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).

Device Description

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.

AI/ML Overview

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

Acceptance Criterion	Reported Device Performance
MRI to CT Registration: Error of registration between MR images and 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." (Specific numerical acceptance criteria and reported error values are not provided).
CT Image Processing (Gantry Tilt): Does not affect object segmentation performance compared to the predicate device.	"Results demonstrated that the cropping image processing does not affect the performance of the software as compared to its predicate." (Specific metrics for "performance" or "affect" are not provided).

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.

Summary

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September 13, 2019

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" on the right. The symbol on the left is a stylized image of an eagle, and the text on the right is written in a bold, sans-serif font. The text is blue, and the symbol is black and white.

Surgical Information Sciences, Inc. % Ms. Kelliann Payne Regulatory Counsel Hogan Lovells, US LLP 1735 Market Street, Suite 2300 PHILADELPHIA PA 19103

Re: K192304

Trade/Device Name: SIS Software Version 3.6.0 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: August 23, 2019 Received: August 23, 2019

Dear Ms. Payne:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

Device Name SIS Software Version 3.6.0

SIS Software is an application intended for use in the viewing, presentation and documentation of medical imaging, including different modules for image processing, 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).

Typical users of the SIS Software are medical professionals, including but not limited to surgeons, neurologists and radiologists.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Sponsor's Name, Contact Information, and Date Prepared

Surgical Information Sciences, Inc. 10405 6th Avenue North, Suite 110 Plymouth, MN 55441 Contact Person: Ann Quinlan-Smith Phone: 612-325-0187 E-mail: ann.quinlan.smith@surqicalis.com

Date Prepared: August 23, 2019

Trade Name of Device: SIS Software version 3.6.0

Common or Usual Name/Classification Name: System, Image Processing, Radiological (Product Code: LLZ; 21 C.F.R. 892.2050)

Regulatory Class: Class II

Predicate Device: Surgical Information Sciences SIS Software version 3.3.0 (K183019)

Intended Use / Indications for Use

Typical users of the SIS Software are medical professionals, including but not limited to surgeons, neurologists and radiologists.

Technological Characteristics

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 patientspecific, 3D anatomical model of the patient's own brain structures that supplements other clinical information to facilitate visualization in neurosurgical procedures.

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tilt. The web user interface has also been enhanced to allow additional options for administrators/supervisors, and has added audit logging functions.

Substantial Equivalence

The subject and predicate versions of the SIS Software have the same intended use and indications for use. The subject software version, like the predicate, operates on other computing platforms and uses a proprietary algorithm to generate 3D segmented anatomical models from patients' MRI and CT scans. The visualization of the STN is performed in exactly the same way as for the predicate device. While minor modifications to the registration and CT image processing techniques are introduced, the environment of use, role in the clinical workflow, and basis for the device algorithm remain the same, and the core image processing/segmentation principles employed to enable these steps resemble those employed for the MR-based visualization step already cleared. In addition, software validation testing using the same protocol as used for the predicate confirmed that the subject device continues to perform in accordance with its specifications and is as safe and as effective as the predicate.

	SIS Software version 3.6.0(Subject)	SIS Software version 3.3.0(Predicate)
Allows for importing ofdigital imaging sets	Yes	Yes
Uses proprietarysoftware algorithm togenerate 3D segmentedanatomical models frompatient's MR scans	Yes	Yes
Allows for review andanalysis of data in 2Dand 3D formats	Yes	Yes
Performs image fusion ofdatasets usingautomated or manualimage matchingtechnique	Yes	Yes
Segments structures inimages with manual andautomated tools andconverts them into 3Dobjects for display	Yes	Yes
Creates hybrid datasetsby filing in segmentedregions slice-by-slice onanatomical datasets	Yes	Yes

				SIS Software Technological Characteristics Comparison Table
--	--	--	--	-------------------------------------------------------------

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	SIS Software version 3.6.0(Subject)	SIS Software version 3.3.0(Predicate)
Can be downloaded toplanning system	Yes	Yes
Segmentation of CT scanto identify structures inrelation to thosevisualized on MR	Yes	Yes
Feature to Account forCT images with gantry tilt	Yes	No
Cross-registers imagesand creates 3D (fused)model	Yes	Yes
Different registrationmethods (linear and non-linear) by multipleregistration tools (ANTSand ELASTIX)	Yes	No

Performance Data

Following the modifications, the software verification and validation testing has been repeated to validate that the modified software functions as specified and performs similarly to the predicate device. In particular, the company has repeated the 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. In addition, the new image processing for CT images with gantry tilt has been tested to validate objects segmentation. Using the same CT scans that were used in the validation testing for the predicate device, results demonstrated that the cropping image processing does not affect the performance of the software as compared to its predicate.

Conclusions

The updated SIS Software version 3.6.0 is as safe and effective as the predicate version previously cleared in K183019. The subject device has the same intended use and indications for use as the predicate, and very similar technological characteristics and principles of operation, with minor differences supported by performance validation testing that the subject device is as safe and effective as the predicate device and performs as intended. Thus, the minor technological differences between SIS Software version 3.6.0 and its predicate device raise no new issues of safety or effectiveness, and the updated SIS Software version 3.6.0 is substantially equivalent.

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).