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The VySpan™ PCT System, which is used to promote fusion of the cervical spine and the cervicothoracic (C1-T3), and 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 VySpan™ PCT System can also be linked to the VyLink™ Screw System using the dual diameter rods and rod-to-rod connectors.

The VySpan™ PCT System is comprised of implant and instrument components. The implant component, the VySpan™ device, consists of posterior attachments with a set screw and The VySpan™ pedicle screw component is offered in both poly-axial and mono-axial rod. 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, or Cobalt Chrome, and should not be used with implants of different materials. The purpose of this submission is to add additional connectors and rods to the VySpan™ PCT System.

This document pertains to the 510(k) premarket notification for the VySpan™ PCT System, a medical device for spinal fixation. The submission focuses on adding new components to an existing system, and as such, relies on demonstrating substantial equivalence to a previously cleared predicate device rather than presenting new performance study data.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets these criteria (including specific details about sample sizes, expert involvement, ground truth establishment, MRMC studies, standalone performance, and training sets for an AI/algorithm) cannot be provided based on the provided text.

The document explicitly states:
"Engineering rationale was used to determine no new worse-case was introduced; therefore, no new performance testing has been performed on the subject VySpan™ PCT System. The subject VySpan™ PCT System has the same design, sizes, indication of use & biocompatibility as the predicate devices."

This indicates that the submission did not involve new clinical, software, or algorithm performance studies. The substantial equivalence was established through an engineering rationale and comparison of technological characteristics to predicate devices. The device described also does not contain software or electrical equipment, as stated in the document.

In the context of this specific product (VySpan™ PCT System), the "acceptance criteria" and "study that proves the device meets the acceptance criteria" would primarily refer to the demonstration of substantial equivalence to a predicate device based on design, materials, intended use, and other characteristics, as opposed to performance metrics from a new, specific study.

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The VySpan™ PCT System, which is used to promote fusion of the cervical spine and the cervicothoracic (C1-T3), and 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 VySpan™ PCT System can also be linked to the VyLink™ Screw System using the dual diameter rods and rod-to-rod connectors.

The VySpan™ PCT System is comprised of implant and instrument components. The implant component, the VySpan™ device, consists of posterior attachments with a set screw and rod. The VySpan™ pedicle screw component is offered in both poly-axial and mono-axial configuration. In addition to these components, there are also ancillary components such as hooks, connectors, crosslinks, 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. The purpose of this submission is to add additional connectors to the VySpan™ PCT System.

The provided text is a 510(k) summary for the VySpan™ PCT System, which is a spinal fixation device. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving the device meets specific performance acceptance criteria for a diagnostic or AI-based medical device.

Therefore, many of the requested points, such as acceptance criteria, reported device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and how ground truth was established, are not applicable or available in this document.

The document states that "Engineering rationale was used to determine no new worse-case was introduced; therefore, no new performance testing was performed on the subject VySpan™ PCT System." This indicates that the device's substantial equivalence is based on its similarity to a predicate device and not on new, specific performance studies directly demonstrating its efficacy against defined acceptance criteria.

Here's an attempt to address the applicable points based on the provided text:

1. Table of acceptance criteria and the reported device performance

Not applicable. The document states "no new performance testing was performed on the subject VySpan™ PCT System." The basis for clearance is substantial equivalence to a predicate device in terms of material, intended use, levels of attachment, size range, and strength.

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

Not applicable. No new performance testing was conducted.

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. No ground truth was established for a test set as no new performance testing was conducted.

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

Not applicable. No test set was used.

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 device is a mechanical spinal fixation system, not an AI-based diagnostic tool.

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

Not applicable. This device is a mechanical spinal fixation system, not an algorithm.

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

Not applicable. No ground truth was established as no new performance testing was conducted.

8. The sample size for the training set

Not applicable. No training set was used as this is not an AI/algorithm-based device.

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

Not applicable. No training set was used.

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