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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. 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.

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

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

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

The occipital bone screws are limited to occipital fixation only

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

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

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

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

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

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

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

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

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

1. Table of Acceptance Criteria and Reported Device Performance

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

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

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

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

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

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

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

• Not Applicable: This is a submission for a spinal implant, not an AI-powered diagnostic or screening device, so MRMC studies are irrelevant.

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

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

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

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

8. The sample size for the training set

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

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

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

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

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

The occipital bone screws are limited to occipital fixation only.

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

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

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

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

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

The provided text is a 510(k) summary for the Caspian Spinal System, which is a medical device for spinal fixation. It describes the device, its intended use, and its comparison to predicate devices for substantial equivalence.

However, a critical review of the document reveals that it does not contain any information regarding clinical studies, acceptance criteria, or performance metrics in the way that would typically be described for a diagnostic AI/ML device.

The relevant sections of the document describe:

• Device Description: A top-loading, multiple component, posterior (cervical-thoracic) spinal fixation system made from Ti6A14V Eli and Cobalt Chrome.
• Intended Use: Provides stabilization as an adjunct to fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3) for various conditions.
• Comparison to Predicate Devices: Mechanical testing (static and dynamic compression bending and static torsion) was performed in accordance with ASTM F1717. The additional components were determined not to represent worst-case for the system for mechanical testing compared to existing components. The design features, sizing, materials, and intended uses were found to be substantially the same as predicate devices (K2M Caspian Spinal System and DePuy Mountaineer).

Therefore, I cannot provide the requested information for acceptance criteria and study details because the provided document does not contain this type of data.

This document is a 510(k) summary for a spinal implant (a mechanical device), not a diagnostic AI/ML device. For spinal implants, the "acceptance criteria" and "study" typically refer to mechanical testing (e.g., fatigue, static strength, bending stiffness) and biocompatibility testing, rather than clinical performance metrics like sensitivity, specificity, or reader studies associated with diagnostic algorithms.

The document states:
"Mechanical testing of the subject components included static and dynamic compression bending and static torsion testing in accordance with ASTM F1717. When compared to the existing components of the K2M Caspian OCT Spinal System, the additional components were determined not to represent worst case for the system for mechanical testing."

This indicates that mechanical tests were done, and the results were deemed equivalent to the predicate device, implying they met the predicate's performance. However, specific numerical acceptance criteria or performance results (e.g., "device withstood X N of force") are not provided in this summary.

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The Everest Spinal System if used in conjunction with the Range (Mesa and Denali) Spinal Systems are:

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 (thoracic-lumba) spinal fixation system which consists of pedicle screws, rods, locking set screws, and hooks. The purpose of this submission is to increase the range of screw sizes and to add connectors to enable use with Range Spinal System conponents.

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.

The provided 510(k) summary for the "Everest Spinal System" is for a physical medical device (spinal fixation system) and not for an AI/ML-driven device or software. Therefore, the questions regarding acceptance criteria, study design, ground truth, and reader studies that are typically applicable to AI/ML device performance evaluation do not directly apply in this context.

This summary focuses on demonstrating substantial equivalence to existing predicate devices based on mechanical performance and material compatibility.

Here's an analysis of the provided information, framed as closely as possible to your request, but highlighting the differences for a physical device:

Acceptance Criteria and Device Performance (for a physical medical device)

Summary of Device Evaluation and Study for Substantial Equivalence:

The study presented is not an AI/ML algorithm validation study, but rather a comparative engineering and design study to demonstrate substantial equivalence of a physical medical device.

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

   • This is not applicable in the context of an AI/ML study. For a physical device, "test set" refers to physical prototypes or components of the Everest Spinal System. The document doesn't specify the exact number of components tested but implicitly suggests sufficient samples were used to conduct the required ASTM F1717 mechanical tests.
   • Data Provenance: The tests were conducted according to ASTM and ISO standards, implying a controlled laboratory environment. The "country of origin of the data" would be where these tests were performed, but this detail is not provided. It is a prospective generation of test data from manufactured components.

2. 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. The "ground truth" for a mechanical device is established by objective, verifiable physical measurements and engineering standards (ASTM F1717, ISO standards). There are no human "experts" establishing a subjective ground truth in this type of study.

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

   • Not applicable. Mechanical tests are typically evaluated against predefined quantitative limits set by standards like ASTM F1717, not through human adjudication.

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:

   • Not applicable. This is a physical device, and no human "readers" or AI assistance are involved in its performance evaluation.

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

   • Not applicable. This is a physical device, not an algorithm.

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

   • For this physical device, the "ground truth" is defined by established engineering performance standards (ASTM F1717) and material specifications (ASTM and ISO standards for Titanium Alloy and Chrome). The performance of the device is directly compared to these objective standards and to the performance of existing legally marketed predicate devices under the same test conditions.

7. The sample size for the training set:

   • Not applicable. There is no AI/ML model being trained.

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

   • Not applicable. No AI/ML model training occurred.

Conclusion for this Device:

The K2M Everest Spinal System demonstrated substantial equivalence by:

• Showing that its mechanical performance (static compression, static torsion, dynamic compression) was "equally to or better than" the predicate devices when tested according to ASTM F1717.
• Confirming its design features and sizing were "substantially the same" as predicate systems.
• Verifying its materials (Titanium Alloy and Chrome) met the relevant ASTM and ISO standards.
• Confirming its intended use aligns with the predicate devices.

This allows the FDA to conclude there are no significant differences that would adversely affect the product's use, thus granting 510(k) clearance based on substantial equivalence.

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