Search Results

OZARK Cervical Plate System is indicated for use in anterior screw fixation to the cervical spine (C2-T1) for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylisthesis, trauma(including fractures), spinal stenosis and tumors (primary and metastatic), failed previous fusion (Pseudarthrosis) and deformity (defined as scoliosis, kyphosis or lordosis).
PYRENEES and BLUE RIDGE Cervical Plate System are indicated for use in anterior screw fixation to the cervical spine (C2-T1) for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radioaraphic studies), spondylolisthesis, trauma (including fractures), spinal stenosis and tumors (primary and metastatic), failed previous fusions (pseudarthrosis) and deformity (defined as scoliosis, kyphosis or lordosis).
The EVEREST Spinal System may be used in conjunction with the RANGE® (MESA® and DENALI®) Spinal Systems, all of which are cleared for the following indications: Posterior non-cervical fixation as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis, kyphosis); tumor, pseudoarthrosis; and/or failed previous fusion. Except for hooks, when used as an anterolateral thoracic/lumbar system the EVEREST Spinal System may also be used for the same indications as an adjunct to fusion. When used for posterior non-cervical pedicle screw fixation in pediatric patients the EVEREST Spinal System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scolosis. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
RANGE (MESA and DENALI) and ARI are cleared for the following indications: Posterior non-cervical fixation as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis, kyphosis); tumor, pseudoarthrosis; and/or failed previous fusion. Except for hooks, when used as an anterolateral thoracic/lumbar system the Range Spinal System may also be used for the same indications as an adjunct to fusion. Except for the ARI staples, the Range Spinal System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis when used for posterior noncervical fixation in pediatric patients. The Range Spinal System for pediatric use is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
The Caspian OCT/MESA Mini Spinal System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine (T1-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudoarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The Caspian OCT/MESA Mini Spinal 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 spine in whom life expectancy is of insufficient duration to permit achievement of fusion. In order to achieve additional levels of fixation, the Caspian OCT/MESA Mini/Spinal System may be connected to Range/MESA/DENALI Spinal System and Everest Spinal System components via the rod to rod connectors or transition rods.
The Caspian OCT/MESA Mini/DENALI Mini Spinal System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine (T1-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudoarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The Caspian OCT/MESA Mini/DENALI Mini Spinal 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 spine in whom life expectancy is of insufficient duration to permit achievement of fusion. In order to achieve additional levels of fixation, the Caspian OCT/MESA Mini/DENALI Mini Spinal System may be connected to Range/MESA/DENALI Spinal System and Everest Spinal System components via the rod to rod connectors or transition rods.
RANGE (MESA and DENALI) and ARI are cleared for the following indications: Posterior non-cervical fixation as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis, kyphosis); tumor, pseudoarthrosis; and/or failed previous fusion. Except for hooks, when used as an anterolateral thoracic/lumbar system the Range Spinal System may also be used for the same indications as an adjunct to fusion. Except for the ARI staples, the Range Spinal System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis when used for posterior noncervical fixation in pediatric patients. The Range Spinal System for pediatric use is intended to be used with autograft and/or allograff. Pediatric pedicle screw fixation is limited to a posterior approach.
The Caspian OCT/MESA Mini/DENALI Mini Spinal System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine (T1-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudoarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The Caspian OCT/MESA Mini/DENALI Mini Spinal 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 spine in whom life expectancy is of insufficient duration to permit achievement of fusion. In order to achieve additional levels of fixation, the Caspian OCT/MESA Mini/DENALI Mini Spinal System may be connected to Range/MESA/DENALI Spinal System and Everest Spinal System components via the rod to rod connectors or transition rods.
