(15 days)
Advantage Windows /MR Fusion provides an easy means for comparison of three dimensional (3D) images from X-ray angiography (XR: providing anatomical imaging) and Magnetic Resonance (MR: providing anatomical imaging). It allows registration between two volumetric acquisitions, which may come from different acquisition modalities (X-Ray and MR), to help physicians in diagnostic radiology or therapy planning.
The GEMS Advantage Windows X-Ray/MR Fusion software package is an option on Advantage Windows that provides easy comparison of three dimensional (3D) images from X-ray angiography and Magnetic Resonance (MR). It allows 3D registration between two volumer. : acquisitions, which may come from different acquisition modalities, producing fusion of angiographic and other anatomical images.
The provided text is a 510(k) summary for the GE Medical Systems Advantage Windows X-Ray/MR Fusion software package. It focuses on demonstrating substantial equivalence to predicate devices rather than proving a new device's performance against detailed acceptance criteria via a specific study.
Therefore, many of the requested details about acceptance criteria, study specifics, ground truth, and sample sizes for training/test sets are not explicitly present in this type of regulatory submission document.
However, based on the available information, here's what can be inferred and stated:
1. A table of acceptance criteria and the reported device performance
The document doesn't provide a specific table of acceptance criteria with numerical performance metrics. Instead, the acceptance criterion for regulatory clearance in this context is "substantial equivalence" to legally marketed predicate devices.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Devices | "The Advantage Windows X-Ray/MR Fusion does not result in any new potential safety risks and performs as well as devices currently on the market. GE considers features of the Advantage Windows X-Ray/MR Fusion to be equivalent to Advantage Windows Fusion (K983256) and Advantage Windows (CT/PET) Fusion (K010336)." |
| Performance to Specifications, Federal Regulations, and User Requirements | Controlled by: "Software Development, Validation and Verification Process to ensure performance to specifications, Federal Regulations and user requirements." and "Adherence to industry and international standards." |
2. Sample size used for the test set and the data provenance
- Sample size for the test set: Not specified. This document emphasizes equivalence rather than a new de novo performance study with a specific test set.
- Data provenance: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not specified. (Ground truth establishment for new performance is not the focus of this 510(k) summary.)
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not specified.
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, an MRMC comparative effectiveness study is not mentioned. This device is for image registration and comparison, not primarily an AI algorithm for diagnostic interpretation in the way that would typically warrant an MRMC study for AI assistance. The focus is on the functional equivalence of the registration capabilities.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The document implies that the software's functional capabilities (3D registration and comparison) were verified as performing "as well as devices currently on the market." This suggests verification of the algorithm's standalone functionality. However, a specific "standalone study" in the context of clinical performance metrics (e.g., sensitivity, specificity) is not described. The validation mentioned ("Software Development, Validation and Verification Process") would cover the standalone performance to specifications.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not specified directly regarding a clinical ground truth for a performance study. For software validation, "performance to specifications" and "user requirements" would be the 'ground truth' for the validation process.
8. The sample size for the training set
- Not applicable/Not specified. This is a software package for image fusion, not a machine learning model that typically undergoes a training phase with a distinct training set.
9. How the ground truth for the training set was established
- Not applicable/Not specified, as this isn't a machine learning model with a training set.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The "study" or justification for meeting acceptance criteria described in this 510(k) summary is based on the concept of substantial equivalence to previously cleared predicate devices.
- Description: GE Medical Systems asserts that its Advantage Windows X-Ray/MR Fusion software package functions are substantially equivalent to:
- Methodology (implied): The equivalence is primarily argued by comparing the functional features and intended use of the new device with the predicate devices. The new device offers "3D registration of anatomical images from X-Ray with anatomical images from MR," which is functionally similar to what the predicate devices do for CT/MR and CT/PET fusion. The document also states that a "Software Development, Validation and Verification Process" was used to ensure performance to specifications, Federal Regulations, and user requirements, along with adherence to industry and international standards. This process would involve internal testing and validation activities but is not detailed as a clinical "study" in this submission.
- Conclusion: The claim is that the device "does not result in any new potential safety risks and performs as well as devices currently on the market," thereby establishing its equivalence. The FDA concurred with this assessment, granting clearance.
