The INTIO ClearStart.SVM™ system is a self-contained image analysis desktop workstation addressing the needs of physicians performing diagnostic oncologic imaging, treatment planning, and post-procedure or systemic therapy follow-up assessment. ClearStart.SVM™ provides semi-automated tools for segmentation of suspicious lesions including primary and metastatic lung and liver tumors, and lymph node assessment using non-contrast and contrast CT images. Following lesion segmentation, ClearStart.SVM™'s automated volumetric, RECIST and WHO lesion measurements provide the user with data on the time-course of patient response to therapy. An on-board large disk storage capacity allows the user to easily track each patient's CT data from initial diagnosis through therapeutic interventions and follow up exams and includes a reporting package to aid in the assessment of response to therapy.

Device Description

The ClearStart•SVM™ product consists of a custom-configured desktop computer system consisting of high-performance commercial-off-the-shelf computer components, and INTIO proprietary software running on a Linux operating system. CT data is read into the system from a CD or DVD and stored uncompressed into a database which allows easy retrieval for follow up assessments.

The ClearStart.SVM™ system uses data from contrast and non-contrast CT examinations of patients presenting with solid tumors. SVM segments the turnor within the organ and determines measurements such as longest tumor length in axial views and tumor volume. Diagnostic CT scans are viewed in both multiplanar reformatted (MPR) views and 3D volume rendered (VR) views, allowing the user to choose the best visualization of selected tumors to be treated. Typically tumors are best visualized in the contrast CT exam which is used for analysis. User selected lesions are segmented with minimal user input. The user places a cursor over the tumor and by clicking a mouse button inserts one or more region-growing seed points in the tumor to be segmented. Feedback of the seed location is shown in graphical overlays on the MPR views. After the seed or seeds are placed, the user activates a computer determined bounding box surrounding the marked lesion, with the surrounding tissue demonstrating a contrast difference to the marked tumor. The lesion is then segmented using 3D active contour methodology.

As a follow up to a specific therapy the ClearStart+SVM™ system provides tools to help assess the effectiveness of image-guided loco-regional or systemic therapies for solid or semi-solid tumors throughout the body. Users are able to review changes in tumor dimensions based on follow up CT scans with computer-assisted segmentation and automated measurement of lesions to determine tumor response to therapy over time. The ClearStart SVM system is designed to semi-automatically segment and automatically measure tumors of the liver, lung, and lymph nodes.

INTIO engineers have developed ClearStart-SVM™'s image processing and display software which provides both 2D (MPR) image display and 3D volume-rendered (VR) display capability. Response of tumors to therapy, either loco-regional or systemic, is facilitated by lesion segmentation and automated measurement leveraging INTIO's proprietary image segmentation algorithm. The automated measurements include both conventional and specific quantitative measurements such as RECIST, WHO and volumetric CT measurements.

AI/ML Overview

The provided 510(k) summary for INTIO ClearStart.SVM™ does not contain acceptance criteria or detailed study results that prove the device meets specific performance metrics.

The document focuses on demonstrating substantial equivalence to a predicate device (Siemens syngo CT Oncology) by comparing features and outlining the general testing performed for safety and efficacy. It describes the design and intended use but lacks the quantitative data typically found in performance studies.

Here's a breakdown of the information that is available and the information that is missing based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

This information is largely missing from the provided text. The document describes the device's functionality (semi-automated segmentation, automated volumetric measurements for liver, lung, and lymph nodes) but does not provide specific numerical acceptance criteria (e.g., accuracy, precision, dice score thresholds) or quantitative performance results against those criteria.

Acceptance Criteria	Reported Device Performance
Not provided. The document focuses on feature comparison and general safety/efficacy testing, not explicit performance metrics for segmentation or measurement accuracy.	Not provided. No specific numerical results (e.g., accuracy percentages, precision values) are given for segmentation or volumetric measurement. The document states that internal and third-party testing was performed to "assure that the system is safe and efficacious" and that "the system design specifications were realized," but these are general statements, not quantifiable performance metrics.

Acceptance Criteria

Reported Device Performance

Not provided. The document focuses on feature comparison and general safety/efficacy testing, not explicit performance metrics for segmentation or measurement accuracy.

Not provided. No specific numerical results (e.g., accuracy percentages, precision values) are given for segmentation or volumetric measurement. The document states that internal and third-party testing was performed to "assure that the system is safe and efficacious" and that "the system design specifications were realized," but these are general statements, not quantifiable performance metrics.

