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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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SUSTAIN® Spacers: When used as lumbar intervertebral body fusion devices, SUSTAIN® SUSTAIN® R and SUSTAIN® R TPS) 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® 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®, REVOLVE®, or BEACON® Stabilization Systems. When used as cervical intervertebral body fusion devices, SUSTAIN® 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 sketally mature and have had 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. When used as vertebral body replacement devices, SUSTAIN® 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 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.

PATRIOT® Lumbar Spacers: PATRIOT® Spacers (including Constitution®, Constitution® TPS, Signature®, Signature® TPS, Continental®, Continental® TPS, 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 have had 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.

PATRIOT® Cervical Spacers: PATRIOT® Spacers (including COLONIAL® and COLONIAL® TPS) 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. 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.

CALIBER® Spacers: CALIBER® Spacers (including CALIBER® 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 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). 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.

COALITION® Spacers: COALITION® Spacers (including COALITION® TPS) are stand-alone 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 have had at least six (6) weeks of non-operative treatment. COALITION® Spacers are to be filled with autogenous bone graft material, and are to be used with two titanium alloy screws which accompany the implants.

INDEPENDENCE® Spacers: INDEPENDENCE® Spacers (including INDEPENDENCE® TPS) are stand-alone 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 radios. 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 autogenous bone graft material, and are to be used with three titanium alloy screws, which accompany the implants.

FORTIFY® Corpectomy Spacers: FORTIFY® (including FORTIFY®-R TPS) and FORTIFY®-R TPS) and FORTIFY® Integrated (including FORTIFY® I-R and FORTIFY® I-R TPS) Corpectomy Spacers 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). 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, anterior screw and rod systems). The interior of the spacers can be packed with autogenous bone graft or allografi. These spacers are designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.

XPand® Corpectomy Spacers: XPand® Corpectomy Spacers (including XPand®-R and XPand®-R TPS) 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® 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 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.

NIKO® Corpectomy Spacers: NIKO® Corpectomy Spacers (including NIKO® TPS) 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.

SUSTAIN® Spacers (including SUSTAIN® R and SUSTAIN® R TPS) 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 surqical 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. SUSTAIN® Radiolucent (SUSTAIN® R) and SUSTAIN® R TPS Spacers are made from radiolucent PEEK polymer with titanium alloy or tantalum markers as specified in ASTM F136, F560, F1295, and F2026. SUSTAIN® R TPS Spacers also have a commercially pure titanium plasma spray coating, as specified in ASTM F67 and F1580.

PATRIOT® Lumbar Spacers (including Constitution®, Constitution® TPS, Signature®, 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 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.

PATRIOT® Cervical Spacers (including COLONIAL® and COLONIAL® TPS) are cervical interbody fusion devices used to provide structural stability in skeletally mature individuals following discectorny. 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 alloy or tantalum markers, as specified in F2026, F136, F1295, and F560. PATRIOT® TPS Spacers also have a commercially pure titanium plasma spray coating, as specified in ASTM F67 and F1580.

CALIBER® Spacers (including CALIBER® TPS) 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. CALIBER® TPS Spacers also have a commercially pure titanium plasma spray coating, as specified in ASTM F67 and F1580.

COALITION®Spacers (including COALITION®TPS) are stand-alone cervical interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. COALITION® 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. Screws are inserted through the anterior titanium portion of the implant into adjacent vertebral bodies for bony fixation. The spacers are to be filled with autogenous bone graft material. COALITION® Spacers are 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 allov, as specified in ASTM F136 and F1295. COALITION® TPS Spacers also have a commercially pure titanium plasma spray coating, as specified in ASTM F67 and F1580.

INDEPENDENCE® Spacers (including INDEPENDENCE® TPS) are stand-alone 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 spacers are to be filled with autogenous bone graft material. INDEPENDENCE® Spacers are made from radiolucent polymer, with titanium allov 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 screws are available with or without hydroxyapatite (HA) coating, as specified in ASTM F1185. INDEPENDENCE® TPS Spacers also have a commercially pure titanium plasma spray coating, as specified in ASTM F67 and F1580.

