(87 days)
The ACQA system is a software on GE Advantage Windows workstation computers that allow the user to create averaged CT images for attenuation correction of the whole body or myocardial perfusion PET images, and to register CT images with myocardial perfusion PET images, and save registered CT images for attenuation correction of myocardial perfusion PET images. The PET images corrected with the CT images of ACQA are not a replacement of the original PET images, and they serve as a secondary data set to assist the physicians read the original PET images.
ACQA is a software application installed on GE Advantage Windows workstation computers which allows physicians and healthcare professionals (1) to create averaged CT images for attenuation correction of the whole body oncology or myocardial perfusion PET images, and (2) to register the averaged or helical CT images with their corresponding myocardial perfusion PET images, and save the registered CT images for attenuation correction of the myocardial perfusion PET images. Use of this system is limited to qualified, licensed healthcare providers (radiologists, nuclear cardiologists, or nuclear medicine physicians) trained in the use of nuclear medicine imaging devices.
Here's a breakdown of the acceptance criteria and study findings for the ACQA system, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary for the ACQA system is a general summary and does not include specific quantitative acceptance criteria or detailed performance metrics. However, it does state a general conclusion:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Device meets specifications | "The tests with both laboratory and clinical data sets included in the submission passed the requirements and met specifications." |
| Functionality (Attenuation Correction) | "create averaged CT images for attenuation correction of the whole body oncology or myocardial perfusion PET images" |
| Functionality (Image Registration) | "register the averaged or helical CT images with their corresponding myocardial perfusion PET images, and save the registered CT images for attenuation correction of the myocardial perfusion PET images." |
| Safety & Effectiveness (Assisted Reading) | "The PET images corrected with the CT images of ACQA are not a replacement of the original PET images, and they serve as a secondary data set to assist the physician read the original PET images." |
2. Sample Size Used for the Test Set and Data Provenance
The 510(k) summary mentions "both laboratory and clinical data sets" were used for testing. However, it does not specify the sample size for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the data).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
The 510(k) summary does not provide information on the number of experts used to establish ground truth or their qualifications for the test set.
4. Adjudication Method for the Test Set
The 510(k) summary does not provide information on the adjudication method used for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The 510(k) summary does not mention a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it quantify an effect size for human readers improving with AI vs. without AI assistance. The device is described as assisting physicians, but direct comparison of physician performance with and without the tool is not detailed.
6. Standalone (Algorithm Only) Performance Study
The 510(k) summary indicates that the ACQA system performs specific functions (creating averaged CT images and registering images) as a software application. The statement "The tests with both laboratory and clinical data sets included in the submission passed the requirements and met specifications" implies some form of standalone performance evaluation of these technical functionalities. However, it doesn't explicitly detail a standalone performance study in terms of traditional diagnostic metrics (e.g., sensitivity, specificity) for a clinical diagnosis, as the output is described as "secondary data set to assist the physician read the original PET images."
7. Type of Ground Truth Used
The 510(k) summary does not explicitly state the type of ground truth used. Given the device's function (attenuation correction and image registration), the "ground truth" would likely relate to the accuracy of these technical tasks rather than a clinical diagnosis. This could involve:
* Image registration accuracy metrics: Comparing the alignment achieved by ACQA to a manually confirmed or gold-standard registration.
* Attenuation correction accuracy: Comparing PET images corrected by ACQA to those corrected by established methods or phantoms with known attenuation properties.
8. Sample Size for the Training Set
The 510(k) summary does not specify the sample size for the training set.
9. How the Ground Truth for the Training Set Was Established
The 510(k) summary does not provide information on how the ground truth for the training set was established. Given the nature of the device (software for image processing, not a diagnostic AI system predicting disease), it's possible that the "training set" in the context of this device refers to data used for algorithm development and testing of technical parameters, rather than a clinical ground truth labeling.
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510(K) Summary as per 21 CFR 807.92(c)
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Image /page/0/Picture/3 description: The image shows the logo for Texas Medical Imaging Consultants (TMIC). The logo consists of the letters "TMIC" in large, bold, sans-serif font. Below the letters, in a smaller font, are the words "TEXAS MEDICAL IMAGING CONSULTANTS."
General Information:
| A. Submitted by: | Texas Medical Imaging Consultants |
|---|---|
| 4027 Underwood St. | |
| Houston, TX 77025 | |
| Tel: 713-409-3801 |
Tinsu Pan Contact Person:
Date Summary Prepared: 8/25/2011
- Device Trade Name: ACQA B.
