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When used with the Mariner, Daytona Small Stature, Malibu, Newport, and Coral Spinal Systems:

The Mariner Outrigger Revision System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion system (T1-S2/ilum) in the treatment of the following acute and chronic instabilities or deformities:

· degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)

• · spondylolisthesis,
• · trauma (i.e., fracture or dislocation),
• · spinal stenosis,
• · deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
• · tumor,
• · pseudarthrosis (i.e., failed previous fusion)

When used with Daytona Small Stature Spinal System for posterior non-cervical pediativ patients, the Mariner Outrigger Revision System is also indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis (AIS), neuromuscular scoliosis. and congental scoliosis. Pedicle screw fixation is limited to a posterior approach.

The Mariner Outrigger Revision System is intended to be used with autograft or allograft.

The Mariner Outrigger Revision System is a thoracolumbar revision system designed to help reduce the trauma associated with revision surgeries by allowing the user the option to leave the existing hardware in and extend the construct or remove and replace with new SeaSpine hardware.

The Mariner Outrigger Revision System includes a variety of non-sterile implants manufactured from titanium alloy or cobalt chrome alloy and is comprised of various axial and parallel connectors of different shapes, rod slots, and also of various rods. The Mariner Outrigger Revision System is compatible with other SeaSpine posterior spinal fixation systems (e.g. Mariner, Davtona Small Stature, Malibu, Newport, and Coral Spinal Systems) which offer titanium and/or cobalt chrome alloy rods ranging in sizes of 04.5mm to Ø6.35mm.

The Mariner Outrigger Revision implants are manufactured from titanium alloy Ti-6Al-4V ELI (per ASTM F136), or cobalt chrome alloy (per ASTM F562). The instruments included in the system facilitate the placement, removal, adjustment, and final locking of the system implants. Other accessories to the system also include the trays and caddies for storage, protection, and organization prior to and during the steam sterilization process.

The provided document is a 510(k) premarket notification decision letter and summary for a medical device called the "Mariner Outrigger Revision System". This document does not describe the acceptance criteria and the study that proves the device meets the acceptance criteria in the context of an AI/ML device.

It is a traditional medical device approval, focusing on demonstrating substantial equivalence to a predicate device through mechanical testing, not a study evaluating AI/ML performance.

Therefore, the requested information regarding acceptance criteria, reported device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance for an AI/ML device cannot be extracted from this document.

The document explicitly states under "Clinical Testing": "Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data."

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