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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 system used to build constructs within the body to act as temporary or permanent non-cervical spinal fixation devices and is intended for use as a posterior pedicle screw fixation system, a posterior non-pedicle fixation system, and/or an anterolateral fixation system to correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusion to occur.

The Mariner Pedicle Screw System includes a variety of single-use implants manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F136) and/or cobalt chrome alloy (Co-28Cr-6Mo per ASTM F1537 or Co-35Ni-20Cr-10Mo per ASTM F562) and is comprised of fixed, uni-planar, and polyaxial and motion-limiting modular pedicle screws, as well as connecting spinal rods, hooks, connectors, crossbars, and a separate set screw locking element. The instruments included in the Mariner Pedicle Screw System facilitate the placement, final locking, and removal, if necessary, of the system implants, and accessories to the system include trays and caddies for storage, protection, and organization prior to and during the steam sterilization process.

The purpose of this submission is to add an additional set screw to the Mariner Pedicle Screw System.

This document describes a 510(k) premarket notification for the Mariner Pedicle Screw System (K212692). The relevant sections indicate that this is a medical device, not an AI/Software as a Medical Device (SaMD).

Therefore, the requested information regarding AI/SaMD acceptance criteria and study details (such as sample size for test/training sets, data provenance, expert ground truth establishment, MRMC studies, standalone performance, etc.) is not applicable to this submission.

The "Clinical Testing" section explicitly states "Not applicable. The determination of substantial equivalence is not based on an assessment of clinical performance data." This further confirms that no clinical studies as you've described for AI/SaMD were performed or required for this device's clearance.

The "Non-Clinical Testing" section describes mechanical testing performed to demonstrate substantial equivalence, but this pertains to the physical performance of the pedicle screw system, not an AI algorithm.

In summary, because this is a physical medical device (a pedicle screw system) and not an AI/SaMD, the questions about acceptance criteria for an AI algorithm and the detailed study design for an AI/SaMD are not relevant to this specific FDA submission.

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