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The JAZZ Spinal System is intended for posterior, non - cervical fixation as an adjunct to fusion for skeletally mature patients 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 and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion. In addition, when used as a pedicle screw fixation system, the JAZZ Spinal System is intended for skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral, L5-S1 vertebra, who are receiving fusion by autogenous bone graft only, who are having the device attached to the lumbar and sacral spine (levels may be from L3 to the sacrum/ilium), who are having the device removed after the attainment of a solid fusion.

The JAZZ Spinal System consists of a variety of shapes and sizes of screws and rods that can be rigidly locked in a variety of configurations, with each construct being tailor-made for the individual case. Fixation is provided via a posterior approach. The components are made from titanium alloy, unalloyed titanium, or cobalt chrome alloy. Implant components of the system include straight and pre-bent rods, monoaxial and polyaxial screws, reduction screws, domino connectors, crosslinks, dual headed screws and connectors, transverse and sagittal uniplanar screws, favored angle screws, modular screws, iliac screws, along with associated set screws.

The provided FDA 510(k) clearance letter for the JAZZ Spinal System does not describe a study related to AI/algorithm performance for a diagnostic or imaging device. Instead, it details a clearance for a medical implant device (Thoracolumbosacral Pedicle Screw System).

Therefore, I cannot extract the information requested about acceptance criteria, study design, ground truth establishment, or human-in-the-loop performance related to an AI/algorithm. The document focuses on the mechanical performance and material safety of the spinal implant.

Specifically:

• Acceptance Criteria & Reported Performance (Table): Not applicable for an AI/algorithm study based on this document. The document mentions "Performance testing" for the spinal implant, including "static compression bending, static torsion, and dynamic compression bending per ASTM F1717-21, as well as static neutral angle dissociation and static maximum angle dissociation per ASTM F1798-13." However, these are mechanical tests for the implant itself, not metrics for an AI's diagnostic performance.
• Sample size and data provenance, number of experts, adjudication, MRMC study, standalone performance, type of ground truth, training set size and ground truth: None of this information is present in the document because it pertains to the validation of a software algorithm or AI, not a spinal implant. The "ground truth" for a spinal implant would be its material properties and mechanical integrity, tested in a lab setting, not clinical annotation by experts.

In summary, the provided document is irrelevant to the prompt's request for details on an AI/algorithm performance study.

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ANAX™ OCT 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 the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine from T1-T3: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); 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. ANAX™ 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, ANAX™ OCT Spinal System may be connected to Perfix™ Spinal System and ANAX™ 5.5 Spinal System rods with the rod connectors. Transition rods with differing diameters may also be used to connect ANAX™ OCT Spinal System to Perfix™ Spinal System and ANAX™ 5.5 Spinal System.

The ANAX™ OCT Spinal System is for fixation the cervicocranium (Occiput/C2), the true subaxial region (C3/C6), and the cervicothoracic junction (C7 to T2) by one system. The ANAX™ OCT Spinal System consists of polyaxial screws, polyaxial shank screws, hooks, rods, set screws, transverse (cross) links and occipital plate. Connectors are also provided for surgical convenience. The ANAX™ OCT Spinal System allows surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The single-use ANAX™ OCT Spinal System components are supplied as non-sterile and are fabricated from medical grade titanium alloy (ASTM F136) and medical grade cobalt-chromium-molybdenum alloy (ASTM F1537). All polyaxial screws have self-tapping functions in the ANAX™ OCT Spinal System.

Specialized instruments made from surgical instrument grade stainless steel are available for the application and removal of the ANAX™ OCT Spinal System implants.

The provided FDA 510(k) Clearance Letter for the ANAX™ OCT Spinal System does not describe acceptance criteria or a study that proves the device meets specific acceptance criteria based on performance metrics such as sensitivity, specificity, or accuracy.

Instead, this document focuses on demonstrating substantial equivalence to predicate devices. This is a common pathway for medical device clearance, where the new device is shown to be as safe and effective as a legally marketed device that does not require Pre-Market Approval (PMA).

