(77 days)
Vantage 2.5 is a software program, which will be marketed as an addition to ADAC Laboratories Gamma Camera products. This is a modification of the Vantage 2.0 ExSPECT software package, cleared in 510k K971878.
Vantage 2.5 is intended to provide quality assurance enhancements to nuclear medicine images acquired using the gold Gama Camera Systems. It includes scatter correction capability for scatter correction capability for
Vantage 2.5 is a software program, which will be marketed as an optional addition to ADAC Laboratories Gamma Camera products. This is a modification of the Vantage 2.0 ExSPECT software package, cleared in 510(k) K971878.
Vantage 2.5 is a computer program that provides a patient's anatomical information using the external radioactive scanning line sources with special collimation to minimize patient exposure, and the acquisition electronics and software, cleared in 510(k) K943596 for Vantage 1.0 and in 510(k) K971878 for Vantage 2.0 ExSPECT.
The system uses the same imaging technique of Single Photon Emission Computed Tomography (SPECT) with attenuation correction, as in Vantage 2.0 ExSPECT, but adds Quality Assurance (QA) Tools by using Pre-Scan, Automatic Energy Window Checking and Transmission QA Reference.
This 510(k) summary for the Vantage 2.5 Gamma Camera System does not contain the detailed information necessary to complete the acceptance criteria table and answer all the questions regarding the study. The document primarily focuses on demonstrating substantial equivalence to a predicate device and describes the general function of the software.
Here's what can be extracted and what information is missing:
1. A table of acceptance criteria and the reported device performance
This information is not provided in the document. The 510(k) summary states, "Images were acquired using the protocol outlined in the Vantage user manual," but it does not specify any acceptance criteria or present performance data for the Vantage 2.5 itself. The basis for clearance appears to be substantial equivalence to the Vantage 2.0 ExSPECT, which implies a similar performance profile, but no specific metrics are given for Vantage 2.5.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not provided in the document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This information is not provided in the document.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not provided in the document.
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
An MRMC study is not mentioned in the document. Given the description, Vantage 2.5 is a software program that enhances quality assurance for nuclear medicine images and provides scatter correction. It is not described as an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
A standalone performance study focused on specific metrics is not explicitly described. The document states that the "Vantage 2.0 ExSPECT and Vantage 2.5 devices have the same indications for use, source type and geometry, system hardware, operating principles, and reconstruction algorithms, with the exception of minor modifications to the acquisition software." This implies that its performance is presumed to be similar to Vantage 2.0, which was previously cleared, rather than providing new standalone performance data for Vantage 2.5 itself. The "Quality Assurance (QA) Tools" are functions, not necessarily requiring a standalone performance study in the way an AI diagnostic algorithm might.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not provided in the document.
8. The sample size for the training set
This information is not provided in the document. The submission focuses on modifications to existing software rather than the development of a new algorithm with a distinct training set.
9. How the ground truth for the training set was established
This information is not provided in the document.
{0}------------------------------------------------
JUL 26 1999
| Vantage 2.5 | |
|---|---|
| ADAC Laboratories | |
| 510(k) Premarket Notification |
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS DATA
I. General Information
- ADAC Laboratories A. Submitted by: 540 Alder Drive Milpitas, California 95035 Tel: (408) 468-3989 Fax: (408) 435-7427 Dennis W. Henkelman at address above Contact Person: Vantage 2.5 B. Device Trade Name: Gamma Camera Systems Common Name: System, Emission Computed Tomography Classification Name:
- C. Vantage 2.0 Predicate Device:
- D. Device Description:
Vantage 2.5 is a software program, which will be marketed as an optional addition to ADAC Laboratories Gamma Camera products. This is a modification of the Vantage 2.0 ExSPECT software package, cleared in 510(k) K971878.
Vantage 2.5 is a computer program that provides a patient's anatomical information using the external radioactive scanning line sources with special collimation to minimize patient exposure, and the acquisition electronics and software, cleared in 510(k) K943596 for Vantage 1.0 and in 510(k) K971878 for Vantage 2.0 ExSPECT.
The system uses the same imaging technique of Single Photon Emission Computed Tomography (SPECT) with attenuation correction, as in Vantage 2.0 ExSPECT, but adds Quality Assurance (QA) Tools by using Pre-Scan, Automatic Energy Window Checking and Transmission QA Reference.
- E. Indications for Use:
Vantage 2.5 is a software program, which will be marketed as an addition to ADAC Laboratories Gamma Camera products. This is a modification of the Vantage 2.0 ExSPECT software package, cleared in 510k K971878.
{1}------------------------------------------------
- F. Technological Comparison:
The Vantage 2.0 ExSPECT and Vantage 2.5 devices have the same indications for use, source type and geometry, system hardware, operating principles, and reconstruction algorithms, with the exception of minor modifications to the acquisition software.
II. Testing
Images were acquired using the protocol outlined in the Vantage user manual.
{2}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a person with their arms outstretched.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 26 1999
Dennis W. Henkelman, R.A.C. Director, Regulatory Affairs & Quality Assurance ADAC Laboratories 540 Alder Drive Milipitas. California 95035
Re: K991607
Vantage 2.5 Gamma Camera System Dated: May 7, 1999 Received; May 10, 1999 Regulatory Class: II 21 CFR 892.1200/Procode: 90 KPS
Dear Mr. Henkelman:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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 labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
Page
K991607 SIO(k) NUMBER (IF KNOWN): _
Vantage 2.5 DEVICE NAME:
INDICATIONS FOR USE:
Vantage 2.5 is intended to provide quality assurance enhancements to nuclear medicine images acquired using the gold Gama Camera Systems.
scatter correction capability for It includes scatter correction capability for
(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) OR
Over-The-Counter-Use (Optional Format 1-2-96
David L. Segerson
(Division Sign-Off) Division of Reproductive, Abdominal, ENT and Radiological D 510(k) Number
§ 892.1200 Emission computed tomography system.
(a)
Identification. An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.(b)
Classification. Class II.