Search Results

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 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.

Ask a specific question about this device

RANGE/DENALI/MESA and SMALL STATURE and ARI are cleared for the following indications:

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, kyphosis and/or lordosis); tumor; pseudoarthosis; and/or failed previous fusion.

Except for hooks, when used as an anterolateral 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 non-cervical fixation in pediatric patients. The Range Spinal System for pediatric use is intended to be used with autograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The Range/Denali/Mesa Spinal System is a top-loading, multiple component, posterior (thoraciclumbar) spinal fixation system which consists of pedicle screws, rods, hooks and rod connectors. The subject 510(k) adds additional screws and rods to the system.

Function: The system functions as a spinal fixation device to provide support and stabilization of the posterior thoracic and lumbar spine.

This document is a 510(k) premarket notification for a medical device called the RANGE/DENALI/MESA Spinal System. It's a regulatory submission to the FDA, not a clinical study report. Therefore, much of the requested information regarding acceptance criteria and clinical study details is not present in this type of document.

However, I can extract what is available and clarify what is not.

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

This document does not provide explicit acceptance criteria or reported device performance in the context of a clinical study. Instead, it describes a "Technological Comparison to Predicate(s)" and "Non-clinical Performance Evaluation."

• Acceptance Criteria (Implicit from Non-clinical Testing): The implicit acceptance criterion for the non-clinical performance evaluation is that the proposed implants (new screws and rods) are "substantially the same as the predicate devices" in terms of design features, materials, and sizes, and perform comparably in "worst case components" testing.
• Reported Device Performance (Non-clinical):
  • Performance evaluations were previously conducted on constructs representing the worst-case components.
  • Tests included: static torsion, static compression, and dynamic compression bending.
  • These tests were performed in accordance with ASTM F1717.
  • "Engineering rationales determined that the proposed implants were substantially the same as the predicate devices."

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

This document describes non-clinical performance evaluations (mechanical testing), not a clinical test set involving human subjects. Therefore, information about human sample size, data provenance (country, retrospective/prospective) is not applicable or provided.

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 there is no clinical test set or ground truth established by medical experts for device performance in this document. The "ground truth" for the non-clinical testing is compliance with ASTM F1717 and comparability to predicate devices.

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

This is not applicable as there is no clinical test set or adjudication process described.

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, an MRMC comparative effectiveness study was not done. This device is a spinal fixation system (physical implant), not an AI diagnostic tool.

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

No, this is not an algorithm or AI device.

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

For the non-clinical performance evaluation, the "ground truth" is adherence to ASTM F1717 standards and demonstrating substantial equivalence in mechanical properties to previously cleared predicate devices. There is no clinical ground truth established or used in this submission.

8. The sample size for the training set

This is not applicable as this is not an AI/machine learning device that requires a training set.

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

This is not applicable for the same reason as above.

Ask a specific question about this device