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

This information is missing. The summary states that "internal and third party testing was performed" and that "Medical professionals... validated the software workflow and usability," but it does not specify:

The number of cases or images used in any test sets.
The country of origin for any data used.
Whether the data was retrospective or prospective.

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

This information is missing. The document does not mention how ground truth was established for any performance testing, nor does it specify the number or qualifications of experts involved in such a process. It only states that "Medical professionals who are familiar with similar systems validated the software workflow and usability." This is a general statement about usability validation, not ground truth establishment for quantitative performance.

4. Adjudication Method for the Test Set

This information is missing. No details are provided on any adjudication methods (e.g., 2+1, 3+1) for establishing ground truth or resolving expert discrepancies in a test set.

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

No, a MRMC comparative effectiveness study is not mentioned. The document focuses on comparing the device's features to a predicate device and general safety/efficacy testing. There is no mention of a study comparing human readers with and without AI assistance, or any effect size in terms of improvement.

6. If a Standalone (Algorithm Only) Performance Study Was Done

A standalone performance study, with specific quantitative results, is not explicitly detailed. While the device features "semi-automated tools for segmentation" and "automated volumetric, RECIST and WHO lesion measurements," the summary does not present a standalone performance study with metrics like sensitivity, specificity, Dice score, or measurement error against a defined ground truth. The testing described is more aligned with software verification and usability validation.

7. The Type of Ground Truth Used

This information is missing. The document does not specify the type of ground truth used for any performance evaluation (e.g., expert consensus, pathology, outcomes data).

8. The Sample Size for the Training Set

This information is missing. The document does not mention any training data or its size, which is common for AI/ML-based devices. Given the 2011 submission date, this device might have used more traditional image processing techniques rather than deep learning, and thus a "training set" might not be applicable in the modern sense. However, the use of "3D active contour methodology" suggests some fitting or parameter optimization, which would imply a dataset for development.

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

This information is missing. As with the training set size, details on how ground truth was established for any development or training data are not provided.

In summary, the provided 510(k) summary focuses on demonstrating substantial equivalence through feature comparison and general statements about safety and efficacy testing, rather than presenting detailed quantitative performance studies with specific acceptance criteria, sample sizes, ground truth methodologies, or expert involvement. This is common for predicate-based 510(k) submissions, especially those from an earlier era (2011), where extensive clinical performance data or AI-specific validation might not have been required to the same extent as for devices submitted today.

Summary

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K 113541

510(k) Summary

DEC 1 6 2011

Company address and contact:

INTIO Inc, 325 Interlocken Parkway Building C Broomfield, CO 80021

Main telephone: 303-800-3700 Fax: 3030-396-0033 Contact: David Gustafson, Vice President, Research and Development Date Prepared: October 21, 2011

1. Identification of the Device

Proprietary Trade Name: ClearStart SVM™, Segmentation and Volumetric Measurement (SVM) Classification Name: System, Image Processing, Radiological Common/Usual Name: System, Image Processing Radiological Product Code: LLZ

2. Equivalent Legally Marketed Device:

Manufacturer: Siemens Medical Solutions, USA, Inc. Name of Predicate Device: syngo CT Oncology FDA 510(k) Number: K071310 FDA Clearance Date: June 8, 2007.

3. Indications for Use Statement

The system is password protected so that only the above mentioned trained medical professionals are authorized users.

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4. Description of Device

5. Comparison to Predicate Device

A predicate product, syngo CT Oncology from Siemens Medical Solutions, is our substantially equivalent product for comparison. The main features of the INTIO ClearStart.SVM™ and Siemens CT Oncology products are shown in Table 5-1. There is nearly a complete feature set match between the ClearStart+SVMT™ and CT Oncology svstems. Siemens references "automated" tumor segmentation, but since their system requires some user inputs it more correctly should be called semi-automated

1 Adams R and Bishof L, Seeded Region Growing, IEEE Trans PAMI (1994) 16(6): 641-647.

2 Zhang L et al., Segmentation of liver tumors in CT scans using a 3D active contour method. Int J CARS (2010) 5 (Suppl 1): $287

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segmentation. Similarly, the INTIO ClearStart+SVM™ product is a user initiated semiautomated segmentation process wherein the user identifies the target lesion to be assessed and uses a computer mouse to graphically mark one or more areas in the lesion. From that point onward all the processing is automated. Both products provide summary information for reports which the users may utilize in their assessment of the response to various cancer therapies.

