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The EasyGuide is intended for planning neurosurgery and for localizing and navigating during neurosurgery. The EasyGuide facilitates image-supported decisions that may lead to more effective craniotomies, fewer unforeseen complications and shorter surgery times. As an interactive lightbox, Philips EasyGuide Neuro can facilitate image-based decision making. Anatomical structures can be visualized and surgical paths precisely determined before surgery. Decisions on the location and size of a tumor, or an arteriovenous malformation can be made with confidence. Critical areas can be identified and avoided for better access to pathology.

The Philips EasyGuide Neuro is an image guided surgery system for use in planning, localization, and navigation of neurosurgery. The system includes a mobile workstation (based on the Easyvision workstation platform K925950), position digitizer, and dedicated instruments. The workstation is a combination of a Sun SPARC for running the EasyGuide software and a computer for processing the data from the position digitizer. The optical position digitizer uses two infrared CCD cameras mounted on a titanium alloy sub-frame and has a laser for easy positioning of the cameras. The instruments (pointers) are equipped with infrared light emitting diodes (LED). Signals from the LEDs are received by the CCD cameras. The computer processes this information and calculates the position, direction, and rotation of the pointer tip in space. The point of space is then shown on the monitor, overlaid on the image generated from the pre-operative scans.

The Philips EasyGuide Neuro is an image guided surgery system for use in planning, localization, and navigation of neurosurgery. While the input document provides details on the system description, performance standards, safety information, and intended use, it does not contain specific acceptance criteria tables or detailed study designs that definitively "prove" the device meets such criteria in a statistically rigorous manner.

However, based on the provided text, we can infer a key performance metric and a qualitative assessment of the device's benefits.

Here's an attempt to structure the information based on your request, acknowledging the limitations of the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly state "acceptance criteria" with predefined thresholds. The "reported device performance" is derived from the results of the clinical evaluation described.

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

• Sample Size: The document refers to "the patient population in the study" for which the mean RMSE was calculated. A specific number for this patient population/test set is not provided.
• Data Provenance: The system "has been extensively investigated during clinical trials in the United States and Europe." This indicates a prospective nature for at least part of the data collection in a clinical setting across multiple geographies.

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

• The document describes a comparative planning study where "two plannings for neurosurgery were made: a planning using conventional means... and a planning using EasyGuide Neuro interactively." These were performed by neurosurgeons or medical professionals involved in neurosurgical planning.
• The comparison involved "Both incision lines and planned craniotomy were compared in term of size. Shape and location (centering)."
• Number of Experts: Not explicitly stated. It implies at least one neurosurgeon or planning expert for each planning method ("a planning... was performed prior to using EasyGuide Neuro," and "a planning using EasyGuide Neuro interactively... led to a second incision line.").
• Qualifications of Experts: Implied to be neurosurgeons or professionals involved in neurosurgical planning. No specific years of experience or board certifications are mentioned.

4. Adjudication Method for the Test Set

• The document describes a comparison between two planning methods (conventional vs. EasyGuide Neuro). The comparison was made "in term of size. Shape and location (centering)" of incision lines and planned craniotomy.
• Adjudication Method: The text does not describe a formal adjudication process (e.g., 2+1, 3+1). It appears to be a direct comparison of the outputs of the two planning methods, likely assessed by the involved surgeons or study investigators.

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

• No, an MRMC comparative effectiveness study is not explicitly described. The study focused on comparing two planning methods (conventional vs. EasyGuide Neuro) rather than comparing multiple human readers' performance with and without AI assistance. The "assistance" itself is the EasyGuide Neuro system.
• Effect Size: Therefore, no effect size of how much human readers improve with AI vs. without AI assistance is reported. The benefit is framed as the system's ability to achieve "significantly smaller craniotomies" and offering other clinical advantages compared to conventional methods.

6. Standalone (Algorithm Only) Performance

• Yes, in part. The "mean RMSE = 4.1 mm" for neuronavigation accuracy is a standalone performance metric of the system's ability to correlate a point in space with pre-operative images, distinct from comparing human decision-making. The system's interactive nature means the "algorithm only" aspect is integrated with human review, but the RMSE is a measurement of the system's intrinsic accuracy.

7. Type of Ground Truth Used

• Inferred based on the study design:
  • For the "mean RMSE = 4.1 mm," the ground truth for navigation accuracy would likely involve physical phantom measurements and/or intraoperative verification (e.g., comparing the system's indicated position with known anatomical landmarks or actual surgical targets). The document states the "interactive portion (the optical position digitizer) has been tested in both laboratory and clinical environments," supporting this inference.
  • For the craniotomy size and clinical benefits, the ground truth was based on the outcome and assessment of surgical planning by medical professionals in a clinical setting compared to conventional methods. This can be considered a form of expert assessment/consensus on clinical utility and efficacy.

8. Sample Size for the Training Set

• Not provided. The document describes a study to evaluate benefits and effectiveness, implying a test or evaluation cohort. There is no information about a separate training set or the process of training the system (as it predates modern deep learning paradigms for most medical devices of this era).

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

• Not applicable/Not provided. As no training set information is given, the method for establishing its ground truth is also not mentioned. The system appears to rely on established engineering principles for image processing, digitization, and anatomical correlation rather than a machine learning model requiring a distinct training phase in the modern sense.

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