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The Vertefix® Pedicle Screw Spinal System is intended for posterior, non cervical pedicle fixation in skeletally mature patients receiving fusion by autogenous bone graft in the thoracolumbar spine for the following indications: Spondylolisthesis, Trauma (e.g.fracture or dislocation), Spinal stenosis, deformities or curvatures (scollosis, kyphosis or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

Removal of the implants after the attainment of a solid fusion is optional.

The Vertefix® Pedicle Screw Spinal System is a multiple component, posterior spinal fixation system which consists of pedicle screws, rods, set screws, connectors, hooks, and a transverse (cross) linking mechanism.

The Vertefix® Pedicle Screw Spinal System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The Vertefix® Pedicle Screw Spinal System components are supplied non-sterile, and are single use.

The provided document is a 510(k) summary for the Vertefix® Pedicle Screw Spinal System, which is a medical device for spinal fixation, not an AI/ML-driven diagnostic or therapeutic device. As such, the concept of "acceptance criteria" based on device performance metrics like sensitivity, specificity, or AUC, and a "study that proves the device meets the acceptance criteria" in the context of AI/ML performance, is not applicable here.

Instead, this document describes a traditional medical device submission where "acceptance criteria" would refer to demonstrating substantial equivalence to a legally marketed predicate device through engineering performance testing (e.g., biomechanical testing) and material characterization. The "study" proving acceptance criteria would be these engineering tests.

Here’s an explanation tailored to the information provided for this type of medical device:

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

   Acceptance Criteria	Reported Device Performance
   Demonstration of Substantial Equivalence:	The Vertefix® Pedicle Screw Spinal System was determined to be substantially equivalent to the following predicate devices: OPTIMA™ Spinal System (K051971), Denali™ Spine System (K042635), and XIA™ Spine System Hooks (K001319).
   * Design, Function, Materials, Operational Principles, and Intended Use: No significant differences compared to predicate devices that would adversely affect use.	The device's design, function, materials, operational principles, and intended use were deemed substantially equivalent to the predicate devices and other currently marketed spinal fixation systems.
   * Biomechanical Performance: Compliance with ASTM F1717 for spinal implant constructs.	Biomechanical testing in accordance with ASTM F1717 demonstrated substantial equivalence to the predicate systems and other marketed systems.
   * Material Composition: Fabrication from titanium alloy (Ti-6Al-4v ELI) conforming to ASTM F 136.	Vertefix® Spinal System components are fabricated from titanium alloy (Ti-6Al-4v ELI) that conforms to ASTM F 136.

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

   • Sample Size: Not applicable in the context of device performance in biomechanical testing for spinal implants. The "sample size" would refer to the number of test articles (e.g., pedicle screws, rods) subjected to various mechanical loads as per ASTM F1717. This information is typically detailed in the full test reports, which are not part of this 510(k) summary.
   • Data Provenance: Not applicable in the context of biomechanical testing. The tests are conducted under laboratory conditions.

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 the AI/ML context, does not apply to the biomechanical testing of a spinal implant. The "ground truth" for this device is established by engineering standards (e.g., ASTM F1717) and material specifications.

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

   • Not applicable. Adjudication methods are typically for clinical or interpretation studies, not for the biomechanical assessment of a physical device.

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 not an AI/ML device, and no MRMC study would be performed for a spinal fixation system.

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

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

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

   • For this device, the "ground truth" for demonstrating safety and effectiveness lies in its adherence to established engineering standards (like ASTM F1717) for biomechanical performance and material standards (like ASTM F136) for material composition, as well as its substantial equivalence in design and intended use to predicate devices already on the market.

8. The sample size for the training set

   • Not applicable. This is not an AI/ML device, so there is no training set.

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

   • Not applicable. This is not an AI/ML device.

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