The YUKON OCT Spinal System is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine (T1-T3): traumatic spinal fractures and/ or traumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudoarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The YUKON OCT Spinal 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 spine in whom life expectancy is of insufficient duration to permit achievement of fusion. In order to achieve additional levels of fixation, the YUKON OCT Spinal System may be connected to Everest Spinal System components via the rod to rod connectors or transition rods.
The Xia® 3 Spinal System is intended for use in the non-cervical spine. When used as an anterior/ anterolateral and posterior, non-cervical pedicle and non-pedicle fixation system, the Xia® 3 Spinal System is intended to provide additional support during fusion using auto graft or allograft in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities: Degenerative Disc Disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), Spondylolisthesis, Trauma (i.e. fracture of dislocation), Spinal stenosis, Curvatures (i.e., scoliosis, kyphosis, and/or lordosis), Tumor, Pseudarthrosis, Failed previous fusion. The 5.5 mm rods from the Stryker Spine Radius™ Spinal System and 6.0 mm Vitallium rods from the Xia® Spinal System are intended to be used with the other components of the Xia® 3 Spinal System. When used for posterior, non-cervical, pedicle screw fixation in pediatric patients, the Xia® 3 Spinal System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the Xia® 3 Spinal System is intended to treat pediatric patients diagnosed with: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. This system is intended to be used with autograft and/ or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
The EVEREST Spinal System may be used in conjunction with the RANGE® (MESA® and DENALI®) Spinal Systems, all of which are cleared for the following indications: Posterior non-cervical fixation as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis); tumor; pseudarthrosis; and/or failed previous fusion. Except for hooks, when used as an anterolateral thoracic/lumbar system the EVEREST Spinal System may also be used for the same indications as an adjunct to fusion. When used for posterior non-cervical pedicle screw fixation in pediatric patients the EVEREST Spinal System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
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 contiquous 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 skeletally 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 skeletally 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 anterior cervical plate as the form of supplemental fixation.
The CAYMAN Buttress Plates are intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts or autografts. The device is not intended for load bearing indications. The CAYMAN Thoracolumbar Plates are indicated for use via the lateral or anterolateral surgical approach in the treatment of thoracic and thoracolumbar (T1-L5) spine and for use as an anteriorly placed supplemental fixation device for the lumbosacral level below the bifurcation of the vascular structures (L5-S1). The Cayman Thoracolumbar Plate System is intended to provide temporary stabilization during fusion using autograph or allograft in skeletally mature patients in the treatment of the following acute and chronic instabilities and deformities: a) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), b) pseudoarthrosis, c) spondylolysis, d) spondylolisthesis, e) fracture, f) neoplastic disease, g) unsuccessful previous fusion surgery, h)lordotic deformities of the spine, i) thoracolumbar or lumbar scoliosis, j) deformity (i.e., scoliosis, kyphosis, and/or lordosis) associated with deficient posterior elements such as that resulting from laminectomy.
The CAYMAN Buttress Plates are intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts or autografts. The device is not intended for load bearing indications. The CAYMAN Thoracolumbar Plates are indicated for use via the lateral or anterolateral surgical approach in the treatment of thoracic and thoracolumbar (T1-L5) spine and for use as an anteriorly placed supplemental fixation device for the lumbosacral level below the bifurcation of the vascular structures (L5-S1). The Cayman Thoracolumbar Plate System is intended to provide temporary stabilization during fusion using autograph or allograft in skeletally mature patients in the treatment of the following acute and chronic instabilities and deformities: a) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), b) pseudoarthrosis, c) spondylolysis, d) spondylolisthesis, e) fracture, f) neoplastic disease, g) unsuccessful previous fusion surgery, h )lordotic deformities of the spine, i) thoracolumbar or lumbar scoliosis, j) deformity (i.e., scoliosis, kyphosis, and/or lordosis) associated with deficient posterior elements such as that resulting from laminectomy.
The CAYMAN LP Plate System is intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts or autografts. The device is not intended for load bearing indications.

