The Vantage 3.0 InSynch ™ option to the ADAC Gamma Camera Systems is intended to produce images of two emission isotopes simultaneously while also acquiring a transmission image.

Device Description

Vantage 3.0 InSynch™ 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 3.0 InSynch™ is a computer program that produces nuclear medicine images of two isotopes acquired simultaneously, corresponding to specific energy levels and a transmission image from external radioactive scanning line sources. Vantage 3.0 InSynch™ is an extension of Vantage 2.0 ExSPECT which acquires a single isotope image with the transmission image produced by the external radioactive scanning line sources.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Vantage 3.0 InSynch™ device:

Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state quantitative acceptance criteria in a dedicated section. However, the "Testing" section implies that the primary acceptance criterion was demonstrating comparable image quality between simultaneous dual-isotope scanning (new device, Vantage 3.0 InSynch™) and sequential dual-isotope scanning (predicate device, Vantage 2.0 ExSPECT).

Acceptance Criteria (Implied)	Reported Device Performance
Comparable image quality between simultaneous dual-isotope scanning (Vantage 3.0 InSynch™) and sequential dual-isotope scanning (Vantage 2.0 ExSPECT).	"The quality of the images produced was similar to the quality of images produced by the predicate device." "A study was conducted to demonstrate that Vantage 3.0 InSynch™ provides comparable images..."

Detailed Study Information:

Sample size used for the test set and the data provenance:
- The document does not specify the sample size (number of images or patients) used for the test set.
- The data provenance (e.g., country of origin, retrospective or prospective) is not mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not mention the use of experts to establish ground truth or their qualifications. The evaluation of image quality appears to be a direct comparison within the study, rather than against an independently established ground truth.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- The document does not describe any adjudication method.
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:
- The document describes a comparison between two imaging methods (simultaneous vs. sequential dual-isotope scanning) produced by different software versions. It does not describe an MRMC study or evaluate the improvement of human readers with or without AI assistance. The device itself is software for image acquisition and reconstruction, not an AI-assisted diagnostic tool for human readers in the modern sense.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, the study described is a standalone evaluation of the algorithm's output (image quality). The comparison is between the images produced by the new software (Vantage 3.0 InSynch™) and the images produced by the predicate software (Vantage 2.0 ExSPECT). There's no human reader "in-the-loop" as part of the primary performance evaluation described.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The concept of a "ground truth" as a separate, definitive diagnostic standard does not appear to be directly applicable or explicitly used in the described study. Instead, the study's goal was to demonstrate equivalence in image quality between the new and predicate device's output. The "ground truth" for the comparison was effectively the image quality produced by the predicate device as a benchmark for what is acceptable.
The sample size for the training set:
- The document does not mention a "training set" in the context of machine learning, as this device appears to be a software modification for image acquisition and reconstruction in a gamma camera, not an AI/ML algorithm that requires a traditional training set.
How the ground truth for the training set was established:
- Not applicable, as a training set and its associated ground truth are not mentioned for this device.

Summary

{0}------------------------------------------------

K981291

Vantage 3.0 InSynch™
ADAC Laboratories
510(k) Premarket Notification

Appendix IX, 510(k) Summary of Safety and Effectiveness Data Page 1 of 2

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS DATA

I. General Information

Submitted By: A.

ADAC Laboratories 540 Alder Drive Milpitas, CA 95035 Tel: (408) 321-9100 Fax: (408) 321-9686

Contact Person:

Dennis Henkelman at address above

Vantage 3.0 InSynch™ Device Trade Name: B. Gamma Camera Systems Common Name: System, Emission Computed Tomography Classification Name:
Vantage 2.0 ExSPECT C. Predicate Device:
Device Description: D.

Vantage 3.0 InSynch™ is a computer program that produces nuclear medicine

images of two isotopes acquired simultaneously, corresponding to specific energy levels and a transmission image from external radioactive scanning line sources. Vantage 3.0 InSynch™ is an extension of Vantage 2.0 ExSPECT which acquires a single isotope image with the transmission image produced by the external radioactive scanning line sources.

{1}------------------------------------------------

Indications for Use: E.

The Vantage 3.0 InSynch ™ option to the ADAC Gamma Camera Systems is intended to produce images of two emission isotopes simultaneously while also acquiring a transmission image.

F. Technological Comparison:

The Vantage 3.0 InSynch™ and Vantage 2.0 ExSPECT devices have the same source type, source strength, source geometry, system hardware, and operating principles. Whereas the Vantage 2.0 ExSPECT device was intended for the acquisition and reconstruction of a single emission isotope in addition to a line source, the Vantage 3.0 InSynch™ is intended for the acquisition of dual isotopes simultaneously.

II. Testing

A study was conducted to demonstrate that Vantage 3.0 InSynch™ provides comparable images using simultaneous dual-isotope scanning to sequential dualisotope scanning. The quality of the images produced was similar to the quality of images produced by the predicate device.

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name arranged in a circular fashion around a symbol. The symbol is a stylized representation of a human figure embracing a bird, which is meant to represent the department's mission of protecting the health of all Americans and providing essential human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 9 1998

Dennis W. Henkelman Director, Regulatory Affairs and Quality Affairs ADAC Laboratories 540 Alder Drive Milpitas, CA 95035

Re:

K981291 Vantage 3.0 InSynch™M Dated: April 8, 1998 Received: April 9, 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 (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 (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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/dsma/dsmamain.html".

Sincerely yours,

Lillian Yin, Ph.D.

Lillian Yin, Ph.D. Director, Division of Reproductiv Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

Vantage 3.0 InSynch™ Device Name:

ADAC Laboratories Sponsor Name:

Indications for Use

The Vantage 3.0 InSynch ™ option to the ADAC Gamma Camera Systems is intended to produce images of two emission isotopes simultaneously while also acquiring a transmission image.

Do Not Write Below This Line - Continue on Another Page if Needed

Concurrence of CDRH, Office of Device Evaluation (ODE)

David H. Slyman

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devi 510(k) Number

ਲ Prescription Use Over-The-Counter Use 0

Regulation Number and Section

§ 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.