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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 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 and/or lordosis); 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.

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 and/or lordosis); tumor; pseudarthrosis; 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/DENALI Mini Spinal System is intended to provide immobilization and stabilization of spinal seqments 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 (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 and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1to C7) and the thoracic spine (T1-T3): traumatic spinal fractures and/or traumatic dislocations: instability or deformity: failed previous fusions (e.q., 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 previously cleared K2M EVEREST, RANGE (MESA and DENALI), CASPIAN OCT (MESA Mini and DENALI mini) and YUKON OCT Spinal Systems are top-loading, multiple component posterior spinal fixation implants consisting of pedicle screws, hooks, rods and connectors, intended to provide support during spinal fusion procedures. The primary purpose of this submission is to establish an MR Conditional labeling claim for these implants. In addition, CASPIAN components that were previously provided non-sterile are now being optionally offered as sterile packaged devices.

Here's an analysis of the provided text regarding the acceptance criteria and study for the EVEREST, RANGE, CASPIAN OCT, and YUKON OCT Spinal Systems:

Based on the provided FDA 510(k) summary, the primary purpose of this submission is not to introduce a new device with novel performance criteria, but rather to:

1. Establish an MR Conditional labeling claim for existing, previously cleared spinal systems.
2. Optionally offer previously non-sterile CASPIAN components as sterile packaged devices.

Therefore, the "acceptance criteria" and "device performance" in this context refer to demonstrating the safety and compatibility of the devices in an MRI environment, and that their core technological characteristics remain equivalent to their predicates.

It is important to note that this document is a 510(k) summary for modifications to existing devices (primarily MR compatibility and sterilization options), not for the initial clearance of the spinal systems themselves. The original studies for the biomechanical and clinical performance of the spinal systems would have been part of their initial 510(k) submissions. This document focuses on the new testing related to the modifications.

Acceptance Criteria and Reported Device Performance

Study Details (Relevant to this 510(k) submission)

The primary study mentioned in this document is related to MR Compatibility testing.

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

   • The document does not specify a "sample size" in terms of number of patients or cases for this particular testing. MR compatibility testing (per ASTM F2503) typically involves testing the physical devices themselves (e.g., assessing heating, artifact generation, and displacement forces), not patient data.
   • Data provenance: Not applicable in the context of device testing for MR compatibility. The tests would be conducted in a controlled laboratory environment.

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

   • Not applicable as this is a device performance test, not an AI or diagnostic expert review study. MR compatibility testing is conducted by engineers and technicians following established ASTM protocols.

3. Adjudication method for the test set:

   • Not applicable for device performance testing. Results are typically determined by measurements against predefined ASTM standards.

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:

   • No. This document pertains to spinal implants (physical medical devices), not AI software or diagnostic imaging analysis. Therefore, no MRMC study, AI integration, or human reader improvement assessment was performed or is relevant to this submission.

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

   • No. This is not an algorithm or software device.

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

   • Not applicable as this concerns the physical properties of the device for MR compatibility. The "ground truth" would be the measured physical interactions (e.g., temperature rise, deflection) of the implant components in an MRI electromagnetic field compared to acceptable limits defined by ASTM F2503.

7. The sample size for the training set:

   • Not applicable. There is no software or AI model involved that would require a training set.

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

   • Not applicable. There is no software or AI model involved.

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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 the craniocervical junction, the cervical spine (Cl 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 eyen 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 Caspian OCT/MESA Mini/ DENALI Mini Spinal System is a top-loading, multiple component, posterior (occipital-cervical-thoracic) spinal fixation system. The purpose of the current submission is to add modified plates and rods and to revise the Indications for Use.

The provided text is an FDA 510(k) Premarket Notification for a spinal system, not a study evaluating an AI/CADe medical device. Therefore, it does not contain the information required to answer your prompt regarding acceptance criteria and a study that proves the device meets those criteria, specifically concerning AI/CADe performance, ground truth, sample sizes, or expert adjudication.

