Search Results

Ascent POCT System: When intended to promote fusion of the cervical spine-cervico-thoracic junction (Occiput - T3), the Ascent POCT System is indicated for: · Degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies); - · Spondylolisthesis; - · Fracture/dislocation; - · Spinal Stenosis; - · Atlanto-axial fracture with instability; - · Occipito-cervical dislocation' - · Tumors' - · Revision of previous cervical spine surgery. The occipital bone screws are limited to occipital fixation only. The use of the multi-axial screws is limited to placement in the upper thoracic spine (T1-T3) for the treatment of thoracic conditions only. They are not intended to be placed in the cervical spine. The lateral offset adapter is indicated for use in the upper thoracic spine (TI-T3). The hooks are intended to be placed from C1 to T3. The Songer Cables (titanum) System to be used with the Ascent POCT System allows for wire/cable attachment to the posterior cervical spine. The Ascent POCT System can also be linked to the Spinal Fixation System using the axial or parallel rod connector.

Centurion POCT System: The Centurion POCT 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 Centurion POCT 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 Centurion POCT System can also be linked to the Orthofix Spinal Fixation System using the Axial or Parallel Rod Connector.

Connector System: 1. 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. 2. 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 and stabilization 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 scoliosis. Pediation is limited to a posterior approach. The Connector System is intended to be used with autograft or allograft.

Spinal Fixation System (SFS): The Spinal Fixation System (SFS) is intended for non-cervical use in the spine. The Spinal Fixation System (SFS), when used for pedicle screw fixation, is intended only for patients: - · Having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint; - · Who are receiving fusion using autogenous bone graft only; - · Who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and - · Who are having the device removed after the development of a solid fusion mass. The Spinal Fixation System (SFS), when used as a pedicle screw system in skeletally mature patients, is intended to provide immobilization and stabilization of spinal segments, as an adjunct to fusion, in treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: a) Degenerative spondylolistheses with objective evidence of neurologic impairment; b) Fracture; c) Dislocation; d) Scoliosis: e) Kyphosis; f) Spinal tumor; and g) Failed previous fusion (pseudarthrosis). The Spinal Fixation System (SFS), when used for anterolateral non-pedicle screw fixation to the non-cervical spine, is intended for the following indications: a) Degenerative disc disease (as defined as back pain of discogenic origin with degenerative disc confirmed by history and radiographic studies); b) Spondylolistheses; c) Spinal stenosis; d) Spinal deformities (i.e., scoliosis, kyphosis, lordosis); e) Tumor: f) Pseudoarthrosis; g) Previous failed fusion; and h) Trauma (i.e., fracture or dislocation).

Firebird Spinal Fixation Systems: The Firebird Spinal Fixation Systems are intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion 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 fixation to the ilium, the offset connectors of the Firebird Spinal Fixation System must be used in conjunction with pedicle screws placed at the S1 or S2 spinal level. The Firebird Spinal Fixation Systems components are used with certain components of the Spinal Fixation System (SFS), including rods, rod connectors and cross-connectors. When used for posterior pedicle screw fixation in pediatric patients, the Firebird Spinal Fixation Systems are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Pediatric pedicle screw fixation is limited to a posterior approach. The Firebird Spinal Fixation Systems are intended to be used with autograft or allograft. The Phoenix MIS Fixation System when used with the Firebird Systems is indicated to provide the surgeon with a minimally invasive approach for posterior spinal surgery. The JANUS Midline Fixation Screw and the JANUS Fenestrated Screw when used with the Firebird Spinal Fixation Systems is indicated to provide the surgeon with an open, minimally invasive or midline approach for posterior spinal surgery. The JANUS Fenestrated Screws are intended to be used with saline and radiopaque dye.

FIREBIRD SI Fusion System: The FIREBIRD System is intended for fixation of sacroiliac joint disruptions, and intended for sacrolliac joint fusion for conditions including; · sacroiliac joint disruptions, · degenerative sacroiliitis, · to augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion and · Acute, non-acute, and non-traumatic fractures involving the sacroiliac joint.

Ascent POCT System - The Ascent POCT System is a temporary, multiple component system comprised of a variety of non-sterile, single use components made of titanium alloy or cobalt chrome alloy, that allow the surgeon to build a spinal implant construct. The Ascent POCT System consists of an assortment of rods, set screws, cross connectors, axial connectors, lateral offset adapters, multi-axial screws, hooks, plates, bone screws and songer cables. When used in the occipito-cervico-thoracic spine. the Ascent POCT System may be used from the Occiput to T3.

