The Vantage 2.0 ExSPECT option to the ADAC Gamma Camera Systems produces images which depict the anatomical density of a patient. The system is intended to provide an enhancement to the emission images acquired using the ADAC Gamma Camera Systems by correcting for attenuation effects in the patient.

Device Description

Vantage 2.0 ExSPECT 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 1.0 software package, cleared in 510k K943596.

Vantage 2.0 ExSPECT 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 510k K943596 for Vantage 1.0.

The system uses the same imaging technique of Single Photon Emission Computed Tomography (SPECT) with attenuation correction, as in Vantage 1.0, but adds image quality enhancements by correcting for the Photopeak scatter, Downscatter, and Resolution Recovery (RR).

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Vantage 2.0 ExSPECT device.

Acceptance Criteria and Study Details for Vantage 2.0 ExSPECT

Based on the provided documentation, the Vantage 2.0 ExSPECT is a software program designed to enhance image quality in ADAC Gamma Camera Systems by correcting for attenuation effects, Photopeak scatter, Downscatter, and Resolution Recovery (RR). The 510(k) submission primarily focuses on demonstrating substantial equivalence to its predicate device, Vantage 1.0.

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific quantifiable acceptance criteria (e.g., minimum accuracy, sensitivity, or specificity thresholds) or detailed reported device performance metrics tied to such criteria. The submission focuses on demonstrating that the modifications (Vantage 2.0 ExSPECT) maintain the same indications for use and do not introduce new safety or effectiveness concerns compared to the predicate device (Vantage 1.0).

Implicit Acceptance Criteria:

Given the nature of a 510(k) submission for a software modification, the implicit acceptance criteria would revolve around:

Maintaining existing image quality and diagnostic utility: The enhanced images from ExSPECT 2.0 should be at least as good as, if not better than, those from Vantage 1.0, without degrading diagnostic information.
Safety equivalence: The modifications should not introduce new safety hazards (e.g., increased radiation dose, misinterpretation risk).
Functional equivalence: The system should perform its intended function (producing images depicting anatomical density and correcting attenuation) as effectively as the predicate.

Acceptance Criterion (Implicit)	Reported Device Performance
Images depict anatomical density and provide enhancement by correcting for attenuation.	"The Vantage 2.0 ExSPECT option to the ADAC Gamma Camera Systems produces images which depict the anatomical density of a patient. The system is intended to provide an enhancement to the emission images acquired using the ADAC Gamma Camera Systems by correcting for attenuation effects in the patient." The device "adds image quality enhancements by correcting for the Photopeak scatter, Downscatter, and Resolution Recovery (RR)." The FDA's substantial equivalence determination implies that these performance enhancements were deemed acceptable and did not raise new questions of safety or effectiveness compared to the predicate device.
Maintain indications for use and safety/effectiveness profile of predicate device (Vantage 1.0).	"The Vantage 1.0 and Vantage 2.0 ExSPECT 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 reconstruction algorithm to better account for resolution recovery and Photopeak and down scatter." The FDA's clearance (K971878) confirms that this substantial equivalence was met.

Acceptance Criterion (Implicit)

Reported Device Performance

Images depict anatomical density and provide enhancement by correcting for attenuation.

"The Vantage 2.0 ExSPECT option to the ADAC Gamma Camera Systems produces images which depict the anatomical density of a patient. The system is intended to provide an enhancement to the emission images acquired using the ADAC Gamma Camera Systems by correcting for attenuation effects in the patient." The device "adds image quality enhancements by correcting for the Photopeak scatter, Downscatter, and Resolution Recovery (RR)." The FDA's substantial equivalence determination implies that these performance enhancements were deemed acceptable and did not raise new questions of safety or effectiveness compared to the predicate device.

Maintain indications for use and safety/effectiveness profile of predicate device (Vantage 1.0).

"The Vantage 1.0 and Vantage 2.0 ExSPECT 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 reconstruction algorithm to better account for resolution recovery and Photopeak and down scatter." The FDA's clearance (K971878) confirms that this substantial equivalence was met.