FORTIFY® (including FORTIFY®-R and FORTIFY®-R TPS) and FORTIFY® Integrated (including FORTIFY® I-R and FORTIFY® I-R TPS) 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 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-R Corpectomy Spacers are manufactured from titanium alloy per ASTM F136 and F1295. FORTIFY®-R, FORTIFY®-R TPS, FORTIFY® I-R, and FORTIFY® I-R TPS Corpectomy Spacers are manufactured from radiolucent PEEK polymer, 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. FORTIFY® R TPS and FORTIFY® I-R TPS Corpectomy Spacers also have a commercially pure titanium plasma spray coating, as specified in ASTM F67 and F1580.

XPand® Corpectomy Spacers (including XPand®-R and XPand®-R TPS) 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 the spacer. Protrusions on the superior and inferior surfaces of each device 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®-R and XPand®R TPS Corpectomy Spacers are made from radiolucent polymer and titanium alloy as specified in ASTM F2026, F136 and F1295, and include markers made from titanium allov or tantalum as specified in ASTM F136, F1295 and F560. XPand®-R TPS Corpectomy Spacers also have a commercially pure titanium plasma spray coating, as specified in ASTM F67 and F1580.

NIKO® Corpectomy Spacers (including NIKO® TPS) 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 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 the spacer. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion. NIKO® Corpectomy Spacers are made from radiolucent polymer and titanium alloy or tantalum as specified in ASTM F2026, F136, F1295, and F560. NIKO® TPS Corpectomy Spacers also have a commercially pure titanium plasma spray coating, as specified in ASTM F67 and F1580.

This document refers to an FDA 510(k) premarket notification for several intervertebral body fusion and corpectomy spacers, all with Titanium Plasma Spray (TPS) coatings. The primary purpose of this submission is to demonstrate substantial equivalence to previously cleared devices.

Based on the provided text, the following information can be extracted regarding acceptance criteria and performance studies:

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

The document does not provide a table with specific numerical acceptance criteria. Instead, it states that performance was evaluated in accordance with recognized standards and guidance documents. The reported performance is a general statement of compliance.

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

The document does not specify the sample size used for the mechanical or coating tests. These are typically in-vitro (laboratory) tests performed on a representative number of device samples. The data provenance is laboratory testing, not human subject data, so country of origin, retrospective/prospective, etc., are not applicable in the way they would be for clinical studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is a submission for a medical device (surgical implant), not an AI/diagnostic device that relies on expert interpretation of data. Therefore, the concept of "ground truth established by experts" in this context is not applicable. The "ground truth" for these tests would be the accepted parameters and methods defined by the referenced ASTM standards and FDA guidance documents.

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

This is not applicable as the studies described are in-vitro mechanical and material characterization tests, not clinical studies requiring adjudication of outcomes or interpretations.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC comparative effectiveness study was done. This document pertains to physical orthopedic implants, not AI-powered diagnostic or assistive technologies.

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

This is not applicable as the device is a physical implant, not an algorithm or software.

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

The "ground truth" for the performance data presented is based on established engineering and material science standards (ASTM F2077, F1044, F1147, F1160, F1854, F1978) and FDA guidance documents for mechanical testing and coating characterization of orthopedic implants. It is not derived from biological pathology or clinical outcomes in the same way a diagnostic device would.

8. The sample size for the training set

This is not applicable as this is a physical medical device, not an AI model requiring a training set.

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

Not applicable, as there is no training set for a physical implant.

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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® Spacers are to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. These devices are intended to be used with supplemental fixation.

