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The NEO Pedicle Screw System™ is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion. The system is intended for posterior, non-cervical firation 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, tumor, pseudarthrosis, and/or failed previous fusion.

The NEO Pedicle Screw System™ consists of pedicle screws and connecting rods which differ in length and diameter. The system includes the relevant instruments which are single use, disposable and delivered sterile. All components and instruments are sterilized by gamma irradiation.

The screws are offered in diameters of 5.0 - 7.0 mm and lengths of 35 - 55 mm. Three different types of rods are available: pre-bent, straight or special bent rod for S1/L5. All rods have a diameter of 5.5 mm. Pre-bent rods are offered in lengths of 40 - 100 mm, straight rods in lengths from 30 - 300 mm and the special-bent rod in either 30 or 40 mm length. All spinal implant components are made of titanium alloy (Ti6Al4V Eli) in accordance with ASTM F136. The screws are color coded for better identification of the different diameters. The screws are double threaded, cannulated, fenestrated and selftapping.

This document pertains to the 510(k) premarket notification for a medical device called the "NEO Pedicle Screw System™." This submission is for a Class II medical device, and as such, it focuses on demonstrating "substantial equivalence" to legally marketed predicate devices, rather than proving a totally new level of device performance through extensive clinical trials.

Therefore, the information typically sought regarding acceptance criteria and studies proving the device meets those criteria (especially in the context of device performance metrics like accuracy, sensitivity, specificity, or human-AI reader performance improvements) is not present in this type of regulatory submission.

Here's why and what information IS available:

1. Nature of the Device: The NEO Pedicle Screw System™ is an orthopedic implant (pedicle screws and rods) used for spinal fixation. Its primary function is mechanical support. Unlike diagnostic AI software, its performance is not measured by diagnostic accuracy or an effect size on human reader improvement.
2. Regulatory Pathway (510(k)): The 510(k) pathway for Class II devices primarily requires demonstration of "substantial equivalence" to a predicate device already on the market. This is achieved by showing that the new device has:
   • The same intended use as the predicate.
   • The same technological characteristics as the predicate, OR
   • Different technological characteristics, but these do not raise new questions of safety and effectiveness, AND the device is as safe and effective as the predicate.
3. Focus of Testing: The testing detailed in this document is primarily non-clinical and focuses on:
   • Material properties: Biocompatibility (ISO 10993-1), chemical analysis.
   • Mechanical performance: Static and dynamic axial compression, static torsion (in accordance with ASTM F1717), showing comparability to other marketed systems.
   • Sterilization: Validation (ISO 11137-2), pyrogenicity.
   • Packaging: Shelf life (ISO 11607-1), transport studies.
   • MRI Compatibility: Magnetic field interactions, heating, artifacts (ASTM F2052-15, F2182-11a, F2119-07).
   • Usability: WetLab study with orthopedic surgeons.

Therefore, I cannot provide the requested information about acceptance criteria for AI performance, MRMC studies, or specific effect sizes, as this device is a mechanical implant and not an AI/diagnostic software.

However, I can extract the information relevant to the types of studies conducted for this specific device:

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

For this device, the "acceptance criteria" are not based on diagnostic performance metrics (e.g., sensitivity, specificity). Instead, they are based on meeting established standards for mechanical performance, biocompatibility, sterility, and durability, demonstrating "comparability" and "substantial equivalence" to predicate devices. The document implies that the device met these standards, as it received 510(k) clearance.

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

• Sample Size for Test Set: Not applicable in the context of diagnostic AI. For mechanical and biological testing, sample sizes are dictated by the specific ASTM/ISO standards referenced (e.g., number of test specimens for mechanical strength, number of samples for sterility validation), but these specifics are not provided in this summary. Data provenance is implied to be from the manufacturer's own internal testing and external certified labs commissioned by the manufacturer. It is not clinical data (retrospective or prospective) in the sense of patient data.

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

• Not applicable for this type of device. "Ground truth" in the context of AI diagnostic performance relies on expert consensus or biopsy/pathology. Here, the "truth" for mechanical performance is defined by adherence to engineering standards (ASTM, ISO), and human experts (orthopedic surgeons) were involved in a "WetLab study" for usability, but not to establish "ground truth" for a diagnostic test.

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

• Not applicable. This refers to methods for consolidating expert opinions in diagnostic studies, which is not relevant here.

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 study is for evaluating human performance with and without AI assistance for diagnostic tasks. This device is a surgical implant, not a diagnostic AI.

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

• Not applicable. This refers to the performance of an AI algorithm alone.

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

• For this device, "ground truth" is established by:
  • Engineering standards and specifications: For mechanical strength (ASTM F1717), sterility (ISO 11137-2), biocompatibility (ISO 10993-1), MRI compatibility (ASTM F2052-15, F2182-11a, F2119-07), and packaging (ISO 11607-1).
  • Functional verification: For the monoaxial mode and overall usability (WetLab confirmation by surgeons).
  • Published scientific literature: Used for clinical evaluation to demonstrate equivalence to predicate devices, as "Clinical studies were not required."

8. The sample size for the training set:

• Not applicable. This term is relevant for machine learning models.

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

• Not applicable. This term is relevant for machine learning models.

In summary, the provided document describes a regulatory submission for a physical medical device (spinal implant) through the 510(k) pathway. The evidence presented focuses on ensuring the device is safe and effective as a mechanical and biological component, rather than as a diagnostic tool or AI algorithm.

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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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