The previously cleared devices consist of a variety of plate and screw systems designed to provide support across implanted levels in the cervical, thoracolumbar, and lumbosacral spine until fusion is achieved. The primary purpose of this submission is to update previously cleared MR safety information, establish an MR Conditional labeling claim, update cleaning, disinfection and sterilization instructions.

This appears to be a 510(k) summary for various spinal plate and screw systems. The document focuses on establishing substantial equivalence to predicate devices, primarily through updating MRI safety information, cleaning/disinfection/sterilization instructions, and labeling.

Unfortunately, this document does not contain the information requested about acceptance criteria and study results for an AI/software-based medical device. The listed devices are physical implants, and the "performance data" section refers to MR compatibility testing, not the performance of an AI algorithm in classification or detection tasks.

Therefore, I cannot extract the following information from the provided text:

• A table of acceptance criteria and the reported device performance (for an AI/software device)
• Sample size used for the test set and the data provenance
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts
• Adjudication method for the test set
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
• The type of ground truth used
• The sample size for the training set
• How the ground truth for the training set was established

The document primarily addresses the safety and efficacy of physical spinal implants based on their design, materials, and established predicate devices, and MRI compatibility. It is not about an AI-powered diagnostic or therapeutic device.

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Vitoss® BA2X Bioactive Bone Graft Substitute, Vitoss BBTrauma® Bioactive Bone Graft Substitute, Vitoss® BiModal Bioactive Bone Graft Substitute, Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip
These implants are intended for use as bone void fillers for voids or gaps that are not intrinsic to the stability of the bony structure.
They are indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to the bone.
The implants are intended to be used for filling bony voids or gaps of the skeletal system (i.e., the extremities, pelvis and posterolateral spine) and may be combined with saline, autogenous blood, and/or bone marrow. Following placement in the bony void or gap, the scaffold resorbs and is replaced with bone during the healing process.

Vitoss® Bioactive Bone Graft Substitute, Vitoss® Bioactive Bone Graft Substitute Pack Vitoss® Bioactive Foam Bone Graft Substitute is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. Vitoss® Bioactive Foam is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to the bone. Vitoss® Bioactive Foam Bone Graft Substitute is intended to be used for filling bony voids or gaps of the skeletal system (i.e., the extremities, pelvis, and spine, which includes posterolateral fusion procedures) and may be combined with saline, autogenous blood, and/or bone marrow. Following placement in the bony void or gap, the scaffold resorbs and is replaced with bone during the healing process.

Vitoss® Bone Graft Substitute, Vitoss® Bone Graft Substitute - Synthetic Cancellous Chips, Vitoss® Foam Bone Graft Substitute. Vitoss® Bone Graft Substitute Filled Canister These implants are intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure.

These implants are indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to the bone. These implants should not be used to treat large defects that in the surgeon's opinion would fail to heal spontaneously.

These implants are intended to be used for filling bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis) and may be combined with autogenous blood and/or bone marrow. Following placement in the bony void or gap, the scaffold resorbs and is replaced with bone during the healing process.

The Vitoss® Foam family of products may be mixed with saline in addition to autogenous blood or bone marrow.

The Vitoss® Filled Canister is intended for use as a piston syringe system for the aspiration of autogenous blood and/or bone marrow. This canister provides the surgeon with a convenient way to mix autogenous blood with Vitos® and deliver the material to the orthopaedic surgical site.

Vitoss® Bone Graft Substitutes are intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure in the skeletal system. Following placement in the bony void or gap, the scaffold resorbs and is replaced with bone during the healing process.

This document is a 510(k) Premarket Notification from the FDA regarding Stryker's Vitoss® bone graft substitutes. It is a clearance letter, not a study report. Therefore, it does not contain the detailed information required to describe acceptance criteria and a study proving device performance in the context of an AI/ML medical device.

The information provided describes the regulatory classification, indications for use, and a summary of technological characteristics and performance data for various Vitoss® bone graft substitute products. These are materials intended to fill bone voids, not AI/ML-driven diagnostic or therapeutic devices. The only "performance data" mentioned is an analysis of device materials for MRI safety, confirming they meet the definition of "MR Safe."

Therefore, I cannot extract the requested information regarding:

• Acceptance Criteria and Device Performance Table: No such table or performance metrics are provided for an AI/ML device.
• Sample size for test set and data provenance: Not applicable.
• Number of experts and qualifications for ground truth: Not applicable.
• Adjudication method: Not applicable.
• MRMC comparative effectiveness study: Not applicable.
• Standalone algorithm performance: Not applicable.
• Type of ground truth: Not applicable.
• Sample size for training set: Not applicable.
• How ground truth for training set was established: Not applicable.

The document assesses substantial equivalence to predicate devices, which is a regulatory pathway for non-AI/ML devices, focusing on material properties and intended use rather than algorithmic performance.

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The XIA® 4.5 Spinal System is interior/anteriolateral and posterior, non-cervical pedicle and non-pedicle fixation for the following indications: • Degenerative Disc Disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies) - · Spondylolisthesis - · Trauma (i.e. fracture of dislocation) - · Spinal Stenosis - · Curvatures (i.e. scoliosis, kyphosis, and/or lordosis) - Tumor - Pseudarthrosis - · Failed Previous Fusion The Stryker Spine DIAPASON® Spinal System, Opus® Spinal System, and XIA® 4.5 Spinal System can be linked to the XIA® 4.5 Spinal System via the rod-to-rod connector when used for the aforementioned indications in skeletally mature patients as an adjunct to fusion. Except for the staples, when used for posterior non-cervical pedicle screw fixation in pediatric patients, the XIA® 4.5 Spinal System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the XIA® 4.5 Spinal System is intended to treat petients diagnosed with: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. This system is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The subject devices consist of a variety of multiple component spinal fixation systems intended for use as an adjunct to fusion. These devices have been previously cleared by FDA. The primary purpose of this submission is to establish an MR Conditional labeling claim for these implants.