SUSTAIN®-IR Spacers are lumbar intervertebral fusion devices used to provide structural stability in skeletally mature individuals following discectomy and may be inserted using a posterior or transforaminal approach. The devices are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. SUSTAIN® IR Spacers are inserted into the disc space and rotated 90° to the final position. Ridges on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion. SUSTAIN®-IR Spacers have an axial hole to allow autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft to be packed inside the spacer.

SUSTAIN®-IR Spacers are made from radiolucent PEEK polymer with titanium alloy or tantalum markers as specified in ASTM F136, F560, F1295, and F2026.

The provided document is a 510(k) premarket notification for a medical device called "SUSTAIN® Additional Implants," which are intervertebral body fusion devices. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than robust clinical studies with acceptance criteria for device performance as would be seen for a novel device.

Therefore, the document does not contain information on:

• Acceptance criteria for device performance based on clinical outcomes. The "acceptance criteria" discussed are primarily related to mechanical testing standards for intervertebral fusion devices.
• A study proving the device meets clinical acceptance criteria (e.g., diagnostic accuracy, sensitivity, specificity, clinical efficacy endpoints).
• Sample sizes for a test set (clinical data), data provenance, number of experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance studies. These are typically associated with performance evaluations of AI/ML-driven devices or devices requiring clinical outcome validation beyond substantial equivalence.
• Training set sample size or how ground truth was established for a training set. This information is also typically for AI/ML devices.

Instead, the document focuses on bench testing (mechanical testing) and a cadaver implantation study to demonstrate substantial equivalence for a physical implant device.

Here's the information that can be extracted or inferred from the document regarding "acceptance criteria" and "study":

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a submission for an implantable device focused on mechanical efficacy, the "acceptance criteria" are implied by adherence to recognized standards for intervertebral fusion devices. The document states that testing was conducted in accordance with these standards. Quantitative performance metrics against specific acceptance thresholds are not provided in this summary.

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

• Test Set Sample Size: Not specified for the mechanical or cadaver studies in this summary. For mechanical testing, samples typically refer to a number of devices/constructs. For the cadaver study, the number of cadaveric spines or segments is not mentioned.
• Data Provenance: Not explicitly stated, but mechanical testing is typically performed in a laboratory setting. The cadaver study would be performed in a lab or research institution. Data is prospective in the sense that the testing was conducted specifically for this submission.

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

• This is not applicable in the context of this 510(k) submission for a physical implant. "Ground truth" as expert consensus on medical images or patient outcomes is not relevant here. The "truth" for mechanical testing is based on standard test methods and measurements. For the cadaver study, the assessment of insertion feasibility and endplate damage would be observational by the study team, likely including surgeons or anatomists, but their specific number or qualifications are not provided.

4. Adjudication Method for the Test Set

• Not applicable in this context. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert interpretations (e.g., in reading medical images), which is not part of this type of device evaluation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Readers Improvement with AI vs. Without AI Assistance

• No, an MRMC study was not done. This type of study is specifically designed for evaluating the impact of AI on human reader performance, which is not relevant for this physical intervertebral fusion device.

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

• No, a standalone algorithm performance study was not done. This is not an AI/ML device but a physical implant.

7. The Type of Ground Truth Used

• Mechanical Testing: The "ground truth" is derived from physical measurements and adherence to specified ASTM and FDA guidance document standards.
• Cadaver Implantation Study: The "ground truth" relates to direct observation of device insertion feasibility and any associated endplate damage in cadaveric tissue.

8. The Sample Size for the Training Set

• Not applicable. This is not an AI/ML device that requires a training set.

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

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

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The Sustain Tailored Fit, Ultra Thin and Comfort Fit condoms are used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).

The SUSTAIN Natural Rubber Latex Condoms are made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. These condoms conform to ISO 4074 Natural Rubber Latex Condoms - Requirements and Test Methods, ASTM D3492-08 Standard Specification for Rubber Contraceptives (Male Condom), and ISO 10993 Biological Evaluation of Medical Devices.

