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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 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.

The EVEREST Spinal System is a top-loading, multiple component, posterior (thoracic/lumbar/sacral) spinal fixation system consisting of pedicle screws, hooks, rods and connectors.

This document describes a 510(k) premarket notification for the EVEREST Spinal System, which is a medical device for spinal fixation. It details the device's indications for use and states that the current 510(k) submission is specifically for adding a set screw to the existing system.

Based on the provided text, the specific information requested in the prompt regarding acceptance criteria and a study proving device performance (especially related to AI or a software-driven device) is not available. The document focuses on the regulatory clearance process for a physical medical device (spinal system components), not a software or AI-based diagnostic tool.

The "Performance Data" section explicitly states: "The modified device was evaluated via finite element analyses. The results demonstrated the performance of the modified set screw is substantially equivalent to the predicate." This indicates an engineering analysis rather than a clinical study with human data.

Therefore, I cannot fulfill the request to provide details about acceptance criteria, test set sample size, expert ground truth establishment, or multi-reader multi-case studies, as these concepts are not applicable to the information provided about the EVEREST Spinal System.

If your request pertains to a different document or scenario where AI/software performance is being evaluated, please provide that relevant text.

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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 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, 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 pediation 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 EVEREST Spinal System is a top-loading, multiple component, posterior (thoracic-lumbar) spinal fixation system which consists of pedicle screws, rods, hooks and rod connectors. The subject 510(k) adds rod-to-rod connectors to the system.

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

Based on the provided text, the "EVEREST Spinal System" is a medical device, and the document describes its FDA 510(k) clearance. This type of document is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a new medical device meets specific performance acceptance criteria through the kind of clinical study typically associated with AI/software-as-a-medical-device (SaMD).

Therefore, the information required to populate a table of acceptance criteria and a detailed study proving the device meets those criteria (especially related to AI/algorithm performance) is not present in this document.

This document focuses on:

• Substantial Equivalence: The FDA has determined the EVEREST Spinal System is substantially equivalent to predicate devices. This means it has similar indications for use, technological characteristics, and performs similarly in terms of safety and effectiveness as the predicate devices already on the market.
• Device Description: It's a spinal fixation system (pedicle screws, rods, hooks, rod connectors).
• Indications for Use: What conditions it's intended to treat (e.g., degenerative disc disease, scoliosis, trauma).
• Technological Comparison: The proposed implants are substantially "the same" as predicate systems in terms of design, materials, and sizes.
• Non-clinical Performance Evaluation: Mechanical testing was performed (e.g., static torsion, static compression, dynamic compression bending) in accordance with ASTM F1717, and the results were "comparable" to previously cleared devices.

There is no mention of an algorithm, AI, or any software component that would require an AI/SaMD specific study with ground truth establishment, expert adjudication, or MRMC studies. The "device performance" here refers to its mechanical capabilities as a physical implant, not diagnostic or therapeutic performance derived from an AI.

Given this, I cannot provide the requested information about acceptance criteria for an AI/algorithm and a study proving it meets those criteria because the provided text describes a physical medical device (spinal system) and its mechanical testing, not a digital health product with AI.

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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); 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 pediatic 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 EVEREST Spinal System is a top-loading, multiple component, posterior (thoracic-lumbar) spinal fixation system which consists of pedicle screws, rods, hooks and rod connectors. The subject 510(k) adds sterile packaged implants to the system.

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

This document describes a 510(k) premarket notification for the EVEREST Spinal System. Based on the provided text, the device is a spinal fixation system, and the submission is for adding sterile-packaged implants to the system. The acceptance criteria and supporting study details are primarily related to mechanical performance and material compatibility, not a diagnostic or AI-driven device.

Here's an analysis of the provided information:

Assessment of Acceptance Criteria and Proving Study:

The document describes pre-clinical performance evaluations, not clinical studies in the context of an AI/diagnostic device. The "acceptance criteria" and "study" are focused on the mechanical and material aspects of the spinal implant.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not explicitly stated for each test, but implied to be sufficient for the mechanical and material tests performed according to recognized standards (ASTM F1717, AAMI/ANSI/ISO 11607). For mechanical testing of medical devices, sample sizes are typically determined by statistical methods or industry standards to ensure sufficient power to detect differences or confirm compliance.
• Data Provenance: The tests are non-clinical performance evaluations (i.e., laboratory testing). Therefore, there is no "country of origin of the data" or "retrospective/prospective" in the sense of patient data. The provenance is the results of laboratory tests conducted by the manufacturer or a contracted lab.

