The Imbio Segmentation Editing Tool Software is used by trained medical professionals asa tool to modify the contours of segmentation masks produced by Imbio algorithms or to manually create segmentation mask contours. The Segmentation Editing Tool can provide further support to the users of Imbio's algorithms.

Device Description

Imbio Segmentation Editing Tool (SET) Software is a segmentation editing tool designed to allow users to optimize segmentations calculated by Imbio's fully-automated suite of algorithms (Each algorithm is a separate Imbio program and either has or will be submitted for regulatory approval independently). Imbio is building a suite of medical image post-processing applications that run automatically after data transfer off the medical imaging scanner. Automatic image segmentation is often an essential step in Imbio's analyses. To date, the automatic segmentation algorithms used in Imbio's applications have been robust, however segmentation failures do occur. The purpose of the Segmentation Editing Tool is to provide customers with a tool to locally correct poor segmentations. Additionally, if the Imbio automatic segmentation fails such that it is unable to produce a result, this tool can be used to semi-manually draw the segmentation required for analysis. SET reads in anatomical images used in an automatic segmentation algorithm and the results of the automated segmentation algorithm (if available). The user is then able to locally correct insufficiencies in the segmentation result, or create a segmentation mask from scratch. The finalized segmentation mask is then pushed back to Imbio's Core Computing Platform and the job is re-processed.

AI/ML Overview

The provided FDA 510(k) summary for the "Imbio Segmentation Editing Tool Software" (K180129) does not contain details about specific acceptance criteria or a study that proves the device meets such criteria.

Instead, it focuses on demonstrating substantial equivalence to a predicate device (MIM 5.2 Brachy K103576). The document mentions "Non-clinical testing was done to show validity of SET software" and "Design validation was performed using the Imbio Segmentation Editing Tool Software in actual and simulated use settings," but it does not provide the results of these tests, specific acceptance criteria, or detailed methodologies.

Here's a breakdown based on the information provided and not provided in the document:

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

Not provided. The document does not list any specific quantitative acceptance criteria (e.g., Dice score, mean surface distance, sensitivity, specificity) or present device performance metrics against such criteria.

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

Not provided. The document states "Design validation was performed using the Imbio Segmentation Editing Tool Software in actual and simulated use settings," but it does not specify the number of cases (sample size) used for these tests, nor the origin or nature (retrospective/prospective) of the data.

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. Since specific test sets and ground truth establishment are not detailed, this information is absent. The device is a segmentation editing tool meant to be used by "trained medical professionals," suggesting a human-in-the-loop context, but not a fully automated algorithm that produces its own segmentations against a pre-established ground truth for validation.

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

Not provided. This information is typically relevant for studies where multiple readers determine ground truth or interpret results, which is not described for this device's validation.

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 provided. The document states, "This technology is not new; therefore, a clinical study was not considered necessary prior to release. Additionally, there was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device."
While "Usability testing was completed for this product to ensure proper use of the product by intended users," this is not equivalent to an MRMC comparative effectiveness study measuring improved human performance with AI assistance. The device is a tool to edit segmentations, not an AI that provides initial interpretations.

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

Not explicitly stated as a primary validation method for this specific 510(k). The device is described as "a segmentation editing tool designed to allow users to optimize segmentations calculated by Imbio's fully-automated suite of algorithms." It's an editing tool for other Imbio algorithms' outputs. Therefore, its performance is inherently linked to human interaction. The validation focuses on the tool's functionality for editing, not on a standalone algorithmic diagnostic performance.

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

Not provided for the "non-clinical testing" or "design validation." Since the device is an editing tool, the "ground truth" in operational use would be the expert's final, corrected segmentation. How the accuracy of the editing tool itself was measured against a truth standard is not detailed.

8. The sample size for the training set:

Not applicable / Not provided. The Imbio Segmentation Editing Tool Software is described as a software tool for editing segmentation masks, not an AI algorithm that learns from a training set to produce segmentations itself. The document mentions "Imbio's fully-automated suite of algorithms" which do perform segmentation, but this 510(k) is for the editing tool, not for those underlying algorithms. Therefore, a training set for the editing tool is not relevant in the same way it would be for a segmentation algorithm.

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

Not applicable / Not provided. As mentioned above, the editing tool itself does not have a training set in the context of learning to perform segmentation.

Summary

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March 16, 2018

Imbio, LLC % Vipul Goel Sr. Manager 807 Broadwav Street NE. #350 MINNEAPOLIS MN 55413

Re: K180129

Trade/Device Name: Imbio Segmentation Editing Tool Software Regulation Number: 21 CFR 892,2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: January 11, 2018 Received: January 17, 2018

Dear Vipul Goel:

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. 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone

(1-800-638-2041 or 301-796-7100).