The Stryker Spine Sierra Mertz family of spinal implant systems (referred to as "the subject devices" in the document) is seeking an MR Conditional labeling claim.

Here's an analysis of the acceptance criteria and study proving device conformance, 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

• Sample Size: Not explicitly stated in the provided text. The document refers to "the subject devices" which is a family of 20 different spinal systems. It's implied that various components within these systems were subjected to testing.
• Data Provenance: The document does not specify the country of origin of the data. The study was a prospective test conducted to establish MR Conditional labeling for the devices.

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

This is not applicable as the study involved physical testing for MR compatibility according to a standard (ASTM F2503), not human expert evaluation of medical images or data.

4. Adjudication Method for the Test Set

This is not applicable for this type of physical device testing. The results are based on adherence to the parameters set by the ASTM F2503 standard.

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 is not applicable. The submission is for spinal implants and their MR compatibility, not an AI-powered diagnostic or assistive tool for human readers.

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 spinal implant system, not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the test was compliance with the ASTM F2503 standard for MR compatibility. This standard defines specific parameters and limits for evaluating the safety and performance of medical devices in an MRI environment, such as magnetic field interactions, RF-induced heating, and image artifact.

8. The Sample Size for the Training Set

This is not applicable. This is a medical device clearance for physical implants, not a machine learning or AI model that requires a training set.

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

This is not applicable. As stated in point 8, there is no training set for this type of device submission.

Summary of the Study Proving Device Meets Acceptance Criteria:

The study performed was a MR Compatibility testing per ASTM F2503. The FDA document states: "The test results demonstrate that the subject devices performance met the prescribed acceptance criteria and are substantially equivalent to the predicate devices." This indicates that the physical and electrical properties of the spinal implant systems, when subjected to MRI conditions outlined in the ASTM F2503 standard, did not pose unacceptable risks (e.g., excessive heating, dangerous magnetic force, or significant image artifacts) and thus were deemed MR Conditional. The purpose of this testing was to establish the MR Conditional labeling claim for the devices.

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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.

Ask a specific question about this device

Navigated Everest Instruments
The Navigated Everest Screw Inserters and Taps are intended to be used as accessories to the Stryker Spine Navigation System. They are manual surgical instruments used to facilitate placement of Stryker Spine implants.
The Navigated Everest Screw Inserters and Taps may be used as part of the Stryker Spine Navigation System, which is indicated for any medical condition in which the use of computer assisted planning and surgery may be appropriate. The System can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified.
The Navigated Everest Screw Inserters and Taps are intended for use with Rotational Navigation Adapter and associated trackers to facilitate the placement of screws of the Stryker Spine Everest Spinal Fixation System using the Stryker Spine Navigation System.

Navigated Mesa Instruments
The Navigated Mesa Screw Inserters and Taps are intended to be used as accessories to the Stryker Spine Navigation System. They are manual surgical instruments used to facilitate placement of Stryker Spine implants.
The Navigated Mesa Screw Inserters and Taps may be used as part of the Stryker Spine Navigation System, which is indicated for any medical condition in which the use of computer assisted planning and surgery may be appropriate. The System can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified.
The Navigated Mesa Screw Inserters and Taps are intended for use with Rotational Navigation Adapter and associated trackers to facilitate the placement of screws of the Stryker Spine Mesa Spinal Fixation System using the Stryker Spine Navigation System.

Navigated Yukon Instruments
The Navigated Yukon Screw Inserters and Taps are intended to be used as accessories to the Stryker Spine Navigation System. They are manual surgical instruments used to facilitate placement of Stryker Spine implants.
The Navigated Yukon Screw Inserters and Taps may be used as part of the Stryker Spine Navigation System, which is indicated for any medical condition in which the use of computer assisted planning and surgery may be appropriate. The System can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified.
The Navigated Yukon Screw Inserters and Taps are intended for use with Rotational Navigation Adapter and associated trackers to facilitate the placement of screws of the Stryker Spine Yukon Spinal Fixation System using the Stryker Spine Navigation System.

