Spacers are C-shaped, non-integrated PEEK spacers that are intended to be used with supplemental fixation (e.g. facet screws or posterior fixation). When used in conjunction with the INDEPENDENCE MIS AGX™ Integrated Ti Spacer, these devices become the INDEPENDENCE MIS AGX™ Integrated Spacer.

Globus Medical's interbody fusion and vertebral body replacement devices are cervical, thoracic or lumbar devices used to provide structural stability in skeletally mature individuals following discectomy, corpectomy or vertebrectomy and may be inserted using an anterior, posterior, lateral or transforaminal approach. The devices are available in various heights and geometric options to accommodate surgical approaches and patient anatomy. Ridges on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion. These devices are to be used in conjunction with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft to be packed inside the device.

These devices are made from radiolucent PEEK polymer with titanium alloy or tantalum markers or titanium alloy, commercially pure titanium, titanium alloy, and cobalt chromium molybdenum al. Implants are also available with hydroxyapatite (HA) coating.

The provided document is a 510(k) Premarket Notification from Globus Medical Inc. to the FDA, focusing on updating the labeling for MRI compatibility of various intervertebral fusion and vertebral body replacement devices. It is not a study proving the performance of a device against specific acceptance criteria for a diagnostic AI/ML algorithm.

Therefore, most of the requested information regarding acceptance criteria, device performance, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and training set details cannot be extracted from this document, as it pertains to the MRI compatibility of physical implants, not a software algorithm.

However, I can extract the following relevant, albeit limited, information:

Area of Acceptance Criteria and Performance (related to MRI Compatibility):

The document states that MRI testing was performed per specific ASTM standards. While the specific numerical acceptance criteria (e.g., maximum displacement, temperature rise, artifact size) are not explicitly detailed in the provided text, the successful completion of these tests implies that the devices met the relevant acceptance criteria defined by these standards for MRI compatibility.

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is the MRI testing conducted according to 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 explicitly states: "No further device performance testing was required for this submission. The performance testing remains the same for the subject and predicate devices." This implies that the results of these ASTM standard tests were deemed acceptable by the FDA for the purpose of updating the MRI compatibility labeling.

Here's a breakdown of the requested information based on the provided text, highlighting what is present and what is not:

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

   • Acceptance Criteria: Not explicitly stated in numerical terms within the document for each specific test. The acceptance criteria are implicitly those defined by the referenced ASTM standards for MRI safety parameters (magnetic field interaction, heating, artifact size).
   • Reported Device Performance: The document only states that "MRI testing was performed on the subject devices per the following ASTM Standards" and that "No further device performance testing was required." This indicates that the performance met the requirements for MRI compatibility, but specific quantitative results (e.g., measured displacement in Gauss/cm, specific heating in degrees Celsius, or artifact dimensions) are not provided.

   Therefore, a full table with specific numerical criteria and performance cannot be created from this text.

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

   • Sample Size: Not specified. The testing was done on the "subject devices," referring to the various types of implants listed (FORTIFY®, XPand®, NIKO®, SUSTAIN®, etc.). The number of individual implants tested for each type is not mentioned.
   • Data Provenance: Not explicitly stated. This type of testing (MRI compatibility) is typically performed in a laboratory setting on the physical devices, not clinical data from patients.

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

   • Not applicable. This is not a study involving human experts establishing ground truth from clinical images. The "ground truth" for MRI compatibility is determined by physical measurements and adherence to engineering standards.

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

   • Not applicable. There's no adjudication process for this type of physical device testing.

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 about the MRI compatibility of physical implants, not an AI/ML diagnostic device requiring an MRMC study.

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

   • Not applicable. This is not an AI/ML algorithm.

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

   • The "ground truth" for MRI compatibility is established by the specifications and measurement techniques outlined in the referenced ASTM standards. This involves physical measurements of magnetic field interaction, temperature changes, and image artifacts, not clinical ground truth derived from patients or expert consensus.

8. The sample size for the training set:

   • Not applicable. This is not a machine learning model, so there is no training set.

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

   • Not applicable. There is no training set.