The document describes a spinal fixation system, its indications for use, and a comparison to predicate devices, focusing on mechanical testing and material equivalence rather than diagnostic performance metrics.

To answer your prompt, I would need a different type of document, such as a clinical study report or a 510(k) submission for an AI/CADe device that details its performance evaluation.

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The Caspian OCT/MESA Mini/ DENALI Mini Spinal System is intended to provide stabilization as an adjunct to fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3) when used with autograft or allograft and is indicated for the following: DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies), spondylolisthesis, fracture/dislocation, revision of previous cervical spine surgery, tumors, atlantoaxial fracture with instability, occipitocervical dislocation. The occipital bone screws are limited to occipital fixation only. The rod and hook components are in the cervical/upper thoracic (C1-T3) spine. The pedicle screws are limited to placement in the T1-T3 in treating thoracic conditions only. The pedicle screws are not intended to be placed in or treat conditions involving the cervical spine. The Caspian OCT/MESA Mini/ DENALI Mini Spinal System can also be linked to the RANGE® Spinal System using rod connectors or transitional rods.

The Caspian OCT/MESA Mini/ DENALI Mini Spinal System is a top-loading, multiple component, posterior (occipital-cervical-thoracic) spinal fixation system. The purpose of the current submission is to add modified rods, plates and screws to the system.

This document is a 510(k) premarket notification from the FDA for a spinal fixation system. It confirms that the device is substantially equivalent to legally marketed predicate devices. It does not contain information about acceptance criteria or a study proving the device meets said criteria in the context of an AI/ML device. The document is about a mechanical spinal system, not a digital health product.

Therefore, I cannot provide the requested information.

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The CASPIAN OCT/MESA Mini/ DENALI Mini Spinal System is intended to provide stabilization as an adjunct to fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3) when used with autograft or allograft and indicated for the following:

· DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)

• · Spondylolisthesis
• Spinal stenosis
• · Fracture/dislocation
• · Revision of previous cervical spine surgery
• · Tumors
• · Atlantoaxial fracture with instability
• · Occipitocervical dislocation

The occipital bone screws are limited to occipital fixation only

The rod and hook components are in the cervical/upper thoracic (CI-T3) spine. The pedicle screws are limited to placement in the TI-T3 in treating thoracic conditions only. The pedicle screws are not intended to be placed in or treat conditions involving the cervical spine.

The CASPIAN OCT/MESA Mini/ DENALI Mini System can also be linked to the Range Spinal System using rod connectors or transitional rods.

The CASPIAN OCT/MESA Mini/ DENALI Mini System is a top-loading, multiple component, posterior (occipital-cervical-thoracic) spinal fixation system. The purpose of the current submission is to add 03.5 contoured rods to expand the rod offerings for the system.

Materials: The subject devices are manufactured from Ti6Al4V Eli per ASTM and ISO standards.

Function: The system functions as an adjunct to fusion to provide immobilization of stabilization of the posterior cervical and thoracic spine.

The provided document is a 510(k) summary for a spinal fixation system, not a study report for a medical device that uses AI or reports on acceptance criteria and performance data in the typical sense of a diagnostic or screening device.

Therefore, many of the requested categories for acceptance criteria and study design elements (such as sample size for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, training set details, etc.) are not applicable to this type of submission.

This 510(k) summary focuses on demonstrating substantial equivalence to previously marketed devices based on design, function, materials, and intended use, particularly for adding new rod sizes. The "acceptance criteria" here are implicitly related to mechanical testing and engineering rationale to ensure the new components maintain the same safety and effectiveness profile as the predicate devices.

Here's a breakdown of the relevant information from the document in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not Applicable: This submission relies on mechanical testing standards (ASTM F1717) and engineering rationale/finite element analysis, not clinical 'test sets' of patient data in the context of AI or diagnostic devices. There is no mention of "patient data" test sets.

