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When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients using bone graft, the TSRH® Spinal System is indicated for one or more of the following: (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) degenerative spondylolisthesis with objective evidence of neurologic impairment, (3) fracture, (4) dislocation, (5) scoliosis, (6) kyphosis, (7) spinal tumor, and/or (8) failed previous fusion (pseudarthrosis).

In addition, when used as a pedicle screw fixation system, the TSRH® Spinal System is indicated for skeletally mature patients using bone graft: ( 1 ) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (LS-S1) vertebral joint: (2) who are receiving fusions using autogenous bone graft only: (3) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (4) who are having the device removed after the development of a solid fusion mass.

When used as a posterior, non-cervical, non-pedicle screw fixation system, the TSRH® Spinal System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spondylolisthesis, (3) fracture, (4) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (5) spinal stenosis, (6)pseudarthrosis, (7) tumor resection, and/or (8) unsuccessful previous attempts at spinal fusion.

When used as a unilateral supplemental fixation device in the antero-lateral thoracic/lumbar region, the TSRH® L-Plate and VANTAGE™ screws are intended for the following indications: spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudarthritis; and/or failed previous fusion.

For anterior use only the TSRH® Spinal System has the additional indication of: spondylolysis.

The TSRH® Spinal System consists of a variety of shapes and sizes of rods, hooks, screws, cross connectors, staples, plates, and connecting components, as well as implant components from other Medtronic spinal systems, which can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case.

Certain implant components from other Medtronic spinal systems can be used with the TSRH® Spinal System. These components include GDLH® rods, rod/bolt connectors, Variable Angle T-bolts, set screws and locking screws; DYNALOK@ PLUS bolts, CD HORIZON® Low Profile MULTI-SPAN® CROSSLINK® Plates, VANTAGE™ Anterior Fixation System screws, as well as CD HORIZON® rods, screws, set screws and locking screws.

The hooks are intended for posterior use only and the staples are for anterior use only. The TSRH-3D® and TSRH-3DX™ connectors, and TSRH-3D® and TSRH-3DX™ screws are intended for posterior use only. The cobalt chromium rods should only be used with TSRH® 3Dx™ Spinal System. All CROSSLINK® Plates are for posterior use and the CROSSLINK® Axial and Offset Plates may be used anteriorly as well.

Currently, the TSRH® System components are fabricated from medical grade stainless steel, medical grade titanium alloy, or medical grade titanium. The subject components will be manufactured from medical cobalt-chromium-molybdenum alloy described by ASTM F1537. Medical grade titanium, titanium alloy, and/or cobaltchromium-molybdenum alloy may be used together. Never use titanium, titanium alloy, and/or cobalt-chromium-molybdenum alloy with stainless steel in the same construct. The TSRH® Spinal System may be sold sterile or non-sterile.

To achieve best results, do not use any of the TSRH® Spinal System implant components with components from any other system, except those components listed above, or any other manufacturer. As with all orthopaedic and neurosurgical implants, none of the TSRH® Spinal System components should ever be reused under any circumstances.

The provided text is a 510(k) summary for the TSRH® Spinal System, which is a medical device. This type of document is for regulatory clearance and focuses on demonstrating substantial equivalence to existing devices rather than proving a device meets specific performance criteria through a controlled study, especially in the context of an AI/ML device.

Therefore, the document does not contain the information requested for acceptance criteria and a study proving a device meets those criteria, as typically found for AI/ML performance evaluations.

Specifically, the document discusses:

• Device Description: The TSRH® Spinal System consists of various components for spinal fixation.
• Purpose of Submission: To add cobalt chrome rods (already cleared with another system) to the TSRH® Spinal System.
• Indications for Use: Detailed surgical conditions for which the system is intended.
• Substantial Equivalence: The primary focus is on demonstrating that the new cobalt-chrome rods are substantially equivalent to previously cleared components and predicate devices (other spinal systems) through mechanical testing.

There is no mention of:

• Acceptance criteria for performance metrics (e.g., sensitivity, specificity, accuracy).
• A study involving a test set, training set, ground truth establishment, expert readers, or comparative effectiveness with AI.
• Any AI/ML components in the device.

This document pertains to the regulatory clearance of a physical medical implant (spinal system), not a software or AI-driven diagnostic/decision support tool where the requested performance metrics and study details would be relevant.

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