This document is a 510(k) Summary for SUSTAIN Natural Rubber Latex Condoms. It describes the device, its intended use, and compares it to predicate devices to establish substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance:

The document refers to established standards and specifications as acceptance criteria. The device performance is deemed to meet these criteria by conforming to them.

Note: The document focuses on demonstrating substantial equivalence to predicate devices and conformance to recognized standards, rather than reporting specific numerical performance metrics from independent studies for each acceptance criterion with associated confidence intervals or statistical power. The "reported device performance" is essentially the statement that the devices "conform to" these standards.

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

The document does not explicitly state the sample sizes used for each specific test described under "Nonclinical Testing," nor does it mention the data provenance (e.g., country of origin, retrospective or prospective). It simply lists the standards and the types of tests performed. For biological evaluation, the ISO 10993 series refers to standardized testing protocols, which would inherently include specified sample sizes for in vitro and in vivo tests (like guinea pig sensitization). However, these specific sample sizes are not detailed in this submission.

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

This information is not applicable to this type of device submission. The "ground truth" for male latex condoms is established by their adherence to international and national standards (ASTM, ISO), which define performance characteristics for efficacy (e.g., prevention of pregnancy, STI transmission) and safety (e.g., biocompatibility, physical properties). These standards are developed by expert committees, but the individual "experts" establishing ground truth for a specific test set are not described in this document in the context of human interpretation of data for diagnostic purposes.

4. Adjudication Method for the Test Set:

Not applicable. This device is a physical medical device (condom) and its performance is evaluated against engineering/material standards and biological safety tests, not through human interpretation of clinical data requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC comparative effectiveness study was done. This type of study is typically performed for diagnostic or imaging devices where human readers interpret medical images or data. The device in question is a physical barrier contraceptive.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Not applicable. This device is not an algorithm or AI system. Its performance is inherent in its physical properties and biocompatibility.

7. Type of Ground Truth Used:

The "ground truth" used for this device's evaluation is based on established international and national consensus standards and specifications (ASTM D3492-08, ISO 4074, ISO 10993 series). These standards define the acceptable physical properties (length, width, thickness), burst strength, leakage, and biocompatibility requirements for male latex condoms to be considered safe and effective for their intended use. This is a form of standards-based ground truth.

8. Sample Size for the Training Set:

Not applicable. This device is not an AI or machine learning model, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set for this device.

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When used as a lumbar intervertebral body fusion device, SUSTAIN® and 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 non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis 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 a cervical intervertebral body fusion device, the SUSTAIN® and 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 System.

When used as a vertebral body replacement device, SUSTAIN® and 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, anterior plate systems and anterior screw and rod systems). The interior of the spacer can be packed with bone grafting material. SUSTAIN® and SUSTAIN® R Spacers are designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.

SUSTAIN® and 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.

The provided text describes a 510(k) premarket notification for the SUSTAIN® and SUSTAIN® Radiolucent Spacers, which are intervertebral body fusion devices and vertebral body replacement devices. The submission focuses on adding intervertebral indications and making sterile spacers available.

Here's an analysis of the acceptance criteria and the study based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not describe a clinical study on human subjects with a "test set" for the device's performance. Instead, it describes mechanical testing and a claim of substantial equivalence to predicate devices. Therefore, the concepts of "sample size used for the test set" and "data provenance" in the context of clinical data do not apply here. The "test set" for mechanical performance would be the specific number of devices tested in each mechanical test, but this detail is not provided.

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

This information is not applicable as the submission describes mechanical testing and a comparison to predicate devices, not a study involving human subjects or expert assessment for ground truth.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as point 3.

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

An MRMC comparative effectiveness study was not done. This submission is for an implantable spinal device, not an AI-assisted diagnostic or imaging device.

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

This is not applicable as the device is an implantable medical device, not an algorithm or AI system.

