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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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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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The CENTINEL SPINE PCT SYSTEM is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the cervical spine (C1 to C7) and the thoracic spine from T1-T3: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The CENTINEL SPINE PCT SYSTEM is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

The Centinel Spine PCT System consists of a variety of shapes and sizes of rods, hooks, polyaxial screws, and connecting components (e.g., variable and fixed cross connectors). The hooks and polyaxial screws are intended to be attached to the posterior elements of the cervical and/or upper thoracic spine and serve as bone anchors. The rods are longitudinally secured to the bone anchors with the set screw. The various connecting components serve to both secure the construct and provide additional construct configuration options. All implants are manufactured from titanium alloy, Ti6A14V (ASTM F136 or ISO 5832-3)

This document is a 510(k) summary for the Centinel Spine PCT System, a device intended for spinal immobilization and stabilization. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study of the device's performance against specific clinical acceptance criteria in terms of AI/algorithm efficacy. As such, many of the requested categories related to AI performance, ground truth, and expert evaluation are not directly applicable or available in this document.

However, I can extract information related to the device's mechanical performance testing:

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

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

• Test Set Sample Size: Not explicitly stated within this document. The testing refers to "performance testing" and indicates that "published literature" was also used, but does not detail the number of constructs or specimens tested for each mechanical test.
• Data Provenance: The document does not specify the country of origin of the data. The tests are described as "Performance Testing" conducted according to modified versions of ASTM standards (ASTM F1717 and ASTM F1798), implying laboratory-based mechanical testing rather than clinical data from human subjects. It would be considered an in-vitro study.

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

This information is not applicable. The "ground truth" here is mechanical performance measured against engineering standards, not clinical diagnoses or outcomes requiring expert interpretation.

4. Adjudication method for the test set:

Not applicable. Mechanical tests for physical devices typically involve direct measurement against specified engineering limits, not human adjudication.

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 spinal implant, not an AI diagnostic tool that assists human readers.

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:

The ground truth used for performance assessment was based on mechanical engineering standards and the performance of predicate devices. Specifically, the "acceptance criteria were defined by predicate device performance."

8. The sample size for the training set:

Not applicable. This is not an AI/machine learning device that would have a training set.

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

Not applicable.

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