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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, 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 non-sterile, 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-axial, uni-planar, and polyaxial and motion-limiting modular pedicle screws, as well as connecting spinal rods, hooks, connectors, crossbars, and a separate locking element. The instruments included in the Mariner Pedicle Screw System facilitate the placement, adjustment, 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 Mariner RDX System provides additional implants and instruments to expand the functionality of the Mariner platform and provide surgeons with reduction-integrated implants to allow for implant-based reduction techniques with an open or minimally invasive approach. Additional implants include a locking cap and a variety of modular standard tab, and MIS screw heads, as well as additional instruments and accessories.

The provided text describes a medical device, the Mariner RDX System, and its clearance by the FDA based on substantial equivalence to predicate devices, rather than a study proving the device meets acceptance criteria for a new type of performance or diagnostic capability. Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth cannot be extracted.

However, I can provide the following:

1. A table of acceptance criteria and the reported device performance

The provided document describes the non-clinical testing for the Mariner RDX System as follows:

2. Sample sized used for the test set and the data provenance

Not applicable. The clearance is based on non-clinical mechanical testing, not a clinical test set with patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. Ground truth from experts is not relevant for this type of mechanical testing.

4. Adjudication method for the test set

Not applicable. Adjudication methods are not relevant for this type of mechanical testing.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. The document explicitly states: "Clinical Testing: Not applicable. The determination of substantial equivalence is not based on an assessment of clinical performance data." This is a mechanical device, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used

For the non-clinical testing, the "ground truth" or standard for comparison was the mechanical performance of the predicate systems as defined by ASTM F1717.

8. The sample size for the training set

Not applicable. This is not an AI or algorithm-based device that requires a training set.

9. How the ground truth for the training set was established

Not applicable.

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