Navigated Xia 4.5- Xia CT Taps
The Navigated Xia 4.5- Xia CT Taps are intended to be used as accessories to the Stryker Spine Navigation System. They are manual surgical instruments used to facilitate placement of Stryker Spine implants.
The Navigated Xia 4.5- Xia CT Taps may be used as part of the Stryker Spine Navigation System, which is indicated for any medical condition in which the use of computer assisted planning and surgery may be appropriate. The System can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified.
The Navigated Xia 4.5- Xia CT Taps are intended for use with Rotational Navigation Adapter and associated trackers to facilitate the placement of screws of the Stryker Spine Xia 4.5- Xia CT Spinal Fixation System using the Stryker Spine Navigation System.

Navigated Xia 3- Serrato Deformity Screwdriver
The Navigated Xia 3- Serrato Deformity Screwdriver is intended to be used as an accessory to the Stryker Spine Navigation System. They are manual surgical instruments used to facilitate placement of Stryker Spine implants.
The Navigated Xia 3-Serrato Deformity Screwdriver may be used as part of the Stryker Spine Navigation System, which is indicated for any medical condition in which the use of computer assisted planning and surgery may be appropriate. The System can be used for intraoperative guidance where a regid anatomical structure can be identified.
The Navigated Xia 3- Serrato Deformity Screwdriver is intended for use with Rotational Navigation Adapter and associated trackers to facilitate the placement of the Stryker Spine XIA® 3 and ES2® Spinal Fixation Systems using the Stryker Spine Navigation System.

Navigated Spine Instruments are nonsterile, reusable surgical instruments (screw inserters and taps) intended to be used when implanting previously cleared components of Mesa, Everest, Yukon, Xia 3, Xia 4.5, and ES2. These instruments are intended to be used with the Stryker Spine Navigation System.

The provided text describes the regulatory clearance for "Navigated Spine Instruments" by Stryker Spine but does not contain the detailed acceptance criteria or the specific study that proves the device meets those criteria.

The "Summary of the Performance Data" section generically states: "Performance testing was conducted to ensure that the Navigated Spine Instruments are acceptable for their intended use, to ensure functionality and compatibility with the Stryker Spine Navigation System using the Rotational Navigation Adapter and associated trackers, and to demonstrate substantial equivalence to the predicate device. The performance of Navigated Spine Instruments has met all acceptance criteria."

This statement confirms that performance testing was done and acceptance criteria were met, but it does not provide the specifics of:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and their qualifications
4. Adjudication method for the test set
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, or its effect size
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

Therefore, based solely on the provided text, I cannot complete the request. The document describes the device, its intended use, and its equivalence to predicate devices, but it does not delve into the specifics of the performance study's methodology or detailed results.

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The XIA® Spinal System is intended for anterior/anteriolateral and posterior, non-cervical pedicle and non-pedicle fixation in skeletally mature patients as an adjunct to fusion for the following indications: Degenerative Disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; curvature (i.e. scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

The XIA® 3, RADIUS® Spinal Systems are intended for use in the non-cervical spine. When used as an anterior/ anteriolateral and posterior, non-cervical pedicle and non-pedicle fixation system, the XIA® II, XIA® 3, and RADIUS® Spinal Systems are intended to provide additional support during fusion using autograft or allograft in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radies); spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis,kyphosis); tumor; pseudoarthrosis; and failed previous fusion.

The XIA® 4.5 Spinal System is intended for anterolateral and posterior, non-cervical pedicle and non-pedicle fixation for the following indications: degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies); spondylolisthesis; trauma (i.e. fracture of dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor; pseudarthrosis; failed previous fusion.

The Stryker Spine DIAPASON® Spinal System, OPUS® Spinal System, and XIA® 4.5 Spinal System can be linked to the XIA® 4.5 Spinal System via the rod-to-rod connector when used for the aforementioned indications in skeletally mature patients as an adjunct to fusion.

