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

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

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

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

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

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

The CAPRI Corpectomy System implants are vertebral body replacement devices that are designed in a variety of lengths, widths, and heights to match the patient's anatomy. Static (titanium) and expandable (titanium and cobalt chrome) cervical cages are available and are implanted via an anterior approach. The cervical implants of the CAPRI Corpectomy Cage Systems are manufactured from Titanium (per ASTM F3001 and ASTM 136) and Cobalt Chrome (per ASTM F1537). The purpose of this Traditional 510(k) submission is to introduce a new 12x14mm cervical expandable footprint size to the previously cleared CAPRI Corpectomy Cage System.

Function: The system is used to provide structural stability in skeletally mature individuals following a corpectomy or vertebrectomy.

The provided text describes the 510(k) premarket notification for the K2M, Inc. CAPRI Corpectomy Cage System. This submission introduces a new 12x14mm cervical expandable footprint size to an already cleared system. As such, the study focuses on demonstrating the substantial equivalence of this new footprint to the predicate device, rather than proving a new device's performance against specific clinical acceptance criteria for effectiveness or safety in a clinical trial setting. The studies conducted are mechanical tests to ensure the new footprint maintains the same structural integrity and performance characteristics as the predicate.

Here's the information extracted from the provided text, addressing your points:

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

The document does not explicitly state "acceptance criteria" in terms of specific numerical thresholds for each test, but it lists the mechanical tests performed to demonstrate substantial equivalence to the predicate device. The performance is implied to be "met" if the device demonstrates substantial equivalence.

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

The document does not specify sample sizes (number of devices tested) for the mechanical tests. It also does not mention data provenance in terms of country of origin or whether a retrospective/prospective study was conducted, as these were benchtop mechanical tests, not clinical studies involving patient 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)

This is not applicable to the type of study described. The study involves mechanical testing against ASTM standards and comparison to a predicate device, not expert-based ground truth establishment as would be seen in diagnostic imaging or clinical effectiveness studies.

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

This is not applicable as the study involves mechanical testing against defined standards, not human evaluation requiring adjudication.

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

This is not applicable. The device is a spinal implant, not an AI-assisted diagnostic tool.

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

This is not applicable as the device is a medical implant, not an algorithm.

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

For mechanical testing, the "ground truth" is typically defined by adherence to established engineering standards (e.g., ASTM F2077-18, ASTM F2267-04 R18) and meeting performance characteristics comparable to the predicate device. There is no expert consensus, pathology, or outcomes data used as ground truth for this type of submission.

8. The sample size for the training set

This is not applicable. There is no training set mentioned, as this is a submission for a medical implant, not a machine learning algorithm.

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

Not applicable, as there is no training set.

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The MESA and DENALI Spinal Systems (including ARI Staples) and the EVEREST Spinal System 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; pseudoarthosis; 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 MESA, DENALI and EVEREST Spinal Systems are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis when used for posterior non-cervical fixation in pediatric patients. The MESA, DENALI and EVEREST 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.

This traditional 510(k) premarket notification is to introduce the Cannulated Power Driver Attachment instrument for use with Stryker Power Systems.

The Cannulated Power Driver Attachment is an accessory to the Everest and Range (Mesa and Denali) pedicle screw systems intended to facilitate the insertion of pedicle screws using powered instrumentation. The Cannulated Power Driver Attachment, also referred to as the power adaptor or subject device, serves as a mechanical interface between the power driver and screwdriver instrument. When the adaptor is attached, the driver (corded and cordless) provides appropriate power to rotate screw drivers for the insertion of pedicle screws. No changes have been made to the indications for use of the associated thoracolumbar spinal implant systems Everest and Range (Mesa and Denali) Spinal Systems. The indications for use of each spinal system remain consistent with their most recent 510(k) clearance.

The provided text is a 510(k) summary for the "Cannulated Power Driver Attachment". This document is for a medical device that assists in the surgical insertion of pedicle screws, not an AI/ML-driven device for diagnosis or prediction. Therefore, the questions related to AI/ML device performance, such as sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth types, are not applicable.

However, I can extract information related to the acceptance criteria and how the device met them.

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

The document states that the "Cannulated Power Driver Attachment Instrument has demonstrated substantial equivalence to the predicate device." It further states: "The performance of the Cannulated Power Driver Attachment has met all acceptance criteria."

While specific numerical acceptance criteria (e.g., torque values, cycles to failure) are not provided in this summary, the general acceptance criteria can be inferred from the context of "substantial equivalence" and "verification and validation activities."