7. The Type of Ground Truth Used

For the mechanical testing, the "ground truth" would be established by the engineering standards and specifications outlined in the referenced guidance document ("Guidance for Industry and FDA Staff, Class II Special Controls Guidance Document: Intervertebral Fusion Device, June 12, 2007") and the ASTM standards mentioned for material composition (e.g., ASTM F67, F136). The performance of the device against these objective engineering standards serves as its "ground truth."

For substantial equivalence, the ground truth is the performance and characteristics of the legally marketed predicate devices (PATRIOT® Spacers, SUSTAIN® Spacers, CALIBER™ Spacers, COALITION® Spacers, BAK/Cervical Interbody Fusion System).

8. The Sample Size for the Training Set

This is not applicable, as this is not a machine learning or AI device that requires a training set.

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

This is not applicable for the same reasons as point 8.

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The ARCHITEX™ Space Maintenance System is indicated for use as temporary implants to stabilize and support autograft, autograft extenders, allograft, and bone void fillers and/or fractured bone segments with or without bone plates or ritanium mesh in bony defects of oral maxillofacial anatomy.

ARCHITEX™ Space Maintenance System is intended for use in oral-maxillofacial surgical reconstruction and dental regeneration procedures; the implants contained in the System are for maintaining space during bone grating procedures and/or to support soft tissue until bone formation.

The ARCHITEX™ Space Maintenance System consists of a variety of shapes and sizes of screws (Socket Preservation, Tenting, and Mesh Fixation Screws) and titanium mesh implants components as well as placement instruments components. These instruments supplied are general class I instruments added as a convenience for doctors to use to place the provided implants.

The ARCHITEX™ Space Maintenance System includes a selection of Socket Preservation screws which are designed to aid in extraction socket grafting while simultaneously supporting the original gingival margins and papilla.

The ARCHITEX™ Space Maintenance System components are fabricated from medical grade stainless steel and medical grade titanium or titanium alloy. Medical grade titanium and titanium alloy may be used together. The subject implants components will be manufactured from medical grade titanium allov described by such standards as ASTM F 136-08el or ISO 5832-3, and/or from medical grade unalloyed titanium described by such standard as ASTM F67-06. The placement instruments components will be manufactured from medical grade stainless steel as described in ASTM F8PP-09. The ARCHITEX™ Space Maintenance System is sold non-sterile.

The purpose of this 510(k) application is to seek marketing clearance for the ARCHITEX™ Space Maintenance System to be used as a root-form endosseous dental implants system.

The ARCHITEX™ Space Maintenance System (ARCHITEX™) a device used for dental implants used for oral-maxillofacial surgical reconstruction and dental regeneration procedures was evaluated for substantial equivalence to its predicate devices in accordance with the FDA 510(k) premarket notification process.

1. Table of Acceptance Criteria & Reported Device Performance

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

The document does not explicitly state the sample size for the test set. However, the non-clinical tests involved "Subject Devices and Predicate Devices" to compare their performance. The data provenance is not specified, but these are primarily bench performance tests conducted on the physical devices rather than patient data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable. The study involved non-clinical bench testing and material/dimensional analysis, not clinical ground truth established by experts.

4. Adjudication Method

This information is not applicable, as the study did not involve expert adjudication of clinical data.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study focused on the physical and mechanical properties of the device and its predicates.

6. Standalone (Algorithm Only) Performance

No, a standalone (algorithm only) performance study was not done. This device is a physical implant system, not a software algorithm.

7. Type of Ground Truth Used

The "ground truth" for this submission was established through:

• Dimensional and Material Analysis: Comparing the physical specifications and materials of the ARCHITEX™ components against the predicate devices.
• Bench Performance Testing: Conducting standardized and non-standardized mechanical tests (Static Axial Pullout, Static Subsidence, Static Cantilever Bending, Static "Removal Torque" and "Torque to Failure") on both the subject and predicate devices. The results of these tests served as the empirical "ground truth" for equivalence claims.