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Image /page/0/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined and enclosed within a circle. There are decorative swirls or flourishes around the outer edge of the circle, giving it a dynamic and stylized appearance. The logo is in black and white.
AUG 01 2002
GE Medical Systems
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.87(h).
- Submitter Larry A. Kroger, Ph.D. Senior Regulatory Program Manager Telephone: (414) 544-3894 Fax: (262) 544-3863 GE Medical Systems 3000 North Grandview Blvd. Waukesha, WI 53188 USA Date Prepared: May 15, 2002.
PRODUCT IDENTIFICATION
| Name: | Advantage Windows X-Ray/MR Fusion | |
|---|---|---|
| Classification Name: | Accessory to X-Ray | |
| Manufacturer : | General Electric Medical Systems283, rue de la Minière78533 Buc Cedex, FRANCE | |
| Distributor: | General Electric Medical Systems, Buc, France. | |
| Marketed Devices | The X-Ray/MR Fusion is substantially equivalent to the devices listed below: | |
| Model: | Advantage Windows Fusion (CT/MR Fusion) | |
| Manufacturer: | General Electric Medical Systems, Milwaukee, WI | |
| 510(k) #: | K983256 | |
| Model: | Advantage Windows Fusion (CT/PET Fusion) | |
| Manufacturer: | General Electric Medical Systems, Milwaukee, WI | |
| 510(k) #: | K010336 |
Device Description:
The GEMS Advantage Windows X-Ray/MR Fusion software package is an option on Advantage Windows that provides easy comparison of three dimensional (3D) images from X-ray angiography and Magnetic Resonance (MR). It allows 3D registration between two volumer. : acquisitions, which may come from different acquisition modalities, producing fusion of angiographic and other anatomical images.
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Indications for Use:
Advantage Windows /MR Fusion provides an easy means for comparison of three dimensional (3) 1 images from X-ray angiography (XR: providing anatomical imaging) and Magnetic Resonance (Mi providing anatomical imaging). It allows registration between two volumetric acquisitions, which may come from different acquisition modalities (XRay and MR), to help physicians in diagnostic radiology or therapy planning.
Comparison with Predicate:
The Advantage Windows X-Ray/MR Fusion option allows merged 3D registration of anatomica. images from X-Rav with anatomical images from MR. The functional features of this package are substantially equivalent to that of the following devices:
| Device Name | FDA Clearance Number |
|---|---|
| Advantage Windows Fusion | K983256 |
| Advantage Windows CT/PET Fusion | K010336 |
Adverse Effects on Health:
The potential hazards are identified in a risk management summary (hazard analysis) and are controlled by:
- · Software Development, Validation and Verification Process to ensure performance to specifications, Federal Regulations and user requirements.
- · Adherence to industry and international standards.
Conclusions:
The Advantage Windows X-Ray/MR Fusion does not result in any new potential safety risks and performs as well as devices currently on the market. GE considers features of the Advantage Windows X-Ray/MR Fusion to be equivalen (K983256) and Advantage Windows (CT/PET) 1 usion (K010336).
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three stripes extending from its back, symbolizing health, services, and people. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 01 2002
General Electric Medical Systems % Mr. Wolfram Gmelin Technical Manager TÜV Rheinland of North America 12 Commerce Road NEWTON CT 06470
Re: K022310 Trade/Device Name: Advantage Windows X-ray/MR Fusion Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: July 16, 2002 Received: July 17, 2002
Dear Mr. Gmelin:
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 10 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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
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); good manufacturing practice requirements as set forth in the quality systems (QS) 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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This letter will allow you to begin marketing your device as described in your 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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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General Electric Medical Systems
Image /page/4/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 logo is black and white.
STATEMENT OF INTENDED USE
Device name: XR/MR Fusion
022310
Intended Use:
Advantage Windows /MR Fusion provides an easy means for comparison of three dimensional (3D) images from X-ray angiography (XR: providing anatomical imaging) and Magnetic Resonance (MR: providing anatomical imaging). It allows registration between two volumetric acquisitions, which may come from different acquisition modalities (X-Ray and MR), to help physicians in diagnostic radiology or therapy planning.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
510(k) Number
-OR-
Over-The-Counter Use _
Nancy C Brigdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices 4022310
§ 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).