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

This device is a mechanical instrument. Testing would involve engineering evaluations (e.g., mechanical stress tests, fatigue tests) rather than data from human subjects or medical images. Therefore, the concepts of "test set sample size" and "data provenance" as typically applied to AI/ML systems are not relevant here. The "test set" would be the manufactured Cannulated Power Driver Attachment instruments subjected to various non-clinical performance evaluations. The number of units tested is not specified.

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

This is not applicable as the device is a mechanical instrument. Ground truth in this context would be defined by engineering standards and specifications, not expert medical opinion on clinical data.

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

Not applicable for a mechanical device.

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

Not applicable as this is a mechanical medical instrument, not an AI/ML diagnostic or predictive tool.

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

Not applicable as this is a mechanical medical instrument, not an AI/ML algorithm.

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

The "ground truth" for a mechanical device would be established by engineering specifications, validated test methods, and performance benchmarks against predicate devices. The summary indicates that "Verification and validation activities" were conducted to demonstrate that the device "met all acceptance criteria" and "does not represent a new worst case for powered pedicle screw insertion," implying a comparison to established performance characteristics of the predicate device.

8. The sample size for the training set

Not applicable as this is not an AI/ML device.

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

Not applicable as this is not an AI/ML device.

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K2M Navigation Instruments are intended to be used in the preparation and placement of K2M screws (Denali, Mesa, Everest, and Yukon) during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. MESA screw navigation is intended for open procedures only. These instruments are designed for use with the Medtronic StealthStation® 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 a vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy. Navigated Screw Inserters are also compatible with the Medtronic IPC POWEREASE System. The K2M Navigation Instruments are not intended for navigation of occipital screws.

K2M Navigation Instruments are nonsterile, reusable surgical instruments (inserters, taps, probes, and awls) and single use drill bits intended be used when implanting previously cleared components of Mesa, Denali, Everest, and Yukon Spine Systems. These instruments are designed to interface with the Medtronic StealthStation® System when used for navigation during cervical and thoracolumbar spinal surgery.

The provided text is a 510(k) summary for the K2M Navigation Instruments. It discusses the device's indications for use, its substantial equivalence to predicate devices, and the design validation testing conducted. However, it does not contain the specific information required to answer the questions about acceptance criteria for an AI/ML powered device, associated performance data, test set details (sample size, provenance, ground truth establishment, adjudication), training set details, or any multi-reader multi-case (MRMC) comparative effectiveness study.

The document states:

• "Design validation testing was conducted to ensure the K2M Navigation Instruments are acceptable for their intended use, to ensure functionality and compatibility with the Medtronic StealthStation® using the NavLock tracker, and to demonstrate substantial equivalence to the predicate instruments."

This indicates that performance testing was done for the navigational instruments themselves, focusing on their functionality and compatibility with a navigation system, rather than evaluating the performance of an AI/ML algorithm that predicts or diagnoses. The device described, "K2M Navigation Instruments," appears to be physical surgical instruments (inserters, taps, probes, and awls) designed to work with a stereotactic navigation system (Medtronic StealthStation® System) to assist surgeons with screw placement. It is not an AI/ML powered diagnostic or predictive device.

Therefore, since the device is not an AI/ML system, the requested information regarding AI/ML acceptance criteria and study results (including AI performance metrics like sensitivity, specificity, MRMC studies, ground truth establishment by experts, training set details, etc.) is not applicable to the content of this 510(k) summary.

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

The MOJAVE Expandable Interbody System is comprised of expandable titanium implants designed to allow for intraoperative adjustment to aid the surgeon in matching implant fit to the vertebral anatomy in the lumbar spine. The implants have titanium endplates designed to allow for bone ingrowth and engagement with the vertebral body end plates. The implants are manufactured from medical grade titanium alloy (ASTM F1472, ASTM F136, ASTM F3001) and cobalt chromium alloy (ASTM F1537) and are available in a variety of heights to accommodate anatomical variations.

The provided document describes an FDA 510(k) clearance for the MOJAVE Expandable Interbody System. This is a medical device, not an AI/software product, and the information provided does not include acceptance criteria or a study proving that an AI/software device meets acceptance criteria.

The document discusses the substantial equivalence of the MOJAVE Expandable Interbody System to predicate devices based on:

• Technological Comparison to Predicate: Minor modifications to enhance user experience, comparable in design, function, intended use, materials, and size.
• Non-clinical Performance Evaluation: Risk assessment, including benchtop and mechanical testing, to confirm no new issues of safety or effectiveness.

Therefore, I cannot provide the requested information for an AI/software device from this text as it is not applicable.

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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 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 fusion (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 absences 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, MESA, and DENALI Spinal System components via the rod to rod connectors or transition rods.