In summary, this document is a regulatory submission for physical medical devices and their MRI compatibility labeling, not for a software-based diagnostic device. Therefore, most of the questions pertaining to AI/ML device study design parameters are not addressed and are not relevant to the provided text.

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SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, COALITION® Spacers, COALITION® Spacers, COALITION AGX™ Spacers, INDEPENDE® Spacers, FORTIFY@-R Corpectomy Spacers, FORTIFY® I-R Corpectomy Spacers, XPand®-R Corpectorny Spacers, NIKO® Corpectony Spacers, MONUMENT™ Spacers, MAGNIFY™ Spacers, InterContinental® Plate-Spaces

SUSTAIN® R Spacers:
When used as lumbar intervertebral body fusion devices, SUSTAIN® Radiolucent (SUSTAIN® R) Spacers are intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). 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 at least six (6) months of nonoperative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis at the involved level(s). The SUSTAIN® and SUSTAIN® R Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation, such as the REVERE®, REVOLVE® or BEACON® Stabilization Systems.
When used as cervical intervertebral body fusion devices, the SUSTAIN® R Spacers are intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) at one level. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. The SUSTAIN® and SUSTAIN® R Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation, such as the ASSURE®, PROVIDENCE® or XTEND® Anterior Cervical Plate Systems.
When used as vertebral body replacement devices, SUSTAIN® R Spacers are intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e., fracture). The spacers are intended to be used with supplemental spinal fixation systems that have been labeled for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and rod systems and anterior screw and rod systems). The interior of the spacer can be packed with bone grafting material. SUSTAIN® R Spacers are designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.

PATRIOT® Spacers:
Lumbar Spacers: PATRIOT® Spacers (including Constitution®, Constitution® TPS, Signature® TPS, Continental®, Continental® TPS, TransContinental®, TransContinental® TPS, TransContinental® M and TransContinental® M TPS) are interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc as confirmed by history and radiographic studies. These patients should be skeletally mature and at least six (0) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis at the involved level(s). PATRIOT® Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine (e.g. posterior pedicle screw and rod systems, anterior plate systems, and rod systems). Hyperlordotic interbody devices (≥20° lordosis) must be used with at least anterior supplemental fixation.
Cervical Spacers: PATRIOT® Spacers (COLONIAL® ACDF) are interbody fusion devices intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C3-T1) at one level. DDD is defined as discogence pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of nonoperative treatment. PATRIOT® Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation, such as the ASSURE® or PROVIDENCE® Anterior Cervical Plate System.

CALIBER® Spacers:
CALIBER® Spacers are interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). 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 at least six (6) months of nonoperative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). CALIBER® Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation, such as the REVERE® or REVOLVE® Stabilization Systems.

RISE® Spacers:
The RISE® Spacer is a lumbar interbody fusion device intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). 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 at least six (6) months of nonoperative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The RISE® Spacer is to be filled with autogenous bone graft material. This device is intended to be used with supplemental fixation, such as the REVERE® or REVOLVE® Stabilization Systems.

COALITION® and COALITION AGX™ Spacers:
The COALITION® and COALITION AGX™ Spacers are interbody fusion devices intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) at one level. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and at least six (6) weeks of non-operative treatment. These devices are to be filled with autogenous bone graft material. The COALITION® Spacer is a stand-alone interbody fusion device. The COALITION AGX™ Spacer is intended to be used with supplemental fixation such as the COALITION AGX™ Plate, ASSURE®, PROVIDENCE™, VIP®, XTEND®, or UNIFY™ Anterior Cervical Plate Systems. When used with the COALITION AGX™ Plate, the assembly takes on the indications for use of the COALITION AGX™ Spacer, with the COALITION AGX™ Plate acting as the supplemental fixation. The COALITION AGX™ Plate is intended for anterior screw fixation to the cervical spine (C2-C7) for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis.