When used for posterior, non-cervical, pedicle screw fixation in pediatric patients, the Xia® 3 Spinal System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the Xia® 3 Spinal System is intended to treat pediatric patients diagnosed with: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. This system is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

Except for the staples, when used for posterior non-cervical pedicle screw fixation in pediatric patients, the XIA® 4.5 Spinal System implants are indicated as an adjunct to treat progressive spinal deformities (i.e. scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenttal scoliosis. Additionally, the XIA® 4.5 Spinal System is intended to treat pediatric patients diagnosed with: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. This system is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The MANTIS® Spinal System, MANTIS® Redux Spinal System, and ES2® Spinal System is intended for percutaneous, posterior, non-cervical pedicle and non-pedicle fixation of the spine to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radies); spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

The intended use for the Xia 3 Power Adaptor is to facilitate the placement of pedicle screws using the power technique (corded and cordless), the use of the Xia 3 Power Adaptor is intended for exclusive use with the Stryker Cordless and Corded Power Drivers. When the power adaptors are attached, the Stryker Power Drivers (corded and cordless) provide power to rotate screwdrivers for the insertion of pedicle screws.

Pedicle screws from select Stryker Spine implant systems may be implanted in the non-cervical spine using powered (corded and cordless) instrumentation. The systems included are the family of XIA® Spinal Systems (XIA® Stainless Steel, XIA® II, XIA® Anterior, and XIA® Precision), XIA® 3 Spinal System, XIA® 4.5 Spinal System, Radius® Spinal System, MANTIS® Spinal System, MANTIS® Redux Spinal System, and the ES2® Spinal System.

This special 510(k) premarket notification is to expand the intended use of the Xia 3 Power Adaptor.

The Xia 3 Power Adaptor instrument accessory is intended to facilitate the insertion of pedicle screws using powered instrumentation. To facilitate the insertion of pedicle screws using the power technique, the use of the Xia 3 Power Adaptor is intended for use with Stryker power system drivers (corded and cordless). The adaptor serves as a mechanical interface between the power driver and screwdriver instrument. When the adaptor is attached, the driver (corded and cordless) provides appropriate power to rotate screw drivers for the insertion of pedicle screws. No changes have been made to the indications for use of the associated thoracolumbar spinal implant systems XIA® Spinal Systems (XIA® Stainless Steel, XIA® II, XIA® Anterior, and XIA® Precision), XIA® 3 Spinal System, XIA® 4.5 Spinal System, Radius® Spinal System, MANTIS® Spinal System, MANTIS® Redux Spinal System, and the ES2® Spinal System. The indications for use of each spinal system remain consistent with their most recent 510(k) clearance.

The provided text does not contain any information about acceptance criteria or a study proving that the "Xia 3 Power Adaptor" meets acceptance criteria.

The document is an FDA 510(k) clearance letter for the Stryker Xia 3 Power Adaptor. It outlines the device's indications for use, its classification, and declares its substantial equivalence to previously cleared predicate devices.

Specifically, it states:

• "No changes have been made to the indications for use of the associated thoracolumbar spinal implant systems..."
• "The Xia 3 Power Adaptor Instrument has demonstrated substantial equivalence to the predicate device. Engineering analysis demonstrated connection of the Xia 3 Power Adaptor to various Stryker Power Drivers does not represent a new worse case or affect the performance of the Xia 3 Power Adaptor."

This indicates that the clearance was based on an engineering analysis and comparison to a predicate device, rather than a clinical study with acceptance criteria of the type commonly associated with AI/ML devices or new medical technologies requiring performance validation studies.

Therefore, I cannot provide the requested information from the given text. The text does not discuss:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for test sets or data provenance.
3. Number of experts or their qualifications for ground truth.
4. Adjudication methods.
5. MRMC comparative effectiveness studies.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for training set.
9. How ground truth for the training set was established.

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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 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.

The purpose of this submission is to introduce an expandable posterior lumbar cage intended for use as an aid in lumbar spinal fixation.

The expandable Tritanium® X PL Expandable Posterior Lumbar Cage and the Tritanium® X TL Expandable Curved Posterior Lumbar Cage (also referred to as Tritanium X Cages) are Intervertebral Body Fusion Cages intended for use as an aid in lumbar spinal fixation. The TL cages are crescent shaped, and the PL cages are straight shaped.

These cages consist of a unique configuration of both solid and porous structures that are simultaneously built using Laser Rapid Manufacturing (LRM) method applying Stryker's proprietary Tritanium® In-Growth Technology. The cage is offered in a variety of lengths, heights, widths and lordotic angles to adapt to a variety of patient anatomies. It has serrations on the superior and inferior surfaces designed for multidirectional fixation and to maximize surface area for endplate contact with the implant. The implants have a smooth, tapered leading edge to facilitate cage insertion into the intervertebral space. The implants have graft windows spanning endplate to endplate for graft containment and to aid in fusion throughout the interbody cage.