Centurion POCT System - The Centurion POCT System is a temporary, multiple component system comprised of a variety of non-sterile, single use components made of titanium allov or cobalt chrome alloy that allow the surgeon to build a spinal implant construct. The Centurion POCT System consists of an assortment of rods, set screws, axial connectors, lateral offset adapters, multi-axial screws, hooks, plates, bone screws, and cables (titanium).

Spinal Fixation System (SFS) - The Spinal Fixation System (SFS) is a temporary, titanium alloy, multiple component system comprised of a variety of non-sterile, single use components that allow the surgeon to build a spinal implant construct. The system is attached to the vertebral body by means of screws, and hooks to the non-cervical spine. The Spinal Fixation System consists of an assortment of screws, hooks, rods, spacers, staples, washers, dominos, lateral offsets, and cross-connectors. The Spinal Fixation System (SFS) titanium implants are not compatible with components or metal from any other manufacturer's system. The Spinal Fixation System (SFS) is intended for non-cervical use in the spine. When used as a nonpedicle anterolateral fixation system it may be used from levels T1 to S1. When used with pedicle screw fixation, the Spinal Fixation System (SFS) will be used at L5-S1, with the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation are L3 and below). When used as a posterior non-pedicle fixation system it may be used from levels T 1 to S1. When used as a non-pedicle anterolateral screw fixation system to the non-cervical spine, the staple and washer may be used from levels T6-L5.

Firebird Spinal Fixation Systems: (Firebird Deformity Spinal Fixation System, Phoenix MIS Spinal Fixation System, Phoenix CDX MIS Spinal Fixation System, JANUS Midline Fixation, Screws, Firebird NXG Spinal Fixation System, JANUS Fenestrated Screws)- The Firebird Spinal Fixation Systems include temporary, multiple component systems comprised of a variety of non-sterile and sterile single use components made of titanium alloy or cobalt chrome alloy that allow the surgeon to build a spinal implant construct. The systems are attached to the vertebral body and ilium by means of screw or hook fixation to the non-cervical spine. The systems consist of an assortment of rods, multi-axial and mono-axial pedicle screws, lateral offsets, bone screws, screw bodies, hooks, iliac connectors and sterile packed HA coated bone screws. A subset of the systems' components may be used in pediatric patients. These components consist of a variety of screws ranging in diameters from 4.0mm to 7.5mm and lengths ranging from 25mm to 60mm.

Connector System - 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, and Ascent POCT System) which offer titanium and/or cobalt chrome rods ranging in sizes of 3.0mm to 6.35mm.

FIREBIRD SI Fusion System - The FIREBIRD SI Fusion System is a temporary, multiple component system consisting of non-sterile instruments as well as both non-sterile and sterile, cannulated screws of various lengths and diameters with multiple fenestrations on their shafts. The FIREBIRD SI Screws are constructed from medical- grade titanium alloy (Ti-6Al-4V ELI). The 11mm and 12mm FIREBIRD SI Screws are 3D printed with a mid-shaft porous region. The porous titanium region has open macroscopic 3D pores with a microscopic roughened surface. The FIREBIRD SI Screw allows for packing of autograft and allograft materials. FIREBIRD SI Fusion System consists of cannulated, fenestrated 9mm, 11mm, and 12mm diameter implants in lengths ranging from 25mm to 70mm. The 9mm diameter implant maintains a single pitch thread along the entire shaft of the 11mm diameter implant features a tapered proximal end and dual-pitch threads. The 12mm diameter implant maintains a single pitch thread form on the proximal and distal ends. The principle of operation is based on the bone screw implants which are designed to prevent and minimize motion / micro motion of the sacroiliac (SI) joint, and thereby stabilize the joint or fracture. The mechanism of action is that the interference fit allows for fixation, stabilization and fusion.

The provided text is a 510(k) summary for several spinal fixation systems. This document outlines the devices' intended use, technological characteristics, and performance data related to MR Conditional labeling. It does not contain information about AI/ML algorithm acceptance criteria or studies proving device performance based on AI/ML.

Therefore, I cannot extract the requested information regarding:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method for the test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done.
6. If a standalone (algorithm only) performance was done.
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

This document focuses on the mechanical and material safety of the spinal implants in an MRI environment, not on the performance of a diagnostic or assistive AI/ML algorithm.

Ask a specific question about this device