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Vy Spine™ VySpan™ PCT System, which is used to promote fusion of the cervical spine and the cervicothoracic (C1-T3), is indicated for the following:

• ddd (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)

• Spondylolisthesis
• Spinal stenosis
• Fracture/dislocation
• Revision of previous cervical spine surgery
• Tumors

The use of the mini polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine. Hooks and Rods

The rod and hook components are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

The Vy Spine™ VySpan™ PCT System is comprised of implant and instrument components. The implant component, the VySpan™ device, consists of posterior attachment elements with a set screw and rod. The VySpan™ pedicle screw component is offered in both poly-axial and monoaxial configuration. In addition to these components, there are also ancillary components such as hooks, connectors, cross-links, and lateral offset connectors. All of the components discussed above are fabricated from Titanium alloy and should not be used with implants of different materials.

This document describes the Vy Spine™ VySpan™ PCT System, a posterior cervical screw system. The provided text is a 510(k) premarket notification and does not contain information typically found in a study proving a device meets acceptance criteria related to its performance in vivo or clinical outcomes. Instead, it focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing and comparison of design characteristics.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC studies, standalone performance, ground truth establishment for training set, training set size) are not applicable to the information provided in this regulatory document.

Here's an analysis based on the information available:

Acceptance Criteria and Device Performance

The document does not explicitly state "acceptance criteria" in the traditional sense of clinical performance metrics (e.g., sensitivity, specificity, accuracy). Instead, it implicitly relies on demonstrating that the subject device's non-clinical performance and characteristics are substantially equivalent to legally marketed predicate devices. The "performance" described refers to mechanical and material characteristics tested non-clinically.

Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria

1. Sample size used for the test set and the data provenance: Not applicable. The "test set" here refers to the actual physical devices undergoing non-clinical mechanical testing, not a patient dataset. The document doesn't specify the number of devices or components tested. The "provenance" refers to a "third-party facility."

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For non-clinical mechanical testing, "ground truth" is typically defined by engineering specifications and objective measurements against ASTM standards, not expert consensus.

3. Adjudication method for the test set: Not applicable. Formal adjudication methods (like 2+1 or 3+1) are used for clinical data interpretation or image analysis, not for non-clinical mechanical testing.

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 device is a mechanical implant, not an AI-assisted diagnostic or therapeutic tool.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device does not involve an algorithm.

6. The type of ground truth used: For non-clinical testing, the "ground truth" is adherence to established engineering standards (e.g., ASTM standards) and the measured mechanical properties of the device components compared to those of the predicate devices.

7. The sample size for the training set: Not applicable. This device is not an AI/ML product developed with training data.

8. How the ground truth for the training set was established: Not applicable, as there is no training set for this type of device.

Summary of the Study:

The "study" referenced is a series of Non-Clinical Tests conducted at a third-party facility using various ASTM Standard tests. The purpose of these tests was to demonstrate the substantial equivalence of the Vy Spine™ VySpan™ PCT System to its predicate devices (Reliance Posterior Cervical-Thoracic System K142867 and K122292) in terms of material, design, sizes, intended use, biocompatibility, and strength. The document explicitly states that the subject device "has similar design, sizes, indication of use & biocompatibility as the predicate devices."

The document does not provide specific results from these ASTM tests (e.g., exact load-to-failure values, fatigue life), but rather summarizes that the testing was performed and supports the claim of substantial equivalence.

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