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The Stryker Spine Aero™ -AL is an intervertebral body fusion device indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1.

DDD is defined as back pain of discogenic origin with degeration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy.

The Aero™ - AL Lumbar Cage System is to be implanted via an anterior approach.

The Aero™ - AL Lumbar Cage System is intended to be used with supplemental spinal fixation systems that has been cleared for use in the lumbosacral spine (e.g., posterior pedicle screw and rod systems) in addition to the included fixation anchors.

The Stryker Spine AERO®-C Cervical Cage is indicated for use in cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from the C2-C3 disc to the C7-Tl disc.

DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have six weeks of non-operative therapy.

The AERO®-C Cervical Cage System is to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, and is to be implanted via an open, anterior approach.

The AERO®-C Cervical Cage System is intended to be used with supplemental spinal fixation systems that have been cleared for use in the cervical spine. In addition, the device must be used with the included fixation anchors.

The Stryker Spine Aero™ - LL is an intervertebral body fusion device indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1.

DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy.

The Aero™ -LL Lumbar Cage System is to be implanted via a lateral approach.

The Aero™ -LL Lumbar Cage System is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (e.g., posterior pedicle screw and rod systems). In addition, the device may be used with or without the included fixation anchors.

When used as a cervical intervertebral body fusion device, the Aleutian implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. Cervical IBF implants are intended for use at one level in the cervical spine, from C2 to Tl, for the treatment of cervical disc disease (defined as neck pain of disco genie origin with degeneration of the disc confirmed by history and radiographic studies). The cervical device is intended to be used in patients who have had six weeks of non-operative treatment.

When used as a lumbar intervertebral body fusion device, the Aleutian implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. The lumbar IBF implants are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S 1, for the treatment of degenerative disc disease (DOD) with up to Grade I spondylolisthesis. ODD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is intended to be used in patients who have had six months of non-operative treatment.

When used as vertebral body replacement devices the Aleutian implants are indicated for use in the thoracolumbar spine (TI to LS) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body, resected or excised for the treatment of tumors or trauma/fracture in order to achieve anterior decompression of the spinal tissues, and to restore the height of a collapsed vertebral body. The Aleutian implants are designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period.

For all the above indications the Aleutian implants are intended to be used with supplemental internal fixation appropriate for the implanted level. including K2M Pedicle Screw and Hook Systems, and K2M Spinal Plate Systems.

The Ascential IBD PEEK. Spacers are indicated for use in cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from the C2-C3 disc to the C7-T1 disc. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Ascential IBD PEEKc Spacers are to be used with autogenous bone and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, and are to be implanted via an open, anterior approach.

The Ascential IBD PEEKc Spacer is intended to be used with supplemental fixation systems that have been cleared for use in the cervical spine. This cervical device is to be used in patients who have had six weeks of non-operative treatment.

The Stryker Spine AVS® AL and AVS® ALign PEEK Spacers are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous bone graft when the subject device is used an adjunct to fusion in patients with degenerative disc disease (DDD) and one level or two contiguous levels from L2 to S1.

DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy.

Additionally, the AVS® AL and AVS® ALign PEEK Spacers can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis.

The AVS® AL and AVS® ALign PEEK Spacers are to be implanted via anterior or anterolateral approach.

The AVS® AL and AVS® ALign PEEK Spacers are intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine.

The Stryker Spine AVS® Anchor-C Cervical Cage System is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. The AVS® Anchor-C Cervical Cage is to be used with autogenous bone graft and implanted via an open, anterior approach.

The AVS® Anchor-C Cervical Cage must be used with the internal screw fixation provided by AVS® Anchor-C Fixation Screws. This cervical device is to be used in patients who have had six weeks of non-operative treatment.

The Stryker Spine AVS® Anchor-L is an intervertebral body fusion device indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1.

DDD is defined as back pain of discogenic origin with degeration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy.

The AVS® Anchor-L Lumbar Cage system is to be implanted via an open, anterior approach.

The AVS® Anchor-L Lumbar Cage system may be used as a stand-alone device or in conjunction with supplemental fixation. When used as a stand-alone device, the AVS® Anchor-L Lumbar Cage must be used with the internal screw and plate fixation provided by the AVS® Anchor-L Fixation Screws and Locking Plate. If AVS® Anchor-L is used with less than three or none of the provided screws, then additional supplemental fixation that has been cleared by the FDA for use in the lumbar spine must be used to augment stability. The accompanying Locking Plate must be vice is used with any number of screws.

The Stryker Spine AVS® ARIA PEEK Spacers are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous bone graft when the subject device is used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1.

DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy.

Additionally, the AVS® ARIA PEEK Spacers can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis.

The AVS® ARIA PEEK Spacers are intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine.

The Stryker Spine AVS® AS PEEK Spacers are indicated for use in cervical interbody fusion procedures in sketally mature patients with degenerative disc disease (DDD) at one level from the C2-C3 disc to the C7-T1 disc. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The AVS® AS PEEK Spacers are to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, and are to be implanted via an open, anterior approach.

The AVS® AS PEEK Spacers are intended to be used with supplemental fixation systems that have been cleared for use in the cervical spine. This cervical device is to be used in patients who have had six weeks of non-operative treatment.

The Stryker Spine AVS® Navigator PEEK Spacers are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous bone graft when the subject device is used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1.

DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy.

Additionally, the AVS® Navigator PEEK Spacers can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis.

The AVS® Navigator PEEK Spacers are to be implanted via a posterolateral approach.

The AVS® Navigator PEEK Spacers are intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine.

The Stryker Spine AVS® PL and AVS® UniLIF™ PEEK Spacers are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous bone graft when the subject device is used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1.

DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy.

Additionally, the AVS® PL and AVS® UniLIFIM PEEK Spacers can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis.

