(176 days)
AdvantageSim™ MD is used to prepare geometric and anatomical data relating to a proposed external beam radiotherapy treatment prior to dosimetry planning. Anatomical volumes can be defined automatically or manually in three dimensions using a set of CT images acquired with the patient in the proposed treatment position. Definition of the anatomical volumes may be assisted by additional CT, MR or PET studies that have been co-registered with the planning CT scan. Additionally, CT & PET data from a respiratory tracked examination may be used to allow the user to define the target or treatment volume over a defined range of the respiratory cycle.
The geometric parameters of a proposed treatment field are selected to allow non-dosimetric, interactive optimization of field coverage. Defined anatomical structures and geometric treatments fields are displayed on transverse images, on reformatted sagittal, coronal or oblique images, on 3 D views created from the images, or on a beam eye's view display with or without the display of defined structures with or without the display of digitally reconstructed radiograph.
AdvantageSim™ MD is a CT/MR/PET oncology application used by clinicians (radiologist, radiation oncologist, medical oncologist nuclear medicine physicians and trained healthcare professional) to assist treatment planning.
AdvantageSim MD with MR pelvic organ at risk segmentation Option is used to provide MR based prostate and pelvic organs-at-risk segmentation. A suite of semi-automated MR based organ segmentation contouring allows generating complex structures around organs at risk. These contours overlay on the co-registered CT planning image.
The segmentation methods in the modified device are semi-automatic. The user has to place seed points to identify an inner point of the organ to contour.
The software offers a suite of manual contour editing tools enabling the user to edit, modify, or change contours generated from the MR segmentation tools to their desired configuration based on their medical and clinical knowledge and experience. The results provided by the software needs to be approved by the experienced clinician and can always be modified or corrected by him/her. It is up to the expert user to accept the result without any change, reject it completely and delineate manually, or modify the result and then save it. The software does not provide any auto-detection or auto-saving functionalities.
Same as the predicate devices, the clinician retains the ultimate responsibility for making the pertinent diagnosis and patient management decisions based on their standard practices and visual comparison of the individual images, regardless of the accuracy of the output generated by the software.
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Acceptance Criteria and Study for GE Healthcare AdvantageSim™ MD with MR pelvic organ at risk segmentation Option
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Accuracy of measurement | Not explicitly quantified, but reported to be "substantially equivalent to the predicate devices" and that the "new software device has the potential to reduce inter-operator variability". |
| Precision of the measurement | Not explicitly quantified, but reported to be "substantially equivalent to the predicate devices" and that the "new software device has the potential to reduce inter-operator variability". |
| Efficiency (time comparison) | Reported to provide "statistically significant and practically meaningful clinical efficiency improvements". |
| General user Qualitative feedback | Substantiated "the characteristics of this feature, among others, as easy to learn, useful, efficient and providing increased throughput." |
Important Note: The document focuses on demonstrating substantial equivalence to predicate devices rather than providing specific numerical acceptance criteria and performance metrics (e.g., Dice coefficients, Hausdorff distances, specific time savings). The reported performance is generally qualitative or comparative.
2. Sample Size Used for the Test Set and the Data Provenance:
- Sample Size for Test Set: Not explicitly stated. The document mentions "consented clinical images" but does not specify the number of cases.
- Data Provenance: "consented clinical images" - the country of origin is not specified, but the submission is from GE Hungary Kft. The study appears to be retrospective as it uses existing clinical images.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- Number of Experts: Three.
- Qualifications of Experts: "board certified Radiation Oncologists who were considered experts."
4. Adjudication Method for the Test Set:
- The document does not explicitly state a formal adjudication method (e.g., 2+1, 3+1). It describes the experts assessing accuracy, precision, and efficiency, and providing qualitative feedback. It implies each expert evaluated the software's performance, but not how disagreements were resolved to establish a single ground truth.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- The study described is a usability study that compared the new software against manual methods (implied through efficiency and inter-operator variability assessment). It involved "three board certified Radiation Oncologists". While it involved multiple readers, it is not explicitly labeled as an "MRMC comparative effectiveness study" in the sense of a formal statistical study with defined effect sizes of improvement with AI assistance.