INDEPENDENCE® Spacers:
INDEPENDENCE® (including INDEPENDE® MIS, INDEPENDENCE® TPS, and INDEPENDENCE® MIS TPS) Spacers are interbody fusion devices intents with degenerative disc disc disc discase (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). 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 at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis at the involved level(s). INDEPENDENCE® Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone. The INDEPENDENCE® Spacer is a stand-alone interbody fusion device intended to be used with three titanium alloy screws which accompany the implant. The INDEPENDENCE® MIS Spacer is an interbody fusion device to be used with three titanium alloy screws or anchors which accompany the implants. When used with screws. the INDEPENDENCE® MIS Spacer is a stand-alone interbody fusion device. When used with anchors, the INDEPENDENCE® MIS Spacer is intended for use with supplemental fixation (e.g. facet screws or posterior fixation). Hyperlordotic implants (≥25° lordosis) are intended for use with supplemental fixation (e.g. facet screws or posterior fixation).

FORTIFY®-R and FORTIFY® I-R Corpectomy Spacers:
FORTIFY® (FORTIFY® and FORTIFY®-R) and FORTIFY® Integrated (FORTIFY® I and FORTIFY® I-R) Corpectomy Spacers are vertebral body replacement devices intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). These devices are intended to be used with supplemental spinal fixation systems that have been labeled for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and rod systems, and anterior screw and rod systems). The interior of the spacers can be packed with autogenous bone graft or allograft. These spacers are designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.

XPand®-R Corpectomy Spacers:
The XPand® and XPand® Radiolucent Corpectomy Spacers are vertebral body replacement devices intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The XPand® and XPand® Radiolucent Corpectomy Spacers are intended to be used with supplemental spinal fixation systems that have been labeled for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and rod systems). The interior of the spacer can be packed with bone grafting material. The XPand® and XPand® Radiolucent Corpectomy Spacers are designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.

NIKO® Corpectomy Spacers:
The NIKO® Corpectomy Spacer is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-LS) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The NIKO® Corpectomy Spacer is intended to be used with supplemental spinal fixation systems that have been labeled for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and rod systems, and anterior screw and rod systems). The interior of the spacer can be packed with bone grafting material. The NIKO® Corpectomy Spacer is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.

MONUMENT™ Spacers:
The MONUMENT™ Spacer is an interbody fusion device intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). 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 at least six (6) months of nonoperative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The MONUMENT™ Spacer is to be filled with autogenous bone graft material, and is to be used with four titanium alloy screws that accompany the implant. The device is intended to be used with supplemental fixation (i.e. pedicle screws, facet fixation).

ALTERA™ Spacers:
The ALTERA™ Spacer is an interbody fusion device intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). 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 at least six (6) months of nonoperative treatment. In addition, these patients may have up to Grade 1spondylolisthesis or retrolisthesis at the involved level(s). The ALTERA™ Spacer is to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation.

MAGNIFY™ Spacers:
The MAGNIFY™ Spacer is an interbody fusion device intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). 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 at least six (6) months of nonoperative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The MAGNIFY™ Spacer is to be filled with autogenous bone graft material, and is to be used with supplemental fixation, such as the CREO®, REVERE® or REVOLVE® Stabilization Systems. The MAGNIFY™-S Spacer is a stand-alone interbody fusion device intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). 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 at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The MAGNIFY™-S Spacer is to be filled with autogenous bone graft material, and is to be used with three titanium alloy screws that accompany each implant.

InterContinental® Plate-Spacers:
InterContinental® Plate-Spacers (including InterContinental® TPS) are lateral lumbar interbody fusion devices intended for use in patients with degenerative disc disease (DOD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DOD is defined as discogenic back pain with degeneration of the disc confirmed by history and radios. These patients should be skeletally mature and at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). InterContinental® PlateSpacers are to be filled with autogenous bone graft material, and are to be used with two titanium alloy screws which accompany the implant. These devices are intended to be used with supplemental fixation (e.g. pedicle or facet screw systems) in addition to the integrated screws.

SUSTAIN® and SUSTAIN® Radiolucent (SUSTAIN® R) Spacers are devices that can be used as intervertebral fusion devices or as vertebral body replacement devices. These spacers are available in different shapes and heights to accommodate various surgical approaches and anatomical needs. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion. Each spacer has an axial hole to allow grafting material to be packed inside the spacer. These spacers are used to provide structural stability in skeletally mature individuals following discectomy, corpectomy, or vertebrectomy (including partial). Lumbar spacers may be inserted using a posterior, transforaminal, anterior, anterolateral, or lateral lumbar approach. Cervical spacers are inserted using an anterior cervical approach. The SUSTAIN® Spacers are made from commercially pure titanium or titanium alloy as specified in ASTM F67, F136, and F1295.The SUSTAIN® R Spacers are made from radiolucent PEEK polymer with titanium alloy or tantalum markers as specified in ASTM F136, F560, F1295, and F2026.