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 to this type of device submission. Ground truth, in the context of expert consensus, is relevant for diagnostic devices (especially those involving image interpretation or clinical assessment). For a spinal implant, "ground truth" relates to material properties and mechanical performance, which are evaluated through standardized physical testing, not expert interpretation of clinical data.

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

This is not applicable. Adjudication methods are used in clinical studies, particularly for diagnostic devices, to resolve discrepancies among multiple expert readers. For mechanical testing, the results are quantitative measurements against predefined standards.

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. An MRMC study is relevant for diagnostic devices that involve human interpretation, particularly when evaluating the impact of AI assistance on reader performance. The EVEREST Spinal System is a physical implant, not a diagnostic or AI-assisted device.

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

This is not applicable. This question refers to the performance of an AI algorithm in isolation. The EVEREST Spinal System is a physical medical device.

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

The "ground truth" for this device's performance evaluation is based on established engineering and material science standards and specifications. For example:

• Mechanical Strength: The "ground truth" is passing the load and fatigue requirements specified in ASTM F1717 (e.g., maintaining structural integrity and specific mechanical properties under defined static and dynamic loads).
• Biocompatibility/Material Safety: The "ground truth" is meeting the bacterial endotoxin limits and aging requirements as per relevant ISO standards (e.g., AAMI/ANSI/ISO 11607 for packaging and sterility).

8. The sample size for the training set:

This is not applicable. The device is not an AI/machine learning device, so there is no training set in this context.

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

This is not applicable. As there is no training set (being a physical medical device), the concept of establishing ground truth for it does not apply.

Ask a specific question about this device

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. Pediatric pedicle screw fixation is limited to a posterior approach.

The Everest Spinal System is a top-loading, multiple component, posterior (thoracic-lumbar) spinal fixation system which consists of pedicle screws, rods, hooks and rod connectors. The subject 510(k) adds fenestrated cannulated screws to the system.

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

This document is a 510(k) premarket notification for the Everest Spinal System, which is a medical device. The document does not describe the acceptance criteria of a study or the methods and results of a study designed to prove a device meets acceptance criteria. Instead, it is a submission to the FDA for market clearance, asserting that the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot extract the requested information (acceptance criteria, study details, sample sizes, expert qualifications, etc.) as this document does not contain a description of such a study. It primarily focuses on regulatory classification, device description, indications for use, and a technological comparison to predicate devices, supported by general mechanical testing in accordance with an ASTM standard. No information regarding AI/algorithm performance or ground truth establishment is present.

Ask a specific question about this device

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.

The Everest Spinal System is a top-loading, multiple component, posterior (thoracic-lumbar) spinal fixation system which consists of pedicle screws. rods, hooks and rod connectors. The Everest Spinal System implants are manufactured from titanium alloy per ASTM F136 and F1472 and Cobalt Chrome per ASTM F1537. The subject 510(k) adds additional connectors and rods to the system.

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

This document, a 510(k) Premarket Notification for the Everest Spinal System, primarily focuses on demonstrating substantial equivalence to previously cleared devices rather than establishing novel acceptance criteria for a new type of performance. Therefore, the provided text does not contain detailed information on acceptance criteria based on accuracy metrics for a medical device or a study designed to prove the device meets such criteria in the way envisioned by the prompt.

The document discusses the mechanical performance evaluation of the Everest Spinal System, which is a spinal fixation system, against established standards for such devices.

Here's an analysis based on the information provided:

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

The document does not present specific quantitative acceptance criteria and reported device performance in a table format for accuracy or clinical effectiveness as one might expect for a diagnostic or AI-driven device. Instead, it states that:

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

This information is not provided in the document. The "tests" referred to are mechanical evaluations of the physical device components, 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 information is not applicable and not provided. The ground truth for mechanical testing is based on engineered specifications and standardized test protocols (ASTM F1717), not expert consensus from medical professionals.

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

This information is not applicable and not provided. Adjudication methods are relevant for clinical studies or image interpretations, not for mechanical engineering tests.

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

This information is not applicable and not provided. The Everest Spinal System is a physical implant, not an AI-driven diagnostic or imaging device. Therefore, MRMC studies and AI assistance are not relevant to its evaluation here.

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

This information is not applicable and not provided. The Everest Spinal System is a physical medical device, not an algorithm.

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

The "ground truth" for the mechanical performance evaluation is the established mechanical properties and performance standards for spinal fixation systems as defined by ASTM F1717. This is based on engineering principles and regulatory requirements for the device's function and safety, not clinical outcomes or expert consensus in the medical sense.

