Vantage ExSPECT II 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 510k K971878.

Vantage ExSPECT II is a computer program that provides a patient's functional information, which is further improved by using the anatomical information, obtained using the external radioactive scanning line sources with special collimation to minimize patient exposure, and the acquisition electronics and software, cleared in 510k K943596 for Vantage 1.0.

Vantage ExSPECT II is a modification of Vantage 2.0 ExSPECT and is designed to provide the user with additional quality assurance (QA) to improve the consistency and usability of the Vantage 2.0 ExSPECT product. The Post Acquisition QA tool provides the user with feedback regarding the quality of the acquired images in that it alerts the user as to the level of any banding or truncation in the data as well as the level of counts acquired in each data set. The other improvement is two user-selectable iterative reconstruction methods for reducing the noise level in the transmission image.

AI/ML Overview

The Vantage ExSPECT II is a software program designed to provide quality assurance (QA) enhancements to nuclear medicine images. It is a modification of the Vantage 2.0 ExSPECT software package.

Here's an analysis of the provided text regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Post Acquisition QA Tool:
Alerts user to level of banding in data	"alerts the user as to the level of any banding or truncation in the data"
Alerts user to level of truncation in data	"alerts the user as to the level of any banding or truncation in the data"
Alerts user to level of counts acquired in each data set	"as well as the level of counts acquired in each data set"
Transmission Reconstruction Algorithms:
Provides two user-selectable iterative reconstruction methods	"The other improvement is two user-selectable iterative reconstruction methods"
Reduces noise level in the transmission image	"for reducing the noise level in the transmission image."

Explanation of "Reported Device Performance": The provided text is a 510(k) summary, which outlines the device's features and intended function rather than providing quantitative performance metrics from a specific study. The "reported device performance" directly reflects the claims made for the device's capabilities in the summary. No numerical or statistical performance data (e.g., sensitivity, specificity, accuracy, or reduction in banding magnitude) are provided to objectively "prove" these claims in a quantitative sense. The acceptance appears to be qualitative based on the functionality descriptions.

2. Sample size used for the test set and the data provenance:

Sample Size: Not explicitly stated. The text only mentions "Images were processed using both the Post Acquisition QA tool and the transmission iterative reconstruction methods." It does not specify the number of images or cases used for testing.
Data Provenance: Not explicitly stated. It is not mentioned if the data was retrospective or prospective, or the country of origin.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not specified. The document does not mention the use of experts or how ground truth was established for the testing.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not specified. There is no mention of an adjudication method.

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:

No, a multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned. The device focuses on quality assurance enhancements for image acquisition and reconstruction, not on assisting human readers in interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Yes, the testing described appears to be a standalone evaluation of the algorithm's functionality. The statement "Images were processed using both the Post Acquisition QA tool and the transmission iterative reconstruction methods" implies an assessment of the algorithm's output without direct human interaction as part of the primary test of its claimed QA and noise reduction features.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not explicitly stated. Given the nature of the device (quality assurance and noise reduction), the "ground truth" would likely be related to objective measures of image quality, such as quantifiable levels of banding, truncation, or noise reduction as assessed against a reference standard or known simulated data. However, the document does not elaborate on how these were defined or measured.

8. The sample size for the training set:

Not applicable/Not specified. This is a 510(k) summary for a software modification, not a machine learning or AI-based device that would typically involve a distinct "training set" in the context of supervised learning. The modifications are described as "improvements" to existing algorithms (Post Acquisition QA tool and iterative reconstruction methods), suggesting development or refinement of rule-based or model-based algorithms rather than data-driven AI training.

9. How the ground truth for the training set was established:

Not applicable/Not specified, as it is not an AI/ML device with a training set.

Summary

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

SEP - 1

K992078

Vantage ExSPECT II
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

General Information I.

Submitted By: A.

ADAC Laboratories 540 Alder Drive Milpitas, CA 95035 Tel: (408) 468-3989 Fax: (408) 435-7427

Dennis W. Henkelman at address above Contact Person:

B. Device Trade Name: Vantage ExSPECT II Common Name: Gamma Camera Systems System, Emission Computed Tomography Classification Name:

C. Predicate Device: Vantage 2.0 ExSPECT

D. Device Description:

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

user-selectable iterative reconstruction methods for reducing the noise level in the transmission image.

E. Indications for Use:
Vantage ExSPECT II is intended to provide quality assurance enhancements to nuclear medicine images acquired using the ADAC Gamma Camera Systems.
F. Technological Comparison:
The Vantage 2.0 ExSPECT and Vantage ExSPECT II devices have the same indications for use, source type and geometry, system hardware, operating principles, and emission reconstruction algorithm, with the exception of the Post Acquisition QA tool and minor modifications to the transmission reconstruction algorithm.
II. Testing
Images were processed using both the Post Acquisition QA tool and the transmission iterative reconstruction methods.

{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 features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" are arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP = 1 1999

Ms. Genine M. Grant Sr. Software Engineer ADAC Laboratories 540 Alder Drive Milpitas, CA 95035

Re: K992078

Vantage ExSPECT II Dated: June 18, 1999 Received: June 18, 1999 Product Code: 90 KPS Requlatory Class: Il (two) 21 CFR 892.1200

Dear Ms. Grant:

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, 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 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/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}------------------------------------------------

INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

Vantage ExSPECT II Device Name:

ADAC Laboratories Sponsor Name:

Indications For Use:

Vantage ExSPECT II is intended to provide quality assurance enhancements to nuclear medicine images acquired using the ADAC Gamma Camera Systems.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David k. Skymm
(Division Sign-Off)

Division of Reproductive, Abdominal, EN and Radiological Device 510(k) Number

ખ Prescription Use Over-The-Counter Use 0

ﺳ

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.