The AVS® PL PEEK Spacers and AVS® UniLIF™ PEEK Spacers are to be implanted via posterior approach.

The AVS® PL PEEK Spacers and AVS® UniLIF™ PEEK Spacers are intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e., posterior pedicle screw and rod systems).

The Stryker Spine AVS® TL PEEK Spacers are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used an adjunct to fusion in patients with degenerative disc disease (DDD) and one level or two contiguous levels from L2 to S1.

DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy.

Additionally, the AVS® TL PEEK Spacers can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis.

The AVS® TL PEEK Spacers are to be implanted via posterior approach.

The AVS® TL PEEK Spacers are intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine (i.e., posterior pedicle screw and rod systems).

The Stryker Spine AVS® PL and AVS® UniLIF™ PEEK Spacers are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous bone graft when the subject device is used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1.

DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy.

Additionally, the AVS® PL and AVS® UniLIFIM PEEK Spacers can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis.

The AVS® PL PEEK Spacers and AVS® UniLIF™ PEEK Spacers are to be implanted via posterior approach.

The AVS® PL PEEK Spacers and AVS® UniLIF™ PEEK Spacers are intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e., posterior pedicle screw and rod systems).

CAPRI Corpectomy Cages are vertebral body replacement devices intended for use in the cervical and thoracolumbar spine.

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

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

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

When used in the thoracolumbar spine, the CAPRI Static and Expandable Corpectorny cages are intended to be used with supplemental internal fixation appropriate for the implanted level, including K2M Pedicle Screw and K2M Spinal Plate Systems.

When used in the cervical spine at one or two levels, the CAPRI Static and Expandable cages with supplemental fixation cleared by the FDA for use in the cervical spine. When used at more than two levels, supplemental fixation should include posterior fixation which is cleared by the FDA.

The CASCADIA lumbar implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients should be sketally mature and have six months of nonoperative therapy. Additionally, the CASCADIA lumbar implants can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. CASCADIA lumbar implants are intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine.

The CASCADIA hyperlordotic lateral lumbar implants (≥22°), are intended for levels L2-L5 and are to be used with CAYMAN United plates in addition to posterior supplemental fixation. The CASCADIA non-hyperlordotic lateral lumbar implants may optionally be used with CAYMAN United plates, in addition to supplemental spinal fixation systems.

The CASCADIA cervical implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion in patients with cervical disc disease (DDD) at one level or two contiguous levels from C2 to T1. These patients should be sketally mature and have had six weeks of non-operative treatment. The CASCADIA cervical implants are also to be used with supplemental fixation; the hyperlordotic CASCADIA cervical implants (i.e., ≥10°) are required to be used with an atterior cervical plate as the form of supplemental fixation.

When used as a cervical intervertebral body fusion device, the CHESAPEAKE Stabilization System implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. Cervical IBF implants are intended for use at one level in the cervical spine, from C2 to T1, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radies). The cervical device is intended to be used in patients who have had six weeks of non-operative treatment.

When used as a lumbar intervertebral body fusion device, the CHESAPEAKE Stabilization System implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. The Lumbar IBF implants are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is intended to be used in patients who have had six months of non-operative treatment.

The hyperlordotic lumbar implants (i.e., > 15°) must be used with supplemental fixation (i.e., posterior pedicle screw and rod system) cleared for use in the lumbar spine, in addition to the bone screws provided. Otherwise, the Chesapeake Stabilization System implants (i.e., ≤15°) may be used as a stand-alone device, which is intended to be used with the bone screws provided (i.e., 2 or 3 screws for the 2-screw and 3-screw implants, respectively).

The MOJAVE Expandable Interbody System implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous bone graft when used as an adjunct to fusion in patients with degenerative disc disease (DOD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radios. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy. Additionally, the MOJAVE lumbar implants can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. MOJAVE lumbar implants are intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine.

The Stryker Spine Monterey™ AL Interbody System - Stand-Alone) is an interbody fusion device indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion in patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1.

DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of non-operative therapy.

Additionally, the Monterey™ AL Stand-Alone System can be used as adjunct to fusion in patients diagnosed with degenerative scoliosis.

The Monterey™ AL Stand-Alone System is intended to be implanted via an anterior approach.

The Monterey™ AL Stand-Alone System may be used as a stand-alone device or in conjunction with supplemental fixation. When used as a stand-alone device, the Monterey™ AL Stand-Alone System must be used with the bone screws provided and requires no additional supplemental fixation. If Monterey™ AL Stand-Alone System is used with less than three or none of the provided bone screws, then additional supplemental fixation that has been cleared by the FDA for use in the lumbosacral spine must be used to augment stability. Hyperlordotic implants (>20° lordosis) are intended to be used with supplemental fixation (e.g., posterior fixation),

The Stryker Spine Monterey™ AL Interbody System – Spacer) is an intervertebral body fusion device indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion in patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1.

DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of non-operative therapy.

Additionally, the Monterey™ AL Spacer System can be used as adjunct to fusion in patients diagnosed with degenerative scoliosis.

The Monterey™ AL Spacer System is intended to be implanted via an anterior approach.

The Monterey™ AL Spacer System is intended to be used with supplemental fixation systems that have been cleared by the FDA for use in the lumbosacral spine.

The SAHARA Stabilization System implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy. Additionally, the SAHARA implants can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis.

Hyperlordotic (angles > 15°) and Lateral implants must be used with supplemental fixation (i.e., posterior pedicle screw and rod system) cleared for use in the lumbar spine, in addition to the bone screws provided. Additional supplemental fixation (i.e. pedicle screw and rod system) is needed when used as an adjunct to fusion for degenerative scoliosis. Otherwise, the SAHARA Stabilization System implants may be used as a stand-alone device, which is intended to be used with the bone screws provided.

