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Spineology Navigation Instruments are intended to be used during the preparation and placement of Spineology's Fortress, Threshold V2, and Palisade pedicle screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are 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, long bone, or vertebra, can be identified relative to a CT- or MR-based model, fluoroscopic images, or digitalized landmarks of the anatomy.

Spineology Navigation Instruments are non-sterile, reusable instruments; including awls, bone taps, drills, and screwdrivers that are operated manually. These instruments are manufactured from stainless steel in accordance with ASTM F899 and are intended to be used within the context and limitations of the indications for use for Spineology's FDA-cleared Fortress, Threshold V2, and Palisade Pedicular Fixation Systems and the Medtronic Synergy Experience StealthStation System 57 (v2.1.0).

The provided text is a 510(k) Summary for the Spineology Navigation Instruments. While it describes the device, its intended use, and indicates that design verification testing was conducted, it does not provide specific acceptance criteria or detailed results of a study that proves the device meets those criteria.

Here's an analysis of the information available and what is missing:

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

• Missing: The document states that "Design verification testing, including mating, registration, and accuracy, was conducted to ensure that Spineology Navigation Instruments are safe and effective for their intended use..." However, it does not list the specific acceptance criteria for "mating," "registration," or "accuracy." It also does not report the performance results (e.g., specific accuracy metrics, successful mating rates, or registration success rates) for the Spineology Navigation Instruments.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Missing: The document mentions "testing" but does not specify any sample sizes for the test sets used for mating, registration, or accuracy testing. It also does not provide any information regarding data provenance (e.g., country of origin, retrospective/prospective). This type of device typically uses in-vitro or bench testing, not patient data in the same way an AI/software device would.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

• Not Applicable/Missing: For a stereotaxic instrument, "ground truth" is typically established through precise engineering measurements and metrology, not expert review of images or clinical outcomes in the same way an AI diagnostic device would. If the "accuracy testing" involved human assessment of alignment, the number and qualifications of those individuals are not mentioned.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

• Not Applicable/Missing: Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving human interpretation or subjective assessments, often for establishing ground truth. For this type of device, which involves mechanical and software-based accuracy, "adjudication" in this sense is not relevant.

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: This is a physical navigation instrument intended for use with a pre-existing medical device (Medtronic StealthStation® System), not an AI algorithm designed to assist human readers (e.g., radiologists interpreting images). Therefore, an MRMC study related to AI assistance is not relevant to this submission.

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

• Not Applicable: This is a physical instrument. While the StealthStation® System has an algorithm component, the Spineology Instruments themselves are not standalone algorithms. The testing here focuses on the instruments' compatibility and physical performance when used with the StealthStation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not explicitly stated/Implied by Device Type: For "accuracy testing" of navigation instruments, the ground truth would typically be established through highly precise mechanical measurements against known reference points, using CMMs (Coordinate Measuring Machines) or similar metrology equipment, rather than clinical ground truth like pathology or outcomes data. The document does not explicitly state the method for establishing this ground truth.

8. The sample size for the training set

• Not Applicable: This is a medical device, not a machine learning or AI model that requires a training set.

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

• Not Applicable: As above, this is not an AI/ML device requiring a training set.

Summary of what is present in the document regarding the study:

• Study Description: Design verification testing was performed, including "mating, registration, and accuracy."
• Purpose of Study: To ensure the instruments are safe and effective, functional, compatible with the Medtronic StealthStation®, and substantially equivalent to the predicate device.
• Comparison: Accuracy testing included a "side-by-side comparison of Spineology Navigation Instruments to the predicate device."

In conclusion, while the document confirms that testing was performed, it lacks the detailed information requested regarding specific acceptance criteria, performance results, sample sizes, and detailed methodology for establishing ground truth, which are typically found in more comprehensive study reports or test protocols. This 510(k) Summary focuses on demonstrating substantial equivalence primarily through design and technological characteristics and high-level summaries of testing, rather than an in-depth clinical or performance study report.

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