(15 days)
The system is intended for use by Nuclear Medicine (NM) or Radiology practitioners and referring physicians for display, processing, archiving, printing, reporting and networking of NM data including planar scans (Static, Whole Body, Dynamic, Multi-Gated) and tomographic scans (SPECT, Gated SPECT, dedicated PET or Camera-Based-PET) acquired by gamma cameras or PET scanners. The system can run on dedicated workstation or in a server-client configuration. The NM or PET data can be coupled with registered and/or fused CT or MR scans and with physiological signals, in order to: depict, localize, and/or quantify the distribution of radionuclide tracers and anatomical structures in scanned body tissue for clinical diagnostic purposes.
Xeleris 3, as a modification of its predicate device - Xeleris 2 (K051673), is a Nuclear Medicine, PET, NM/CT, and PET/CT workstation. Xeleris 3, as a medical device, is computer workstation software used for the display, processing, archiving, printing, reporting and networking of NM, PET, NM/CT, and PET/CT studies. Xeleris 3 runs on Microsoft Windows XP based PC workstation (color monitor, keyboard, mouse, and CD-RW for archiving), an Ethernet network connection and system software. Optional DVD device is also available. Xeleris 3 also operates in client-server configurations. Xeleris 3 is classified as class II medical device, complies with voluntary Digital Imaging and Communication in Medicine (DICOM) standard.
The provided 510(k) summary does not contain specific acceptance criteria or a study that proves the device meets such criteria in the way typically expected for a new medical device claiming a specific performance metric. Instead, the document describes a modification of an existing device (Xeleris 3 as a modification of Xeleris 2) and asserts substantial equivalence to the predicate device.
Here's an analysis based on the provided text, addressing your points where information is available:
1. Table of Acceptance Criteria and Reported Device Performance
None provided in the document. The submission focuses on device modifications and substantial equivalence to a predicate device. Therefore, a table comparing specific performance metrics against pre-defined acceptance criteria is not included.
2. Sample size used for the test set and data provenance
No specific test set or clinical data is cited for validating performance against acceptance criteria. The document states: "The XELERIS 3 PROCESSING AND REVIEW WORKSTATION did not require clinical studies to support substantial equivalence." This implies that clinical performance was not evaluated with a separate test set to establish new performance metrics. The validation activities mentioned are:
- Risk Analysis
- Requirements Reviews
- Design Reviews
- Testing on unit level (Module verification)
- Integration testing (System verification)
- Final acceptance testing (Validation)
- Performance testing (Verification)
- Safety testing (Verification)
These activities are focused on software development and verification rather than clinical performance evaluation against a patient dataset.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No ground truth establishment by experts for a clinical test set is mentioned, as clinical studies were not deemed necessary for substantial equivalence.
4. Adjudication method for the test set
Not applicable, as no clinical test set requiring adjudication is described.
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 such study was conducted or reported. This device is a "Nuclear Medicine Workstation" for display, processing, archiving, etc., and not an AI-assisted diagnostic tool that would typically undergo MRMC studies to assess reader improvement. The device employs "the same fundamental scientific technology as its predicate devices."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a "workstation" intended for use by "Nuclear Medicine (NM) or Radiology practitioners," indicating a human-in-the-loop system. Its function is to provide tools for practitioners, not to perform diagnoses independently.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable, as no clinical performance study requiring ground truth is detailed.
8. The sample size for the training set
Not applicable. The document does not describe the development of an algorithm that would require a "training set" in the context of machine learning or AI. The device is a modification of existing software.
9. How the ground truth for the training set was established
Not applicable.
Summary of Acceptance Criteria and Study Approach in the Provided Document:
The acceptance criteria for the XELERIS 3 PROCESSING AND REVIEW WORKSTATION, as implied by this 510(k) summary, are primarily centered around functional equivalence, safety, and effectiveness compared to its predicate device (XELERIS 2). The study that "proves the device meets the acceptance criteria" is, in essence, the documentation of software development, verification, and validation activities (Risk Analysis, Requirements Reviews, Design Reviews, various levels of testing), asserting that these activities ensure the modified device retains the same fundamental scientific technology and performs comparably to the predicate. The key phrase "The XELERIS 3 PROCESSING AND REVIEW WORKSTATION did not require clinical studies to support substantial equivalence" indicates that formal clinical performance studies with specific acceptance criteria and patient data were not conducted for this submission.