Here's an analysis based on the information provided, highlighting why certain questions cannot be answered from this document:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The "acceptance criteria" here are implicitly related to demonstrating that the new CoCr rods perform at least as well as, or better than, the existing titanium rods in terms of mechanical properties and do not alter the overall system's safety or intended function. The FDA's acceptance of the 510(k) implies that these criteria were met.

Regarding the specific study details for AI/software-based devices, the following cannot be answered from this document because the ANAX™ OCT Spinal System is a physical implantable medical device, not an AI or software device.

2. Sample size used for the test set and the data provenance: Not applicable. The "test set" here refers to physical components tested.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for physical components is typically derived from engineering specifications and material science, not expert consensus in the diagnostic sense.
4. Adjudication method for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For a physical device, "ground truth" relates to material properties (e.g., tensile strength, yield strength), dimensional accuracy, and mechanical performance under simulated physiological loads, established by engineering standards (e.g., ASTM F136, F1537, F1717, F1798).
8. The sample size for the training set: Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable.

Summary of Relevant Information from the Document:

• Device Type: Physical implantable spinal fixation system (ANAX™ OCT Spinal System).
• Modification: Addition of cobalt-chromium-molybdenum (CoCr) rods.
• Mechanism of Proof: Substantial equivalence to predicate devices.
• Key Evidence for Substantial Equivalence:
  • Indications for Use: Identical to predicate devices.
  • Design & Components: Equivalent overall construct, dimensions, and components, with the only change being rod material.
  • Material Properties: CoCr rods demonstrate higher tensile and yield strength than the previously cleared titanium (Ti) rods.
  • Manufacturing: CoCr rods are manufactured and processed using the same methods and surface treatments as the Ti rods.
  • Performance Testing: Comprehensive mechanical testing (e.g., ASTM F1717, F1798) was conducted, including a worst-case configuration.
  • Failure Analysis: All observed failure modes occurred at the screw-housing interface, not within the rod itself, suggesting the rods are sufficiently strong.
• Conclusion of Study: The mechanical integrity of the CoCr rods was confirmed, and the comparative material analysis showed comparable or superior performance, leading to the conclusion that the addition of CoCr rods does not raise new questions of safety or effectiveness.

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The VCFix Spinal System is indicated for use in the reduction of vertebral compression fractures that may result from osteoporosis or trauma (fracture types A according to Magerl/AO Spine classification) with or without posterior instrumental fixation, and compression fractures that result from malignant lesions (myeloma or osteolytic metastasis). The VCFix Spinal System is intended to be used in combination with Teknimed F20 bone cement, and to be placed, using a transpedicular approach, in a fractured vertebra from level T9 to L5.

The VCFix Spinal System is a cannulated screw-shaped implant with an expandable plate structure and is available in multiple sizes to accommodate varying patient anatomy. A pair of implants are inserted into the pedicles and manipulated with the toolset, resulting in the expansion of the device to restore the vertebral height. The implant is made of titanium alloy (Ti6Al4V ELI). During the procedure, the surgeon inserts the implants bilaterally through each pedicle of the fractured vertebra and adjusts the height and angle of the device (to correct local kyphosis) based on the unique vertebral fracture of the patient.
The VCFix Spinal System includes sterile, single-use implantation kits and a preparation kit. The kits include a pair of implants and all tools necessary for preparing the implant site and vertebral body expansion. The positioning and expansion of the implant must imperatively be followed by the injection of Teknimed F20 bone cement (K103433) to fixate the restored vertebral body. The bone cement and its delivery system are sold separately.

The provided text is a 510(k) clearance letter and summary for a medical device (VCFix Spinal System). It focuses on demonstrating substantial equivalence to predicate devices based on indications for use, technological characteristics, and performance testing.

Crucially, this document describes performance testing for a medical implant (a physical device), not an AI/ML medical device. The questions you've asked are specific to AI/ML device studies, particularly concerning acceptance criteria based on metrics like sensitivity, specificity, or F1 score, and elements like ground truth establishment and expert adjudication.

