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SIS Software is an application intended for use in the viewing, presentation and documentation of medical imaging, including different modules for image processing, image fusion, and intraoperative functional planning where the 3D output can be used with stereotactic image guided surgery or other devices for further processing and visualization. The device can be used in conjunction with other clinical methods as an aid in visualization of the subthalamic nuclei (STN).

SIS Software uses machine learning and image processing to enhance standard clinical images for the visualization of the subthalamic nucleus ("STN"). The SIS Software supplements the information available through standard clinical methods, providing adjunctive information for use in visualization and planning stereotactic surgical procedures. SIS Software provides a patient-specific, 3D anatomical model of the patient's own brain structures that supplements other clinical information to facilitate visualization in neurosurgical procedures.

The version of the software that is the subject of the current submission (Version 3.6.0) is a modification to the predicate SIS Software version 3.3.0 that was cleared under K183019. The subject and predicate devices rely on the same core technological principles. The only minor changes were modifications to enable the use of a more comprehensive MR to post operation CT registration methodology, and image processing techniques for CT images acquired with gantry tilt. The web user interface has also been enhanced to allow additional options for administrators/supervisors, and has added audit logging functions.

The provided text is a 510(k) summary for SIS Software Version 3.6.0. It describes the device, its intended use, and argues for its substantial equivalence to a predicate device (SIS Software Version 3.3.0). However, it does not provide detailed acceptance criteria or a comprehensive study report with the level of detail requested for each point in the prompt.

The document states that "software verification and validation testing has been repeated to validate that the modified software functions as specified and performs similarly to the predicate device." It also mentions "MRI to CT registration testing using the new methodology, which demonstrated that the software continued to register MR images to the CT space. The error was within the acceptance criteria, and was comparable to that for SIS Software version 3.3.0, which used the same protocol."

Based on the provided text, here is an attempt to address your request, highlighting where information is not provided in the source document.

Description of Acceptance Criteria and Proving Device Meets Criteria (Based on Provided Text)

The SIS Software Version 3.6.0 is a modification of a previously cleared device (Version 3.3.0). The study aims to demonstrate that the updated software continues to function as specified and performs similarly to the predicate device, specifically regarding MRI to CT registration and image processing for gantry-tilted CT scans. The primary acceptance criterion broadly seems to be that performance ("error") for the modified functions remains "within the acceptance criteria" and "comparable" to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document states that the MRI to CT registration testing used a "new methodology," and that the CT image processing for gantry tilt used "the same CT scans that were used in the validation testing for the predicate device." The specific numerical sample size (number of MR and CT scans) for the test sets is not provided.
• Data Provenance: The document does not provide information regarding the country of origin of the data or whether the data was retrospective or prospective.

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

• Not provided. The document describes software validation and verification testing but does not mention the use of experts or their qualifications for establishing ground truth for the test set.

4. Adjudication Method for the Test Set

• Not provided. The document does not describe any adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• No. The document describes a software validation study demonstrating that the modified software performs comparably to its predicate. It does not describe an MRMC comparative effectiveness study involving human readers with and without AI assistance. Therefore, no effect size for human reader improvement is provided.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done

• Yes, implicitly. The performance data section describes "software verification and validation testing" which "demonstrated that the software continued to register MR images to the CT space" and that "the cropping image processing does not affect the performance of the software." This implies standalone algorithm performance testing. No human-in-the-loop studies are mentioned.

7. The Type of Ground Truth Used

• The document implies that the ground truth for registration and segmentation performance was established against results from the predicate device and internal specifications/protocols ("within the acceptance criteria," "comparable to that for SIS Software version 3.3.0," "functions as specified"). It does not explicitly state the type of ground truth used (e.g., expert consensus, pathology, outcome data, etc.) beyond comparison to the predicate's performance.

8. The Sample Size for the Training Set

• Not provided. The document does not discuss the training set, only the validation/test set. The device uses "proprietary algorithms" and states "minor modifications to the registration and CT image processing techniques are introduced... the basis for the device algorithm remain the same." This suggests the core algorithm was developed previously.

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

• Not provided. As the training set is not discussed, information on how its ground truth was established is absent.

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