Sincerely,

Michael D'Hara For

Robert Ochs. Ph.D Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K180129

Device Name

Imbio Segmentation Editing Tool Software

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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5.0 510(k) Summary

K180129

	Table 3: 510(k) summary

Table 3: 510(k) summary (As required by Section 21 CFR 807.92(c))
Submitter:	Imbio LLC807 Broadway ST NE, #350Minneapolis MN 55413 USA
Contact Person:	Vipul GoelSr. Manager, QA/RATelephone: 612-520-7360Email: vipulgoel@imbio.com
Date Prepared:	Jan 11, 2018
Trade Name:	Imbio Segmentation Editing Tool Software
Common/Usual Name:	Software Accessory for Radiological Image Processing Device
Classification:	System, Image Processing, Radiological21 CFR 892.2050Product Code LLZ, Class II
Product Code:	LLZ, Class II
Manufacturer:	Imbio LLC807 Broadway ST NE, #350Minneapolis MN 55413 USA
EstablishmentRegistration:	MD6099829
Predicate Device:	Manufacturer: MIM 5.2 (Brachy)Trade name: MIM Software Inc510(k) Number: K103576Date Cleared: 18-Feb-2011
510(k) Summary	(As required by Section 21 CFR 807.92(c))
Device Description	Imbio Segmentation Editing Tool (SET) Software is asegmentation editing tool designed to allow users to optimizesegmentations calculated by Imbio's fully-automated suite ofalgorithms (Each algorithm is a separate Imbio program andeither has or will be submitted for regulatory approvalindependently). Imbio is building a suite of medical imagepost-processing applications that run automatically after datatransfer off the medical imaging scanner. Automatic imagesegmentation is often an essential step in Imbio's analyses. Todate, the automatic segmentation algorithms used in Imbio'sapplications have been robust, however segmentationfailures do occur. The purpose of the Segmentation EditingTool is to provide customers with a tool to locally correct poorsegmentations. Additionally, if the Imbio automaticsegmentation fails such that it is unable to produce a result,this tool can be used to semi-manually draw thesegmentation required for analysis.SET reads in anatomical images used in an automaticsegmentation algorithm and the results of the automatedsegmentation algorithm (if available). The user is then able tolocally correct insufficiencies in the segmentation result, orcreate a segmentation mask from scratch. The finalizedsegmentation mask is then pushed back to Imbio's CoreComputing Platform and the job is re-processed.
Intended Use	Segmentation Editing Tool Software is intended for use bytrained medical professionals including, but not limited to,radiologists, oncologists and medical imaging technologists. Itis intended to locally correct errors in the segmentationmasks produced by Imbio's automatic segmentationalgorithms Additionally, if the Imbio segmentation algorithmis unable to produce a segmentation mask, this tool could beused to semi-manually create a segmentation mask. Theapplication will be accessed most typically from a PACSworkstation over a modern Internet browser (e.g. IE>10).
510(k) Summary	(As required by Section 21 CFR 807.92(c))
Summary of TechnicalComparisons	The fundamental functional characteristics of SET are verysimilar to the analogous functions included in MIM 5.2(Brachy). The primary differences between the proposed andpredicate devices are that:Imbio SET is not a standalone application and can onlybe used in conjunction with other Imbio algorithmsinstalled on Imbio's platform. Imbio SET has contour snapping and interpolationfeatures that serve as workflow optimization tools forcontouring tasks involving large regions of interest. Imbio SET has a much more limited set of featuresthan MIM 5.2 (Brachy).
Non-Clinical Testing	Non-clinical testing was done to show validity of SETsoftware. Results can be seen in Software TestProtocol/Report attached in Appendix E/Appendix F
Design Validation	Design validation was performed using the ImbioSegmentation Editing Tool Software in actual and simulateduse settings.
Clinical Testing	This technology is not new; therefore, a clinical study was notconsidered necessary prior to release. Additionally, there wasno clinical testing required to support the medical device asthe indications for use is equivalent to the predicate device.Usability testing was completed for this product to ensureproper use of the product by intended users.
Conclusion:	The Imbio Segmentation Editing Tool Software has the sametechnological characteristics as the predicate device in that ithas a similar intended use, same general operating principle.The specific details of the predicate device may vary fromthose of Imbio Segmentation Editing Tool Software.It has been shown in this 510(k) submission that thedifferences between the Imbio Segmentation Editing ToolSoftware and the MIM 5.2 (Brachy) (K103576) do not raiseany questions regarding safety and effectiveness. The ImbioSegmentation Editing Tool Software, as designed andmanufactured, is substantially equivalent to, and as safe and

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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).