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

• Not Applicable: "Ground truth" in this context would relate to defining mechanical testing parameters and interpreting engineering analyses, handled by biomechanical engineers and regulatory specialists, rather than clinical experts establishing ground truth for diagnostic imaging.

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

• Not Applicable: This relates to clinical data adjudication, which is not part of this 510(k) submission.

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 submission for a spinal implant, not an AI-powered diagnostic or screening device, so MRMC studies are irrelevant.

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

• Not Applicable: This is a medical device (spinal implant), not an algorithm.

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

• For the mechanical performance, the "ground truth" is established by adherence to recognized biomechanical testing standards (e.g., ASTM F1717) and engineering principles/ finite element analysis (FEA), indicating that the device meets defined physical strength and durability criteria. The overall ground truth for regulatory clearance is substantial equivalence to existing, legally marketed devices.

8. The sample size for the training set

• Not Applicable: This is a spinal implant, not a machine learning model, so there is no training set.

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

• Not Applicable: No training set exists for this type of device.

In summary, the provided document is a regulatory submission for a spinal fixation system, cleared based on substantial equivalence demonstrated through mechanical testing and engineering rationale, not clinical study data in the context of diagnostic performance.

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The CASPIAN OCT / MESA Mini / DENALI Mini Spinal System is intended to provide stabilization as an adjunct to fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3) when used with autograft or allograft and is indicated for the following:

• DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)
• . Spondylolisthesis
• . Spinal stenosis
• Fracture/dislocation
• . Revision of previous cervical spine surgery
• . Tumors
• Atlantoaxial fracture with instability
• t Occipitocervical dislocation

The occipital bone screws are limited to occipital fixation only.

The rod and hook components are intended for use in the cervical/upper thoracic (C1-T3) spine. The pedicle screws are limited to placement in T1-T3 in treating thoracic conditions only. The pedicle screws are not intended to be placed in or treat conditions involving the cervical spine.

The CASPIAN OCT / MESA Mini / DENALI Mini System can also be linked to the Range Spinal System using the 3.5mm/5.5mm rod connectors or transitional rods.

The Caspian OCT Spinal System is a top-loading, multiple component, posterior (occipital-cervicalthoracic) spinal fixation system. The purpose of this submission is to add the Occipital Anchor to the system.

Materials: The subject devices are manufactured from Ti6A14V Eli per ASTM and ISO standards.

Function: The system functions as an adjunct to fusion to provide immobilization of the posterior cervical and thoracic spine.

The provided text describes a 510(k) summary for the Caspian OCT Spinal System, specifically focusing on the addition of an Occipital Anchor. The submission details the device, its intended use, and a comparison to predicate devices, along with mechanical and biomechanical testing to demonstrate substantial equivalence.

However, the document does not contain the kind of information typically associated with acceptance criteria for device performance in the context of clinical studies, diagnostic accuracy, or AI models. Instead, the "acceptance criteria" here refers to the demonstration of substantial equivalence to a previously cleared device, primarily through mechanical and biomechanical testing in accordance with ASTM standards.

Therefore, many of the requested categories in your prompt cannot be directly answered from the provided text, as they pertain to clinical or diagnostic performance studies that were not conducted or reported in this 510(k) summary. The summary focuses on the physical and functional characteristics of an implantable medical device.

I will fill in the table and address the other points based only on the information available in the provided text. Where information is not present, I will explicitly state that.

Acceptance Criteria and Study for the Caspian OCT Spinal System

The "acceptance criteria" for this 510(k) submission revolve around demonstrating substantial equivalence to predicate devices. This was primarily achieved through mechanical and biomechanical testing.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: The document does not specify exact sample sizes (e.g., number of constructs or cadaveric specimens) for the mechanical or biomechanical testing. It refers to "the constructs" and "the devices."
• Data Provenance: The mechanical testing was conducted by K2M, Inc. to ASTM standards. The biomechanical testing was "cadaver" testing, implying human cadaveric tissue. The country of origin for the data is not specified, but the submitter is K2M, Inc. in Leesburg, VA, USA. The studies are prospective in nature for validating the device's performance against established standards and predicate devices.