2. Sample Size Used for the Test Set and Data Provenance

The provided document does not specify the sample size for any test set (e.g., number of patients or images). It only states, "Images were acquired using the protocol outlined in the Vantage user manual."

The data provenance is not explicitly mentioned (e.g., country of origin, retrospective or prospective nature of data collection). However, given that it's a 510(k) for a modification to an existing device (Vantage 1.0), it's plausible that the testing involved data typical of SPECT imaging performed on ADAC Gamma Camera Systems, potentially from internal testing or clinical sites where the predicate device was in use.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

The document does not provide any information regarding the number of experts used or their qualifications for establishing ground truth for any test set.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for a test set.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

An MRMC comparative effectiveness study was not described or referenced in the provided text. There is no mention of comparing human reader performance with or without AI assistance, nor any effect size provided.

6. Standalone (Algorithm Only) Performance

The document does not explicitly describe a standalone performance study in terms of quantitative metrics. The submission focuses on the software program integrating with existing gamma camera systems to produce enhanced images. The "performance" described is the functionality of the software in correcting for scatter, resolution recovery, and attenuation, which are image processing enhancements rather than a direct diagnostic output that would typically have standalone performance metrics like sensitivity/specificity for a disease.

7. Type of Ground Truth Used

The type of ground truth used is not explicitly stated. However, for a device that enhances image quality for anatomical density and attenuation correction, ground truth could implicitly refer to:

Physical phantoms: Used to validate the accuracy of attenuation, scatter, and resolution corrections against known properties.
Clinical expert consensus: Radiologists or nuclear medicine physicians would visually assess the improved quality and diagnostic utility of the enhanced images compared to unenhanced images or images from the predicate device.
Quantitative image quality metrics: Such as contrast-to-noise ratio, spatial resolution, or artifact reduction, which can be measured and compared.

The text does not specify which, if any, of these were formally established as ground truth.

8. Sample Size for the Training Set

The document does not provide any information regarding the sample size for a training set. This is consistent with the era (1997) and the nature of the device as a software modification for image enhancement, which might not rely on machine learning models requiring explicit "training sets" in the modern sense. The "training" might refer to the development and tuning of the image processing algorithms using various image data.

9. How the Ground Truth for the Training Set Was Established

As no training set is explicitly mentioned, how its ground truth was established is also not provided. If the algorithms involved development and tuning, the performance improvement (e.g., better correction of scatter) would have likely been validated against known physics models or simulated data, or visually assessed by experts.

Summary

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524 118 18
AUG - 8 1997

System, Emission Computed Tomography

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS DATA

I. General Information

ADAC Laboratories Submitted By: A. 540 Alder Drive Milpitas, CA 95035 Tel: (408) 321-9100 Fax: (408) 321-9686 Dennis Henkelman at address above Contact Person: Vantage 2.0 ExSPECT B. Device Trade Name: Gamma Camera Systems Common Name:

C. Vantage 1.0 Predicate Device:
Classification Name:
D. Device Description:
. '

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E. Indications for Use:

F. Technological Comparison:

The Vantage 1.0 and Vantage 2.0 ExSPECT 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 reconstruction algorithm to better account for resolution recovery and Photopeak and down scatter.

II. Testing

.
"

Images were acquired using the protocol outlined in the Vantage user manual.

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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 eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is facing left and has its wings spread. The text "DEPARTMENT OF HEALTH & HUM" is arranged in a semi-circle around the left side of the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 8 1997

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

Dear Mr. Henkelman:

Re: K971878

Vantage 2.0 ExSPECT Gamma Camera Dated: May 19, 1997 Received: May 21, 1997 Regulatory Class: II 21 CFR 892.1200/Procode: 90 KPS

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 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 equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, 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 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/dsmamain.html".

Sincerely yours

h.J.Liau Yin
Lillian Yin, Ph.D.

Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, 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):

Vantage 2.0 ExSPECT Device Name:

_ADAC Laboratories Sponsor Name:

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ro Phillips

Prescription Use Over-The-Counter Use 0

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

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.