SANTORINI Corpectomy Cages are vertebral body replacement devices intended for use in the cervical and thoracolumbar spine.

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

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

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

When used in the thoracolumbar spine, the Santorini Corpectomy cages are intended to be used with supplemental internal fixation appropriate for the implanted level. including K2M Pedicle Screw and K2M Spinal Plate Systems.

When used in the cervical spine at one or two levels, the SANTORINI Corpectomy Cage System is intended to be used with supplemental fixation cleared by the FDA for use in the cervical spine. When used at more than two levels, supplemental fixation should include posterior fixation which is cleared by the FDA.

The Tritanium® C Anterior Cervical Cage is indicated for use in cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level or two contiguous levels from the C2 to T1 disc.

DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have six weeks of non-operative therapy.

The Trianium® C Anterior Cervical Cage System is to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, and is to be implanted via an open, anterior approach.

The Tritanium® C Anterior Cervical Cage System is intended to be used with supplemental spinal fixation systems that have been cleared for use in the cervical spine.

The Stryker Spine Tritanium® PL Cage is an intervertebral body fusion device indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1.

DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD pairents may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy.

Additionally, the Tritanium® PL Cage can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis.

The Tritanium® PL Cage is to be implanted via a posterior approach.

The Tritanium® PL Cage is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine.

The Stryker Spine Tritanium® TL cage is an intervertebral body fusion device indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1.

DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy.

Additionally, the Tritanium TL Cage can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis.

The Tritanium TL Cage is to be implanted via a posterior approach.

The Tritanium TL Cage is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine.

The Tritanium® X PL Expandable Posterior Lumbar Cage and Tritanium® X TL Expandable Curved Posterior Lumbar Cage are intended for intervertebral body fusion with autografic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have completed six months of non-operative treatment.

Additionally, the Tritanium® X PL Expandable Posterior Lumbar Cage and Tritanium® X TL Expandable Curved Posterior Lumbar Cage can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis.

The Tritanium® X PL Expandable Posterior Lumbar Cage and Tritanium® X TL Expandable Curved Posterior Lumbar Cage are always to be used with supplemental internal spinal fixation. Additionally, the Tritanium® X PL Expandable Posterior Lumbar Cage and Trianium® X TL Expandable Curved Posterior Lumbar Cage are to be used with autograff and/or allogenic bone graft comprised of cancellous bone graft when the subject device is used as an adjunct to fusion.

The Tritanium® X PL Expandable Posterior Lumbar Cage and Tritanium® X TL Expandable Curved Posterior Lumbar Cage are intended for intervertebral body fusion with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have completed six months of non-operative treatment.

Additionally, the Tritanium® X PL Expandable Posterior Lumbar Cage and Tritanium® X TL Expandable Curved Posterior Lumbar Cage can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis.

The Tritanium® X PL Expandable Posterior Lumbar Cage and Tritanium® X TL Expandable Curved Posterior Lumbar Cage are always to be used with supplemental internal spinal fixation. Additionally, the Tritanium® X PL Expandable Posterior Lumbar Cage and Tritanium® X TL Expandable Curved Posterior Lumbar Cage are to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion.

Stryker Spine VLIFT™ is a vertebral body replacement system intended to replace a vertebral body or an entire vertebra. It is for use in the thoracolumbar spine (TI-LS) to replace a collapsed, or unstable vertebral body or vertebra resected or excised during total and partial corpectomy and vertebrectomy procedures due to turnor of trauma (i.e., fracture). For both corpectomy and vertebrectomy procedures, the VLIFT™ system is intended to be used with supplemental internal fixation systems. The supplemental internal fixation systems that may be used with VLIFTM include, but are not limited to Stryker Spine plate or rod system, Spiral Radius 90D, and Trio). The use of bone graft with VLIFTTM is optional.

VLIFT®-s Vertebral Body Replacement System is indicated for use in the cervical spine (C3-C7) and the thoracolumbar spine (TI-L5) in skeletally mature patial or total replacement of a diseased, collapsed, damaged, or unstable vertebral body due to tumor, osteomyelitis, trauma (i.e., fracture), or for reconstruction following corpectorny performed to achieve decompression of the spinal cord and neural tissue in degenerative disorders.

The VLIFT®-s Vertebral Body Replacement System is intended for use with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, as an adjunct to fusion. The VLIFT®-s Vertebral Body Replacement System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical, thoracic, and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.

The VLIFT®-s Vertebral Body Replacement System is intended to be used with FDA-cleared supplemental spinal fixation systems that have been labeled for use in the cervical, thoracic, and/or lumbar spine (i.e., posterior screw and rod systems, anterior plate systems, and rod systems). When used at more than two levels, supplemental fixation should include posterior fixation.

The subject devices consist of a variety of intervertebral body fusion devices and spinal vertebral body replacement devices designed to provide support across implanted levels of the cervical, thoracolumbar, and lumbosacral spine until fusion is achieved and have been previously cleared by FDA. The purpose of this submission is to establish an MR Conditional labeling claim for these implants.

This document is a 510(k) Summary for a range of spinal implants. The purpose of this submission is to establish an MR Conditional labeling claim for these implants. The submission does not detail specific acceptance criteria or performance metrics beyond stating that MR Compatibility testing was performed and met acceptance criteria.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table with specific quantitative acceptance criteria or reported device performance for the various spinal implants. It states generally:

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

• Sample Size: The document does not specify the exact sample size for the test set (number of devices tested).
• Data Provenance: The data appears to be from laboratory testing ("MR Compatibility testing per ASTM F2503-13 was performed"). There is no mention of country of origin for data or whether it was retrospective or prospective. Given the nature of MRI compatibility testing for medical implants, it would typically be prospective laboratory testing on a selection of devices.

