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The ExcelsiusGPS is intended for use as an aid for precisely locating anatomical structures and for spatial positioning and orientation of an instrument holder or guide to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy. The system is indicated for the placement of spinal and orthopedic bone screws and interbody spacers, and intracranial devices including biopsy needles, electrodes, and tubes.

The ExcelsiusGPS® Cranial Module includes hardware and software that enables real time surgical navigation using radiological patient images (MRI, CT, and fluoroscopy), using a dynamic reference base and positioning camera. The navigation system determines the registration or mapping between the virtual patient (points on the patient images) and the physical patient (corresponding points on the patient's anatomy). Once this registration is created, the software displays the relative position of a tracked instrument on the patient images. As an aid to visualization, the surgeon can plan trajectories for instrument placement on the patient images prior to surgery. Registration provides the necessary information to provide visual assistance to the surgeon during freehand navigation. During surgery, the system tracks the position of GPS compatible instruments in or on the patient anatomy and continuously updates the instrument position on patient images utilizing optical tracking. System software is responsible for all navigation functions, data storage, network connectivity, user management, case management, and safety functions. ExcelsiusGPS® surgical instruments include non-sterile, re-usable instruments and sterile instruments that are operated manually or with the use of the positioning system.

The ExcelsiusGPS® Cranial Module is designed to assist with stereotactic procedures that include guidance to cranial targets for instrument navigation and device placement. Instruments consist of end effector instruments, registration instruments, navigated instruments, patient positioning instruments, and surgical instruments. End effector instruments include instruments to the Interchangeable Guide End Effector. Registration and navigated instruments incorporate unique array patterns with reflective markers, and are used to track patient anatomy and surgical instruments. Patient positioning instruments aid in patient fixation. Surgical instruments are used to access and prepare the local site and place devices, such as needles, electrodes, and tubes.

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

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

The document does not explicitly state the specific sample size for the "human cadaveric quantitative validation" study or the "surgical simulations conducted on phantom models cranial sawbone models." It mentions "phantom models cranial sawbone models" and "human cadaveric quantitative validation under clinically relevant scenarios." The provenance of the data (country of origin, retrospective/prospective) is not specified.

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)

This information is not provided in the document.

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

The document does not describe any adjudication method for establishing ground truth or evaluating device performance.

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

No MRMC comparative effectiveness study involving human readers and AI assistance is mentioned in the provided text. The device is a computer-assisted surgical system, not an AI diagnostic tool that assists human readers.

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

The performance testing described (navigational accuracy) appears to be a standalone assessment of the algorithmic/system accuracy for position and angle. The device itself is described as a "computer-assisted surgical device" that provides "real-time surgical navigation" and "visual assistance to the surgeon," implying that the reported accuracy values relate to the algorithm's ability to track and guide instruments.

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

For the "surgical simulations conducted on phantom models cranial sawbone models," the ground truth was likely derived from the known physical properties and measurements of these models. For the "human cadaveric quantitative validation," the ground truth would typically be established by precise physical measurements of the actual position and angle of instruments relative to anatomical landmarks on the cadaver, using highly accurate measurement tools independent of the device under test. The document does not specify the exact method for establishing this ground truth.

8. The sample size for the training set

This information is not provided in the document. The document describes verification and validation testing, but not details about a training set for machine learning models.

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

Since no training set information is provided, the method for establishing its ground truth is also not mentioned.

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