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The Momentum™ Posterior Spinal Fixation System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion of the thoracolumbar and sacroiliac spine. When used as a posterior spine system, Momentum is intended for the following indications: degenerative disc disease, spinal stenosis, spondylolisthesis, spinal deformities (i.e., scoliosis, and/ or lordosis), trauma (i.e., fracture or dislocation), tumor, pseudoarthrosis and failed previous fusion.

In order to achieve additional levels of fixation, the Momentum Posterior System can also be connected to the neon3® universal OCT spinal stabilization system via transition rods or connectors. Please refer to the neon3 Instructions for Use for a list of indications for use.

The Momentum™ Posterior Spinal Fixation System consists of longitudinal members (rods), anchors (screws), connectors (rod/rod and rod/anchor) and fasteners in a variety of sizes to accommodate differing anatomic requirements.

This document is a 510(k) summary for the Momentum™ Posterior Spinal Fixation System. It describes the device, its intended use, and its substantial equivalence to predicate devices, primarily based on mechanical testing. It does not describe an AI/ML-based medical device. Therefore, the questions related to acceptance criteria and studies proving the device meets those criteria, specifically concerning AI/ML performance metrics, ground truth, expert involvement, and sample sizes for AI model training/testing, are not applicable to the provided document.

The document focuses on the mechanical performance of a spinal fixation system. Below is the relevant information from the document related to its performance as a physical medical device, structured as closely as possible to the request, while noting the non-applicability of AI/ML specific criteria.

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

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

• The document mentions "Mechanical testing of worst case Momentum™ System constructs." However, it does not specify the sample size (number of constructs tested) used for these mechanical tests.
• Data Provenance: Not specified, but generally, mechanical testing for medical devices is conducted in a laboratory setting, not typically described by country of origin or retrospective/prospective data.

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 question is not applicable as the device is a mechanical spinal fixation system, not an AI/ML diagnostic or prognostic tool. "Ground truth" in this context would refer to the physical and mechanical properties measured in a lab, not expert interpretations of medical images or data.

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

• This question is not applicable. Mechanical testing typically involves predefined test methods and measurements, not adjudication by human experts.

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 question is not applicable as the device is a mechanical spinal fixation system and does not involve human readers or AI assistance.

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

• This question is not applicable as the device is a mechanical spinal fixation system and does not involve algorithms or AI.

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

• The "ground truth" for this device would be its measured mechanical properties (e.g., strength, stiffness, resistance to pull-off) determined experimentally and compared against established industry standards (ASTM F1717) and the performance of predicate devices. This is not "expert consensus," "pathology," or "outcomes data" in the medical sense.

8. The sample size for the training set

• This question is not applicable as the device is a mechanical spinal fixation system and does not involve AI/ML models with training sets.

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

• This question is not applicable for the same reason mentioned in point 8.

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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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