The implant is designed to be used with supplemental fixation cleared for use in the lumbosacral spine.

The Tritanium X cages are constructed from Titanium alloy: Ti-6Al-4V (ASTM F1472-08), Stainless Steel: 316 LVM (ASTM F138-08), and Silicone Rubber, and are provided sterile.

The provided text describes a 510(k) premarket notification for a medical device, the Tritanium® X PL Expandable Posterior Lumbar Cage and Tritanium® X TL Expandable Curved Posterior Lumbar Cage. This document is a regulatory submission to the FDA, not a study report detailing acceptance criteria and performance data for an AI-medical device.

The "Summary of the Performance Data" section does mention various mechanical tests performed on the device to demonstrate substantial equivalence to identified predicate devices, and compliance with FDA guidance documents and ASTM standards. However, these are physical and mechanical performance tests for an implantable device, not acceptance criteria or study results for an AI-powered medical device.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves an AI-powered device meets the acceptance criteria based on the provided text. The document is about an intervertebral body fusion device and its mechanical testing, not an AI device.

To answer your question directly based on the provided text:

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

• Cannot be provided for an AI device. The document discusses the mechanical performance of an intervertebral body fusion device against standards like ASTM F2077, F2267-04, F1147-05, F1044-05, F1160-05, E8/E8M, and F2129-15, and compliance with various FDA guidance documents for orthopedic implants. These are physical performance metrics, not AI performance metrics.

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

• Cannot be provided for an AI device. The document does not mention test set sample sizes or data provenance relevant to an AI model's performance (e.g., number of images, patient demographics, retrospective/prospective). It refers to the number of test articles used for mechanical testing of the physical implant.

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

• Not applicable for an AI device in this document. The ground truth discussed (implicitly) in the document is the physical and mechanical properties of the device as measured by standardized tests, not expert-labeled data for an AI model.

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

• Not applicable for an AI device in this document.

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 study was mentioned as this is not an AI device.

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

• Not applicable; this is not an AI device.

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

• Not applicable for an AI device. The "ground truth" for this medical device's performance involved adherence to established ASTM standards and FDA guidance documents for mechanical and material properties (e.g., strength, corrosion resistance, wear debris).

8. The sample size for the training set

• Not applicable; this is not an AI device.

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

• Not applicable; this is not an AI device.

In summary, the provided document is a 510(k) summary for a physical orthopedic implant (intervertebral body fusion cage), not an AI-powered medical device. Therefore, the information requested about AI device acceptance criteria and study data cannot be extracted from this text.

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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 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 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® 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 Tritanium® PL Intervertebral Body Fusion Cage is intended for use as an aid in lumbar spinal fixation. The cage is a hollow, rectangular implant that consists of a unique configuration of both solid and porous structures that are simultaneously built using Laser Rapid Manufacturing (LRM) method applying Stryker's proprietary Tritanium® In-Growth Technology. The cage is offered in a variety of footprints to adapt to a variety of patient anatomies. It has serrations on the superior and inferior porous surfaces of the implant for fixation, an ergonomically shaped anterior edge, and a flat posterior edge. The implant is designed to be used with supplemental fixation cleared for use in the lumbosacral spine.

The Tritanium® PL Cages are constructed from Titanium alloy: Ti-6Al-4V (ASTM F1472-08) and are provided sterile.

The provided text describes a 510(k) premarket notification for a medical device, the Tritanium® PL Cage. It outlines the device's indications for use, its characteristics, and references performance data to demonstrate substantial equivalence to a predicate device. However, this document does not describe acceptance criteria for a study proving device meets acceptance criteria, nor does it detail a clinical study with human readers or specific statistical performance metrics often associated with AI/software devices.

This document specifically focuses on a physical implant (intervertebral body fusion device) and its mechanical performance testing. The "Summary of Performance Data" refers to engineering analyses and mechanical tests, not clinical studies or AI algorithm performance.

Therefore, many of the requested fields cannot be filled from the provided text as they relate to AI/software performance evaluations.

Here's an attempt to answer based only on the information provided, highlighting what is not available:

Acceptance Criteria and Device Performance

The document states that "Verification and validation activities demonstrated that all relevant acceptance criteria were met." However, it does not explicitly list the acceptance criteria themselves, nor does it provide specific numerical results of the device's performance against those criteria. Instead, it refers to multiple mechanical tests according to ASTM standards, implying that meeting the standards' requirements was the acceptance criteria.

