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The VyLink™ Spinal Screw System is a pedicle screw system intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

The VyLink™ Spinal Screw System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally-mature patients receiving fusion by autogenous bone graft and having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

When used posteriorly, the VyLink™ Spinal Screw System is also a hook and sacraliliac screw fixation system of the noncervical spine indicated for: spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis). Levels of fixation are for the thoracic, lumbar and sacral spine.

When used in a percutaneous, posterior approach with MIS instrumentation, the VyLink™ Spinal Screw System components are intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, and/or lordosis), tumor, pseudarthrosis, and failed previous fusion in skeletally-mature patients.

The VyLink™ Spinal Screw System, when used with staples and two rods as an anterior thoracic/lumbar screw fixation system, is indicated for spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous- failed fusion (pseudarthrosis).

The Vy Spine™ VySpan™ PCT System can also be linked to the Vy Spine™ VyLink™ Screw System using the dual diameter rods.

The 06.5mm and larger screws may be used for sacroiliac joint fusion. The VyLink™ Spinal Screw System when used in the sacroiliac joint is intended for sacroiliac joint fusion for the following conditions:

· Sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroilitis. This includes conditions whose symptoms began during pregnancy or in the period and have persisted postpartum for more than 6 months.

· To augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.

· Acute, non-acute, and non-traumatic fractures involving the sacroiliac joint

The VyLink™ Spinal Screw System consists of longitudinal rods, monoaxial screws, polyaxial screws, reduction screws, MIS screws, cannulated screws, fenestrated screws, hooks, reduction hooks, set screws, and transverse connectors.

The VyLink™ Spinal Screw System components are available in titanium alloy conforming to ASTM F-136 specifications. Furthermore, various rods of the Reliance Spinal Screw System are available in Cobalt-Chrome conforming to ASTM F-75 and ASTM F-1537 specifications.

The provided text is a 510(k) summary for the VyLink™ Spinal Screw System, a medical device for spinal fixation, not a software or AI/ML-driven device. As such, it does not involve acceptance criteria, performance studies, sample sizes, expert ground truth, MRMC studies, or standalone algorithm performance as described in the prompt.

The document explicitly states:

• "No new performance testing has been performed on the subject VyLink™ Spinal System."
• "The subject VyLink™ Spinal System has similar design, materials, sizes, indication of use & biocompatibility as the predicate devices."
• "This device does not contain software or electrical equipment."

Therefore, I cannot provide the requested information for acceptance criteria and study details based on the given text, as these concepts are not applicable to the clearance pathway described for this particular mechanical medical device.

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The VyLink™ Spinal Screw System is a pedicle screw system intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusion (pseudarthrosis).

The VyLink™ Spinal Screw System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally-mature patients receiving fusion by autogenous bone graft and having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

When used posteriorly, the VyLink™ Spinal Screw System is also a hook and sacraliliac screw fixation system of the noncervical spine indicated for: spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis). Levels of fixation are for the thoracic, lumbar and sacral spine.

When used in a percutaneous, posterior approach with MIS instrumentation, the VyLink™ Spinal Screw System components are intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, and/or lordosis), tumor, pseudarthrosis, and failed previous fusion in skeletally-mature patients.

The VyLink™ Spinal Screw System, when used with staples and two rods as an anterior thoracic/lumbar screw fixation system, is indicated for spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous-failed fusion (pseudarthrosis).

The Vy Spine™ VySpan™ PCT System can also be linked to the Vy Spine™ VyLink™ Screw System using the dual diameter rods.

The VyLink™ Spinal Screw System consists of longitudinal rods, monoaxial screws, polyaxial screws, reduction screws, MIS screws, cannulated screws, fenestrated screws, hooks, reduction hooks, set screws, and transverse connectors.

The VyLink™ Spinal Screw System components are available in titanium alloy conforming to ASTM F-136 specifications. Furthermore, various rods of the Reliance Spinal Screw System are available in Cobalt-Chrome conforming to ASTM F-75 and ASTM F-1537 specifications. The components of one material should not be used with components of another material, with the exception that the Cobalt-Chrome rods may be used with titanium alloy implants. The extension tabs on the reduction and MIS screw and hook components are intended to be removed intraoperatively. The safety and effectiveness of this device has not been established when used in conjunction with bone cement or for use in patients with poor bone quality (e.g., osteoporosis, osteopenia). This device is intended only to be used with saline or radiopaque dye.

The provided text is a 510(k) summary for the VyLink™ Spinal Screw System, a medical device used for spinal fixation. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive clinical studies with specific acceptance criteria in the traditional sense of a diagnostic or AI-driven device.

Therefore, the document does not contain the requested information regarding acceptance criteria, device performance from a clinical study, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details.

The "Non-Clinical Testing" section states:

"The predicate Reliance Spinal Screw System has undergone Non-Clinical Testing including Static Compressive, Static Torsion, and Dynamic Compressive in accordance with ASTM F1717. The subject VyLink™ Spinal Screw System has the same design, size range, materials, indications of use, and biocompatibility as the predicate."

This implies that the VyLink™ Spinal Screw System was not subjected to independent testing to prove specific acceptance criteria. Instead, its substantial equivalence is based on having the same design, materials, and indications for use as a previously cleared predicate device that already met relevant performance standards (ASTM F1717 for mechanical testing).

If this were a submission for a diagnostic or AI-driven device, the information requested would be crucial. However, for a mechanical implant like a spinal screw system, the "acceptance criteria" are generally met through mechanical testing to established ASTM standards and demonstration of substantial equivalence to a predicate device.

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