FlightPlan for Liver is a post processing software package that helps the analysis of 3D X-ray images of the liver arterial tree. Its output is intended as an adjunct means to help identify arteries leading to the vicinity of hypervascular lesions in the liver. This adjunct information may be used by physicians to aid them in their evaluation of hepatic arterial anatomy during embolization procedures.

Device Description

FlightPlan for Liver is a post-processing software application for use with interventional fluoroscopy procedures, using 3D rotational angiography images as input. It operates on the AW VolumeShare 4 [K052995] and AW VolumeShare 5 [K110834] platform. It is an extension to the Volume Viewer application [K041521] utilizing the rich set of the 3D processing features of Volume Viewer. FlightPlan for Liver delivers post-processing features that will aid physicians in their analysis of 3D X-ray images of the liver arterial tree. Additionally FlightPlan for Liver includes an algorithm to highlight the potential vessel(s) in the vicinity of a target.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the FlightPlan for Liver device:

Acceptance Criteria and Device Performance

There is no explicit table of acceptance criteria or reported device performance metrics (e.g., sensitivity, specificity, AUC) in the provided document. The submission focuses on demonstrating substantial equivalence to a predicate device and confirming that the software functions as required and fulfills user needs.

The "Performance testing" mentioned is described as "computing time of algorithm on several data," implying it's a speed or efficiency metric rather than a diagnostic performance metric. The "Verification confirms that the Design Output meets the Design Input (Product Specifications) requirements" and "Validation confirms that the product fulfills the user needs and the intended use under simulated use conditions," but specific, quantifiable acceptance criteria are not detailed.

The "Summary of Clinical Tests" states that the study "demonstrate[d] the safety and effectiveness of FlightPlan for Liver" and compared its output "to a reference reading established by two senior interventional oncologists." However, the exact metrics used for comparison and the "acceptance criteria" for those metrics are not provided. The key takeaway is that the clinical data was not intended to support a claim of improved clinical outcomes.

Study Details

Here's what can be extracted about the study that proves the device meets the (unspecified quantitative) acceptance criteria:

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

Acceptance Criteria Category	Specific Criteria (Implicit/General)	Reported Device Performance
Functional Verification	Application works as required; Risk mitigations correctly implemented.	"Verification tests... performed to check whether the application works as required and whether the risk mitigations have been correctly implemented."
Performance Testing	Algorithm computing time (specific targets not provided).	"Performance testing consists of computing time of algorithm on several data."
Design Validation	Product fulfills user needs and intended use under simulated use conditions.	"Validation tests consist of typical use case scenario described by the sequence of operator actions. The Design Validation confirms that the product fulfills the user needs and the intended use under simulated use conditions."
Clinical Effectiveness	Output provides adjunct information to aid physicians in evaluating hepatic arterial anatomy; output compared to reference reading.	Output was compared to a reference reading established by two senior interventional oncologists. No specific quantitative performance metrics (e.g., accuracy, precision) are provided, nor are numerical results of this comparison.
Substantial Equivalence	Functionality, safety, and effectiveness are comparable to the predicate device.	"GE Healthcare considers the FlightPlan for Liver application to be as safe and as effective as its predicate device, and its performance is substantially equivalent to the predicate device."

2. Sample size used for the test set and the data provenance

Test Set Size: 44 subjects, representing a total of 66 tumors.
Data Provenance: Retrospective study. The country of origin is not explicitly stated, but given the submitter's address (Buc, FRANCE) and the GE Healthcare global nature, it could be either European or multinational, but this is speculative.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of Experts: Two.
Qualifications: "Senior interventional oncologists." Specific experience (e.g., years) is not provided.

4. Adjudication method for the test set

The ground truth was established by a "reference reading established by two senior interventional oncologists." While it states the two established the reference, it doesn't specify if this was by consensus, independent reads with adjudication, or another method. The phrasing "a reference reading established by two" suggests a single, agreed-upon ground truth, likely consensus or 2-reader agreement if initial reads differed.

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

No, a multi-reader, multi-case (MRMC) comparative effectiveness study comparing human readers with AI assistance vs. without AI assistance was not done. The study specifically states that the clinical data "was not designed nor intended to support a claim of an improvement in clinical outcomes of such procedures, and no such claim is being made." The study focused on comparing the device's output to an expert reference, not on human performance improvement.

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

Yes, the clinical study appears to evaluate the algorithm's standalone performance compared to a "reference reading." The "output of FlightPlan for Liver was compared to a reference reading," indicating the algorithm's direct output was assessed. No mention is made of human interaction or interpretation of the algorithm's output as part of this comparison.

7. The type of ground truth used

Type of Ground Truth: Expert consensus/reference reading. Specifically, "a reference reading established by two senior interventional oncologists."

8. The sample size for the training set

The document does not mention the sample size for the training set. It only describes the clinical study as a "retrospective study" used for verification and validation, implying it was a test set. There's no information about the data used to train the "algorithm to highlight the potential vessel(s)."

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

This information is not provided since the document does not detail the training set or its ground truth establishment.

Summary

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K12 1200

Image /page/0/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined and enclosed within a circle. The logo is black and white, with the letters and the circle outline in black and the background in white.