INTIO ClearStart•SVM™ Feature	Siemens CT Oncology Feature from510(k) K071310 Summary
Semi- automated and Automated toolsfrom CT data for:	Automated tools from CT data for:
Segmentation (semi-automated)	Automated Segmentation
Automated Volumetric Assessmentof Lesions	Automated Volumetric Assessmentof Lesions
Specifically for:	Specific tools for:
Liver	Liver
Lung	Lung and
Lymph nodes	Lymph nodes
Reporting of results for time serial tumor	Reporting of results to track lesions over
response assessment	time
Indications for use: The INTIOClearStart•SVM™ system is a self-contained image analysis desktopworkstation addressing the needs ofphysicians performing diagnostic oncologicimaging, treatment planning, and post-procedure or systemic therapy follow-upassessment. ClearStart•SVM™ providessemi-automated tools for segmentation ofsuspicious lesions including primary andmetastatic lung and liver tumors, andlymph node assessment using non-contrast and contrast CT images.Following lesion segmentation,ClearStart•SVM™'s automated volumetric,RECIST and WHO lesion measurementsprovide the user with data on the time-course of patient response to therapy. Anon-board large disk storage capacityallows the user to easily track eachpatient's CT data from initial diagnosisthrough therapeutic interventions andfollow up exams and includes a reportingpackage to aid in the assessment ofresponse to therapy	Indications for use: syngo CT Oncologyis a self-contained, non invasive imageanalysis software package designed tofast-track routine diagnostic oncology,staging and follow-up. Flexible layouts andautomated image registration facilitate thesynchronous display and navigation ofmultiple datasets for viewing multi-phaseCT data and easy follow-up comparison.The application provides a range ofautomated tools specifically designed tosupport physicians in the segmentationand volumetric evaluation of suspiciouslesions including dedicated tools for lung,liver and lymph node assessment in CTdata. Dedicated workflow-support andintegrated, accumulative reporting allow totrack lesions and their changes in e.g. size,shape and enhancement pattern over time.Syngo CT Oncology also facilitatesfunctional imaging offering fusion withother modalities such as PET data. It alsofeatures syngo LungCAD for detectingsmall lung nodules (PMA-approved).
Hardware/Software Platform:	Hardware Software Platform:
Built Linux operating system, AMD PC Platform	Built on syngo common software, Intel/Windows PC Platform.
User Interface: Graphical user interface for control of all system features.	User Interface: Graphical user interface for control of all system features

Table 5.1 Feature Comparison to Predicate Device

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6. Testing Information and Conclusion

In all material aspects, INTIO ClearStart·SVM is substantially equivalent to the predicate system, both being built on PC platforms using a windowed user interface environment. Both internal and third party testing was performed to assure that the system is safe and efficacious prior to use by customers. INTIO's Test Engineering Department performed software verification testing considering an array of test use cases following internal test procedures to assure that the system design specifications were realized. Medical professionals who are familiar with similar systems validated the software workflow and usability confirming that the system's design intent was realized. Together with these validation and verification processes we engaged a third party electronics testing laboratory (ETL) to assure compliance to appropriate regulatory standards for electromagnetic compatibility and electrical safety. When we receive 510(k) clearance the software and hardware will be formally released to production by an ISO 13485 compliant third party manufacturing partner.

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

INTIO Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313

DEC 1 6 2011

Re: K113541

Trade/Device Name: ClearStart SVM™, Segmentation and Volumetric Measurement Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: November 30, 2011 Received: December 1. 2011

Dear Mr. Job:

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. 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.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, · Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification: The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office

of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours.

Mary Pastel

Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number (if known):

Device Name: ClearStart:SVMTM, Segmentation and Volumetric Measurement

Indications for Use:

The INTIO ClearStart•SVM™ system is a self-contained image analysis desktop workstation addressing the needs of physicians performing diagnostic oncologic imaging, treatment planning, and post-procedure or systemic therapy follow-up assessment. ClearStart SVM™ provides semi-automated tools for segmentation of suspicious lesions including primary and metastatic lung and liver tumors, and lymph node assessment using non-contrast and contrast CT images. Following lesion segmentation, ClearStart.SVM™'s automated volumetric, RECIST and WHO lesion measurements provide the user with data on the time-course of patient response to therapy. An on-board large disk storage capacity allows the user to easily track each patient's CT data from initial diagnosis through therapeutic interventions and follow up exams and includes a reporting package to aid in the assessment of response to therapy.

The system is password protected so that only the above mentioned trained medical professionals are authorized users.

Prescription Use (Part 21 CFR 801 Subpart D)

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K113541.

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).