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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 (scoliosis, 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.

This document describes a 510(k) premarket notification for the Vertefix® Pedicle Screw Spinal System, seeking to demonstrate substantial equivalence to a predicate device. As such, the study design focuses on comparative performance against the predicate rather than establishing novel acceptance criteria and reporting performance for an AI-powered device.

Therefore, many of the typical questions for AI acceptance criteria and studies (like sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.) are not applicable to this type of submission.

Here's an attempt to address the relevant points based on the provided text, and explicitly state when information is not available or not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Not Applicable / Not Provided. This is a mechanical device, not an AI/software device that uses "data" in the typical sense for a test set. The "testing" referred to is mechanical testing of physical components (e.g., construct testing per ASTM F1717, thread pullout testing). The sample size for these mechanical tests is not specified in the provided text.

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

• Not Applicable. Ground truth in the context of an AI device typically refers to clinical diagnosis or outcome verified by experts. For a mechanical implant device, the "ground truth" is defined by established engineering standards (like ASTM F1717) and successful performance in those tests. Expert consensus for clinical diagnosis is not relevant here.

4. Adjudication method for the test set

• Not Applicable. Adjudication methods are relevant for subjective interpretations of data, particularly in clinical assessments where multiple readers might disagree. For mechanical testing against objective standards, adjudication is not a standard practice.

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 a mechanical spinal implant system, not a diagnostic or prognostic AI tool that would assist human readers.

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

• Not Applicable. This is a mechanical device. There is no algorithm.

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

• The "ground truth" for this device's performance is established by conformance to recognized industry standards (e.g., ASTM F1717) for mechanical testing and the material specifications (ASTM F136). The equivalence to a predicate device, which has already established safety and efficacy through its own testing and clinical use, serves as the primary benchmark.

8. The sample size for the training set

• Not Applicable / Not Provided. As a mechanical device, there is no "training set" in the computational sense. The design and testing are based on engineering principles and performance standards, not machine learning.

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

• Not Applicable. There is no training set for this type of device.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study that proves the Vertefix® Pedicle Screw Spinal System meets its acceptance criteria is primarily a bench-top mechanical evaluation demonstrating substantial equivalence to a legally marketed predicate device.

1. Original System Testing: The original Vertefix® Pedicle Screw Spinal System underwent construct testing according to ASTM F1717. This testing demonstrated "substantial equivalence to the predicate systems and other marketed systems" in terms of mechanical performance.
2. Material Conformance: The components are fabricated from Titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F136, which establishes material quality and safety.
3. Modified System Justification: For the modified system (with a 5.5mm rod), a full re-test against ASTM F1717 was not performed. The rationale provided was that this change was expected to "perform slightly better than the already tested Vertefix Spinal System." However, thread pullout testing was performed specifically to "prove the thread design" of the modified system.
4. Comparative Analysis: A comparative analysis against various predicates (including the original Vertefix system) was performed, concluding that there are "no significant differences... which would adversely affect the use of the product" in terms of design, function, materials, operational principles, and intended use.

In essence, the "study" for this 510(k) submission is a combination of prior mechanical testing, material standardization, and a reasoned argument supported by specific additional testing (thread pullout) and comparative analysis to demonstrate that the new device is as safe and effective as a legally marketed predicate.

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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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