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1. 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. .

2. The SeaSpine® Navigation System reusable instruments are intended to be used during the preparation and placement of SeaSpine screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The SeaSpine® Navigation System reusable instruments are specifically designed for use with the Medtronic® StealthStation™ System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy.

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 screw fixation system, or as 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 and a separate locking element.
The Mariner implants are manufactured from titanium alloy Ti-6A1-4V ELI (per ASTM F136), and cobalt chrome (Co-35Ni-20Cr-10Mo per ASTM F562 and Co-28Cr-6Mo per ASTM F1537). 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 also include the trays and caddies for storage, protection, and organization prior to and during the steam sterilization process.
The SeaSpine Navigation System instruments are manual, surgical instruments that assist surgeons in precisely locating anatomical structures in either open, minimally invasive, or percutaneous procedures for preparation and placement of pedicle screw system implants. The SeaSpine Navigation Instruments will be incorporated into the Mariner Pedicle Screw System.
With an increased demand for less invasive posterior fixation, the Mariner MIS Pedicle Screw System will offer instrumentation to its existing modular implant design to assist surgeons with MIS techniques.

The provided text is related to a 510(k) submission for the Mariner MIS Pedicle Screw System and the SeaSpine Navigation System. It primarily focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a detailed clinical study for novel acceptance criteria.

Therefore, the document does not contain the information required to populate a table of acceptance criteria, reported device performance, or details about a study proving the device meets those criteria.

Specifically, the document states:

• "Non-clinical mechanical testing was not performed on the subject devices. The subject devices are the same as the predicate devices in terms of materials, sizes, and intended use. The subject devices do not introduce a new worst case. Engineering analyses of the subject devices determined that no additional mechanical testing is necessary." (Page 6)
• "Clinical Testing: Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data." (Page 7)

Because no clinical performance data was provided or deemed necessary for this 510(k) submission (as it relies on substantial equivalence to existing predicate devices), there is no information about:

1. Acceptance criteria or device performance: No specific performance metrics or thresholds are mentioned.
2. Sample size and data provenance: No test or training sets were used for clinical performance evaluation.
3. Experts for ground truth: Not applicable as there was no clinical study requiring ground truth establishment.
4. Adjudication method: Not applicable.
5. MRMC comparative effectiveness study: No such study was conducted.
6. Standalone performance: No standalone algorithm performance was evaluated, as this is a medical device for spinal surgery, not an AI/algorithm-based device in the context typically discussed for such studies.
7. Ground truth type: Not applicable.
8. Training set sample size: Not applicable.
9. Ground truth for training set: Not applicable.

In summary, this document is a regulatory submission for substantial equivalence based on engineering analysis and comparison to existing predicate devices, not a clinical study designed to establish performance against novel acceptance criteria.

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