Because the VCFix Spinal System is a physical implant and not an AI/ML device, the detailed information requested about AI/ML specific study design (e.g., sample size for test set/training set, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth for AI) is not applicable and therefore not present in this document.

The "Performance Testing Summary" section describes the mechanical and functional testing conducted for the implant. These tests are designed to ensure the physical device meets its engineering specifications and safety requirements, not to evaluate the diagnostic or predictive performance of an AI algorithm.

Here's a breakdown of the relevant information provided and an explanation of why other requested information is absent:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a physical implant, "acceptance criteria" here refers to engineering specifications and mechanical performance standards, not statistical performance metrics for an AI algorithm. The document states that "All necessary testing has been performed for the worst-case configuration of the VCFix Spinal System to assure substantial equivalence to its predicates and to demonstrate the subject devices perform as intended."

Information Not Applicable / Not Available for this Type of Device (Physical Implant):

The following points are specific to AI/ML device studies and are not found in this document because the VCFix Spinal System is a physical implant, not an AI/ML software device.

2. Sample size used for the test set and the data provenance: Not applicable. Performance testing for implants involves physical specimens or in-vitro/in-vivo models, not image or clinical text data sets.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for AI/ML typically refers to expert labels on data. For an implant, "ground truth" relates to objective measurements from mechanical tests or clinical outcomes from trials (which are not detailed here beyond safety and equivalence).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This refers to how expert disagreements are resolved for data labeling in AI/ML studies.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. MRMC studies are for evaluating AI's impact on human diagnostic performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This refers to the performance of an AI algorithm on its own.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the AI/ML sense. The "ground truth" for this device's performance would be the objective results of the specified mechanical and biological tests, demonstrating it meets engineering specifications and safety requirements.
8. The sample size for the training set: Not applicable. This device is not an AI/ML model that undergoes "training."
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided FDA 510(k) pertains to a physical medical device (spinal implant) and its clearances are based on comprehensive engineering, mechanical, and biological testing, demonstrating substantial equivalence to existing predicate devices. Therefore, the specific details and study design elements common to AI/ML medical device evaluations are not present in this documentation.

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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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The CD Horizon™ Spinal System with or without Sextant™ instrumentation is intended for posterior, non-cervical fixation 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, curvatures (i.e. scoliosis, kyphosis, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion.
Except for hooks, when used as an anterolateral thoracic/lumbar system, CD Horizon™ Spinal System titanium, cobalt chrome, and stainless steel implants may also be used for the same indications as an adjunct to fusion.
With the exception of DDD, CD Horizon™ Legacy™ 3.5mm rods and associated components may be used for the aforementioned indications in skeletally mature patients as an adjunct to fusion. The 3.5mm rods may be used for the specific pediatric indications noted below.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, CD Horizon™ Spinal System titanium, cobalt chrome, and stainless steel 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 CD Horizon™ Spinal System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/ spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
The CD Horizon™ PEEK rods are intended to provide posterior supplemental fixation when used with an interbody fusion cage for patients diagnosed with DDD. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level. This device is intended for 1-2 level use in the lumbosacral spine (L2 – S1) in skeletally mature patients. The device is intended for use with an interbody fusion cage at the instrumented level and is not intended for stand-alone use.
The CD Horizon™ Spire™ plate is a posterior, single-level, non-pedicle supplemental fixation device intended for use in the non-cervical spine (T1-S1) as an adjunct to fusion in skeletally mature patients. It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fixation in the following conditions: DDD (as previously defined), spondylolisthesis, trauma, and/or tumor.
To achieve additional levels of fixation, CD HorizonTM Spinal System rods may be connected to the VertexTM Reconstruction System with the VertexTM rod connector. Refer to the VertexTM Reconstruction System package insert for a list of the VertexTM indications of use.