PATRIOT® Cervical Spacers (COLONIAL® ACDF) are cervical interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. COLONIAL® ACDF Spacers are inserted through an anterior cervical approach, and are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. These spacers are to be filled with autogenous bone graft material. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion. PATRIOT® Spacers are made from radiolucent polymer, with titanium allov or tantalum markers, as specified in F2026, F136, F1295, and F560.

PATRIOT® Lumbar Spacers (including Constitution®, Constitution® TPS, Signature®, Signature® TPS, Continental®, Continental® TPS, TransContinental®, TransContinental® TPS, TransContinental® M and TransContinental® M TPS) are lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. Each of the PATRIOT® spacers provides a different shape to accommodate various surgical approaches to the lumbar spine. Constitution® PLIF Spacers are inserted using a posterior approach. Signature® TLIF Spacers are inserted using a transforaminal approach. Continental® ALIF Spacers are inserted using an anterior approach. Transcontinental® and TransContinental® M Spacers are inserted using an anterior or lateral approach. The devices are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. These spacers are to be filled with autogenous bone graft material. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion. PATRIOT® Spacers are made from PEEK radiolucent polymer (ASTM F2026) with titanium alloy or tantalum markers (ASTM F560). Signature® R Spacers also include an internal titanium alloy or commercially pure titanium (ASTM F67) component, and TransContinental® M Spacers also include an integrated titanium alloy nut. The Signature® Ti Spacer is made from titanium alloy or commercially pure titanium. The titanium alloy is TAV (ASTM F136) or TAN (ASTM F1295). PATRIOT® TPS Spacers also have a commercially pure titanium plasma spray coating, as specified in ASTM F67 and F1580.

InterContinental® Plate-Spacers (including InterContinental® TPS) are lateral lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. InterContinental® Plate-Spacers are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. Protrusions on the superior and inferior surfaces grip the endplates of the adjacent vertebrae to aid in expulsion resistance. InterContinental® Plate-Spacers are to be filled with autogenous bone graft material, and are to be used with titanium alloy bone screws, with or without hydroxyapatite coating. Bone screws are used to attach to the lateral portion of the adjacent vertebral bodies for bony fixation. The spacers in the InterContinental® Plate-Spacers are manufactured from radiolucent polymer, with titanium alloy or tantalum markers, as specified in ASTM F136, F560, F1295, and F2026. The plates in the InterContinental® Plate-Spacers are manufactured from titanium alloy, as specified in ASTM F136 and F1295. The screws in the InterContinental® Plate-Spacers are manufactured from titanium alloy, as specified in ASTM F136 and F1295, and are available with or without hydroxyapatite (HA) coating, as specified in ASTM F1185. InterContinental® TPS Plate-Spacers also have a commercially pure titanium plasma spray coatinq, as specified in ASTM F67 and F1580.

CALIBER® Spacers are lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. CALIBER® Spacers provide different shapes to accommodate various surgical approaches to the lumbar spine (posterior, transforaminal [posterolateral] or lateral). The devices are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. These spacers are to be filled with autogenous bone graft material. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion. CALIBER® Spacers are manufactured from radiolucent PEEK polymer and titanium alloy per ASTM F2026, F136 and F1295; non-expandable CALIBER® Spacers are manufactured from PEEK only. CALIBER® Spacers contain radiopaque titanium alloy or tantalum markers as specified in ASTM F136, F1295 and F560.

