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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; 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.

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 minimally invasive implants.

Here's an analysis of the provided text regarding the Everest Spinal System, focusing on acceptance criteria and the study proving device performance:

Summary of Acceptance Criteria and Device Performance for the Everest Spinal System

It's important to note that the provided document is a 510(k) summary for a spinal fixation system, and not a diagnostic AI device. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are geared towards mechanical and design equivalence to predicate devices, rather than diagnostic accuracy metrics like sensitivity, specificity, or AUC which are typical for AI-powered diagnostic tools.

1. Table of Acceptance Criteria and the Reported Device Performance

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

Given this is a mechanical testing and design comparison, the concept of a "test set" and "data provenance" (country of origin, retrospective/prospective) as understood for AI/diagnostic studies is not directly applicable.

• Test Set Sample Size: The document does not specify a numerical sample size for the mechanical tests. It would typically involve a certain number of devices or components tested according to ASTM F1717.
• Data Provenance: Not applicable in the context of mechanical testing. The testing would be conducted in a laboratory environment following standardized procedures.

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

This category is not applicable for the Everest Spinal System 510(k) summary. "Ground truth" in this context refers to an objective standard, which for mechanical performance is established by the ASTM F1717 standard itself and the measured physical properties of the tested devices, not expert human assessment.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1) are used to resolve disagreements among human experts in diagnostic studies. Here, the "truth" is determined by direct mechanical measurements against a standard.

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 device is a surgical implant, not an AI-assisted diagnostic tool. Therefore, MRMC studies for human reader performance with or without AI assistance are irrelevant.

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

Not applicable. The Everest Spinal System is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by:

• Mechanical Measurement Results: Directly measured values from static compression, static torsion, and dynamic compression tests performed according to ASTM F1717.
• Predicate Device Performance: The accepted performance characteristics of the legally marketed predicate devices (K2M Everest Spinal System, K2M Range Spinal System, NuVasive SpherX, Globus Resolve). The new device's performance is compared against these established benchmarks.
• Design and Sizing Equivalence: Direct comparison of the physical design and dimensions of the new components to those of the predicate devices.
• Material Standards: Compliance with ASTM and ISO standards for Titanium Alloy and Cobalt Chrome.

8. The Sample Size for the Training Set

Not applicable. As this is a physical medical device undergoing mechanical testing and design comparison, there is no "training set" in the context of machine learning or AI.

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

Not applicable. There is no training set for this type of device submission.

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The VuePoint® OCT System is intended to promote fusion of the cervical spine and occipito-thoracic junction (Occiput-T3), and is indicated for: (1) Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) Degenerative spondylolisthesis with objective evidence of neurologic impairment, (3) Fracture/Dislocation, (4) Spinal Stenosis, (5) Atlantoaxial fracture with instability, (6) Occipitocervical dislocation, (7) Spinal tumor and/or (8) Revision of previous cervical spine surgery.

The occipital bone screws are limited to occipital fixation only.

The use of polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine.

The VuePoint OCT System can also be linked to the NuVasive SpheRx Spinal System via the rod to rod connectors or transition rods.

The NuVasive VuePoint OCT System consists of a variety of shapes and sizes of screws, rods, offset connectors, set screws, and cross connectors which can be rigidly locked in a variety of configurations to accommodate patient anatomy.

Here's a breakdown of the acceptance criteria and study information for the NuVasive® VuePoint® OCT System based on the provided 510(k) summary:

This device did not involve AI or algorithms; it is a spinal fixation system. Therefore, many of the requested categories related to AI performance, ground truth establishment, expert adjudication, MRMC studies, and training sets are not applicable. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" are focused on demonstrating substantial equivalence to predicate devices through biomechanical testing.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify the exact sample sizes (number of constructs or test specimens) used for each biomechanical test.
• Data Provenance: Not applicable in the context of clinical data. The tests are nonclinical (laboratory-based biomechanical tests) performed to demonstrate mechanical equivalence. Country of origin for data is not specified, but the submission is to the U.S. FDA, implying adherence to U.S. recognized standards. The study is nonclinical (in-vitro testing).

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

• Not applicable. This device is a spinal fixation appliance, and the "ground truth" for its performance is established by standardized biomechanical tests demonstrating its physical and mechanical properties, not by human expert opinion or clinical outcomes in the traditional sense. The "ground truth" is adherence to established engineering standards for strength and durability.

4. Adjudication Method for the Test Set

• Not applicable. There was no human adjudication of "cases" or "ground truth" as this was a nonclinical biomechanical study. The adjudication is against the performance of predicate devices and relevant ASTM standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• No. This is not an AI-powered device. It is a physical spinal implant system. Therefore, MRMC studies and AI assistance are not relevant.

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

• Nonclinical Biomechanical Performance. The "ground truth" for this device's performance is its ability to meet or exceed the biomechanical performance (static and dynamic torsion, compression, interconnection strength) of legally marketed predicate devices, as measured by established ASTM (American Society for Testing and Materials) standards.

8. The Sample Size for the Training Set

• Not applicable. This non-AI device does not have a "training set" in the context of machine learning.

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

• Not applicable. This non-AI device does not have a "training set" or "ground truth" established for training in the context of machine learning.

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