8. The sample size for the training set

This information is not applicable and not provided. As this is a mechanical device, there is no "training set" in the context of machine learning or algorithms. The design and manufacturing processes are likely informed by prior engineering knowledge and material science.

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

This information is not applicable and not provided. There is no "training set" or "ground truth for the training set" in the context of this device's evaluation.

Summary of what the document does provide:

• Device Type: Spinal fixation system (physical implant).
• Purpose of Study: To demonstrate substantial equivalence of new components (connectors and rods) to existing cleared devices based on mechanical performance.
• Methodology: Mechanical testing in accordance with ASTM F1717 (including static torsion, static compression, and dynamic compression bending).
• Conclusion: The mechanical test results were "comparable to previously cleared devices," suggesting the new components meet the established safety and performance profiles for this type of implant.

The document is a 510(k) submission, which aims to show that a new device is "substantially equivalent" to a legally marketed predicate device. This typically involves comparing design features, materials, and performance (often mechanical or bench testing for implants) rather than extensive clinical efficacy or accuracy studies that would involve large patient cohorts or expert assessments in the way the prompt implies.

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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.

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

Materials: The proposed implants are manufactured from Titanium per ASTM standards.

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

Purpose of Submission: Additional connectors

This document is a 510(k) premarket notification for the Everest Spinal System. It does not describe a study to prove device performance against acceptance criteria for an AI/software device. Instead, it demonstrates substantial equivalence to predicate devices through mechanical testing for a physical implantable device.

Therefore, I cannot provide the requested information regarding acceptance criteria and study details for an AI system based on the provided text.

The document discusses:

• Device Name: Everest Spinal System
• Submission Type: 510(k) premarket notification for "Additional Connectors" for an existing spinal system.
• Device Type: Pedicle screw spinal system (physical implant).
• Predicate Devices: Everest Spinal System (K140529) and Medtronic CD Horizon (K132328).
• Testing: Mechanical testing performed in accordance with ASTM F1798 and ASTM F1717 (static torsion, static compression, and dynamic compression bending).
• Conclusion: The device was found substantially equivalent to predicate devices, and the proposed implants do not represent a new worst case.

None of the information requested in points 1-9 (e.g., acceptance criteria for AI, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types) is applicable or present in this document, as it pertains to a different type of medical device (hardware vs. software/AI).

Ask a specific question about this device

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:

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.

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

Materials: The devices are manufactured from Titanium Alloy and Cobalt Chrome per ASTM and ISO standards.

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

The purpose of this 510(k) submission is to add modified screws, rods, hooks and rod to rod connectors.

The provided text is a 510(k) Summary for the Everest Spinal System, which is a medical device. This document focuses on the regulatory submission for clearance of a spinal fixation system and its substantial equivalence to predicate devices, primarily through mechanical testing. It does not contain information on clinical studies involving human patients, AI/human reader performance, or ground truth establishment relevant to the questions asked.

Therefore, many of the requested items cannot be extracted from this document, as they pertain to clinical or AI-related performance studies that were not part of this 510(k) submission.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

Note: The document only refers to mechanical performance based on bench testing (ASTM F1717) for the medical device's structural integrity, not clinical performance or AI diagnostic accuracy.

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

• Sample Size for Test Set: Not applicable. The "test set" here refers to mechanical testing of implants, not a clinical data set. The document does not specify the number of implants tested, only that "worst case implants" were tested.
• Data Provenance: Not applicable. This refers to bench testing of physical devices, not patient data.

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

• Not applicable. Ground truth in this context would refer to clinical diagnoses or pathology. The submission focuses on device mechanics, assessed against ASTM standards, not clinical ground truth.

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

• Not applicable. This pertains to clinical assessment or AI performance, not 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

• No. This document does not mention any MRMC study or AI assistance.

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

• No. This document does not describe any algorithm or standalone performance study.

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

• For the mechanical testing, the "ground truth" was adherence to performance levels established by ASTM F1717 and comparison to predicate devices, interpreted by engineering rationale. This is not clinical ground truth.

8. The sample size for the training set

• Not applicable. There is no mention of a "training set" as this document describes a physical medical device, not an AI or algorithm.

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

• Not applicable.

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RANGE /DENALI/MESA and SMALL STATURE and ARI are cleared for the following indications: 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 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: 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 anterolaicral 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 pcdiatric patients the Everest Spinal System implants arc indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. These devices arc to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The Range and Everest Spinal Systems are top-loading, multiple component, posterior (thoracic-lumbar) spinal fixation system which consist of pedicle screws, rods, locking set screws, hooks, rod connectors and transverse connectors.

