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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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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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