Classification Code: KPS
System, Emission Computed Tomography (per 21 CFR 892 1200) Classification Name: Accessory to Emission Computed Tomography System
-
C. Predicate Devices:
GE Healthcare Technologies (formerly GE Medical Systems) - GE Discovery ST-K041543 GE Medical Systems -- Advantage 4D option - K032915 -
D. Device Description:
ACQA is a software application installed on GE Advantage Windows workstation computers which allows physicians and healthcare professionals (1) to create averaged CT images for attenuation correction of the whole body oncology or myocardial perfusion PET images, and (2) to register the averaged or helical CT images with their corresponding myocardial perfusion PET images, and save the registered CT images for attenuation correction of the myocardial perfusion PET images. Use of this system is limited to qualified, licensed healthcare providers (radiologists, nuclear cardiologists, or nuclear medicine physicians) trained in the use of nuclear medicine imaging devices. -
Intended Use of the Device: ﻧﻨ
The ACQA system is a software on GE Advantage Windows workstation computers that allow the user to create averaged CT images for attenuation correction of the whole body or myocardial perfusion PET images, and to register CT images with myocardial perfusion PET images, and save registered CT images for attenuation correction of the myocardial perfusion PET images. The PET images corrected with the CT images of ACQA are not a replacement of the original PET images, and they serve as a secondary data set to assist the physician read the original PET images. -
F. Comparison of Technical Characteristics to Predicate Device:
The ACQA system and its predicates, the GE DST (K041543) and the GE Advantage 4D-option (K032915) utilize the same type of data sets for analysis and data processing. The ACQA, applicable to all GE PET/CT scanners, accomplishes the tasks of registration of CT and PET, and calculation of averaged CT. The same function of ACQA is only supported on the GE PET/CT
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Image /page/1/Picture/1 description: The image shows the logo for TMIC, which stands for Texas Medical Imaging Consultants. The logo is in black and white, with the letters "TMIC" in large, bold font. Below the letters, the words "TEXAS MEDICAL IMAGING CONSULTANTS" are written in a smaller font. The logo is simple and professional, and it is likely used to represent the company on its website, marketing materials, and other communications.
scanners with Dimension console, and the Advantage 4D option. A summary of differences is provided in the following table.
| Functionality | GE Discovery ST | GE Advantage 4D option | ACQA |
|---|---|---|---|
| 1. Attenuation correction ofPET data with averaged CTdata2. Registration of CT andPET data | 1. Calculation of averagedCT data with the VarianTMrespiratory gatinghardware | 1. Attenuation correctionof PET data with averagedCT data2. Registration of CT andPET data3. No VarianTM respiratorygating hardware isneeded. | |
| Applicable PET/CTs | GE PET/CT with Dimensionconsole | All GE PET/CT scanners | All GE PET/CT scanners |
| Advantages over ACQA | Both data processing anddata correction can beperformed on theDimension console | Can produce 10 phases of4DCT images for RadiationOncology application | Data processing on the GEAdvantage Windowsworkstation, andattenuation correction ofPET data on the PET/CTconsole. |
| ACQA Advantages overGE predicate devices | No averaged CT data isproduced. The user canperform either attenuationcorrection by averaged CTdata or registration ofregular CT with PET data,and cannot use bothoptions. | Can produce averaged CTdata. However, 4DCToption is typically installedfor radiation oncology,not for cardiology. | ACQA is the only softwarethat does not require theDimension console or4DCT option (installationof both costs > $200k.) tocompute averaged CT datafor attenuation correctionof the PET data andregistration of the PETdata with either averagedCT or helical CT data. |
| Large installed base ofAdvantage Windowsworkstation | Over 10,000 Advantage Windows workstations have been installed worldwide. It isvery likely that a clinic/hospital which wants to use the ACQA software is already withan Advantage Windows workstation. In this case, ACQA software can be installedwithout any addition of hardware. |
- G. Performance data: The tests with both laboratory and clinical data sets included in the submission passed the requirements and met specifications.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Mr. Tinsu Pan Chief Technology Officer Texas Medical Imaging Consultants 4027 Underwood Street HOUSTON TX 77025
Re: K113086
Trade/Device Name: ACQA System Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: KPS & JAK Dated: October 12, 2011 Received: October 18, 2011
Dear Mr. Pan:
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
JAN 1 3 2012
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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,
Mary S Patel
Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
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The ACQA system is a software on GE Advantage Windows workstation computers that allow the user to create averaged CT images for attenuation correction of the whole body or myocardial perfusion PET images, and to register CT images with myocardial perfusion PET images, and save registered CT images for attenuation correction of myocardial perfusion PET images. The PET images corrected with the CT images of ACQA are not a replacement of the original PET images, and they serve as a secondary data set to assist the physicians read the original PET images.
Mary Pastel
ation and Safety Office of In
510K K113086
N/A