The YUKON OCT Spinal System is a top-loading, multiple component, posterior (occipital-cervical-thoracic) spinal fixation system consisting of screws, hooks, rods, rod connectors, and occipital components. The system functions as an adjunct to fusion to provide stablilization of the posterior cervical and thoracic spine.

I apologize, but the provided text does not contain information about the acceptance criteria or a study proving that a device meets those criteria.

The document is an FDA 510(k) clearance letter for the "Yukon OCT Spinal System." It details the device's classification, indications for use, and a summary of technological characteristics and non-clinical performance evaluation, which states:

• Non-clinical Performance Evaluation: "The subject implants were compared to the predicates using engineering rationales in addition to static compression, static torsion and dynamic compression testing (ASTM F1717) and performed equivalent to or better than the predicates."

This statement indicates that the device underwent non-clinical (mechanical) testing based on ASTM F1717 standards and demonstrated performance equivalent to or better than predicate devices. However, it does not specify:

• Quantitative acceptance criteria (e.g., specific load endurance, displacement limits).
• The raw performance data of the device against these criteria.
• Details about a clinical study, including sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies (MRMC, standalone algorithm performance).

Therefore, I cannot fulfill your request for the specific details outlined in your prompt based on the provided text.

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Brainlab Compatible K2M Navigation Instruments are intended to be used in the preparation and placement of K2M pedicle screws (DENALI, MESA, EVEREST, YUKON) during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Brainlab Navigation 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 a skull, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy. The Brainlab Compatible K2M Navigation Instruments are not intended for navigation of occipital screws.

Brainlab Compatible K2M Navigation Instruments are manual surgical instruments intended be used when implanting previously cleared components of MESA, DENALI, EVEREST and YUKON Spinal Systems. These instruments are designed to interface with the Brainlab Navigation system when used for navigation during spinal surgery. The subject instruments feature a modification of the connection mechanism geometry and material to enhance user experience.

The provided FDA 510(k) summary for the "Brainlab Compatible K2M Navigation Instruments" does not contain information typically found in a study proving a device meets specific acceptance criteria for performance, especially not in the context of an AI/algorithm-based medical device.

This document describes a conventional surgical instrument that interfaces with an existing navigation system. The "Non-clinical Performance Evaluation" section mentions a risk assessment and rotational testing, which are standard for mechanical devices. It does not refer to any clinical studies, AI performance metrics, or ground truth establishment as would be required for an AI/ML medical device.

Therefore, I cannot provide the requested information regarding acceptance criteria, device performance metrics (like sensitivity, specificity, AUC), sample sizes for test/training sets, expert qualifications, or details about MRMC studies. This is because the device in question is a surgical instrument and not an AI/ML-driven diagnostic or treatment planning system that would necessitate such detailed performance evaluation against ground truth.

The relevant sections state:

• Non-clinical Performance Evaluation: "A risk assessment including sterilization, biocompatibility, and additional rotational testing was conducted to confirm that the subject Brainlab Compatible K2M Navigation Instruments do not introduce new issues of safety or effectiveness."
• Conclusion: "There are no significant differences between the Brainlab Compatible K2M Navigation Instruments and other legally marketed systems. It is substantially equivalent to these other devices in design, function, material and intended use."

These statements indicate that the submission relies on demonstrating substantial equivalence to a predicate device through engineering and safety testing, rather than an AI performance study.

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The SAHARA Stabilization System implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy. Additionally, the SAHARA implants can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis
Hyperlordotic (angles > 15°) and Lateral implants must be used with supplemental fixation (i.e., posterior pedicle screw and rod system) cleared for use in the lumbar spine, in addition to the bone screws provided. Additional supplemental fixation (i.e. pedicle screw and rod system) is needed when used as an adjunct to fusion for degenerative scoliosis. Otherwise, the Sahara Stabilization System implants may be used as a stand-alone device, which is intended to be used with the bone screws provided.

The subject of this 510(k) submission is the addition of lateral implants to the previously cleared SAHARA Stabilization System. The implants function as an expandable intervertebral body fusion device to provide support and stabilization to the lumbar segments of the spine through a lateral approach. The system includes lateral interbody devices as well as bone screws for integrated fixation. The implants are manufactured from Titanium (ASTM F67), Titanium Alloy (ASTM F136, ASTM F1472, ASTM F3001) and Cobalt Chrome (ASTM F1537). The implants contain components that are additively manufactured.

