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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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The intended use of the Mariner Pedicle Screw System is to provide immobilization 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,

• severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusions by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion,

• spondylolisthesis,

• trauma (i.e., fracture or dislocation),

• spinal stenosis.

• deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),

• spinal tumor,

• pseudoarthrosis, and/or

• failed previous fusion.

The SeaSpine Mariner Pedicle Screw system is a system consisting of instruments and single-use implants intended to build constructs within the body to act as a temporary or permanent posterior, non-cervical pedicle fixation system, or an anterolateral fixation system to correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusions to occur.

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

This document is a 510(k) premarket notification from the FDA regarding the Mariner Pedicle Screw System by SeaSpine Orthopedics Corporation. It establishes substantial equivalence to previously marketed devices and does not describe acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML medical device.

Therefore, I cannot provide the requested information for acceptance criteria and a study proving a device meets them because:

• This document is for a traditional medical device (pedicle screw system), not an AI/ML medical device. The questions posed are highly specific to the evaluation of AI/ML algorithms, particularly the use of test sets, ground truth establishment by experts, and analysis of AI-augmented human reader performance.
• The document explicitly states "Clinical Testing: Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data." This further confirms that no clinical study (or AI/ML performance study) was conducted or presented in this 510(k) submission to demonstrate performance against specific acceptance criteria for an AI/ML algorithm.

The non-clinical testing mentioned refers to mechanical testing of the physical screw system components (static and dynamic cantilever mechanical testing with reference to ASTM F1717 and screw head disassociation testing), which is standard for orthopedic implants, not AI/ML software.

The document's purpose is to establish that the new pedicle screw system is substantially equivalent in design, materials, and intended use to predicate devices already on the market, thereby demonstrating safety and effectiveness without requiring new clinical trials.

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