The COALITION® and COALITION AGX™ Spacers are a cervical interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. These spacers are inserted through an anterior cervical approach, and are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to aid in expulsion resistance. The spacer is to be filled with autogenous bone graft material. The COALITION AGX™ Plate is an anterior cervical fixation device that is available in various lengths and widths to fit the anatomical needs of a wide variety of patients. The COALITION® Spacer and the COALITION AGX™ Spacer used with a COALITION AGX™ Plate are stand-alone cervical interbody fusion devices. Screws are inserted through the anterior titanium portion of the implant into adjacent vertebral bodies for bony fixation. The COALITION® and COALITION AGX™ Spacers are manufactured radiolucent PEEK polymer, with titanium alloy or tantalum markers, as specified in ASTM F2026 F136, F1295 and F560. The plates are made from titanium alloy, as specified in ASTM, F136, F1295, and F1472. The screws are manufactured from titanium alloy, as specified in ASTM F136 and F1295.

INDEPENDENCE® (including INDEPENDENCE® MIS, INDEPENDENCE® TPS, and INDEPENDENCE® MIS TPS) Spacers are anterior lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. The spacers are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to aid in expulsion resistance. Screws are inserted through the anterior titanium portion of the implant into adjacent vertebral bodies for bony fixation. The INDEPENDENCE® MIS Spacer may also be used with anchors inserted through the anterior titanium portion of the implants into adjacent vertebral bodies for bony fixation. INDEPENDENCE® and INDEPENDENCE® MIS Spacers are made from titanium alloy and radiolucent polymer with titanium alloy or tantalum markers, as specified in ASTM F136, F560, F1295, and F2026. INDEPENDENCE® MIS Spacers are additionally available in an all titanium alloy version. All PEEK implants are additionally available with a commercially pure titanium plasma spray coating (TPS), as specified in ASTM F1580 and F67. The screws and anchors are manufactured from titanium alloy, as specified in ASTM F136 and F1295, and the screws and anchors are available with or without hydroxyapatite (HA) coating, as specified in ASTM F1185.

The MONUMENT™ Spacer is an anterior lumbar interbody fusion device used to provide structural stability in skeletally mature individuals following discectomy. The MONUMENT™ Spacer is intended to aid in reduction of a Grade 1 spondylolisthesis. The spacers are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to aid in expulsion resistance. Screws are inserted through the anterior titanium portion of the implant into adjacent vertebral bodies for bony fixation. The spacer is to be filled with autogenous bone graft material. The MONUMENT™ Spacer is made from PEEK radiolucent polymer and titanium alloy, as specified in ASTM F136, F1295, and F2026. The mating screws are manufactured from titanium alloy, as specified in ASTM F136 and F1295, and are available with hydroxyapatite (HA) coating, as specified in ASTM F1185.

The XPand® and XPand® Radiolucent Corpectomy Spacer devices are vertebral body replacement devices used to provide structural stability in skeletally mature individuals following corpectomy or vertebrectomy. The system is comprised of spacers of various heights and footprints to fit the anatomical needs of a wide variety of patients. Each spacer has an axial hole to allow grafting material to be packed inside of the spacer. Protrusions on the superior and inferior surfaces of each device will grip the endplates of the adjacent vertebrae to resist expulsion. The XPand® devices are made from titanium alloy as specified in F136 and F1295. The XPand® Radiolucent Corpectomy Spacer devices are made from radiolucent polymer and titanium alloy as specified in ASTM F2026, F136 and F1295, and include markers made from titanium alloy or tantalum as specified in ASTM F136, F1295 and F560.

FORTIFY® and FORTIFY® Integrated Corpectomy Spacers are vertebral body replacement devices used to provide structural stability in skeletally mature individuals following corpectomy or vertebrectomy. The components include a central core and endplates, which are available in a range of sizes and options to accommodate the anatomical needs of a wide variety of patients. The core and endplates can be preoperatively or intraoperatively assembled to best fit individual requirements. Each spacer has an axial hole to allow autogenous bone graft or allograft to be packed inside of the spacer. Protrusions (teeth) on the superior and inferior surfaces grip the endplates of the adjacent vertebrae to resist expulsion. Additional spikes are available on some implants. FORTIFY® Integrated endplates have an integrated plate to accommodate screws for additional fixation and are assembled to the core. FORTIFY® and FORTIFY® I Corpectomy Spacers are manufactured from titanium allov per ASTM F136 and F1295. FORTIFY®-R and FORTIFY® I-R Corpectomy Spacers are manufactured from radiolucent PEEK OPTIMA LT1, with titanium alloy and tantalum components, per ASTM F2026, F136, F1295, and F560. Screws are manufactured from titanium alloy per ASTM F136 and F1295, with or without hydroxyapatite coating per ASTM F1185.