Not Found

This document describes a spinal system, not an AI/ML powered device. Therefore, the requested information pertaining to AI/ML device performance, such as acceptance criteria for AI models, human expert adjudication, MRMC studies, standalone algorithm performance, and training/test set details are not applicable.

The provided text focuses on the substantial equivalence of the Medtronic CD Horizon™ Spinal System to predicate devices, supported by mechanical testing and rationales.

Here's an analysis of the provided text based on the request's categories, indicating where information is present and where it is not applicable for this type of device:

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

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

• Sample Size: Not explicitly stated in this summary. Mechanical testing usually involves a specific number of samples per test type (e.g., 5-10 samples per group).
• Data Provenance: Not applicable in the context of "data provenance" for patient data, as this is a mechanical device. The testing was conducted by Medtronic to demonstrate substantial equivalence to existing predicate devices.

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

• Not Applicable: This is a mechanical device, not an AI/ML diagnostic or therapeutic device that relies on expert interpretation for ground truth. Ground truth for mechanical performance is established through standardized testing protocols (ASTM standards) and engineering principles.

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

• Not Applicable: Adjudication methods are relevant for subjective interpretations, typically in clinical studies or AI model evaluations. For mechanical testing, the results are quantitative and directly measured against engineering specifications.

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

• Not Applicable: This is a mechanical device. MRMC studies are specific to evaluating diagnostic accuracy of imaging systems, often in the context of human reader performance with or without AI assistance.

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

• Not Applicable: This is a mechanical device. "Standalone" performance refers to AI algorithm performance without human intervention.

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

• Engineering Specifications and Standardized Test Methods: The "ground truth" for this device's performance is established by the specified mechanical properties (e.g., strength, durability, fatigue resistance) defined by relevant ASTM (American Society for Testing and Materials) standards (F1717, F1798, F2503). Compliance with these standards indicates the device performs as intended for its mechanical application.

8. The sample size for the training set

• Not Applicable: "Training set" refers to data used to train AI/ML models. This is a mechanical device, not an AI model.

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

• Not Applicable: As no AI training set exists, no ground truth establishment for it is relevant.

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The GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal System is a pedicle screw fixation system intended for immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: · Degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies) - · Spondylolisthesis - · Trauma (e.g., fracture or dislocation) - · Deformity or curvature (e.g., scoliosis, kyphosis, and/or lordosis) - Tumor - · Spinal stenosis - · Pseudarthrosis - · Failed previous fusion Paediatric Use: When used for posterior non-cervical screw fixation in paediatric patients, the GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal System is indicated as an adjunct to treat adolescent idiopathic scoliosis. Additionally, it is intended to treat paediatric patients diagnosed with the following conditions: - · Spondylolisthesis - · Spondylolysis - Fracture caused by tumor and/or trauma. Paediatric pedicle screw fixation is limited to a posterior approach and is intended to be used with autograft and/or allograft.

The posterior non-cervical pedicle screw spinal system consists of a body, bushing, and ball head screw. Inner Screw, rods complete the spinal construct. The body portion of the screw rotates about the ball head on the screw, which provides increased motion over a fixed post of the polyaxial screw. An increase in motion facilitates the capture of rods that are not perfectly aligned. The Screws, Rods are fabricated from Titanium alloy. These implants are supplied non-sterile; the products have to be sterilized prior to use.

This document is a 510(k) Pre-market Notification for a medical device called the "GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal System." It is a submission to the FDA seeking clearance to market this device, demonstrating its substantial equivalence to already legally marketed predicate devices.

The document does not describe or conduct a clinical study with acceptance criteria related to a device's performance in diagnosing or treating patients using metrics like sensitivity, specificity, or accuracy.

Instead, this submission focuses on demonstrating substantial equivalence to existing predicate devices based on:

• Indications for Use: The intended medical conditions the device will treat.
• Material: The materials used in its construction.
• Mechanical Performance: How the device functions under various physical stresses.
• Dimensions: The physical size and shape of the device components.

The "acceptance criteria" discussed in this document refer to the performance standards that the device must meet to demonstrate its mechanical integrity and safety, not its clinical effectiveness in human subjects.

