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iPlan's indications for use are the viewing, presentation and documentation of medical imaging, including different modules for image processing, image fusion, atlas assisted visualization and segmentation, intraoperative functional planning where the output can be used e.g. with stereotactic image guided surgery or other devices for further processing and visualization.

Example procedures include but are not limited to:

• Planning and simulation of cranial surgical procedures such as tumor resection, shunt placement, minimal-invasive stereotactic interventions, biopsy, trajectory planning for stimulation and electrode recording
• ENT procedures such as sinus surgery, tumor surgery -
• Spine procedures such as tumor surgery, pedicle screw planning, vertebroplasty planning
• iPlan View is an application which is intended to be used for reviewing existing treatment plans

Following planning sub-modules are available in the functional applications: Load and Import, View and Adjustment, Registration Points, ACPC Localization, Localization, Image Fusion, Object Creation, Advanced Object Planning, BOLD MRI mapping, Fiber Tracking, Trajectory planning, Stereotactic planning, Electrode recording, Save and Export.

The provided text describes the 510(k) summary for the iPlan device (K101627). However, it does not contain specific details about acceptance criteria, device performance metrics, sample sizes, ground truth establishment, or any formal study results (like MRMC comparative effectiveness studies or standalone performance studies) that prove the device meets acceptance criteria.

The document states that:

• "On different levels of development (module, subsystem, system) specific bench and integration tests were conducted."
• "Internal standards were tested and documented as conformance report, environment compatibility and interfaces."
• "Compatibility with previous version and comparable workflows to predicate devices were documented in corresponding review protocols."
• "Side-by-side comparison testing of the new version of iPlan with its predicate device was conducted to determine substantial equivalences of the new version of iPlan with its predicate version."

This indicates that testing was performed, but the results, specific acceptance criteria, and detailed methodology are not included in this summary. The FDA's letter states a "substantial equivalence determination" to a legally marketed predicate device (iPlan K053127) was made, which is the basis for clearance, rather than a detailed performance study against specific acceptance criteria.

Therefore, I cannot populate the requested table and sections with the information provided. The document outlines:

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

• Not provided. The document generally states "specific bench and integration tests were conducted" and "Internal standards were tested," but no specific criteria or performance metrics are detailed.

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

• Not provided.

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):

• Not provided.

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

• Not provided.

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:

• Not explicitly mentioned or detailed. The device description focuses on planning and visualization tools, not necessarily AI-assisted interpretation to improve human reader performance in a diagnostic context. "Side-by-side comparison testing" was done with the predicate device to determine substantial equivalence, not typically an MRMC study demonstrating human performance improvement.

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

• Not explicitly mentioned or detailed. The device is described as a "Planning System, Stereotactic Instrument" used by "medical professionals," implying human interaction.

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

• Not provided.

8. The sample size for the training set:

• Not applicable/Not provided. The document describes a medical device software for planning and visualization, not typically an AI/ML model that would have a distinct training set in the conventional sense of deep learning. The testing described focuses on functional equivalence to a predicate device.

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

• Not applicable/Not provided. (See point 8)

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