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The intended use of the Mariner Pedicle Screw System in a posterior or anterolateral approach is to provide immobilization and stabilization 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.

The indications for use are as follows:

• degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies,
• . spondylolisthesis,
• trauma (i.e., fracture or dislocation),
• spinal stenosis,
• deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
• spinal tumor,
• pseudarthrosis, and/or
• failed previous fusion.

The Mariner Pedicle Screw System is a non-cervical spinal fixation device and instrumentation system intended for use as a posterior pedicle screw fixation system, a posterior non-pedicle fixation system, and/or an anterolateral fixation system. The system consists of single-use implants including fixed, polyaxial, cephalad/caudal restricted-motion, and medial/lateral restricted-motion pedicle screws as well as connecting spinal rods, crossbars, connectors, and a separate locking element. The Mariner implants are manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F136) and/or cobalt chrome alloys (Co-28Cr-6Mo per ASTM F1537 or Co-35Ni-20Cr-10Mo per ASTM F562). The instruments included in the Mariner Pedicle Screw System facilitate the placement, removal, adjustment, and final locking of the system implants. Other accessories to the system include trays and caddies for storage, protection, and organization prior to and during the steam sterilization process.

The Mariner Deformity System provides additional implants and instruments that expand the functionality of the Mariner platform and provide surgeons with a comprehensive modular system to address adult deformity applications. Additional implants include pre-contoured and constrained rods, uni-planar and fenestrated screws, hooks, lateral connectors, and modular screw heads, including those with a rigidly attached rod connector, as well as instruments for pedicle subtraction osteotomy, iliac fixation, reduction, and correction.

This document is a 510(k) Premarket Notification from the FDA regarding the "Mariner Deformity System." It does not include information about AI/ML device performance or clinical study findings to prove performance against acceptance criteria. The document explicitly states: "Clinical Testing: Not applicable. The determination of substantial equivalence is not based on an assessment of clinical performance data."

Therefore, I cannot provide the requested information, such as:

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 or their qualifications.
4. Adjudication method for the test set.
5. MRMC study details or effect size.
6. Standalone performance details.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This is a traditional medical device submission, cleared based on substantial equivalence to existing predicate devices through mechanical testing, not a de novo or premarket approval for an AI/ML-driven diagnostic or prognostic device that would require a clinical performance study against specific acceptance criteria.

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