The NIKO® Corpectomy Spacer device is a vertebral body replacement device used to provide structural stability in skeletally mature individuals following corpectomy or vertebrectomy. The system is comprised of spacers of various fixed heights to fit the anatomical needs of a variety of patients. Each spacer has an axial hole to allow grafting material to be packed inside of the spacer. Protrusions on the superior and inferior surfaces of each device will grip the endplates of the adjacent vertebrae to resist expulsion. The NIKO® Corpectomy Spacer device is made from radiolucent polymer and titanium alloy or tantalum as specified in ASTM F2026, F136, F1295, and F560.

RISE® Spacers are lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. RISE® Spacers are provided in different shapes to accommodate various surgical approaches to the lumbar spine (posterior, transforaminal [posterolateral] or lateral) and can expand to the desired height. The implants are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. This device is to be filled with autogenous bone graft material. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion. RISE® Spacers are manufactured from titanium alloy, as specified in ASTM F136 and F1295. An internal component is manufactured from radiolucent PEEK polymer, as specified in ASTM F2026.

The ALTERA™ Spacer is an expandable lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. The ALTERA™ Spacer accommodates various surgical approaches to the lumbar spine (posterior or transforaminal [posterolateral]) and allows articulation upon insertion. The devices are available in various height ranges, allowing continuous expansion within the range, to fit the anatomical needs of a wide variety of patients. This device is to be filled with autogenous bone graft material. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion. The ALTERA™ Spacer is made from titanium alloy, as specified in ASTM F136, F1295. and F1472. Internal components are made from radiolucent PEEK polymer and cobalt chromium molybdenum alloy, as specified in ASTM F2026 and F1537, respectively.

MAGNIFY™ Spacers are expandable anterior lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. The devices are available in various height expansion ranges and geometric options to fit the anatomical needs of a wide variety of patients. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to aid in expulsion resistance. These devices are to be filled with autogenous bone graft material. The MAGNIFY™ Spacer is to be used with supplemental fixation. The MAGNIFY™-S Spacer is to be used with three titanium alloy screws that accompany the implant. MAGNIFY™ Spacers are manufactured from titanium alloy, as specified in ASTM F136, and include an internal component manufactured from radiolucent PEEK polymer, as specified in ASTM F2026. The screws used with MAGNIFY™-S are manufactured from titanium allov, as specified in ASTM F136 and F1295, and are available with hydroxyapatite (HA) coating, as specified in ASTM F1185.

The provided document is a 510(k) Pre-market Notification from the FDA regarding a range of intervertebral body fusion devices and vertebral body replacement devices manufactured by Globus Medical, Inc. This document does not contain a study that proves the device meets specific acceptance criteria in terms of clinical performance or diagnostic accuracy of an AI/ML device.

Instead, this document focuses on demonstrating substantial equivalence to existing predicate devices based on technical characteristics, performance, and intended use, primarily through mechanical performance testing as outlined below.

Therefore, many of the requested elements for an AI/ML device's acceptance criteria and study proving its efficacy cannot be found in this document.

Here's an analysis based on the information available:

Acceptance Criteria and Reported Device Performance

The document does not specify quantified acceptance criteria in terms of clinical outcomes or AI/ML performance metrics (e.g., sensitivity, specificity, AUC). Instead, the acceptance criterion for regulatory clearance is "substantial equivalence" to predicate devices. The reported "performance" is that the devices meet or exceed the mechanical performance standards of the predicate devices.

Device Type and Missing Information

It is crucial to understand that the devices described are physical medical implants (spinal spacers/fusion devices), not AI/ML-driven diagnostic or prognostic tools. Therefore, the questions related to AI/ML specific studies, such as sample size for test/training sets, experts for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth types, are not applicable to this type of medical device submission.

Specific Information from the Document:

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

   • See table above. The primary acceptance criterion is substantial equivalence based on mechanical, material, and design similarity to existing devices.

