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INDEPENDENCE® (including INDEPENDENCE® TPS, INDEPENDENCE MIS™, INDEPENDENCE MIS™ TPS, INDEPENDENCE MIS AGX™, and INDEPENDENCE MIS AGX™ TPS) Spacers are interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacal 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.

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

INDEPENDENCE MIS™ and INDEPENDENCE MIS™ TPS Spacers 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, INDEPENDENCE MIS AGX™ TPS Integrated Spacer, and INDEPENDENCE MIS AGX™ Integrated Ti Spacer are interbody fusion devices that may be used with three titanium allov 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™ Soacer and INDEPENDENCE MIS AGX™ TPS Spacer 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.

INDEPENDENCE MIS AGX™ 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 the device grip the endplates of the adjacent vertebrae to aid in expulsion resistance. INDEPENDENCE MIS AGX™ Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone. INDEPENDENCE MIS AGX™ Integrated Spacers may be used with three titanium alloy screws and/or anchors which accompany the implants.

The INDEPENDENCE MIS AGX™ Integrated Ti Spacer is made from titanium alloy as specified in ASTM F136, F1295, and F1472. INDEPENDENCE MIS AGX™ Spacers are made from radiolucent polymer, with titanium alloy or tantalum markers, as specified in ASTM F2026, F136, F1295, and F560. All PEEK implants are additionally available with a commercially pure titanium plasma spray coating, as specified in ASTM F67 and ASTM F1580.

The mating 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 provided document is a 510(k) summary for the INDEPENDENCE® Spacers, which are intervertebral body fusion devices. This type of regulatory submission typically focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria in a clinical sense.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets these criteria in the context of diagnostic or assistive AI devices.

More specifically:

1. A table of acceptance criteria and the reported device performance: This information is not present. The document focuses on mechanical testing standards for this type of medical implant.
2. Sample size used for the test set and the data provenance: Not applicable to this type of device and submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable. The "ground truth" for these implants would be their ability to facilitate fusion and provide stability in vivo, which is assessed through clinical follow-up in post-market studies, not pre-market mechanical testing.
8. The sample size for the training set: Not applicable. This is a medical implant, not an AI/algorithm-based device that requires a training set.
9. How the ground truth for the training set was established: Not applicable.

What the document does provide:

The document describes the performance data as follows:

• Mechanical testing: "Mechanical testing (static and dynamic compression and compression-shear, subsidence, and expulsion) 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 F2267 to demonstrate substantial equivalence to the predicate spacers."
• Bacterial endotoxin testing (BET): "Bacterial endotoxin testing (BET) was conducted in accordance with ANSI/AAMI ST-72:2011."

These tests and standards serve as the basis for demonstrating that the device is substantially equivalent to existing devices and functions as intended for an intervertebral body fusion device. They are not "acceptance criteria" in the sense of a performance study for an AI or diagnostic device, but rather engineering and biocompatibility standards for implantable medical devices.

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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.

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