ADAC MCD-AC option to ADAC Dual Head Emission Tomographic System produces images of biodistribution of positron-emitting radioisotopes previously administered to the human body. The system is intended to provide an enhancement to the emission images acquired using the ADAC MCD System by correcting for attenuation effects in the human body.

Device Description

MCD-AC is a system that will be marketed as an optional addition to the ADAC EPIC-MCD Gamma Camera System (e.g., Vertex+, any other ADAC camera in a dual-head configuration which can take 180° images). MCD-AC is short for Molecular Coincidence Defection Attenuation Correction, and is a modification to the EPIC-MCD system, cleared in 510k K952684. The MCD-AC uses the same principle of coincidence imaging used by the EPIC-MCD, but adds the image quality enhancing feature of attenuation correction. When a radioactive material is administered to a patient and the resulting gamma ray emission detected, attenuation is observed due to the internal parts (e.g., bones, breast tissue, etc.) of the patient. The resulting image is then an underestimation of the actual image, due to the presence of bone or tissue in the pathway of the emission radiation. When an image is generated representing the density of the patient, it is possible to compensate for the attenuation effects, since the attenuation of gamma rays are largely proportional to the density. Such an image can be obtained by sending a known flux of gamma rays from an external source, through the patient at different angles, registering what fraction is transmitted through the patient, and then reconstructing these projections to form an attenuation image (attenuation map). The count density in this image is inversely proportional to the density of the patient and can be used in the reconstruction of the emission image to compensate for gamma ray attenuation.

AI/ML Overview

The provided text describes a 510(k) submission (K971980) for the ADAC MCD-AC, an optional addition to the ADAC EPIC-MCD Gamma Camera System designed to enhance emission images by correcting for attenuation effects.

Here's an analysis of the provided information against your requested points:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state quantitative acceptance criteria for the MCD-AC device. It focuses on demonstrating that the device produces similar image quality to predicate devices.

Acceptance Criteria	Reported Device Performance
Not explicitly stated as quantitative thresholds.	"The quality of the images produced was similar to the quality of images produced by the predicate devices."
Implicitly: Produce images depicting anatomical density of a patient.	The device "produces images which depict the anatomical density of a patient."
Implicitly: Enhance emission images by correcting for attenuation effects.	The device "is intended to provide an enhancement to the emission images acquired using the ADAC MCD Gamma Camera System by correcting for attenuation effects in the patient."

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

Test Set Sample Size: "Images were obtained using phantoms and humans." The exact number of phantoms or humans is not specified.
Data Provenance: The document does not specify the country of origin. Given ADAC Laboratories is located in Milpitas, CA, USA, it's highly probable the human data was collected in the USA. The study design (retrospective or prospective) is not explicitly stated, but "Images were obtained" implies a prospective collection for the purpose of this study.

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

The document does not provide information on the number of experts, their qualifications, or their role in establishing ground truth for the test set. The evaluation seems to be a qualitative comparison of image quality rather than a quantitative diagnostic performance study requiring expert adjudication.

4. Adjudication method for the test set

The document does not specify any adjudication method for the test set. The assessment appears to be a direct comparison of image quality.

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 was not done. The document describes a technical modification (attenuation correction) to an existing gamma camera system and compares the resulting image quality to predicate devices. It does not evaluate the performance of human readers with or without the assistance of this specific AI (attenuation correction is a processing step, not necessarily an AI in the modern sense of deep learning) at making diagnostic interpretations. Therefore, no effect size for human reader improvement is provided.

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

Yes, a standalone performance assessment was effectively done. The study described focuses on the "single source attenuation correction technique on MCD cameras" and evaluates the "quality of the images produced" by the device itself, both with phantoms and humans. This is a technical performance assessment of the algorithm's output (images) rather than a diagnostic performance study involving human interpretation.

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

The document does not explicitly state the type of ground truth used. For phantoms, the ground truth would inherently be "known" (e.g., known distribution of radioactivity). For human images, given the focus on "image quality" and "anatomical density," the "ground truth" implicitly refers to the physical reality of attenuation effects and their correction as observable in the images. It's not a diagnostic ground truth like pathology or outcomes.

8. The sample size for the training set

The document does not mention or specify a training set sample size. This type of device (attenuation correction algorithm) might not involve a distinct "training set" in the same way modern AI/machine learning models do. The algorithms would likely be deterministic or based on established physical models and signal processing techniques.

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

As no training set is mentioned (see point 8), the document does not describe how ground truth for a training set was established.

Summary

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K971980

OCT 2 3 1997

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

ADAC Laboratories Submitted By: A. 540 Alder Drive Milpitas, CA 95035 Tel: (408) 321-9100 Fax: (408) 321-9686 Contact Person: Dennis Henkelman at address above MCD-AC E. Device Trade Name: Gamma Camera Systems Common Name: Classification Name: System, Emission Computed Tomography C. Vantage 1.0 Predicate Device: EPIC-MCD UGM 240H GE ADVANCE

D. Device Description:

The MCD-AC uses the same principle of coincidence imaging used by the EPIC-MCD, but adds the image quality enhancing feature of attenuation correction. When a radioactive material is administered to a patient and the resulting gamma ray emission detected, attenuation is observed due to the internal parts (e.g., bones, breast tissue, etc.) of the patient. The resulting image is then an underestimation of the actual image, due to the presence of bone or tissue in the pathway of the emission radiation.

When an image is generated representing the density of the patient, it is possible to compensate for the attenuation effects, since the attenuation of gamma rays

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are largely proportional to the density. Such an image can be obtained by sending a known flux of gamma rays from an external source, through the patient at different angles, registering what fraction is transmitted through the patient, and then reconstructing these projections to form an attenuation image (attenuation map). The count density in this image is inversely proportional to the density of the patient and can be used in the reconstruction of the emission image to compensate for gamma ray attenuation.

E. Indications for Use:
The MCD-AC 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 MCD Gamma Camera System by correcting for attenuation effects in the patient.
F. Technological Comparison:
MCD-AC is similar to Vantage in that both devices correct for patient attenuation by use of radioactive sources to create attenuation maps. In both devices, the data is combined from attenuation maps with emission data to correct for attenuation due to bones, tissues, etc. within the patient. The algorithms used to perform this attenuation correction are similar. The reconstruction algorithm used for MCD-AC is the same as the algorithm used for EPIC-MCD with the exception that the MCD-AC algorithm is a modification to the EPIC-MCD algorithm to implement attenuation correction for MCD images.

The source type for the MCD-AC (Cs-137) is different from the source type for the Vantage (Gd-153) because it has been chosen to provide the appropriate attenuation for 511 KeV gamma rays. The source geometry is also different. MCD-AC uses a point source, while Vantage uses a line source. However, when the point source is translated along the patient, the computer views it as a line source.

II. Testing

A study was conducted to demonstrate the single source attenuation correction technique on MCD cameras. Images were obtained using phantoms and humans. The quality of the images produced was 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 Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES" written around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 3 1997

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

Re: K971980

MCD-AC Attenuation Correction for SPECT Camera Dated: September 19, 1997 Received: September 22, 1997 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 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 general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranion.

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 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 yitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question 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. lian 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

Revised August 8, 1997

K971980 510(k) Number (if known): Device Name: MCD-AC

ADAC Laboratories Sponsor Name:

Indications For Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Uhvid C. Stymm

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Device

Radiological Devices
510(k) Number K971980

Prescription Use $\sqrt{ }$
(Per 21 CFR 801.109)

Over-The-Counter Use _

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.