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

This information is not provided in the document. The "ground truth" for this device's performance is based on standardized mechanical testing (ASTM F2706) and comparative biomechanical testing against predicate devices, rather than expert interpretation of data.

4. Adjudication method for the test set

This information is not provided as the evaluation method was based on objective mechanical and biomechanical measurements against established standards and predicate device performance, not expert adjudication of subjective assessments.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices, particularly those involving image interpretation or AI assistance, which is not the nature of the Caspian OCT Spinal System (an implantable spinal fixation system).

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

No, a standalone algorithm performance study was not done. This concept is not applicable to an implantable spinal fixation system.

7. The type of ground truth used

The "ground truth" used for demonstrating substantial equivalence was:

• Engineering Standards: Adherence to ASTM F2706 for static and dynamic mechanical properties.
• Predicate Device Performance: Direct comparison of the new device's mechanical and biomechanical performance to that of previously cleared predicate devices (K2M Caspian OCT Spinal System K101084 and Medtronic Vertex K052402).

8. The sample size for the training set

This information is not provided and is not applicable. The listed studies are for device verification/validation, not for training an algorithm.

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

This information is not provided and is not applicable. There was no "training set" in the context of an algorithm or AI model development for this device submission.

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The Caspian OCT/miniMesa/miniDenali Spinal System is intended to provide stabilization as an adjunct to fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3) when used with autograft or allograft and is indicated for the following: DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies), spondylolisthesis, spinal stenosis, fracture/dislocation, revision of previous cervical spine surgery, tumors, atlantoaxial fracture with instability, occipitocervical dislocation.

The occipital bone screws are limited to occipital fixation only.

The rod and hook components are intended for use in the cervical/upper thoracic (C1-T3) spine. The pedicle screws are limited to placement in T1-T3 in treating thoracic conditions only. The pedicle screws are not intended to be placed in or treat conditions involving the cervical spine.

The Caspian OCT/miniMesa/miniDenali Spinal System can also be linked to the Range Spinal System using the 3.5mm/5.5mm rod connectors or transitional rods.

The Caspian Spinal System is a top-loading, multiple component, posterior (cervical-thoracic) spinal fixation system which consists of pedicle screws, rods, locking set screws, hooks, and rod connectors. Additional hooks are being added to the system.

Materials: The devices are manufactured from Ti6A14V Eli and Cobalt Chrome per ASTM and ISO standards.

Function: The system functions as an adjunct to fusion to provide immobilization and stabilization of spinal segments of the cervical and thoracic (TI-T3) spine.

The provided text is a 510(k) summary for the Caspian OCT Spinal System, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device for safety and effectiveness, primarily through comparison of technological characteristics and intended use, rather than through extensive new clinical studies with detailed acceptance criteria and performance metrics.

Therefore, the document does not contain the requested information regarding:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets, data provenance, and ground truth establishment details for a study proving acceptance criteria.
• Number and qualifications of experts for ground truth.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness study results.
• Standalone (algorithm-only) performance.
• Specific types of ground truth used (beyond general clinical and radiographic studies for indications).
• Training set sample size and ground truth establishment for a training set.

Explanation:

The 510(k) summary explicitly states its purpose is to compare the device to predicate devices. It emphasizes:

• "The subject components were compared to the existing components of the K2M Caspian OCT Spinal System were determined not to represent worst case for the system for mechanical testing.." (Page 1, [0])
• "The design features and sizing of the subject devices were also compared to predicate devices... and found to be substantially the same as these systems. It is manufactured from the same materials and is indicated for the same intended uses as these systems." (Page 2, [1])
• "There are no significant differences between the subject implants and other devices currently being marketed. They are substantially equivalent to these other devices in design, function, material and intended use." (Page 2, [1])

The study referenced is mechanical testing to ensure the new components do not represent a "worst case" for the system, implying a focus on engineering specifications rather than clinical performance metrics typically associated with AI/software device studies. The document does not provide details of this mechanical testing, such as specific acceptance criteria or performance results.

