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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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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 reusable instruments are specifically designed for use with the Medtronic Stealth Station 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 SeaSpine Navigation System reusable instruments are Class II, manual, surgical instruments for use with the Medtronic StealthStation Navigation System S7 (v.2.1.0) and NavLock Tracker, to assist surgeons in precisely locating anatomical structures in either open, minimally invasive, or percutaneous procedures for preparation and placement of SeaSpine implants. This surgical imaging technology provides surgeons visualization for complex and MIS procedures and confirms the accuracy of advanced surgical procedures. Use of these navigation systems provides the surgeon access to real-time, multi-plane 3D images (and 2D images) providing confirmation of hardware placement. The instruments are manufactured from stainless steel per ASTM F899.

The SeaSpine Navigation Instruments include the following:

• Taps .
• Awl/Tap
• Probe ●
• Drills ●
• Drill/Tap Guides

The SeaSpine Navigation Instruments are to be used with the following FDA cleared SeaSpine Spinal Systems:

• Atoll
• Coral/Coral MIS ●
• Malibu Spinal System/Daytona ●
• Malibu Spinal System
• Daytona Small Stature ●
• Mariner Spinal System
• NewPort MIS ●
• . Sierra

This document describes the premarket notification (510(k)) for the SeaSpine Navigation System. Based on the provided text, the device is a set of reusable surgical instruments intended to assist surgeons in spinal surgery by precisely locating anatomical structures when used with the Medtronic StealthStation System.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of acceptance criteria and the reported device performance:

The document does not present explicit, quantitative acceptance criteria in a pass/fail table with numerical targets. Instead, the "Non-Clinical Testing" section describes a series of tests performed to ensure "compatibility, accuracy, function, and performance" of the SeaSpine Navigation System reusable instruments, aiming for substantial equivalence to predicate devices. The reported device performance is qualitative, stating that the tests were completed and "demonstrate that the SeaSpine Navigation System reusable instruments are substantially equivalent to the predicate."

Here's a summary of the tests and their qualitative outcomes as reported:

2. Sample size used for the test set and the data provenance:

The document describes "engineering analysis" and "non-clinical testing" which involve physical testing of instruments and CAD model evaluation. It does not refer to a "test set" in the context of patient data or clinical images. The data provenance is from the manufacturer's internal testing as part of their 510(k) submission. No information about country of origin of data or whether it's retrospective/prospective is provided as it's not a clinical study.

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

This is not applicable. The evaluations are engineering tests (e.g., dimensional measurements, rigidity, functional checks with the navigation system), not interpretations of clinical data requiring expert consensus or ground truth establishment by medical professionals.

4. Adjudication method for the test set:

Not applicable. There's no clinical test set requiring adjudication.

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

Not applicable. The device is a set of surgical instruments used with a navigation system, not an AI-powered diagnostic or assistive tool that would typically undergo an MRMC study. The submission focuses on substantial equivalence based on engineering and functional testing of the instruments themselves.

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

Not applicable. The device is a physical set of instruments, not a standalone algorithm. Its function is explicitly with human-in-the-loop (the surgeon) and with another medical device (Medtronic StealthStation System).

7. The type of ground truth used:

The "ground truth" for this device's evaluation is primarily based on:

• Engineering specifications and measurements: For dimensional accuracy, rigidity, etc.
• Functional performance criteria: Ensuring instruments register correctly, mate properly, and function as intended with the predicate navigation system.
• Comparison to predicate devices: The goal is substantial equivalence, meaning the performance is comparable to already marketed devices.

It is not based on expert consensus, pathology, or outcomes data, as this is a device for surgical assistance, and the submission primarily relies on non-clinical performance data for substantial equivalence.

8. The sample size for the training set:

Not applicable. This device is a set of physical instruments engineered for specific functions. There isn't a "training set" in the machine learning context.

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

Not applicable, as there is no training set for this device type.

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