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

This information is not applicable. The "ground truth" for MRI compatibility testing of physical implants is based on validated test methods (ASTM F2503-13) and physical measurements of artifacts, heating, and forces, not expert consensus on interpretations.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of medical images by multiple readers to establish a "ground truth" for diagnosis or assessment. MRI compatibility testing involves physical measurements.

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

No. The document explicitly states this submission is to establish an MR Conditional labeling claim for physical implants. It is not a study comparing human reader performance with or without AI assistance.

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

This information is not applicable. This submission is for physical medical devices (spinal implants) and their MRI compatibility, not an algorithm or AI system.

7. Type of Ground Truth Used

The ground truth for this type of submission is established through physical measurements and adherence to recognized standards (ASTM F2503-13) for evaluating MRI safety and compatibility of medical implants.

8. Sample Size for the Training Set

This information is not applicable. There is no AI or algorithm that requires a training set mentioned in this submission.

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

This information is not applicable, as there is no training set for an AI/algorithm.

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When used as a single-level partial vertebral body replacement device, the Galileo™ devices are indicated for use in the cervical spine (C2-T1) of skeletally mature patients for the partial replacement (i.e., partial vertebrectomy) of a vertebral body resected or excised for the treatment of tumors. or trauma/fracture, or osteomvelitis, or to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. The device is intended for use with autograft or allogenic bone graft comprising cancellous and/or corticocancellous bone graft. When the Galleo ™ device is used as a single-level, partial vertebral body replacement device, supplemental fixation may be used.

The Galileo Vertebral Body Replacement device is a surgical grade titanium (Ti- 6A1-4V) device and is available in various widths and heights. It has openings of various sizes to allow for the placement of bone graft and for the free flow of cells between the bone graft and the bone of the patient. It is intended for partial vertebral body replacement in a single vertebra and to hold bone graft material.

The provided text is a 510(k) premarket notification for the "Galileo Vertebral Body Replacement Device". This document primarily focuses on establishing substantial equivalence to a predicate device based on mechanical performance, rather than evaluating an AI/ML powered device. As such, many of the requested criteria for AI/ML device studies (such as sample sizes for test/training sets, expert ground truth development, MRMC studies, standalone performance, etc.) are not applicable or detailed in this type of submission.

However, I can extract the information relevant to the device's acceptance criteria and the study that proves it meets those criteria, specifically for its mechanical performance.

Acceptance Criteria and Device Performance (Mechanical)

Study Details (Mechanical Performance):

• Sample size used for the test set and the data provenance: Not specified in the document. The testing would involve physical samples of the device.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For mechanical testing, the "ground truth" is typically defined by established engineering standards (ASTM F2077 in this case) and measured by testing equipment.
• Adjudication method: Not applicable for mechanical tests.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, not applicable. This is a mechanical device, not an AI/ML diagnostic tool.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a mechanical device.
• The type of ground truth used: Mechanical performance standards defined by ASTM F2077.
• The sample size for the training set: Not applicable. This is a mechanical device, not an AI/ML algorithm.
• How the ground truth for the training set was established: Not applicable.

Additional Information from the Document:

• Device: Galileo Vertebral Body Replacement Device
• Predicate Device: Galileo Vertebral Body Replacement Device (K192145)
• Reason for new submission (K221542): The Galileo VBR has additional sizes (7mm, 8mm, 9mm, 10mm widths and heights, all 12mm depth) compared to the predicate.
• Changes: No changes were made to the device design, materials, or manufacturing method, only additional sizes were introduced.
• Conclusion: The device is substantially equivalent to the predicate device, and the new device sizes do not raise new questions of safety and effectiveness, based on the required design verification and validation activities (mechanical performance tests). No clinical tests were required or performed for this submission.

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When used as a single-level partial vertebral body replacement devices are indicated for use in the cervical spine (C2-T1) of skeletally mature patial replacement (i.e., partial vertebrectomy) of a vertebral body resected or excised for the treatment of tumors, or traumaffracture, or osteomyelitis, or to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. The device is intended for use with autograft or allogenic bone graft comprising cancellous and/or corticocancellous bone graft. When the Galileo™ device is used as a single-level, partial vertebral body replacement device, supplemental fixation may be used.

The Galileo Vertebral Body Replacement device is a surgical grade titanium (Ti-6A1-4V) device and is available in various widths and heights. It has openings of various sizes to allow for the placement of bone graft and for the free flow of cells between the bone graft and the bone of the patient. It is intended for partial vertebral body replacement in a single vertebra and to hold bone graft material.

The provided document does not describe the acceptance criteria and study that proves a device (Galileo Vertebral Body Replacement Device) meets the acceptance criteria in the context of an AI/ML medical device.

The document is a 510(k) summary for a physical medical device: a vertebral body replacement. The studies described are non-clinical mechanical performance tests (ASTM F2077 and ASTM F2267) to demonstrate the device's structural integrity and resistance to subsidence and expulsion. These are standard engineering tests for implantable devices, not AI/ML performance evaluation studies.

Therefore, I cannot provide the requested information regarding AI/ML device acceptance criteria, performance, sample sizes, expert ground truth adjudication, MRMC studies, or training set details, as this information is not present in the provided text.

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The Choice Spine HAWKEYE™ Vertebral Body Replacement (VBR) Spacers are vertebral body replacement devices intended for use in the thoracolumbar spine (TI -L5). Hawkeye (VBR) Spacers are also intended for use in the cervical spine (C2-T1).

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

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

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

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

The ChoiceSpine HAWKEYE™ Vertebral Body Replacement (VBR) System is composed of implant components which have a basic oval/trapezoidal shape with a hollow center for placement of bone graft. The superior and inferior surfaces have ridges, or “teeth" for resisting migration. The replacement implants, "spacers", are available in an assortment of heights and in multiple angles of lordosis to accommodate different anatomic requirements.

