(62 days)
MIM 3.5 (CIRCA) is a software package that provides the physician with the means to display, register and fuse medical images from multiple modalities. Additionally, it evaluates cardiac left ventricular function and perfusion including left ventricular end-diastolic volume, end-systolic volume, and ejection fraction. Finally, the ROI feature reduces the time necessary for the physician to define objects in medical image volumes by providing an initial definition of object contours. The objects include but are not limited to turnors and organs.
The MIM software program should be used for the registration, fusion and display of medical images from multi-modalities, such as, SPECT, PET, CT, and MRI. MIM assists in definition of structures in medical images including turnors, organs, and cardiac left ventricular cavity.
MIM 3.5 (CIRCA) is a software package designed for use in diagnostic imaging. It is a standalone software package which operates on Windows 2000/XP. Its intended function and use is to provide the physician with the means to display, register and fuse medical images from multiple modalities including DICOM PET, ECAT PET, SPECT, CT and MRI. Additionally it evaluates cardiac left ventricular function and perfusion including left ventricular end-diastolic volume, end-systolic volume, ejection fraction, volumetric curve and ROI contouring.
The provided text makes a general statement that "MIMvista has conducted performance and functional testing on the MIM 3.5 (CIRCA) software. In all cases, the software passed its' performance requirements and met specifications." However, it does not provide specific acceptance criteria or details about the study that proves the device meets those criteria.
Therefore, I cannot populate the table or answer most of your questions based on the given document.
Here's a breakdown of what can be inferred or directly stated from the document regarding the study, and where information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (e.g., Accuracy, Precision, Recall) | Reported Device Performance |
|---|---|
| Not provided in the document | Not provided in the document |
| (The document only states "passed its' performance requirements and met specifications.") | (No specific metrics or quantitative results are given.) |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size: Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of experts: Not specified.
- Qualifications of experts: Not specified.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Adjudication method: 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
- MRMC study: Not specified as having been performed.
- Effect size: Not applicable, as an MRMC study is not mentioned. The device's stated function is to provide tools for display, registration, fusion, and evaluation, and to assist in defining structures, implying a human-in-the-loop context, but no comparative study vs. human readers alone is described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone study: The document implies standalone software functionality ("standalone software package"), and the general statement "passed its' performance requirements and met specifications" refers to the software itself. However, specific details of a standalone performance study with metrics are not provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of ground truth: Not specified.
8. The sample size for the training set
- Training set size: Not specified. (It's worth noting that at the time of this 510(k), the term "training set" in the context of machine learning was not as prevalent or explicitly required for device submissions as it is now. This device is described as "Medical Imaging Software" rather than an AI/ML algorithm in the modern sense.)
9. How the ground truth for the training set was established
- Ground truth establishment for training set: Not specified.
Summary of available information regarding the study:
- What was done: Performance and functional testing.
- Outcome: The software passed its performance requirements and met specifications.
- Details missing: Specific metrics, study design, sample sizes, ground truth methodology, expert involvement, and comparative studies are all absent from this 510(k) summary. The submission focuses on substantial equivalence to predicate devices, which was primarily based on intended use and technical characteristics, not necessarily detailed clinical performance studies as would be expected for novel AI devices today.
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MIMvista Corp.
OCT 3 1 2005
510(k) Summary of Safety and Effectiveness
(The following information is in conformance with 21 CFR 807.92)
Submitter:
MIMvista Corp. 25200 Chagrin Blvd. Suite 200 Cleveland, OH 44122 Phone: 216-896-9798 Fax: 216-896-9796
Contact Person: Peter Simmelink
Date Summary Prepared: August 29, 2005
Device Name
| Trade Name: | MIM 3.5 (CIRCA) |
|---|---|
| Common Name: | Medical Imaging Software |
| Classification Name: | System, Imaging Processing, Radiological |
Predicate Devices
| K001276 | MIM | MiMvista Corp. |
|---|---|---|
| K011572 | QGS, QPS | Digirad Corp. |
| K001026 | 3D-MSPECT | The Regents of the University of MI |
| K040141 | Emory Cardiac Toolbox v2.6 | Syntermed, Inc. |
| K981535 | FOCUS Pilot ContouringWorkstation | Computerized Medical Systems, Inc. |
Intended Use
MIM 3.5 (CIRCA) is a software package that provides the physician with the means to display, register and fuse medical images from multiple modalities. Additionally, it evaluates cardiac left ventricular function and perfusion including left ventricular end-diastolic volume, end-systolic volume, and ejection fraction. Finally, the ROI feature reduces the time necessary for the physician to define objects in medical image volumes by providing an initial definition of object contours. The objects include but are not limited to turnors and organs.
Device Description
MIM 3.5 (CIRCA) is a software package designed for use in diagnostic imaging. It is a standalone software package which operates on Windows 2000/XP. Its intended function and use is to provide the physician with the means to display, register and fuse medical images from multiple modalities including DICOM PET, ECAT PET, SPECT, CT and MRI. Additionally it evaluates cardiac left ventricular
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function and perfusion including left ventricular end-diastolic volume, end-systolic volume, ejection fraction, volumetric curve and ROI contouring.
Substantial Equivalence
MIM 3.5 (CIRCA) is substantially equivalent to; Medical Image Merge (MIM) software (K001276), QGS/QPS software (K011572), 3D-MSPECT Software (K001026), Emory ECTb software (K040141) and Focus Pilot software (K981536).
Performance Data
MIMvista has conducted performance and functional testing on the MIM 3.5 (CIRCA) software. In all cases, the software passed its' performance requirements and met specifications.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", indicating the department's name and national affiliation. The seal is presented in black and white, emphasizing its official and governmental nature.
Public Health Service
OCT 3 1 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Peter Simmelink Chief Operating Officer MIMvista Corp. 25200 Chagrin Blvd. Suite 200 CLEVELAND, OH 44122 Re: K052379 Trade/Device Name: MIM 3.5 (CIRCA) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: August 29, 2005 Received: August 30, 2005
Dear Mr. Simmelink:
·
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 (Premarket Approval), it may be subject to such 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 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 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:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | ( ) | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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) 443-6597 or at its Internet address
http://www.fda.gov/cdrh/industry/support/index.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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INDICATIONS FOR USE
510(k) Number (if known): _ TBD
Device Name: MIM
Indications for Use:
The MIM software program should be used for the registration, fusion and display of medical images from multi-modalities, such as, SPECT, PET, CT, and MRI. MIM assists in definition of structures in medical images including turnors, organs, and cardiac left ventricular cavity.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices KD523 510(k) Number ________________________________________________________________________________________________________________________________________________________________
(Posted November 13, 2003)
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§ 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).