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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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COALITION® Spacers (including COALITION AGX™ and COALITION MIS™) 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 nonoperative treatment. These devices are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone.

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 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 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 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), pseudoarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis.

COALITION® Spacers, COALITION AGX™ Spacers, and COALITION MIS™ Spacers are 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 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. Screws are inserted through the anterior titanium portion of the implants into adjacent vertebral bodies for bony fixation. The COALITION MIS™ Spacer may also be used with anchors inserted through the anterior titanium portion of the implant into adjacent vertebral bodies.

COALITION® and COALITION MIS™ Spacers are manufactured from radiolucent PEEK polymer and titanium alloy, with titanium alloy or tantalum markers, as specified in ASTM F2026, F136, F1295, and F560. COALITION AGX™ Spacers are manufactured from radiolucent PEEK polymer, with titanium alloy or tantalum markers, as specified in ASTM F2026. F136. F1295, and F560. COALITION AGX Plates are made from titanium alloy, as specified in ASTM F136, F1295, and F1472. The COALITION MIS™ Spacer is additionally available in an all-titanium alloy version. The screws and anchors are manufactured from titanium alloy, as specified in ASTM F136 and F1295.

I am sorry, but the provided text describes a medical device (COALITION® Spacers, an interbody fusion device) and its indications for use, along with the regulatory review and basis for substantial equivalence to other devices. This document is an FDA 510(k) clearance letter and summary.

The request asks for:

1. A table of acceptance criteria and reported device performance.
2. Sample size, data provenance, number of experts for ground truth, adjudication method, and MRMC study details for a test set.
3. Standalone algorithm performance.
4. Type of ground truth.
5. Sample size for the training set and how ground truth was established for it.

This document does not contain information about an AI/ML algorithm or a study involving such a device. It describes a physical medical implant (intervertebral body fusion device) and mentions mechanical testing and a cadaveric implantation study to demonstrate substantial equivalence to predicate devices, but not an AI/ML study with acceptance criteria, ground truth, or training/test sets as would be relevant for an AI/ML device.

Therefore, I cannot fulfill the request as the necessary information regarding acceptance criteria, study details, ground truth for an AI device, or training/test set data is not present in the provided text.

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The COALITION® Spacer is a stand-alone interbody fusion device 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 nonoperative treatment. The COALITION® Spacer is to be filled with autogenous bone graft material, and is to be used with two titanium alloy screws which accompany the implant.

The COALITION® Spacer is a stand-alone cervical interbody fusion device used to provide structural stability in skeletally mature individuals following discectorny. 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 COALITION® Spacer is made from radiolucent polymer, with titanium alloy or tantalum markers, as specified in ASTM F2026, F136, F1295, and F560. The anterior portion of the implant and the mating screws are manufactured from titanium alloy, as specified in ASTM F136 and F1295.

The provided text describes a 510(k) summary for the COALITION® Spacer, a medical device. This document focuses on demonstrating substantial equivalence to predicate devices, primarily through mechanical performance testing. It does not contain information about clinical studies with human participants, AI algorithms, or the evaluation of diagnostic performance against expert ground truth.

Therefore, many of the requested categories for AI/clinical performance studies cannot be addressed from the given text.

Here's a breakdown of what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The document states that these tests were conducted and that they demonstrated substantial equivalence, but it does not provide the specific numerical acceptance criteria or the quantitative results from these tests.

Regarding the study that proves the device meets acceptance criteria:

The study described is a mechanical performance study.

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

• Test Set Sample Size: Not explicitly stated. For mechanical testing of medical devices, sample sizes are typically determined by relevant ASTM standards, but the specific number of units tested for each criterion is not provided in this summary.
• Data Provenance: Not applicable in the context of human data. These are laboratory mechanical tests, not clinical data sets from patients or countries.

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

• Not applicable. Ground truth for mechanical testing is based on engineered specifications and standardized test methods, not expert human interpretation.

4. Adjudication method for the test set:

• Not applicable. This refers to consensus among human experts for clinical data, not mechanical testing results.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• No. This study is focused on the mechanical performance of a physical implant, not the diagnostic performance or AI assistance in interpretation.

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

• Not applicable. This refers to AI algorithms, which are not mentioned in this device description. The device itself is a physical implant.

7. The type of ground truth used:

• For mechanical testing, the "ground truth" is defined by the specifications and acceptable ranges outlined in the relevant ASTM standards (F2077) and the FDA's "Class II Special Controls Guidance Document: Intervertebral Fusion Device."

8. The sample size for the training set:

• Not applicable for a physical medical device and mechanical testing. There is no "training set" in the context of algorithm development mentioned here.

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

• Not applicable. There is no training set for an AI algorithm mentioned.

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The COALITION™ Spacer is a stand-alone interbody fusion device 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 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 nonoperative treatment. The COALITION™ Spacer is to be filled with autogenous bone graft material, and is to be used with two titanium alloy screws which accompany the implant.

The COALITION™ Spacer is a stand-alone cervical interbody fusion device used to provide structural stability in skeletally mature individuals following discectorny. 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 COALITION™ Spacer is made from radiolucent polymer, with titanium alloy or tantalum markers, as specified in ASTM F2026, F136, F1295, and F560. The anterior portion of the implant and the mating screws are manufactured from titanium alloy, as specified in ASTM F136 and F1295.

The provided text is a 510(k) summary for a medical device called the COALITION™ Spacer, an intervertebral body fusion device. This document describes the device, its intended use, and its substantial equivalence to predicate devices. It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, or training/ground truth details typically associated with AI/ML device evaluations.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval for a physical medical implant, not a software or AI/ML diagnostic tool.

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