Materials: The devices are manufactured from Titanium Alloy and Chrome per ASTM and ISO standards.

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

This submission is for a spinal fixation system, not an AI/ML device. Therefore, the requested information regarding acceptance criteria, study details for AI/ML performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone AI performance, and training set information is not applicable.

The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices based on design features, materials, intended use, and mechanical performance testing (static compression, static torsion, and dynamic compression in accordance with ASTM F1717). The "acceptance criteria" here refer to the device's ability to meet these established ASTM standards and demonstrate equivalence to previously cleared devices.

Summary of Relevant Information from the Provided Text:

• Device: Range Spinal System, Everest Spinal System (spinal fixation systems)
• Purpose of Submission: To expand the indications for use for these systems.
• Performance Data: The Range and Everest Spinal System components were previously tested in static compression, static torsion, and dynamic compression in accordance with ASTM F1717.
• Conclusion: The devices were determined to be substantially equivalent to predicate devices based on these tests and a review of literature concluding expanded indications do not result in new safety/effectiveness issues.
• Regulatory Class: Class III

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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:

Non-cervical, pedicle screw fixation devices for posterior stabilization as an adjunct to fusion for the following indications: Trauma ( i.e. fracture or dislocation ); spinal stenosis; curvatures (i.e. scoliosis, kyphosis; and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. It is also indicated for the treatment of severe spondylolisthesis ( grades 3 and 4 ) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine ( L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

Non-cervical, non-pedicle spinal fixation devices intended for posterior or anterolateral thoracolumbar screw stabilization as an adjunct to fusion for the following indications: degenerative disc disease (DDD ) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies ); spondylolisthesis; trauma ( i.e. fracture or dislocation ); spinal stenosis; curvatures ( i.e. scoliosis, kyphosis; and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

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

The provided text describes a 510(k) summary for the Everest Spinal System, which is a medical device. As such, the concept of "acceptance criteria" and "device performance" as it pertains to medical image analysis, AI algorithms, or diagnostic tools with quantifiable metrics like sensitivity, specificity, or AUC, is not directly applicable in this context.

Instead, for a spinal fixation system like the Everest Spinal System, "acceptance criteria" are typically met through demonstrating substantial equivalence to predicate devices based on design, materials, function, and mechanical performance. The "study" that proves the device meets these criteria is typically a mechanical testing study.

Here's an analysis based on the provided text, reinterpreting the request for a device like this:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not applicable in the traditional sense for this type of mechanical device. The "test set" would be the collection of components and configurations of the Everest Spinal System that underwent mechanical testing. The specific number of devices or test repetitions for each mechanical test (static compression bending, static torsion, dynamic compression) is not provided in this summary.
• Data Provenance: The mechanical tests were performed by K2M, Inc. to compare against predicate device performance. This is typically internal testing conducted according to recognized industry standards (ASTM F1717). This is a prospective evaluation of the new device components. The "country of origin of the data" would be the United States, where K2M is located.

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

• Not applicable. For mechanical testing of a spinal fixation system, "ground truth" is established by adherence to recognized international mechanical testing standards (e.g., ASTM F1717) and the physical measurements obtained during the tests. It does not involve human expert interpretation in the way radiological images would.

4. Adjudication Method for the Test Set

• Not applicable. This concept relates to reconciling discrepancies in human expert interpretations (e.g., in diagnostic studies). Mechanical testing results are determined objectively by instrumentation and adherence to test protocols, not through human 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

• Not applicable. This study type is relevant for diagnostic devices (especially those involving AI or human interpretation of images/data). The Everest Spinal System is a physical implant, not a diagnostic tool or an AI-assisted system.

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

• Not applicable. This device does not involve an algorithm or AI. Its performance is purely mechanical.

7. The Type of Ground Truth Used

• Objective Mechanical Measurements and Standard Compliance: The "ground truth" is defined by the objective physical measurements (e.g., load, displacement, cycles to failure) obtained during mechanical testing on the device components, compared against the established performance characteristics of predicate devices and the requirements of the ASTM F1717 standard.

8. The Sample Size for the Training Set

• Not applicable. There is no "training set" in the context of a mechanical medical device like this, as it does not involve machine learning or AI.

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

• Not applicable. As there is no training set, this question is irrelevant for the Everest Spinal System.

In summary: The "study" proving the device met acceptance criteria was a mechanical testing study comparing the new components of the Everest Spinal System against predicate devices according to ASTM F1717 standards. The success criterion was that the new components performed "equally to or better than" the predicate devices in static compression bending, static torsion, and dynamic compression, and that their design and materials were substantially equivalent.

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