NOV 2 2012

GE Healthcare 510(k) Premarket Notification Submission

510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided:

October 28, 2012 Date:

GE Healthcare, (GE Medical Systems SCS) Submitter: 283 rue de la MINIERE 78530 Buc, FRANCE

Primary Contact Person:

Ning WEN Regulatory Affairs Leader GE Healthcare, (GE Medical Systems SCS) Tel: (+33)-1-3070-5668 Fax: (+33) 1-3070-4670

Secondary Contact Persons:

John Jaeckle Chief Regulatory Affairs Strategist GE Healthcare Tel: 262-424-9547

Carol Alloian Regulatory Affairs Leader GE Healthcare Tel: (224) 280-1008 Fax: (847) 589-8524

Device: Trade Name: Common/Usual Name: Classification Names: Product Code: FlightPlan for Liver Picture Archiving and Communications System 21CFR 892.2050, Class II

LLZ

K041521, Volume Viewer Plus Predicate Device(s):

Device Description: FlightPlan for Liver is a post-processing software application for use with interventional fluoroscopy procedures, using 3D rotational angiography images as input. It operates on the AW VolumeShare 4 [K052995] and AW VolumeShare 5 [K110834] platform. It is an extension to the Volume Viewer application [K041521] utilizing the rich set of the 3D processing features of Volume Viewer.

FlightPlan for Liver delivers post-processing features that will aid physicians in their analysis of 3D X-ray images of the liver

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K121200 Page 2 of 83

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GE Healthcare 510(k) Premarket Notification Submission

arterial tree.

Intended Use:

Indications for Use FlightPlan for Liver is a post processing software package that helps the analysis of 3D X-ray images of the liver arterial tree. Its output is intended as an adjunct means to help identify arteries leading to the vicinity of hypervascular lesions in the liver. This adjunct information may be used by physicians to aid them in their evaluation of hepatic arterial anatomy during embolization procedures.

FlightPlan for Liver employs the same fundamental scientific Technology: technology as its predicate device (Volume Viewer).

When FlightPlan for Liver is active, all Volume Viewer functionalities are available at the same time.

Additionally FlightPlan for Liver includes an algorithm to highlight the potential vessel(s) in the vicinity of a target.

Determination of Substantial Equivalence:

FlightPlan for Liver when used together with Volume Viewer delivers functionality of comparable type that is substantially equivalent to the predicate device listed above and complies with the same or equivalent standards and has the same Intended Use.

Summary of Non-Clinical Tests:

FlightPlan for Liver complies with voluntary standards IEC 60601-1-4, IEC 62304 and IEC 62366.

The following quality assurance measures were applied to the development of the software application:

Risk Analysis .
Requirements Reviews �
Design Reviews .
and Safety testing (Verification). . Performance The Verification Tests of the FlightPlan for Liver were performed in accordance with device Design Verification Plan and with device Verification Procedure. The verification tests were performed to check whether the application works as required and whether the risk mitigations have been correctly implemented. Performance testing consists of computing time

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Image /page/2/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined within a circular frame. The letters and the frame are in white, set against a black background.

GE Healthcare

510(k) Premarket Notification Submission

of algorithm on several data. The Verification confirms that the Design Output meets the Design Input (Product Specifications) requirements.

Final acceptance testing (Validation). The Validation Tests of the FlightPlan for Liver were executed in accordance with device Design Validation Plan and with device Validation Procedure. The Validation tests consist of typical use case scenario described by the sequence of operator actions. The Design Validation confirms that the product fulfills the user needs and the intended use under simulated use conditions.

Summary of Clinical Tests:

This premarket submission included a clinical test to demonstrate the safety and effectiveness of FlightPlan for Liver.

In this retrospective study (44 subjects representing a total of 66 tumors) performed on a database of hypervascular liver tumors in patients subsequently treated by chemoembolization, the output of FlightPlan for Liver was compared to a reference reading established by two senior interventional oncologists.

The clinical data provided to support that FlightPlan for Liver provides adjunct information that may be used by physicians to aid them in their evaluation of hepatic arterial anatomy during embolization procedures was not designed nor intended to support a claim of an improvement in clinical outcomes of such procedures, and no such claim is being made.

Conclusion:

GE Healthcare considers the FlightPlan for Liver application to be as safe and as effective as its predicate device, and its performance is substantially equivalent to the predicate device.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle symbol, with three curved lines representing the eagle's body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular pattern around the eagle symbol. The text is in all caps and is in a sans-serif font.

Public Health Service

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

GE Healthcare, GE Medical Systems SCS % Ms. Carol Alloian Regulatory Affairs Leader GE Healthcare 9900 W Innovation Drive WAUWATOSA WI 53226-4856

NOV 2 2012

Re: K121200

Trade/Device Name: FlightPlan for Liver Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: October 8, 2012 Received: October 15, 2012

Dear Ms. Alloian:

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,

Janine M. Morris

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): K121200

Device Name: FlightPlan for Liver

Indications For Use:

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Michael D'Ortenzio

Division Sion C

Division of Radiologic

Office of In Vitro

510(k) K121200

Page 1 of 1

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).