- Effect Size of Human Reader Improvement: Not quantitatively reported. The document states it has "the potential to reduce inter-operator variability" and provides "statistically significant and practically meaningful clinical efficiency improvements," but no numerical effect size is given.
6. Standalone Performance Study:
- Yes, a standalone performance was performed. The device's segmentation methods are described as "semi-automatic" where "the user has to place seed points to identify an inner point of the organ to contour." The software then generates contours. The study assessed the software's output in terms of accuracy, precision, and efficiency, even though a clinician would typically review and edit the results. The clinicians evaluated the device's output and how it facilitated their workflow.
7. Type of Ground Truth Used:
- The ground truth for the test set was established by expert consensus/opinion among the three board-certified Radiation Oncologists. They likely compared the device's segmentations against their clinical knowledge and potentially manual segmentations, though this is not explicitly detailed.
8. Sample Size for the Training Set:
- Not specified. The document does not provide any information about the training data or its size.
9. How the Ground Truth for the Training Set Was Established:
- Not specified. As the training set size and details are absent, the method for establishing its ground truth is also not mentioned.
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GE Healthcare AdvantageSim™ MD with MR pelvic organ at risk segmentation Option 510(k) Premarket Notification Submission
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | September 16, 2013 |
|---|---|
| Submitter: | GE Hungary Kft.Akron utca 22040 Budörs, Hungary |
| Primary ContactPerson: | Angelique CruzRegulatory Affairs LeaderTel: 0033 (0)1 30 70 47 55Fax: (262)364-2506 |
| Secondary ContactPerson: | Huy DoanRegulatory Affairs DirectorTel: 262-312-7751Mobile: 414-5818553Fax:: (262)364-2506Helen PengRegulatory Affairs ManagerTel: (262)5485091Fax: (262)364-2506 |
| Device Trade Name: | AdvantageSim™ MD MR pelvic organ at risk segmentation |
| Common/Usual Name: | AdvantageSim™ MD MR pelvic organ at risk segmentation |
| Classification Names: | 21CFR 892.5840, Radiology |
| Product Code: | KPQ |
| Predicate Device(s): | K132045 - AdvantageSim™ MD with CT Atlas-based Contouring andReplanning Options from GE HealthcareK111311 Segasist Prostate Auto-Contouring Software from SegasistTechnologies |
| Device Description /Intended Use: | AdvantageSim™ MD is a CT/MR/PET oncology application used byclinicians (radiologist, radiation oncologist, medical oncologist |
| nuclear medicine physicians and trained healthcare professional)to assist treatment planning. | |
| AdvantageSim MD with MR pelvic organ at risk segmentationOption is used to provide MR based prostate and pelvic organs-at-risk segmentation. A suite of semi-automated MR based organsegmentation contouring allows generating complex structuresaround organs at risk. These contours overlay on the co-registeredCT planning image. | |
| The segmentation methods in the modified device are semi-automatic. The user has to place seed points to identify an innerpoint of the organ to contour. | |
| The software offers a suite of manual contour editing tools enablingthe user to edit, modify, or change contours generated from the MRsegmentation tools to their desired configuration based on theirmedical and clinical knowledge and experience. The resultsprovided by the software needs to be approved by the experiencedclinician and can always be modified or corrected by him/her. It isup to the expert user to accept the result without any change,reject it completely and delineate manually, or modify the resultand then save it. The software does not provide any auto-detectionor auto-saving functionalities. | |
| Same as the predicate devices, the clinician retains the ultimateresponsibility for making the pertinent diagnosis and patientmanagement decisions based on their standard practices andvisual comparison of the individual images, regardless of theaccuracy of the output generated by the software. | |
| Indications for Use: | AdvantageSim™ MD is used to prepare geometric and anatomicaldata relating to a proposed external beam radiotherapy treatmentprior to dosimetry planning. Anatomical volumes can be definedautomatically or manually in three dimensions using a set of CTimages acquired with the patient in the proposed treatmentposition. |
| Definition of the anatomical volumes may be assisted by additionalCT, MR or PET studies that have been co-registered with theplanning CT scan. Additionally, CT & PET data from a respiratorytracked examination may be used to allow the user to define thetarget or treatment volume over a defined range of the respiratorycycle. | |
| The geometric parameters of a proposed treatment field areselected to allow non-dosimetric, interactive optimization of fieldcoverage. Defined anatomical structures and geometric treatmentsfields are displayed on transverse images, on reformatted sagittal,coronal or oblique images, on 3 D views created from the images,or on a beam eye's view display with or without the display ofdefined structures with or without the display of digitallyreconstructed radiograph. | |