8. Sample Size for the Training Set

This is not applicable, as there was no "training set" in the context of an algorithm. The study compared the device components directly to predicate device components through bench testing.

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

This is not applicable, as there was no "training set" for an algorithm. The "ground truth" for the non-clinical evaluation was established through direct comparison of material properties, dimensions, and mechanical performance between the ARCHITEX™ System components and the legally marketed predicate devices, using established ASTM standards where available, and conducting comparative testing where industry standards were absent.

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The Sustain Radiolucent Spacer is a vertebral body replacement device 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 Sustain Radiolucent 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, anterior plate systems, and anterior screw and rod systems). The interior of the spacer can be packed with bone grafting material.

The Sustain Radiolucent Spacer is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.

The Sustain Radiolucent Spacer 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 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 Sustain Radiolucent Spacer devices are made from radiolucent polymer and titanium alloy as specified in ASTM F2026 and F136.

The provided 510(k) summary for the Globus Medical Inc. Sustain Radiolucent Spacer details a medical device, not a software algorithm or AI-powered system, therefore, the requested information regarding acceptance criteria and a study proving device performance in the context of AI/ML is not applicable.

The document indicates that the device's substantial equivalence is based on its similarity to a predicate device (Globus Sustain Spacer K031302) and highlights mechanical testing according to "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s", September 27, 2000. This implies that the 'acceptance criteria' were met through established biomechanical benchmarks for spinal implants, rather than performance metrics related to diagnostic accuracy, sensitivity, or specificity that would be relevant for AI studies.

Therefore, I cannot populate the table or answer the specific questions about sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details as these pertain to the evaluation of AI/ML models.

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The Sustain Spacer is a vertebral body replacement device 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 Sustain 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, anterior plate systems, and anterior screw and rod systems). The interior of the spacer can be packed with bone grafting material.

The Sustain Spacer is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.

The Sustain Spacer 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 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 Sustain Spacer devices are made from commercially pure titanium or titanium alloy as specified in ASTM F67, F136 and F1295.

The Sustain Spacer is a vertebral body replacement device. The provided text indicates that its acceptance criteria and performance were established through mechanical testing.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The provided text details mechanical testing and material specifications. This type of testing typically involves physical samples of the device components. The document does not specify the sample size used for the mechanical tests, nor does it explicitly mention data provenance in terms of country of origin or whether the data was retrospective or prospective. Such details are usually found in the full test report, not the 510(k) summary.

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

For mechanical testing, "ground truth" is typically established by engineering standards and validated testing protocols, not by expert medical review. Therefore, this section is not applicable in the context of the provided information, which focuses on mechanical and material properties. The standard mentioned, "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s", sets the technical benchmark.

4. Adjudication method for the test set:

Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of medical images or patient outcomes. For mechanical testing, the "adjudication" is inherent in the objective, quantitative nature of the tests and their alignment with established engineering standards. Therefore, this section is not applicable.

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

No, an MRMC comparative effectiveness study was not done. The provided information focuses on the mechanical and material equivalence of the Sustain Spacer to predicate devices through engineering testing, not on clinical effectiveness with human readers.

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

This question is typically relevant for AI/software devices. Since the Sustain Spacer is a physical medical implant, the concept of "standalone (algorithm only)" performance without human-in-the-loop is not applicable.

7. The type of ground truth used:

The ground truth used for demonstrating the device's performance is based on engineering standards and specifications. Specifically, the "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s", September 27, 2000, and ASTM material standards (F67, F136, F1295) serve as the benchmarks against which the device's mechanical and material properties are measured.

8. The sample size for the training set:

The concept of a "training set" is relevant for machine learning algorithms. Since the data described pertains to mechanical and material testing of a physical implant, a "training set" in the machine learning sense is not applicable.

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

As mentioned above, the concept of a "training set" is not applicable here. The "ground truth" for the device's performance was established by recognized industry standards and guidance documents for spinal implants, which dictate the required mechanical properties and material composition.

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