In essence, for this type of medical device submission (spinal fixation system), the "proof" of meeting acceptance criteria is the demonstration of substantial equivalence to already marketed devices, supported by mechanical testing ensuring safety and performance characteristics are maintained, rather than a clinical study evaluating specific performance metrics against pre-defined acceptance criteria for, for example, diagnostic accuracy or treatment efficacy in the way an AI diagnostic tool would.

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The Caspian Spinal System is intended to provide stabilization as an adjunct to fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3) when used with autograft or allograft and is indicated for the following:

• DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)
• Spondylolisthesis
• Spinal stenosis
• Fracture/dislocation
• Revision of previous cervical spine surgery
• Tumors
• Atlantoaxial fracture with instability
• Occipitocervical dislocation

The occipital bone screws are limited to occipital fixation only.

The rod and hook components are intended for use in the cervical/upper thoracic (C1-T3) spine. The pedicle screws are limited to placement in T1-T3 in treating thoracic conditions only. The pedicle screws are not intended to be placed in or treat conditions involving the cervical spine.

The Caspian Spinal System can also be linked to the Range Spinal System using the 3.5mm/5.5mm rod connectors or transitional rods.

The Caspian Spinal System is a top-loading, multiple component, posterior (cervical-thoracic) spinal fixation system which consists of pedicle screws, rods, locking set screws, hooks, and rod connectors.

Materials: The devices are manufactured from Ti6AI4V Eli and Cobalt Chrome per ASTM and ISO standards.

Function: The system functions as an adjunct to fusion to provide immobilization of the posterior cervical and thoracic spine.

The provided text is a 510(k) summary for the Caspian Spinal System, a medical device. It focuses on demonstrating substantial equivalence to previously marketed devices based on mechanical testing and design comparisons, rather than clinical efficacy studies with acceptance criteria, human readers, or ground truth.

Therefore, most of the requested information cannot be extracted from this document as it does not describe a study involving an AI device or a device whose performance is measured against acceptance criteria in a clinical context.

Here's what can be extracted:

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

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

Not applicable. The study described is mechanical testing, not a clinical study with a test set of data.

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

Not applicable. There was no ground truth based on expert review for a test set.

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

Not applicable. No expert adjudication for a test set was mentioned.

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 document describes a spinal implant, not an AI device or a device involving human readers.

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

Not applicable. This device is a physical spinal fixation system, not an algorithm.

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

Not applicable. The 'ground truth' for this mechanical testing would be the measured physical properties and performance of the device and its predicates, compared to established ASTM standards.

8. The sample size for the training set

Not applicable. There is no training set for an AI algorithm mentioned in this document.

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

Not applicable. There is no training set for an AI algorithm mentioned in this document.

Ask a specific question about this device

The Caspian Spinal System is intended to provide stabilization as an adjunct to fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3) when used with autograft or allograft and is indicated for the following:

• DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)
• Spondylolisthesis
• Spinal stenosis
• Fracture/dislocation
• Revision of previous cervical spine surgery
• Tumors
• Atlantoaxial fracture with instability
• Occipitocervical dislocation

The occipital bone screws are limited to occipital fixation only.

The rod and hook components are intended for use in the cervical/upper thoracic (C1-T3) spine. The pedicle screws are limited to placement in T1-T3 in treating thoracic conditions only. The pedicle screws are not intended to be placed in or treat conditions involving the cervical spine.

The Caspian Spinal System can also be linked to the Range Spinal System using the 3.5mm/5.5mm rod connectors or transitional rods.