The provided document is a 510(k) premarket notification for the Choice Spine HAWKEYE™ Vertebral Body Replacement (VBR) System. It describes the device, its intended use, and argues for its substantial equivalence to previously cleared predicate devices.

However, the document does not contain information regarding an AI/ML-driven device or study. Therefore, I cannot extract the acceptance criteria or study details related to AI/ML performance as requested. The "Performance Data" section discusses mechanical testing (static and dynamic compression and torsion, subsidence, and expulsion) in accordance with ASTM standards, which are physical tests for the implant device itself, not performance metrics for an AI/ML algorithm. Similarly, "Clinical Literature" refers to a review to support the safety profile of the physical device.

Without the requested information from the provided text, I cannot complete the table or answer the specific questions related to AI/ML device performance and testing.

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The ENDOSKELETON® TA Interbody Fusion Device is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment prior to treatment with the device is intended to be used with supplemental fixation that has been cleared by the FDA for use in the lumbar spine. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). ENDOSKELETON® TA is indicated to be used with autograft bone or allograft bone comprised of cancellous and/ or corticocancellous bone.

The ENDOSKELETON® TAS Interbody Fusion device is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Patients should have received 6 months of nonoperative treatment prior to treatment with the device is a standalone system that is intended to be used with the bone screws provided and requires no additional supplementary fixation. The Device is indicated to be used with autograft bone or allograft bone comprised of cancellous and/ or corticocancellous bone.

Hyperlordotic Devices >16': The ENDOSKELETON® TAS Hyperlordotic Interbody Fusion Device (> 16') is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). Patients should have received 6 months of non-operative treatment with the devices. The device is indicated to be used with autograft bone comprised of cancellous and/ or corticocancellous bone. The ENDOSKELETON® TAS Hyperlordotic Interbody Fusion Device must be used with a posterior supplemental internal spinal fixation that has been cleared by the FDA for use in the lumbar spine.

The ENDOSKELETON® TO Interbody Fusion Device is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. The device must be used with supplemental fixation that has been cleared by the FDA for use in the lumbar spine. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be used with autograft bone comprised of cancellous and/ or corticocancellous bone.

The ENDOSKELETON® TT Interbody Fusion Device is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non- operative treatment with the devices. The devices. The device must be used with supplemental fixation that has been cleared by the FDA for use in the lumbar spine. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be used with autograft bone comprised of cancellous and/ or corticocancellous bone.

The ENDOSKELETON® TC Interbody Fusion Device is indicated for use for anterior cervical interbody fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one disc level from C-3 to C-7. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. Patients should have received 6 weeks of non-operative treatment with the device. The ENDOSKELETON® TC Interbody Fusion Device is indicated to be used with supplemental fixation that has been cleared by the FDA for use in the cervical spine and autograft bone comprised of cancellous and/ or corticocancellous bone.

The Endoskeleton® TCS Interbody Fusion Device System is an anterior cervical intervertebral body fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) (defined as pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) at one disc level from C2 to T1. Patients should have received 6 weeks of non-operative treatment with the device. The device is indicated to be used with autograft bone or allograft bone comprised of cancellous and/ or corticocancellous bone. The device is a standalone system when used with Endoskeleton® TCS interrated screws and when used without the integrated screws it requires additional supplemental fixation cleared for the cervical spine.

The ENDOSKELETON® TL Interbody Fusion Device is indicated for use in spinal fusion procedures in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment with the devices. This devices. This device is intended for use with supplemental fixation systems cleared for use in the lumbar spine. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Patients with previous non-fusion spinal surgery at the involved level(s) may be treated with the device. It is indicated to be used with autograft bone or allograft bone comprised of cancellous and/ or corticocancellous bone.

The ENDOSKELETON® TA Vertebral Body Replacement is for use in the thoracolumbar spine (T1 - L5) to replace all or part of a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e. fracture). The ENDOSKELETON® TA Vertebral Body Replacement is intended for use with supplemental internal spinal fixation systems that has been cleared by the FDA for use in the lumbar spine. The ENDOSKELETON® TA Vertebral Body Replacement may be used with bone graft material and/or allogeneic bone graft.

The current Endoskeleton® system is an interbody and vertebral body family comprised of a variety of sizes and geometries to accommodate various patient anatomy and pathology. All implantable components are manufactured from medical grade titanium alloy (Ti6A14V-ELI). The center of the implant is hollow and is to be filled with autograft material. The design incorporates "windows" through the implant to permit visualization of the graft material and, over time, formation of new bone. This submission seeks to expand the indications of these devices to include use with allograft material.

The predicate Endoskeleton® System (K173535, K170399, and K141953) is provided either non-sterile or sterile via gamma irradiation. The Endoskeleton® TA VBR (K032812) was initially manufactured and submitted by Orthovita, Inc (Malvern, PA). Titan Spine has the 510(k) and maintains the device listing for the device.

The provided document is a 510(k) summary for the Titan Spine Endoskeleton® Interbody Fusion Devices and Vertebral Body Replacement Device. This submission is for a modification to the indications for use, specifically to include the use of allograft material. The document explicitly states that no performance testing was required or performed because the modification relates only to the indications for use and not to the device's design, materials, or function.

Therefore, the study design and associated criteria for "device performance" (as would be tested in a typical clinical or technical performance study) are not applicable or reported in this document. The "proving" of acceptance criteria in this context relies on a literature review to establish substantial equivalence with predicate devices, rather than empirical testing of the device itself.

Since the request asks for "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of device performance, and the document clarifies that no such testing was conducted, I will state that directly.

Here's the breakdown of the requested information based on the provided document:

1. Table of acceptance criteria and the reported device performance

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

• Sample size for test set: Not applicable. No performance testing was conducted.
• Data provenance: Not applicable. The basis for this 510(k) was a comprehensive literature review.

