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When used with the Centurion POCT System or Ascent POCT System for Posterior Occipital-Cervical-Thoracic (Occ -T3)
The Connector System is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine (T1 - T3): traumatic spinal fraumatic dislocations: instability or deformity; failed previous fusions (e.g. pseudoarthrosis); tumors involving the cervical/thoracic 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 Connector 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.

When used with the Firebird System/Phoenix MIS Spinal Fixation System or Spinal Fixation System (SFS) for Thoracic, Lumbar, and Sacral Spine Fixation (T1-S2/Ilium)
The Connector System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion as a pedicle screw fixation system (T1-S2/Ilium), or as an anterolateral fixation system (T8-L5), in the treatment of the following acute and chronic instabilities or deformities:

1. degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)
2. spondylolisthesis,
3. trauma (i.e., fracture or dislocation),
4. spinal stenosis,
5. deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
6. tumor.
7. pseudoarthrosis, and
8. failed previous fusion
   When used for posterior pedicle screw fixation in pediatric patients, the Connector System implants are indicated as an adjunct to fusion to treat adolescent idiopathic screw fixation is limited to a posterior approach. The Connector System is intended to be used with autograft or allograft.

The Connector System is designed to reduce the complexity of revising and extending existing constructs from the Occiput to the Ilium. The Connector System includes a variety of non-sterile implants manufactured from titanium alloy comprised of bypass connectors, rod to rod connectors, Z rods, and an axial in-line connector with an attached rod. The Connector System implant options offered eliminate the need to remove existing hardware while providing stability to adjacent levels. The Connector System is compatible with posterior spinal fixation systems (e.g. Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System, Spinal Fixation System, Centurion POCT System, Ascent POCT System) which offer titanium and/or cobalt chrome rods ranging in sizes of 3.0mm to 6.35mm.

The provided text is a 510(k) premarket notification for a medical device (Connector System). It describes the device's intended use, technological characteristics, and comparison to predicate devices, focusing on demonstrating substantial equivalence. However, it does not contain the information required to answer your specific questions regarding acceptance criteria and performance study details typical for an AI/ML powered medical device.

The document details mechanical performance testing for the physical connector system (e.g., static compression bending, static torsion, dynamic compression bending) against industry standards like ASTM F1717 and F1798. It does not describe:

• Acceptance criteria for an AI/ML algorithm.
• Performance of an AI/ML algorithm (e.g., sensitivity, specificity, AUC).
• Sample sizes for test sets or training sets for AI.
• Data provenance, expert ground truth establishment, or adjudication methods for an AI study.
• Details of a multi-reader multi-case (MRMC) study or standalone AI performance.

Therefore, I cannot extract the information to fill out the table and answer the study-related questions as if this were an AI/ML device submission. This document pertains to a traditional orthopedic implant.

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The EXPEDIUM Spine System and VIPER and VIPER 2 Systems are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment chronic instabilities or deformities of the thoracic, lumbar and sacral spine.

The EXPEDIUM Spine System and VIPER 2 Systems are intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor, pseudoarthrosis; and failed previous fusion in skeletally mature patients.

When used in a posterior percutaneous approach with MIS instrumentation, the VIPER and VIPER 2 Systems are intended for noncervical pedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor, pseudoarthrosis; and failed previous fusion in skeletally mature patients.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the EXPEDIUM Spine System and VIPER and VIPER 2 Systems metallic implants are indicated as an adjunct to treat adolescent idiopathic scoliosis. The EXPEDIUM Spine System and VIPER 2 Systems are intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The EXPEDIUM and VIPER/VIPER 2 Spine Systems are metallic implants intended to provide immobilization and stabilization of spinal segments. They can be used for skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine; or for posterior non-cervical pedicle screw fixation in pediatric patients as an adjunct to fusion to treat adolescent idiopathic scoliosis. The EXPEDIUM and VIPER/VIPER2 systems are intended to be used with autograft and/or allograft.

The EXPEDIUM Spine System consists of longitudinal rods, monoaxial screws, polyaxial screws, uniplanar screws, reduction screws, cable/wire screws, bolts, slotted connectors, wires, hooks, reduction hooks, transverse connectors, SFX Cross Connector System, dual rod connectors, sacral extenders, lateral connectors, and washers. The VIPER and VIPER 2 Systems consist of cannulated polyaxial screws, monoaxial screws, uni-planar screws, reduction screws, and rods used in a percutaneous approach.

This document is a 510(k) premarket notification for spinal systems (EXPEDIUM Spine System, VIPER and VIPER 2 Systems) and primarily focuses on demonstrating substantial equivalence to existing predicate devices based on technological characteristics, materials, and intended use. It does not contain information about the performance or acceptance criteria of a new device or software algorithm, nor does it describe a study proving such a device meets acceptance criteria.

The document discusses:

• Device Description: Spinal systems consisting of metallic implants (rods, screws, connectors) intended for immobilization and stabilization of spinal segments.
• Indications for Use: Treatment of chronic instabilities, deformities, degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, curvatures, tumor, pseudoarthrosis, and failed previous fusion in skeletally mature patients, and adolescent idiopathic scoliosis in pediatric patients.
• Materials: Commercially pure titanium, titanium alloy, stainless steel, cobalt-nickel-chromium-molybdenum alloy, and cobalt-chromium-molybdenum alloy.
• Performance Data: References only mechanical testing (ASTM F1717) and optical/visual analysis for corrosion compatibility of materials, stating that these materials are compatible even in aggressive environments for the duration expected for spinal fusion.

Therefore, based on the provided text, I cannot extract the requested information regarding acceptance criteria, device performance, study design (sample size, data provenance, expert review, adjudication, MRMC, standalone performance), or ground truth establishment for an AI/software device.

The document's "Performance Data" section specifically addresses the compatibility of the materials used in the predicate and subject devices, not the performance of a digital health or AI/ML-enabled device. It confirms material compatibility through mechanical testing and corrosion analysis, which is typical for implantable medical devices, but not for software or AI performance related to diagnostic or evaluative tasks.

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