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The Stryker Navigation System - Neuro Module is intended as a planning and intraoperative guidance system to enable open or percutaneous image guided surgery. The system is indicated for any neurological medical condition in which the use of image guided surgery may be appropriate, and where a reference to a rigid anatomical structure can be identified relative to medical images.

The Stryker Navigation System - Neuro Module provides precise stereotactic determiniation of surgical targets using a stereotactic methdology. The three principle features include computer calculation of stereotactic coordinates from the diagnostic images, measurement of stereotactic coordinates within the surgical field, high-resolution computer display of diagnostic images with stereotactic coordinates indicated. The system is comprised of hardware and software components.

The provided text describes a 510(k) premarket notification for the Stryker Navigation System - Neuro Module. It focuses on demonstrating substantial equivalence to existing devices rather than presenting detailed acceptance criteria and a study proving device performance against specific criteria. Therefore, much of the requested information regarding a specific study and its methodology is not available in the provided document.

However, based on the text, we can infer some aspects and highlight what is missing.

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly provided in the document. The document states that the device provides "precise stereotactic determination of surgical targets using a stereotactic methodology" and highlights features like "computer calculation of stereotactic coordinates from the diagnostic images" and "measurement of stereotactic coordinates within the surgical field." However, specific numerical acceptance criteria (e.g., accuracy +/- X mm) and corresponding measured performance values are absent.

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided. The document does not describe a specific test set of data used to evaluate the device's performance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not provided. As there's no described test set, there's no mention of experts establishing ground truth for it.

4. Adjudication Method for the Test Set

This information is not provided. Without a described test set, there's no mention of an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This information is not provided. The document makes no mention of AI or a comparative effectiveness study involving human readers. The device is a "Navigation System," implying it aids surgeons directly rather than having human readers interpret its output.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not explicitly provided as a standalone performance study. The document describes the system as one contributing to "precise stereotactic determination" and involving "computer calculation" and "measurement within the surgical field." This indicates the system's function, but it doesn't detail a standalone performance study with specific metrics and results. The focus is on its technical capabilities and equivalence to existing devices.

7. The Type of Ground Truth Used

This information is not explicitly provided. Given the nature of a navigation system, ground truth would likely involve highly accurate physical measurements or potentially anatomical landmarks verified through other precise imaging or surgical techniques. However, the document does not specify how ground truth was established for any performance evaluation.

8. The Sample Size for the Training Set

This information is not provided. The document does not describe AI or machine learning components that would require a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not provided. As there's no mention of a training set, this information is not relevant to the provided text.

Summary of the Document's Approach to Demonstrating Acceptability:

The provided document primarily relies on demonstrating substantial equivalence to existing, legally marketed image-guided surgery systems. Key statements supporting this include:

• "The Stryker Navigation System - Neuro Module is equivalent in intended use, safety, and effectiveness to existing image guided surgery systems begin marketed by companies such as Sofamor Danek, Zeiss, and BrainLab."
• "The Stryker Navigation System - Neuro Module does not raise any new safety and efficacy concerns when compared to similar devices already legally marketed."
• "Therefore, the Stryker Navigation System - Neuro Module is substantially equivalent to these existing devices."

This approach means that the "acceptance criteria" were effectively met by showing that the new device functions similarly to and is as safe and effective as predicate devices that have already demonstrated their safety and effectiveness to the FDA. The document focuses on describing the device's intended use and technical features that align with established stereotactic methodologies, rather than presenting a novel study with specific quantitative performance criteria for FDA review.

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