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

• Not applicable. No test set was used for device performance evaluation. The determination of substantial equivalence was based on a literature review which concluded no additional risks for the modified indications.

4. Adjudication method for the test set

• Not applicable. No test set was used.

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

• Not applicable. This is a medical device (spinal implant), not an AI/software device. No MRMC study was conducted.

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

• Not applicable. This is a medical device (spinal implant), not an algorithm/software device.

7. The type of ground truth used

• Not applicable in the context of device performance testing. The "ground truth" for the current submission was established through a comprehensive literature review to assess the safety and equivalence of using allograft material with the existing devices.

8. The sample size for the training set

• Not applicable. No training set was used as no AI/software component is involved, and no performance testing was conducted.

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

• Not applicable. No training set was used.

Summary regarding the "study that proves the device meets the acceptance criteria":

For this specific 510(k) submission (K183557), the device itself (Titan Spine Endoskeleton® Interbody Fusion Devices and VBR Device) was not subjected to new performance testing. The application was a "Special 510(k)" for a modification to the Indications for Use, specifically to add the use of allograft material.

The document explicitly states: "No performance testing was required or performed, as this modification for this Special 510(k) relates only to the indications for use." and "A comprehensive literature review was conducted to assess any additional safety concern for the use of these devices with allograft. The review of the literature concluded that there were no additional risks due to the modification of the indications of these devices to include use with allograft and that these devices are substantially equivalent to the predicate devices."

Therefore, the "proof" that the device (with the expanded indication) meets acceptance criteria comes from a comprehensive literature review demonstrating no additional safety concerns or changes in substantial equivalence due to the inclusion of allograft material. This relies on the established performance and safety profile of the predicate devices and existing knowledge regarding allograft use in similar surgical contexts. There were no specific, quantifiable "acceptance criteria" related to a performance study for this particular submission because no such study was deemed necessary.

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VLIFT®-s Vertebral Body Replacement System is indicated for use in the cervical spine (C3-C7) and the thoracolumbar spine (T1-L5) in skeletally mature patial or total replacement of a diseased, collapsed, damaged, or unstable vertebral body due to tumor, osteomyelitis, trauma (i.e., fracture), or for reconstruction following corpectorny performed to achieve decompression of the spinal cord and neural tissue in degenerative disorders.

The VLIFT®-s Vertebral Body Replacement System is intended for use with autograft oone graft comprised of cancellous and/or corticocancellous bone graft, as an adjunct to fusion. The VLIFT®-s Vertebral Body Replacement System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical, thoracic, and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.

The VLIFT®-s Vertebral Body Replacement System is intended to be used with FDA-cleared spinal fixation systems that have been labeled for use in the cervical, thoracic, and/or lumbar spine (i.e., posterior screw and rod systems, anterior plate systems, and rod systems). When used at more than two levels, supplemental fixation should include posterior fixation.

The VLIFT®-s Vertebral Body Replacement System is intended for use as an aid in spinal fusion and consists of a single, pre-assembled distractible implant. The device may be distracted continuously via an inner concentric ring. The hollow core of the cage allows for packing bone graft. As the implant is distracted via its inner concentric ring, additional slotted openings appear.

The VLIFT®-s cages are available in various diameters and heights.

Modular end caps snap into each end of the VLIFT®-s implant. Serrated teeth at the rim of the end cap attachments help to anchor the implant to the end plates of the vertebral bodies. The VLIFT®-s end caps are available in both flush and contoured designs and are offered in a variety of angles.

Extension pieces are available for each diameter for the VLIFT®-s implants. Extension pieces may be used to achieve the desired height. The use of extension pieces is optional.

The provided text is a 510(k) summary for a medical device called the "VLIFT®-s Vertebral Body Replacement System." This document is not for an AI/ML device, but rather a physical implant. Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment, which are typical for AI/ML device evaluations, are not applicable or available in this document.

The document primarily focuses on establishing substantial equivalence to previously cleared predicate devices for an expanded indication of use (cervical spine). It emphasizes that no changes were made to the actual implants and, consequently, no additional testing was required or performed due to the existing clinical literature demonstrating substantial equivalence.

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The Solidity™ Vertebral Body Replacement is intended for use during open surgical procedures in the thoracic and lumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (e.g., fracture). The Solidity™ is intended to be used with supplemental spinal fixation. The use of bone grafting material with the Solidity™ is optional.

The Solidity™ Vertebral Body Replacement is a system of corpectomy devices used to provide mechanical support to the thoracolumbar spine. The Solidity™ Vertebral Body Replacement components include a cylindrical center piece and end caps. The center piece provides the capability for device expansion. End caps provide the anatomical footprint for the device. The components are offered in expansions, angle, footprint combinations to accommodate varying patient anatomy.

This document is a 510(k) summary for the Solidity™ Vertebral Body Replacement device, which is a medical device for spinal intervertebral body fixation. This type of device does not typically involve AI/ML components, and therefore the concepts of "acceptance criteria for device performance" in the context of AI models, "sample size for test set," "data provenance," "number of experts for ground truth," "adjudication method," "MRMC study," "standalone performance," "type of ground truth," "training set size," and "ground truth establishment for training set" are not applicable to the information provided in this document.

The document discusses the regulatory compliance and mechanical performance of the device, which are different types of acceptance criteria than those for AI/ML performance.

Here's an analysis of the provided text based on the request, reinterpreting "acceptance criteria" and "device performance" in the context of a non-AI medical device:

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

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

This information is not applicable as this is not an AI/ML device study. The provided document details mechanical testing of physical devices. The "test set" here refers to the actual physical devices subjected to mechanical tests. The document does not specify a "sample size" in terms of number of devices tested, other than referring to "worst case Solidity™ devices." Data provenance (country of origin, retrospective/prospective) is also not applicable in this context.