| Technology: | The AdvantageSim MD with MR pelvic organ at risk segmentationOption software employs the same fundamental scientifictechnology as that of its predicate devices. |
| Determination ofSubstantialEquivalence: | Summary of Non-Clinical Tests:The AdvantageSim MD MR pelvic organ at risk segmentation Optionsoftware complies with voluntary standards as detailed in Section9, 11 and 16 of this premarket submission. The following qualityassurance measures were applied to the development of thesystem:• Risk Analysis• Requirements Reviews• Design Reviews• Integration testing (System verification)• Performance testing (Bench testing, verification)• Safety testing (Verification) |
| Summary of Clinical Tests: | |
| A usability study using consented clinical images was conductedby three board certified Radiation Oncologists who wereconsidered experts. The study was meant to assess the following: |
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GE Healthcare AdvantageSim™ MD with MR pelvic organ at risk segmentation Option 510(k) Premarket Notification Submission
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GE Healthcare AdvantageSim™ MD with MR pelvic organ at risk segmentation Option 510(k) Premarket Notification Submission
Image /page/2/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular border. The letters and the border are black, contrasting with the white background.
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GE Healthcare
AdvantageSim™ MD with MR pelvic organ at risk segmentation Option 510(k) Premarket Notification Submission
| Accuracy of measurementPrecision of the measurementEfficiency, as a comparison of amount of timeGeneral user Qualitative feedback The study results demonstrated that when used by qualified clinician the new software device has the potential to reduce inter- operator variability, provides statistically significant and practically meaningful clinical efficiency improvements and substantiates the characteristics of this feature, among others, as easy to learn, useful, efficient and providing increased throughput. | |
|---|---|
| Conclusion: | GE Healthcare considers the AdvantageSim MD with MR pelvic organ at risk segmentation Option software application to be as safe, as effective, and performance is substantially equivalent to the predicate devices. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 14, 2014
GE Hungary Kft. % Mr. Stephen Slavens Regulatory Affairs Director GE Medical Systems, LLC dba GE Healthcare 3000 N Grandview WAUKESHA WI 53188
Re: K132944
Trade/Device Name: AdvantageSim" MD MR pelvic organ at risk segmentation Option Regulation Number: 21 CFR 892.5840 Regulation Name: Radiation therapy simulation system Regulatory Class: II Product Code: KPQ Dated: January 20, 2014 Received: January 22, 2014
Dear Mr. Slavens:
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 (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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Page 2-Mr. Slavens
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/dcfault.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/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Michael D. O'Hara
for
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): K132944
Device Name: AdvantageSim™ MD with MR pelvic organ at risk segmentation Option
Indications For Use:
AdvantageSim™ MD is used to prepare geometric and analomical data relating to a proposed external beam radiotherapy treatment prior to dosimetry planning. Anatomical volumes can be defined automatically or manually in three dimensions using a set of CT images acquired with the patient in the proposed treatment position of the anatomical volumes may be assisted by additional CT, MR or PET studies that have been co-registered with the planning CT scan. Additionally, CT & PET data from a respiratory tracked examination may be used to allow the user define the target or treatment volume over a defined range of the respiratory cycle.
The geometric parameters of a proposed treatment field are selected to allow non-dosimetric. interactive optimization of field coverage. Defined anatomical structures and geometric treatments fields are displayed on transverse images, on reformatted sagittal, coronal or oblique images, on 3D views created from the images, or on a beam eye's view display with or without the display of defined structures with or without the display of digitally reconstructed radiograph.
Prescription Use V (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 Center for Devices and Radiological Health (CDRH)
Michael D. O'Hara
Page 1 of __ 1 _______________________________________________________________________________________________________________________________________________________________
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health K132944 510(k)
§ 892.5840 Radiation therapy simulation system.
(a)
Identification. A radiation therapy simulation system is a fluoroscopic or radiographic x-ray system intended for use in localizing the volume to be exposed during radiation therapy and confirming the position and size of the therapeutic irradiation field produced. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II.