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

   • Not applicable in the context of an AI/ML device. For these physical devices, unspecified "performance testing" was conducted per ASTM F2077. The document does not provide details on the number of samples or specimens tested, nor the provenance of any data beyond indicating it's mechanical testing.

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 to this device type. There is no diagnostic ground truth established by experts mentioned.

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

   • Not applicable to this device type.

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 to this device type. This is an implantable medical device, not an AI-assisted diagnostic tool.

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

   • Not applicable to this device type.

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

   • Not applicable in the AI/ML sense. For the mechanical performance, the "ground truth" would be established by the ASTM F2077 standards and the measured physical properties of the materials and devices.

8. The sample size for the training set

   • Not applicable to this device type.

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

   • Not applicable to this device type.

In summary: The provided FDA 510(k) document is for a range of spinal implants. The "study" mentioned refers to mechanical performance testing against an ASTM standard to demonstrate substantial equivalence to previously cleared predicate devices. It does not contain information relevant to the assessment of an AI/ML powered medical device.

Ask a specific question about this device

The MONUMENT™ Spacer is an interbody fusion device intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). 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 at least six (6) months of nonoperative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The MONUMENT™ Spacer is to be filled with autogenous bone graft material, and is to be used with four titanium alloy screws that accompany the implant. The device is intended to be used with supplemental fixation (i.e. pedicle screws, facet fixation).

The MONUMENT™ Spacer is an anterior lumbar interbody fusion device used to provide structural stability in skeletally mature individuals following discectorny. The MONUMENT™ Spacer is intended to aid in reduction of a Grade 1 spondylolisthesis. The spacer is available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to aid in expulsion resistance. Screws are inserted through the anterior titanium portion of the implant into adjacent vertebral bodies for bonv fixation. The spacer is to be filled with autogenous bone graft material. The MONUMENT™ Spacer is made from radiolucent PEEK polymer and titanium alloy, as specified in ASTM F136, F1295, and F2026. The mating screws are manufactured from titanium alloy, as specified in ASTM F136 and F1295, and are available with hydroxyapatite (HA) coating, as specified in ASTM F1185.

This looks like a 510(k) summary for a medical device called the MONUMENT™ Spacer, an intervertebral body fusion device. The summary describes the device, its indications for use, and a brief mention of performance data and substantial equivalence to predicate devices.

However, the provided text does not contain the specific information needed to fulfill your request for acceptance criteria and a study proving those criteria are met.

Here's why and what's missing:

• Acceptance Criteria Table: The summary states that mechanical testing was conducted "in accordance with the 'Guidance for Industry and FDA Staff, Class II Special Controls Guidance Document: Intervertebral Fusion Device,' June 12, 2007, ASTM F2077, and ASTM 2267." While these documents outline standards for testing, they do not explicitly state the specific numerical acceptance criteria used by Globus Medical for the MONUMENT™ Spacer. For example, it doesn't say "compressive strength must be greater than X N" or "subsidence must be less than Y mm."
• Reported Device Performance: The summary broadly states, "Performance and comparative analysis data demonstrate that the different technological features do not affect the safety and effectiveness of the device and support substantial equivalence to the predicate devices." This is a conclusion, not a presentation of the specific performance results (e.g., actual measured ultimate compressive strength, fatigue life cycles, etc.) against specific criteria.
• Study Details (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth, Training Set): The document refers to "Mechanical testing" but provides no details about study design, sample sizes, data acquisition methods, or any human reader involvement. This type of device (intervertebral body fusion device) typically relies on mechanical bench testing rather than studies involving expert readers, human performance, or image analysis. Therefore, most of the questions related to these aspects are not applicable or cannot be answered from the provided text.

In summary, this document indicates what types of tests were performed (mechanical), but not the specific acceptance criteria or the detailed results from those tests.

To answer your questions, I would need a different type of document, such as the full test report from the mechanical testing, which would outline the specific criteria and the measured performance data.

Therefore, I cannot populate the table or answer the specific questions based on the provided text. The prompt requests "A table of acceptance criteria and the reported device performance," which is not available in the given document.

Ask a specific question about this device