The Caspian Spinal System is a top-loading, multiple component, posterior (occipital-cervical-thoracic) spinal fixation system which consists of pedicle screws, rods, locking set screws, hooks, rod connectors, and occipital components.

Materials: The devices are manufactured from Ti6Al4V (ASTM F1472), Ti6Al4V Eli (ASTM F136), and CP Titanium (ASTM F67).

Function: The system functions as an adjunct to fusion to provide immobilization and stabilization of the posterior cervical and thoracic spine.

The Caspian Spinal System is a medical device intended to provide stabilization as an adjunct to fusion of the cervical spine and occipito-cervico-thoracic junction. The device's performance was evaluated through mechanical testing, with the acceptance criterion being that it performed "equally to or better than" predicate devices.

Acceptance Criteria and Device Performance

Study Details

• Sample Size for Test Set: This information is not explicitly provided. The document states that the system was "mechanically tested," implying a set of samples were used for these tests, but the specific number is not given.
• Data Provenance: Not applicable. The study involved mechanical testing of the device itself, not human data.
• Number of Experts Used to Establish Ground Truth: Not applicable. Mechanical testing relies on established engineering standards (ASTM F2706) rather than expert consensus on individual cases.
• Qualifications of Experts: Not applicable.
• Adjudication Method: Not applicable.
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No. This type of study is relevant for diagnostic or image-interpretation devices involving human readers, which is not the case for a spinal fixation system.
• Standalone (Algorithm Only) Performance: Not applicable. This is a mechanical device, not an algorithm.
• Type of Ground Truth Used: The "ground truth" for this device's performance is defined by the established mechanical testing standards, specifically ASTM F2706, and the performance of legally marketed predicate devices. The system was deemed acceptable if its mechanical performance met or exceeded that of these established devices.
• Sample Size for Training Set: Not applicable. The device is a physical implant, not an AI or machine learning model that requires a training set.
• How Ground Truth for Training Set Was Established: Not applicable.

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The Caspian Spinal System is indicated for the following:

• DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)
• Spondylolisthesis
• Spinal stenosis
• Fracture/dislocation
• Revision of previous cervical spine surgery
• Tumors

The implants are intended to provide stabilization as an adjunct to fusion when used with autogenous bone graft or allograft following the reduction of fractures/dislocations or trauma in the spine.

The rod and hook components are intended for use in the cervical/upper thoracic (C1-T3) spine. The pedicle screws are limited to placement in T1-T3 in treating thoracic conditions only. The pedicle screws are not intended to be placed in or treat conditions involving the cervical spine.

The Caspian Spinal System can also be linked to the Range Spinal System using the 3.5mm/5.5mm rod connectors or transitional rods.

The Caspian Spinal System is a top-loading, multiple component, posterior (cervical-thoracic) spinal fixation system which consists of pedicle screws, rods, locking set screws, hooks, and rod connectors.

Materials: The devices are manufactured from Ti6Al4V Eli and Cobalt Chrome per ASTM and ISO standards.

Function: The system functions as an adjunct to fusion to provide immobilization of spinal segments of the cervical and thoracic (T1-T3) spine.

The provided text describes the 510(k) summary for the Caspian Spinal System, a spinal fixation system. However, it does not contain any information about acceptance criteria, device performance metrics, or study details such as sample sizes, expert qualifications, adjudication methods, or comparative effectiveness studies.

The document focuses on:

• Identification of the device: Trade name, common name, classification, product code, regulatory class.
• Predicate devices: Listing similar legally marketed devices.
• Description of the device: Components, materials, function.
• Intended Use/Indications for Use: Specific conditions for which the device is intended.
• Substantial Equivalence Claim: Stating that the device is similar in design, material, and indications for use to predicate devices and is expected to be equivalent in safety and effectiveness.
• FDA Correspondence: Official letter acknowledging the 510(k) submission and determining substantial equivalence.

Therefore, I cannot fulfill the request to describe acceptance criteria and a study proving the device meets them, as the necessary information is not present in the provided text.

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