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

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

The document does not provide a table with specific quantitative acceptance criteria values (e.g., specific load limits, displacement thresholds) and reported device performance values for a clinical study. Instead, it refers to compliance with established ASTM standards for mechanical testing. For the purpose of this type of submission, compliance with these standards serves as the "acceptance criteria" for mechanical performance.

Note: "Demonstrated performance" in this context means the device met the requirements of these standards. The document does not provide the specific numerical results of these tests, only that the device "has been demonstrated using the following performance testing" and "complied to following material standard."

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

This information is not applicable as the submission relies on non-clinical mechanical testing of the device components, not on a clinical test set from human subjects. The "samples" would be the manufactured implant components themselves, and the testing is performed in a laboratory setting. There is no mention of data provenance in terms of country of origin or retrospective/prospective data collection for clinical outcomes.

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

This information is not applicable. Ground truth, in the context of clinical studies (e.g., for diagnostic accuracy), would typically be established by clinical experts. Since this submission focuses on mechanical and material equivalence, such experts are not involved in defining "ground truth" for the device's physical properties. The "ground truth" for mechanical properties is established by the ASTM standards themselves.

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

This information is not applicable. Adjudication methods are used in clinical studies, particularly for diagnostic imaging, to resolve discrepancies among expert readers. As this is a mechanical testing submission, no such adjudication method is used.

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

An MRMC comparative effectiveness study was not done. This type of study is relevant for AI or diagnostic devices involving human interpretation of results, which is not the subject of this 510(k) submission. Therefore, there is no effect size reported.

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

This information is not applicable. This is a physical medical implant (pedicle screw system), not an algorithm or a software device, so the concept of standalone algorithm performance does not apply.

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

The "ground truth" for this device's mechanical and material properties is established by compliance with the internationally recognized ASTM material and performance standards (ASTM F136, ASTM F1717, ASTM F1798). These standards define the acceptable physical and mechanical characteristics for such spinal implants.

8. The sample size for the training set

This information is not applicable. This is a physical medical implant, not a machine learning or AI device that requires a training set.

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

This information is not applicable for the same reason as point 8.

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IB3D™ PL Spinal System is indicated for use in lumbar spinal fusion procedures for patients diagnosed with Degenerative Disc Disease (DDD) at 1 or 2 contiguous levels from L2 to S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. When used for these indications, the IB3D™ PL Spinal System is intended for use with supplemental fixation systems cleared for use in the lumbar spine.

Additionally, the IB3D™ PL Spinal System can be used to provide anterior column support in patients diagnosed with degenerative scoliosis as an adjunct to pedicle screw fixation.

All patients should be skeletally mature and have had at least 6 months of nonoperative treatment. The IB3D™ PL Spinal System is intended to be used with autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone marrow aspirate when the subject device is used as an adjunct to fusion. These implants may be implanted via an open or a minimally invasive posterior or transforaminal approach. When implanting via posterior approach (PLIF), a minimum of two implants is required per spinal level.

The IB3D™ PL Spinal System implants are inter-somatic spacers manufactured by additive manufacturing (Direct Laser Metal Sintering) from Titanium alloy Ti-6Al-4V ELI powder, according to ASTM F3001 and ASTM F136.

The IB3D™ PL Spinal System implants are intended for insertion between two adjacent vertebrae by a posterior or a transforaminal approach on the lumbar spine only.

The subject IB3D™ PL Spinal System interbody devices are available in a variety of heights and lordosis angles for treatment of lumbar interbody fusion procedure. The implant is designed with a large hollow region in the center to house autograft or allograft bone comprised of cancellous and/or corticocancellous bone and/or demineralized allograft bone marrow aspirate. The design incorporates hexalock macro-rough surface on the superior and inferior surfaces of the device along with angular teeth to prevent expulsion from the interbody space.

This is a medical device submission, not an AI/ML device submission. Therefore, it does not contain information about acceptance criteria, test sets, ground truth, or training sets typical for AI/ML performance evaluation.