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 information is not applicable. For mechanical testing of a medical device, "ground truth" is established by physical measurement against engineering standards (like ASTM F2077), not by expert consensus on data interpretation.

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

This information is not applicable. Adjudication methods are relevant for subjective data interpretation, which is not the case for mechanical testing of a physical device.

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

This information is not applicable. This is a physical medical device, not an AI/ML system. Therefore, no MRMC study involving human readers and AI assistance would have been conducted or reported here.

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

This information is not applicable. This describes a physical medical device, not an algorithm.

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

The "ground truth" for the device's mechanical performance is based on established engineering standards and material specifications (e.g., ASTM F2077 for mechanical properties, ASTM F136 for material composition). For substantial equivalence, the "ground truth" refers to the characteristics and performance of the legally marketed predicate devices.

8. The sample size for the training set

This information is not applicable. This is a physical medical device, not an AI/ML system. There is no "training set."

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

This information is not applicable. There is no "training set" for this type of device.

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The Modulift VBR System is indicated for use in the cervical soine (C3-C7 vertebral bodies for the small VBR implant) and thoracolumbar spine (T1-L5 vertebral bodies for the small/medium/large VBR implant) in skeletally mature patients for partial or total replacement of a diseased, collapsed, damaged, or unstable vertebral body due to tumor, osteomyelitis, trauma (i.e. fracture), or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in degenerative disorders.

The Modulift VBR System is intended for use with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, as an adjunct to fusion. The Modulift VBR System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical, thoracic, and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.

The Modulift VBR System is intended to be used with supplemental fixation systems that have been cleared by the FDA. When used in the thoracolumbar spine, the Modulift VBR System is intended for use with supplemental spinal fixation systems such as the Aesculap MACS TL or S4 Systems. When used in the Cervical Spine at one or two levels, the Modulift Vertebral Body Replacement (VBR) System is intended to be used with supplemental fixation systems (i.e., ABC Anterior Cervical System or the Quintex Cervical System). When used at more than two levels in the cervical spine, supplemental fixation should include posterior fixation that has been cleared by FDA (i.e., Aesculap S4 Cervical System).

The Modulift VBR System is an adjustable vertebral body replacement device that is implanted into the vertebral body space to improve stability of the system is comprised of spacers and foot plates of various heights and sizes to fit the anatomical needs of a wide variety of patients. The device can be adjusted to the required height after implantation. Once it is adjusted to the desired height the column is mechanically locked in place by means of locking screws (grub screws). Each spacer has an axial hole to allow grafting material to be packed inside the device. Spikes on the end of the foot plates improve the anchoring of the implant to the vertebral body. The foot plates of the device are available in various lordotic and kyphotic angles. Components are manufactured from titanium alloy (Ti6Al4V) per ASTM F-136, and cobalt chrome (CoCr) per ASTM F1537

The purpose of the subject 510(k) is to expand the indications to include use in the cervical spine (C3-C7) of the small VBR devices.

The provided text is a 510(k) summary for the Modulift Vertebral Body Replacement (VBR) System, focusing on expanding its indications to include the cervical spine. This document primarily addresses regulatory approval based on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study description with specific acceptance criteria and performance metrics for an AI/device.

Therefore, many of the requested categories for a study demonstrating acceptance criteria and performance cannot be directly filled from this document. The device in question is a physical implant, not an AI or digital health device with typical software-based performance metrics.

Here's an attempt to extract relevant information or state why it's not present:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document mentions "A comprehensive clinical literature review and retrospective study has been conducted".

• Sample Size (Test Set): Not explicitly stated. The "test set" here refers to the patient population included in the retrospective study and clinical literature review. The exact number of patients or cases from these sources is not provided.
• Data Provenance (e.g., country of origin of the data, retrospective or prospective):
  • Study Type: Retrospective study and clinical literature review.
  • Country of Origin: Not specified.

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

This information is not provided in the document. For a medical device like a VBR system, "ground truth" would typically relate to clinical outcomes and safety, which are usually assessed by treating physicians and follow-up clinical observations, rather than a panel of experts specifically establishing a 'ground truth' score for a diagnostic output.

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

Not applicable/Not provided. Adjudication methods are typically used when multiple readers assess data (e.g., medical images) and their interpretations need to be reconciled. This document describes a physical implant and its clinical claims based on literature and retrospective data, not an AI diagnostic tool requiring multi-reader assessment.

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

Not applicable. This device is a physical vertebral body replacement system, not an AI-assisted diagnostic or treatment planning tool that would involve human readers or AI assistance.

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

Not applicable. This device is a physical implant.

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

For the retrospective study and clinical literature review, the "ground truth" would implicitly be:

• Outcomes Data: Clinical outcomes related to the safety and efficacy of VBR devices in the cervical spine (e.g., stability, fusion rates, complications, neurological outcomes).
• Literature Consensus: The overall findings and conclusions from published clinical studies on VBR use in the cervical spine.

8. The sample size for the training set

Not applicable/Not provided. The device itself is not an AI algorithm that undergoes a "training" process. The "retrospective study" and "clinical literature review" serve to provide evidence for the clinical safety and effectiveness of the device in its expanded indication.

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

Not applicable. As noted above, this device is a physical implant and does not involve a training set for an AI algorithm.

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The Choice Spine HawkeyeTM Vertebral Body Replacement (VBR) System is intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, or unstable vertebral body due to tumor or trauma (i.e., fracture). The Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) System is intended for use with supplemental fixation and is to be used with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.

The Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) System is composed of implant components which have a basic oval/trapezoidal shape with a hollow center for placement of bone graft. The superior and inferior surfaces have ridges, or "teeth" for resisting migration. The replacement implants, "spacers", are available in an assortment of heights and in multiple angles of lordosis to accommodate different anatomic requirements. This system includes implants made of PEEK (ASTM F2026) with Tantalum markers (ASTM F560) or Ti-6Al-4V ELI (ASTM F136 or ASTM F3001).

