(90 days)
The ADAC 3D-MSPECT application is intended to provide processing and 3-dimensional display of reconstructed Cardiac SPECT studies.
3D-MSPECT is a software application designed to review and quantitatively analyze cardiac SPECT perfusion nuclear medicine patient studies. 3D-MSPECT operates as an independent application on the ADAC Pegasys system. The application provides tools for viewing standard and gated cardiac SPECT images on both a slice-by-slice basis and as a three-dimensional rendered image. Additionally, it provides a quantitative assessment of heart function by computing and displaying left ventricular chamber volume, ejection fraction, and transient ischemic dilation (TID) values and provides an assessment of the data set in comparison to similar patients. Physicians use this information to assess the anatomical and physiological functionality of the heart and analyze the presence of myocardial defects.
3D-MSPECT can be used to display the left ventricular endocardial and epicardial surfaces, polar maps indicating perfusion, wall thickening, wall motion, and reversibility, a 3D rendered image of the cardiac surfaces, and the short axis, vertical long, and horizontal long slice data. These can be displayed for a single data set or as a comparison of related data sets (i.e., stress, rest, delay, or Vantage). Physicians can also use this application to create, modify and review Normals files from patient data available in the Pegasys database.
The provided text does not contain acceptance criteria for the 3D-MSPECT device, nor does it describe a study that uses such criteria to prove the device's performance.
Instead, the document is a 510(k) Premarket Notification summary and an FDA clearance letter. It mainly focuses on:
- Device Description: What the 3D-MSPECT software does (review and quantitatively analyze cardiac SPECT perfusion nuclear medicine patient studies, providing tools for viewing images and assessing heart function).
- Indications for Use: The intended purpose of the device (processing and 3-dimensional display of reconstructed Cardiac SPECT studies).
- Technological Comparison: States that the 3D-MSPECT has similar indications for use and utilizes similar data types as predicate devices (ADAC CEQUAL and Sopha Sophy NXT), performing similar quantifications.
- Testing (briefly mentioned): "Images were generated using a prototype of the application. The quality of the images produced was verified to be similar to the quality of images produced by the predicate devices." This is the only mention of "testing" and it's a very high-level statement without specific metrics or a detailed study description.
- FDA Clearance: A letter from the FDA stating that the device is substantially equivalent to predicate devices and can be marketed.
Therefore, I cannot provide the requested information in the table or answer most of the specific questions because the necessary details are not present in the provided document.
Here's what can be inferred or explicitly stated based only on the provided text, with most items marked as "Not provided":
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not provided | "quality of the images produced was verified to be similar to the quality of images produced by the predicate devices." (No specific metrics) |
2. Sample size used for the test set and the data provenance
- Sample Size: Not provided.
- Data Provenance: Not provided (e.g., country of origin, retrospective or prospective). The text only mentions "Images were generated using a prototype of the application."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not provided.
4. Adjudication method for the test set
- Not provided.
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. The closest statement is that the "quality of the images produced was verified to be similar to the quality of images produced by the predicate devices," but this doesn't describe a comparative effectiveness study with human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The testing description is too vague to confirm if standalone performance was specifically assessed as an algorithm only without human-in-the-loop. It focuses on image quality being similar to predicate devices.
7. The type of ground truth used
- Not provided. The text only mentions "verified to be similar to the quality of images produced by the predicate devices," implying a comparison to existing, accepted methods or images, but it doesn't describe how the truth was established for the specific prototype images.
8. The sample size for the training set
- Not provided. The document primarily discusses a prototype application and its comparison to predicate devices, not the specifics of an AI model's training.
9. How the ground truth for the training set was established
- Not provided. The document does not mention a training set or how ground truth was established for it.
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JUN 4 1998
3D-MSPECT ADAC Laboratories 510(k) Premarket Notification
Appendix VIII, 510(k) Summary of Safety and Effectiveness Data Page 1 of 2
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS DATA
I. General Information
C.
A. Submitted By: ADAC Laboratories 540 Alder Drive Milpitas, CA 95035 Tel: (408) 321-9100 Fax: (408) 321-9686
Contact Person: Dennis Henkelman at address above
3D-MSPECT B. Device Trade Name: Gamma Camera System Common Name: System. Emission Computed Tomography Classification Name:
| Predicate Device: | ADAC CEQUAL®Sopha Sophy NXT |
|---|---|
| ------------------- | --------------------------------- |
D. Device Description:
3D-MSPECT is a software application designed to review and quantitatively analyze cardiac SPECT perfusion nuclear medicine patient studies. 3D-MSPECT operates as an independent application on the ADAC Pegasys system. The application provides tools for viewing standard and gated cardiac SPECT images on both a slice-by-slice basis and as a three-dimensional rendered image. Additionally, it provides a quantitative assessment of heart function by computing and displaying left ventricular chamber volume, ejection fraction, and transient ischemic dilation (TID) values and provides an assessment of the data set in comparison to similar patients. Physicians use this information to assess the anatomical and physiological functionality of the heart and analyze the presence of myocardial defects.
3D-MSPECT can be used to display the left ventricular endocardial and epicardial surfaces, polar maps indicating perfusion, wall thickening, wall motion, and reversibility, a 3D rendered image of the cardiac surfaces, and the
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short axis, vertical long, and horizontal long slice data. These can be displayed for a single data set or as a comparison of related data sets (i.e., stress, rest, delay, or Vantage). Physicians can also use this application to create, modify and review Normals files from patient data available in the Pegasys database.
E. Indications for Use:
The ADAC 3D-MSPECT application is intended to provide processing and 3-dimensional display of reconstructed Cardiac SPECT studies.
- Technological Comparison: F.
The ADAC 3D-MSPECT, ADAC CEQUAL, and Sopha Sopha Sophy NXT Cardiac Software have similar indications for use and utilize similar types of data sets for analysis, with the exception of the Vantage data sets used by 3D-MSPECT. In addition, these applications perform similar quantifications (calculations) used to produce image displays of the data sets.
Testing II.
Images were generated using a prototype of the application. The quality of the images produced was verified to be similar to the quality of images produced by the predicate devices.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
1 1998 JUN
Dennis W. Henkelman Director, Regualtory Affairs and Quality Assurance ADAC Laboratories 540 Alder Drive Milpitas, CA 92035
Re:
K980867 3D-MSPECT (Gamma Camera System) Dated: March 5, 1998 Received: March 6, 1998 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 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 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 895. A substantially eculvalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) 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 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 device on our 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/odrh/dsmaldsmamain.html".
Sincerely yours,
William Yin
Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
3D-MSPECT Device Name:
ADAC Laboratories Sponsor Name:
Indications for Use
The ADAC 3D-MSPECT is intended to provide processing and 3-dimensional display of reconstructed Cardiac SPECT studies.
Do Not Write Below This Line - Continue on Another Page if Needed
Concurrence of CDRH, Office of Device Evaluation (ODE)
17 Prescription Use Over-The-Counter Use
David le. Seymour
(Division Sign-Off) Division of Reproductive, Abdominal, EN and Radiological Devic 510(k) Number J
§ 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.