The provided document describes the IB3D™ PL Spinal System, an intervertebral body fusion device. The acceptance criteria and supporting studies for this type of device focus on mechanical performance, biocompatibility, and manufacturing quality, not diagnostic accuracy or AI algorithm performance.

Here's a breakdown of the relevant information from the document:

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

The document mentions several non-clinical tests performed to support substantial equivalence. These tests serve as the basis for demonstrating the device meets certain performance criteria. However, explicit "acceptance criteria" presented in a table format with corresponding "reported device performance" values are not detailed in this summary.

Non-clinical tests performed in support of substantial equivalence:

The summary states that these tests were performed on "worst-case constructs" of the IB3D™ PL Spinal System. The implication is that the device met the performance requirements of these standards, demonstrating substantial equivalence to its predicates.

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

For mechanical and material tests of this nature, "sample size" typically refers to the number of test articles (implants) subjected to testing. This information is not specified in the provided 510(k) summary. The document does not describe patient data (e.g., country of origin, retrospective/prospective) because no clinical testing was used to support the submission.

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

This information is not applicable as the submission is for a medical device (intervertebral body fusion device) and does not involve diagnostic interpretation or AI algorithm evaluation requiring human experts to establish ground truth from medical images or clinical data.

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

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

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

This information is not applicable as this is not an AI-assisted device. The submission explicitly states: "No clinical testing was used in order to support this submission."

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

This information is not applicable as this is not an AI algorithm.

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

For the non-clinical tests, the "ground truth" is defined by the specified test standards (ASTM, ISO). Meeting the criteria outlined in these standards for mechanical strength, fatigue, wear, and biocompatibility constitutes the "ground truth" for proving the device's performance characteristics and safety.

8. The sample size for the training set:

This information is not applicable as this is a medical device, not an AI/ML product that requires a training set.

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

This information is not applicable as this is not an AI/ML product.

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The Adaptix™ PEEK Interbody System with Nanotechnology devices and the Capstone Control™ PEEK Spinal System with Nanotechnology devices including those with macro-, micro- and nano-roughened surface textures are intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies) at one or two contiguous spinal levels from L2-S1. These patients should have had six months of nonoperative treatment. These patients may have had a previous non-fusion spinal surgery and/or may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved spinal level(s).
Additionally, Adaptix™ PEEK Interbody System with Nanotechnology and the Capstone Control™ PEEK Spinal System with Nanotechnology devices can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. The Adaptix™ PEEK and the Capstone Control™ PEEK devices are to be used with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft and/or demineralized allograft bone with bone marrow aspirate. These implants are intended for use with supplemental fixation indicated for lumbar spinal fusion procedures and may be implanted via an open or a minimally invasive posterior approach and/or transforaminal approach.

The Adaptix™ PEEK Interbody System with Nanotechnology and Capstone Control™ PEEK Spinal System with Nanotechnology consist of interbody implants designed for restoration of sagittal alignment in the lumbar spine. The upper and lower surfaces of the implant incorporate a three-dimensional titanium scaffold with interconnected pores averaging 523 μm, and pore interconnections averaging 229 μm in diameter. This product demonstrates the requirements for nanotechnology. The surface has been deliberately manipulated to produce nanoscale dimensions which exhibit specific properties. The scaffold of the Adaptix™ PEEK and Capstone Control™ PEEK devices is electrochemically treated to possess a controlled nanotopography composed of nanotube arrays having a pore size diameter between 30-90 nanometers. Calcium and phosphate are incorporated into the nanotube surface. The scaffold with nanotubes assists in securing the implant in the intervertebral space and provides radiographic confirmation of the implant location. The Adaptix™ PEEK and Capstone Control™ PEEK devices are available in a variety of sizes to accommodate the individual anatomic and clinical circumstances of each patient.

The provided text describes a medical device, the Adaptix™ PEEK Interbody System with Nanotechnology and Capstone Control™ PEEK Spinal System with Nanotechnology, and its 510(k) submission for substantial equivalence to predicate devices. It does not present acceptance criteria or a study that proves the device meets those criteria in the context of an AI/ML powered medical device.