Here's a breakdown of the acceptance criteria and study information based on the provided text, focusing on the Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) System:

This document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to a predicate device rather than strictly defining and meeting performance-based acceptance criteria for a novel device. Therefore, the "acceptance criteria" here are primarily framed as demonstrating equivalence through mechanical testing, especially for worst-case designs. There is no mention of a study involving human-in-the-loop performance, expert ground truth establishment for diagnostic accuracy, or multi-reader multi-case studies as typically seen for AI/diagnostic devices. The acceptance criteria and "study" are focused on the mechanical performance of the implant.

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and the Reported Device Performance (Mechanical Testing)

Important Note: This device is a physical implant, not an AI/diagnostic software. Therefore, the typical acceptance criteria and study methodologies for AI/diagnostic devices (e.g., sensitivity, specificity, MRMC studies, human reader improvement) do not apply to this submission. The "study" here refers to non-clinical mechanical testing.

Study Details (Mechanical Testing)

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

• Sample Size: Not explicitly stated for each mechanical test, but typically, mechanical testing for medical implants involves a small number of samples (e.g., n=3 or n=5) per test condition to demonstrate compliance with standards and equivalence.
• Data Provenance: Not explicitly stated, but implies lab-based mechanical testing of manufactured implant samples. No country of origin for "data" in the sense of patient data, as this is a mechanical test. The testing is non-clinical/pre-clinical. It is not retrospective or prospective in the clinical sense.

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

• N/A. This is mechanical testing of a physical device against engineering standards, not a diagnostic or AI device requiring expert interpretation of medical images or data. Ground truth is established by the specifications of the device and the mechanical properties derived from experiments.

4. Adjudication method for the test set:

• N/A. Adjudication is not applicable as this is mechanical testing, not a diagnostic interpretation or clinical outcome assessment.

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:

• N/A. This is a physical implant device, not an AI or diagnostic software. Therefore, no MRMC study or human reader assistance is relevant.

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

• N/A. This is a physical implant device. The "standalone performance" is its mechanical integrity under various loads without human interaction.

7. The type of ground truth used:

• Engineering specifications and ASTM standards (e.g., ASTM F2077, ASTM F2267). The "ground truth" for this device's performance is its ability to meet the mechanical strength, durability, and subsidence requirements as defined by recognized engineering standards and to demonstrate similar or superior performance to its predicate devices.

8. The sample size for the training set:

• N/A. This is a physical implant, not a software or AI device that requires a "training set" in the machine learning sense.

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

• N/A. Not applicable for this type of device.

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CERVICAL INTERBODY FUSION DEVICE

When used as a cervical intervertebral body fusion implant, the Interbody Fusion (IBF)/ Vertebral Body Replacement (VBR) System ("IBF/VBR System") is indicated for intervertebral body fusion of the spine in skeletally mature patients. Cervical IBFs are intended for use at one level in the cervical spine, from the C2 to C3 intervertebral body space to the C7 to T1 intervertebral body space, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). Cervical IBFs are to be used in patients who have had six weeks of non-operative treatment. IBFs are designed for use with autogenous bone graft and/or allogenic bone graft comprised of cancellous, cortical, and/or corticocancellous bone graft to facilitate fusion. IBFs are intended to be used with supplemental spinal fixation cleared for the implanted level.

LUMBAR INTERBODY FUSION DEVICE

When used as a lumbar intervertebral body fusion implant, the Interbody Fusion (IBF) / Vertebral Body Replacement (VBR) System ("IBF/VBR System") is indicated for intervertebral body fusion of the spine in skeletally mature patients. Lumbar IBFs are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1 intervertebral body space, for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Lumbar IBFs are to be used in patients who have had six months of non-operative treatment. IBFs are designed for use with autogenous bone and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. IBFs are intended to be used with supplemental spinal fixation cleared for the implanted level.

VERTEBRAL BODY REPLACEMENT

When used as a vertebral body replacement (VBR) implant, the Interbody Fusion (IBF) / Vertebral Body Replacement (VBR) System ("IBF/VBR System") is intended for use in the thoracolumbar spine, from T1 to L5, for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. VBRs are also indicated for treating fractures of the thoracic and lumbar spine. VBRs are designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column, even in the absence of fusion for a prolonged period of time. The system is intended to be used with supplemental fixation cleared for the conditions listed above (i.e., tumor or trauma of T1 to L5). Additionally, the VBR implant is intended to be used with bone graft.

The system includes implantable devices manufactured from PEEK with tantalum or titanium alloy radiographic markers that are available in a variety of different shapes and sizes to accommodate varying patient anatomy and surgical approach. The IBF/VBR implants may be implanted via a variety or open or minimally invasive approaches, including anterior, lateral, posterior and oblique. Implant-specific and 510(k) exempt orthopedic manual surgical instruments, including the Clarity Retractor System, are also available for use with the system.

The provided text is a 510(k) premarket notification letter from the FDA regarding an Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) System. It details the device's indications for use and a summary of the submission. Crucially, this document explicitly states that "No new performance data was provided to support substantial equivalence" and "A literature analysis was performed and no new performance data was required to support substantial equivalence."

Therefore, I cannot extract the information required for acceptance criteria and the study that proves the device meets them from this document. The device in question was cleared based on its substantial equivalence to previously marketed predicate devices, with no new performance data submitted to demonstrate its own performance against specific acceptance criteria. The submission focused on expanding an indication for use for bone graft types and administrative changes, not on new performance studies of the device itself.

In summary, the document does not contain the information needed to answer your request about acceptance criteria and a study proving the device meets them, as no such new performance study was conducted or submitted for this particular 510(k) clearance.

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