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510(k) Summary
JAN - 8 2010
1093982
In accordance with 21 CFR 807.92 the following summary of information is provided: Date: October ,8,2009 Submitter: GE Healthcare, GE Medical Systems Israel, Functional Imaging 4 HAYOZMA St TIRAT HACARMEL, 30200, ISRAEL Primary Contact Person: Eli Werner Regulatory Affairs Leader GE Healthcare, GE Medical Systems Israel, Functional Imaging +972-4-8563666 +972-4-8563664 Secondary Contact Person: Laurence Bigio OA site manager GE Healthcare, GE Medical Systems Israel, Functional Imaging +972-4-8563666 +972-4-8563664 Device: Trade Name: XELERIS 3 PROCESSING AND REVIEW WORKSTATION Common/Usual Name: Nuclear Medicine Workstation Classification Names: System, Image Processing, Radiological Class II :21CFR 892.2050 LLZ Product Code: Predicate Device(s): K051673 XELERIS 2 PROCESSING AND REVIEW WORKSTATION XELERIST™ 3 PROCESSING AND REVIEW WORKSTATION Device Description: (Xeleris 3), as a modification of its predicate device - Xeleris 2 (K051673), is a Nuclear Medicine, PET, NM/CT, and PET/CT workstation. Xeleris 3, as a medical device, is computer workstation software used for the display, processing, archiving, printing, reporting and networking of NM, PET, NM/CT, and PET/CT studies. Xeleris 3 runs on Microsoft Windows XP based PC workstation (color monitor, keyboard, mouse, and CD-RW for archiving), an Ethernet network connection and system software. Optional DVD device is also available. Xeleris 3 also operates in client-server configurations. Xeleris 3 is classified as class II medical device, complies with voluntary Digital Imaging and Communication in Medicine (DICOM) standard.
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- Intended Use: The system is intended for use by Nuclear Medicine (NM) or Radiology practitioners and referring physicians for display, processing , archiving, printing, reporting and networking of NM data including planar scans (Static, Whole Body, Dynamic, Multi-Gated) and tomographic scans (SPECT, Gated SPECT, dedicated PET or Camera-Based-PET) acquired by gamma cameras or PET scanners.
The system can run on dedicated workstation or in a server-client configuration.
The NM or PET data can be coupled with registered and/or fused CT or MR scans and with physiological signals, in order to: depict, localize, and/or quantify the distribution of radionuclide tracers and anatomical structures in scanned body tissue for clinical diagnostic purposes.
The "XELERIS 3 PROCESSING AND REVIEW Technology: WORKSTATION" employs the same fundamental scientific technology as its predicate devices "XELERIS 2 PROCESSING AND REVIEW WORKSTATION (K051673)".
AND Determination of ని PROCESSING The XELERIS REVIEW Substantial Equivalence: WORKSTATION and its applications is designed to comply with voluntary standards as detailed in Section 9, 11 and 17 of this premarket submission. The following quality assurance measures were applied to the development of the system:
Risk Analysis Requirements Reviews Design Reviews Testing on unit level (Module verification) Integration testing (System verification) Final acceptance testing (Validation) Performance testing (Verification) Safety testing (Verification)
3 PROCESSING AND REVIEW The XELERIS WORKSTATION did not require clinical studies to support substantial equivalence.
Conclusion: GE Healthcare considers the "XELERIS 3 PROCESSING AND REVIEW WORKSTATION" to be as safe, as effective, and performance is substantially equivalent to the predicate device(s) "XELERIS 2 PROCESSING AND REVIEW WORKSTATION (K051673)".
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Image /page/2/Picture/0 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
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 Israel % Mr. Casey Conry Senior Project Engineer Underwriters Laboratories, Inc 1285 Walt Whitman Rd. MELVILLE NY 11747
- JAN - 8 2010
Re: K093982
Trade/Device Name: Xeleris 3 Processing and Review Workstation Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: December 22, 2009 Received: December 24, 2009
Dear Mr. Conry:
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 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 -
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device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/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/MedicalDevices/Resourcesfor You/Industry/default.htm.
http://www.fda.gov/MedicalDevices/ResourceforYou/Industry/default.htm.
Sincerely yours,
Janine M. Morris
Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):
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Device Name: XELERIS 3 PROCESSING AND REVIEW WORKSTATION
Indications for Use:
The system is intended for use by Nuclear Medicine (NM) or Radiology practitioners and referring physicians for display, processing, archiving, reporting and networking of NM data including planar scans (Static, Whole Body, Dynamic, Multi-Gated) and tomographic scans (SPECT, Gated SPECT, dedicated PET or Camera-Based-PET) acquired by gamma cameras or PET scanners.
The system can run on dedicated workstation or in a server-client configuration.
The NM or PET data can be coupled with registered and/or fused CT or MR scans and with physiological signals, in order to: depict, localize, and/or quantify the distribution of radionuclide tracers and anatomical structures in scanned body tissue for clinical diagnostic purposes.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use_ (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devic 510(k) Number.
§ 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).