The "Performance Data" section solely discusses mechanical and MR compatibility testing, which are standard for interbody fusion devices and not related to AI/ML performance.

Therefore, I cannot extract the requested information about acceptance criteria and a study proving their fulfillment for an AI/ML device from the given document. The document pertains to a physical medical implant, not an AI/ML software.

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When used as a pedicle screw fixation system, the Spinal System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the posterior thoracic, lumbar, and sacral spine:

1. Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
2. Degenerative spondylolisthesis with objective evidence of neurologic impairment
3. Fracture
4. Dislocation
5. Scoliosis
6. Kyphosis
7. Spinal tumor and/or
8. Failed previous fusion (pseudoarthrosis)

The Spinal System is also indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebral joint in skeletally mature patients receiving fusion by autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (L3 to sacrum), with removal of the implants after attainment of a solid fusion.

When used as an anterolateral non-pedicle screw system in the thoracic and lumbar spine, the Spinal System is also intended for the following indications:

1. Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
2. Spinal stenosis
3. Spondylolisthesis
4. Spinal deformities
5. Fracture
6. Pseudoarthrosis
7. Tumor resection and/or
8. Failed previous fusion

The Teslake Spinal System Navigation Instrumentation is intended to be used during the preparation and placement of Teslake Spinal System screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The instruments are specifically designed for use with the Medtronic Stealth Station System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy.

The Spinal System consists of a variety of polyaxial screws, fixed angle screws, rods, hooks, locking nuts, and transverse connectors. Implant components can be rigidly locked into a variety of different configurations to suit the individual pathology and anatomical conditions of the patient.

The purpose of the current submission is to add additional implants and navigated instruments to the Teslake Spinal System.

The provided text does not describe an AI/ML device or a study proving its performance against acceptance criteria.

The document is an FDA 510(k) clearance letter for a Spinal System (mechanical implants) and related navigated instruments. The information provided pertains to:

• Device Description: Spinal implants (screws, rods, hooks, nuts, connectors) and navigation instruments.
• Indications for Use: Stabilization of spinal segments, treatment of degenerative disc disease, spondylolisthesis, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed fusion. The navigation instruments assist surgeons in locating anatomical structures.
• Predicate Devices: Other spinal systems and navigation instrumentation.
• Non-Clinical Tests: Mechanical testing (static/dynamic compression bending, static torsion, transverse moment, axial grip, torsional grip) per ASTM standards F1717 and F1798 to demonstrate mechanical equivalence to predicates.
• Clinical Tests: Stated as "Not applicable".
• Conclusion: Substantial equivalence based on information and non-clinical performance testing.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving an AI/ML device meets them, as this document does not concern an AI/ML device.

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The Ingenix™ Spinal System is intended to provide immobilization of spinal segments in sketally mature patients as an adjunct to fusion in the treatment of the following acute and chromic instabilities of thoracic, lumbar, and sacral spine; degenerative spondylolisthesis, with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal tumor, severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra with autogenous bone graft, and failed previous fusion (pseudarthrosis).

The Ingenix™ Spinal System (originally cleared as "Arisstos Spinal System") is an internal fixation device for spinal surgery consisting of rods, screws, and connectors available in various sizes to accommodate patient anatomy. A series of manual instruments intended to assist in the insertion and placement of the implants, such as taps, drivers, and rod benders, is provided in separate instrument trays.

The subject rods, screws, and connectors are manufactured of Ti-6Al-4V titanium alloy per ASTM F136. Additionally, 5.5mm and 6.0mm cobalt chrome rods are also available, conforming to ASTM F1537. All instruments are manufactured from stainless steel, aluminum, and select polymers.

The subject submission seeks to gain clearance for the following:

• . Minor modifications made to screws
• . Size expansion for the polyaxial deformity screws
• . Sterile packaging of a kit configuration

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