This document describes the SAHARA Stabilization System, an intervertebral body fusion device. The acceptance criteria and supporting study are related to the mechanical performance of the device.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document only states that "mechanical tests were performed" and that the system "has demonstrated substantial equivalence to the identified predicate devices" based on material, design, and mechanical performance. It does not provide specific numerical values for the acceptance criteria or the reported performance for each test. The acceptance criteria are implicitly tied to demonstrating substantial equivalence to predicate devices, meaning the device's performance must be at least as safe and effective as the legally marketed predicate devices.

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

This information is not provided in the document. The study described is a series of mechanical tests, not a clinical study involving human data.

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 described study involves mechanical testing, not a clinical study requiring expert assessment of ground truth.

4. Adjudication method for the test set

This information is not applicable as the described study involves mechanical testing.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study described is a series of mechanical tests of an intervertebral body fusion device, not an AI-assisted diagnostic or imaging system.

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

This information is not applicable. The device is a physical implant, not an algorithm.

7. The type of ground truth used

The "ground truth" for this device's performance is established through industry standards and mechanical testing protocols (e.g., ASTM F2077, ASTM F2267). The device's performance is compared against these criteria and the performance of predicate devices to demonstrate substantial equivalence.

8. The sample size for the training set

This information is not applicable. The device is a physical implant and does not involve a training set as would be used for an AI algorithm.

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

This information is not applicable.

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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 CAYMAN LP Plate System are non-load bearing devices, each consisting of a plate and screw for attachment to the vertebral body. The plates are designed to be used as additions to spinal fusion procedures from the lateral and anterior approaches, forming a preventative barrier to intervertebral cage movement. Materials: The devices are manufactured from Ti6Al4V per ASTM and ISO standards. Function: The plates are designed to be used in a spinal fusion procedures to provide stabilization and buttressing of tissue in the intervertebral space.

The provided text describes the CAYMAN LP Plate System, a spinal implant, and its 510(k) summary for FDA clearance. It focuses on demonstrating substantial equivalence to predicate devices through nonclinical testing. No information is provided in the document regarding acceptance criteria for an AI/ML device, nor any study proving an AI/ML device meets such criteria.

The document describes a medical device, the CAYMAN LP Plate System, which is a physical implant used in spinal fusion procedures. It is not an AI/ML device, and thus, the concepts of a "test set," "training set," "ground truth," "human readers," or "AI assistance" do not apply to the information presented.

Therefore, I cannot provide a table of acceptance criteria, details on sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment relevant to an AI/ML device.

The study described in the document is a nonclinical mechanical test to demonstrate the ability of the physical plates to resist migration or expulsion of graft material, and to show mechanical superiority to a legacy predicate device. This is a performance test for a physical medical device.

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PYRENEES and BLUE RIDGE Cervical Plate Systems 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 radiographic studies), spondylolisthesis, trauma (including fractures), spinal stenosis and tumors (primary and metastatic), failed previous fusions (pseudarthrosis) and deformity (defined as scoliosis, kyphosis or lordosis).

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), spondylolisthesis, trauma (including fractures), spinal stenosis and tumors (primary and metastatic), failed previous fusions (pseudarthrosis) and deformity (defined as scoliosis, kyphosis or lordosis).

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 previously cleared K2M PYRENEES, BLUE RIDGE, OZARK and CAYMAN plate systems consist of a variety of plates and screws designed to provide support across implanted levels of the cervical, thoracolumbar and lumbosacral spine until fusion is achieved. The primary purpose of this submission is to establish an MR Conditional labeling claim for these implants. In addition, PYRENEES, BLUE RIDGE and CAYMAN components that were previously provided non-sterile are now being optionally offered as sterile packaged devices.

The provided text does not contain information about acceptance criteria and a study proving a medical AI device meets those criteria. Instead, it describes K2M Inc.'s PYRENEES, BLUE RIDGE, OZARK, and CAYMAN spinal plate systems, which are physical medical devices (spinal fixation systems).

The document discusses:

• Indications for Use for various spinal plate systems.
• The purpose of the submission as establishing an MR Conditional labeling claim for these implants and optionally offering previously non-sterile components as sterile.
• Performance Data related to:
  • MR Compatibility testing per ASTM F2503. The text states, "The test results demonstrate that the PYRENEES, BLUE RIDGE and OZARK Cervical Plate Systems and the CAYMAN Thoracolumbar and Buttress Plate Systems performance met the prescribed acceptance criteria."
  • Bacterial endotoxin testing (BET) performed in accordance with AAMI ST72:2011. The text states, "The test results demonstrate that the sterile devices met the specified testing limit."

Therefore, I cannot provide the requested table or information regarding acceptance criteria for an AI device. The details provided in the input pertain to the testing of spinal implants.

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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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