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"POINT" Kinguide Agile Hybrid Navigation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical and orthopedic procedures.

The device is indicated for pedicle screw entry point alignment and angular orientation when using a posterior approach into T12 and L1 vertebrae, and where reference to the rigid anatomical structure can be identified by intraoperative 3D reconstruction images.

"POINT" Kinguide Agile Hybrid Navigation System (Kinguide Agile) is an imageguided system (IGS) that consists of an infrared navigation camera, a system workstation (computer), navigation software, and surgical instruments. This medical device system can also be referred to as an orthopedic stereotaxic instrument (OLO) according to the U.S. FDA Device Classification.

Kinguide Agile uses optical positioning technologies to track the position of surgical instruments in relation to patient anatomy by means of Dynamic Reference Frames (DRFs) and identify the patient anatomical structure on intraoperative images (obtained using the 3D C-arm or CT*). The user loads the software to plan the surgical procedure and then registers the patient anatomy during surgery to allow the software to track the patient's anatomy and the navigable surgical instruments in real-time.

The software application primarily provides the stereotactic navigation function to match the coordinates of the patient anatomical structure and establishes a surgical navigation map. The user can perform the operation according to the surgical navigation map through the use of navigable surgical instruments. During surgery, the positions of navigable surgical instruments are continuously updated on the imaging system via optical tracking.

*CT image DICOM file reconstructed from the 3D C-arm or the same function equipment.

The "POINT" Kinguide Agile Hybrid Navigation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical and orthopedic procedures. Specifically, it is indicated for pedicle screw entry point alignment and angular orientation when using a posterior approach into T12 and L1 vertebrae, and where reference to the rigid anatomical structure can be identified by intraoperative 3D reconstruction images.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state the specific sample size used for the test set for the accuracy verification. It mentions a "Cadaveric Validation Report," suggesting that testing was performed on cadaveric specimens, which would be retrospective data. The provenance (country of origin) of this data is not specified.

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

The document does not specify the number of experts or their qualifications used to establish ground truth for the test set.

4. Adjudication Method for the Test Set:

The document does not mention any adjudication method used for the test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not mentioned. The device is a "Kinguide Agile Hybrid Navigation System," which is an image-guided system for surgical navigation, not an AI-assisted diagnostic tool that would typically involve human reader studies for comparative effectiveness.

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

Yes, a standalone performance evaluation of the device's accuracy was conducted. The "Non-clinical Performance (Accuracy)" section specifically states: "The system has a mean accuracy of ≤ 2.0 mm for location error and ≤ 2.0° for trajectory angle error." This refers to the intrinsic accuracy of the navigation system itself, independent of human interaction during the measurement process, aside from the initial setup and data acquisition.

7. The Type of Ground Truth Used:

The ground truth for the positional and trajectory accuracy would have been established through precise measurements using a highly accurate reference system (e.g., a calibrated measurement device or a pre-defined anatomical landmark with known coordinates) during the "Performance and Accuracy Verification Report" and "Cadaveric Validation Report." This is typically a technical ground truth rather than expert consensus or pathology.

8. The Sample Size for the Training Set:

The document describes the device as an image-guided navigation system and does not explicitly mention "training set" in the context of machine learning or AI models with distinct training phases. Therefore, no information is provided regarding the sample size for a training set.

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

As the document does not discuss a training set in the context of machine learning, it also does not elaborate on how ground truth for such a set would have been established. The core technology lies in optical positioning and image-to-patient registration, not typically in a machine learning model that requires a distinct training phase in the same way a diagnostic AI would.

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