Study Details (as inferable from the document)

1. Sample size used for the test set and the data provenance: This refers to the mechanical tests conducted. The document does not specify the number of samples (e.g., number of implants or test specimens) used for each mechanical test. Data provenance (country of origin, retrospective/prospective) is not applicable or stated for these engineering analyses and mechanical tests.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" for these mechanical tests would be the physical properties and performance metrics measured according to the ASTM standards, not expert clinical interpretations.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This relates to clinical studies with expert reviewers, not mechanical testing.

4. 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 for an AI/imaging device, not a physical implant.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is for an AI/software device, not a physical implant.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the mechanical tests, the "ground truth" is typically defined by the precise measurement outcomes of the physical tests according to established scientific and engineering principles and standards (e.g., maximum load at failure, displacement under load, wear rates).

7. The sample size for the training set: Not applicable. This is for an AI/software device. The "Engineering Analysis" mentions two FEAs (Finite Element Analyses), which are computational simulations, but there is no "training set" in the context of device performance in this document.

8. How the ground truth for the training set was established: Not applicable. This is for an AI/software device.

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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 Tritanium® 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® C Anterior Cervical Cage is a hollow, ring shaped titanium alloy (Ti-6Al-4V) interbody fusion cage intended for use in the cervical spine. The cage consists of an open window for bone graft containment and has serrations on the superior and inferior surfaces of the cage for fixation. The cage is offered in a variety of footprints, heights, and lordotic angles to adapt to varying patient anatomies. The Tritanium® C Anterior Cervical Cage consists of a unique configuration of both solid and porous structures that are simultaneously built using Laser Rapid Manufacturing (LRM) method applying Stryker's proprietary Tritanium® In-Growth Technology. The Tritanium® C Anterior Cervical Cage is provided sterile.

This document is a 510(k) summary for the Stryker Spine Tritanium® C Anterior Cervical Cage, an intervertebral body fusion device. It details the device's characteristics, intended use, and the non-clinical testing performed to establish substantial equivalence to predicate devices.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

• Static Compression (per ASTM F2077)
• Dynamic Compression (per ASTM F2077)
• Static Compression Shear (per ASTM F2077)
• Dynamic Compression Shear (per ASTM F2077)
• Static Torsion (per ASTM F2077)
• Dynamic Torsion (per ASTM F2077)
• Expulsion (per ASTM F04-25-02-02 Draft)
• Subsidence (per ASTM F2267)
• Wear Debris Assessment
• Impaction |
  | Material Properties | FDA guidance documents:
• "Guidance Document for testing orthopedic implants with modified metallic surfaces apposing bone or bone cement [April 28, 1994]"
• "Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses [January 16, 2003]"
• Draft guidance for "Technical considerations for Additive Manufactured Devices [May 10, 2016]"
  ASTM Standard:
• ASTM 1472-08: Standard Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy (UNS R56400) for Surgical Implant Applications | "established that the porous surface design of the cage meets at minimum the requirements outlined in the [referenced FDA guidance documents and ASTM standard]." |
  | Material Mechanical Properties | ASTM standards:
• ASTM F1147-05: Standard Test Method for Tension Testing of Calcium Phosphate and Metallic Coatings
• ASTM F1044-05: Standard Test Method for Shear Testing of Calcium Phosphate and Metallic Coatings
• ASTM F1160-05: Standard Test Method for Shear and Bending Fatigue Testing of Calcium Phosphate and Metallic Medical and Composite Calcium Phosphate/Metallic Coating
• ASTM E8/E8M: Standard Test Methods for Tension Testing of Metallic Materials | Characterization of the Mechanical Properties of the Tritanium® C Anterior Cervical Cage material was performed in accordance with these standards. The conclusion states "results of the mechanical testing... demonstrated substantial equivalence." |
  | Corrosion Susceptibility | ASTM F2129-15: Standard test method for conducting cyclic potentiodynamic polarization measurements to determine the corrosion susceptibility of small implant devices. | "Electromechanical performance evaluation of additive manufactured Ti-6Al-4V alloy was also performed per ASTM F2129-15." The overall conclusion implies satisfactory performance. |
  | Pyrogenicity | ANSI/AAMI ST72:2011: For bacterial endotoxin testing (BET) to achieve an endotoxin limit of

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