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The AIS S4 Navigation Instruments are intended to assist the surgeon in precisely locating anatomical structures in either open, minimally invasive, or percutaneous procedures. They are indicated for use in surgical spinal procedures, in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the pelvis or a vertebrae can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy. These procedures include but are not limited to spinal fusion during the navigation of polyaxial screws (T1-T3).

The AIS S4 Navigation Instruments are manual surgical instruments which are designed to interface with BrainLAB's already cleared surgical navigation systems. Instruments in this system may be pre-calibrated or manually calibrated to already cleared systems using manufacturers' instructions. These instruments are intended to be used in spine applications to perform general or manual functions within the orthopedic surgical environment.

1. Table of Acceptance Criteria and Reported Device Performance:

The document explicitly states: "The AIS S4 Navigation Instruments met the performance requirements. No safety or effectiveness issues were raised by the performance testing." However, specific numerical acceptance criteria (e.g., accuracy thresholds, precision values) are not provided in this submission. The nature of the device (surgical navigation instruments designed to interface with other cleared systems) suggests that the performance requirements likely relate to the accuracy and reliability of tracking and spatial localization when used with the BrainLAB navigation systems.

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

The document states "BrainLAB conducted validation activities including usability testing with the AIS S4 Navigation Instruments." However, no information regarding the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective) is provided.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications:

The document does not describe the specific ground truth establishment process for the performance data. Therefore, the number of experts and their qualifications are not mentioned. Given that the performance data appears to be from "validation activities including usability testing," it's plausible that healthcare professionals were involved in assessing the usability and functionality, but their specific roles in establishing a quantifiable ground truth are not detailed.

4. Adjudication Method:

No adjudication method is described in the provided text.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC comparative effectiveness study is mentioned. The submission focuses on the standalone performance and equivalence of the AIS S4 Navigation Instruments when used with existing BrainLAB navigation systems, rather than comparing human readers with and without AI assistance.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance):

This submission is about surgical navigation instruments, which are physical tools that assist a surgeon; they are not an AI algorithm in the typical sense that would have "algorithm-only" performance without human interaction. The "performance data" described refers to "validation activities including usability testing" of the instruments themselves. Therefore, while technically these instruments are used "standalone" in the sense that they are physical tools, their performance is inherently tied to human use and their interface with the BrainLAB navigation system. The study described focuses on their functional performance in this context, rather than a quantifiable, algorithm-only output.

7. Type of Ground Truth Used:

The document mentions "validation activities including usability testing," and states that the instruments "met the performance requirements." This suggests the ground truth was likely based on functional assessment and verification against predefined specifications for accuracy, precision, and usability when integrated with the BrainLAB navigation systems. It is not explicitly stated to be based on expert consensus, pathology, or outcomes data in the traditional sense, but rather on the technical performance and usability of the instruments.

8. Sample Size for the Training Set:

This device is a set of physical surgical instruments, not an AI or machine learning algorithm that requires a "training set" of data. Therefore, this concept is not applicable, and no training set sample size is provided.

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

As the device is a set of physical surgical instruments and not an AI algorithm, there is no training set and therefore no ground truth establishment for a training set.

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