The MG ATC attenuation correction system is an optional addition to the Millennium MG gamma camera (K962738). It comprises additional hardware and software to generate a correction map and corrected NM images for non-uniform attenuation.

AI/ML Overview

The provided text describes the MG ATC: Attenuation Correction System for Dual-Head Variable-Angle Gamma Camera. Here's an analysis of the acceptance criteria and study information:

1. Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Deliver better uniformed images than regular SPECT without attenuation correction.	Meets Criteria: "Bench data and Clinical data show that the MG ATC option delivers better uniformed images than regular SPECT without attenuation correction."
No significant difference compared to V TransACT images (predicate device).	Meets Criteria: "Comparison to V TransACT images shows no significant difference."
Substantially equivalent in terms of safety and effectiveness to the V TransACT option for the Varicam (K980959).	Meets Criteria: "In the opinion of ELGEMS Ltd., the MG ATC is substantially equivalent in terms of safety and effectiveness to the V TransACT option for the Varicam (K980959)."
Same intended use as the predicate device.	Meets Criteria: "The MG ATC has the same intended use as the predicate device..."
No new safety or effectiveness concerns raised.	Meets Criteria: "...and no new safety or effectiveness concerns are raised."

Study Details:

The document provides a high-level summary of the studies but lacks specific quantitative details for many of the requested points.

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

Sample Size for Test Set: Not specified. The document only mentions "Bench data and Clinical data."
Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

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

Not specified.

4. Adjudication Method for the Test Set:

Not specified.

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

Not explicitly mentioned. The statement "Comparison to V TransACT images shows no significant difference" suggests a comparison, but it doesn't specify if human readers were part of an MRMC study or if it was an assessment based on objective metrics. Therefore, the effect size of human readers improving with AI vs. without AI assistance is not provided.

6. Standalone (Algorithm Only) Performance Study:

The nature of the "Bench data" suggests some form of standalone evaluation of the algorithm's output (images). However, the document doesn't explicitly state a separate standalone performance study or provide specific metrics for it. The primary comparison is implied to be visual image quality and equivalence to the predicate.

7. Type of Ground Truth Used:

The document mentions "better uniformed images" and "no significant difference" in comparison, suggesting that the ground truth was likely based on subjective image quality assessment or comparison to an established reference standard for image uniformity and accuracy in SPECT imaging. It does not mention pathology, outcomes data, or expert consensus in a structured way for ground truth creation.

8. Sample Size for the Training Set:

Not specified. The document focuses on demonstrating equivalence to a predicate device rather than detailing model training.

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

Not specified. As it's a device for attenuation correction, the "training" (if any, as this predates modern deep learning) would likely involve calibration data and possibly phantom studies to accurately model photon attenuation. However, no specifics are provided.

Overall Conclusion from the Provided Text:

The submission focuses heavily on demonstrating substantial equivalence to a legally marketed predicate device (V TransACT) based on the stated intended use and general performance improvements (better uniformed images compared to uncorrected SPECT). While "Bench data and Clinical data" are cited, specific details regarding sample sizes, expert involvement, and ground truth methodologies are not included in this summary document. The information is high-level for a 510(k) summary, aiming to establish equivalence rather than a detailed performance report for a novel AI algorithm.

Summary

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Image /page/0/Picture/0 description: The image shows the word "ELGEMS" in a stylized font. The letters are in bold, and the "G" is larger than the other letters. There is a curved line that starts at the top of the "G" and goes around to the bottom of the "G", creating a loop.

ELGEMS Ltd. • P.O. Box 170 • Tirat Hacarmel 30200 ISRAEL• TEL: 972-4-8310335/420 • FAX: 972-4-8310515

K991896

9. 510(k) Summary of Safety and Effectiveness (in accordance to 21 CFR 807.87(b)

Device Name

AUG 23

MG ATC: Attenuation Correction System for Dual-Head Variable-Angle Gamma Camera.

Establishment Name and Registration Number of Submitter

ELGEMS Ltd.

Name: Registration Number: Corresponding Official:

9613299 Laor Dan ELGEMS Ltd. P.O. Box 170 Tirat Hacarmel 30200, ISRAEL

Device Classification

Classification Code: 90 KPS Classification Class: Class II Product Panel Identification: Radiology

Reason for 510(k) Submission

Modification of legally marketed device.

Identification of Legally Marketed Equivalent Devices

V TransACT: Attenuation Correction System for Dual-Head Variable-Angle Gamma Camera - K980959.

Device Description

Description of Change or Modification

The Millennium MG gamma camera (K962738) gamma camera has been modified to accommodate for the MG ATC attenuation correction system, by including an additional correction map for attenuation, obtained by two scanning line sources attached to the heads supports of the camera. This map is used to create an attenuation-corrected image.

Intended Use of Device

The intended use of the device is to produce attenuation-corrected NM images, even when attenuation coefficients are not uniform over the FOV.

Summary of Studies

Bench data and Clinical data show that the MG ATC option delivers better uniformed images than regular SPECT without attenuation correction. Comparison to V TransACT images shows no significant difference.

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$\mathcal{ELGEMS}$

ELGEMS Ltd. • P.O. Box 170 • Tirat Hacarmel 30200 ISRAEL• TEL: 972-4-8310335/420 • FAX: 972-4-8310515

Conclusion

加法规划。

In the opinion of ELGEMS Ltd., the MG ATC is substantially equivalent in terms of safety and effectiveness to the V TransACT option for the Varicam (K980959). The MG ATC has the same intended use as the predicate device and no new safety or effectiveness concerns are raised.

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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure with three lines extending from the head, possibly representing ideas or communication.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Dan Laor Quality and Requlatory Affairs ELGMENS, Ltd. P.O. Box 170 Tirat Hacarmel 30200

Re:

K991896 MG ATC: Attenuation Correction System for Dual-Head Variable-Angle Gamma Camera Requlatory Class: II (two) Product Code: 90 KPS 21 CFR 892.1200 Dated: June 1, 1999 Received: June 3, 1999

Dear Mr. Laor:

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, 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 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,

CART David C. Stahl, M.D.

APT 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

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510(k) Number (if known): DEVICE NAME: MG ATC: Attenuation correction system for dualhead variable-angle Gamma Camera

INDICATION FOR USE: MG ATC is indicated to improve the quality of emission SPECT images obtained on the Millennium MG dual head camera by attenuation correction. : : :

(Please do not write below this line - continue on another page if needed)

	(Concurrence of CDRH, Office of Device Evaluation (ODE))
	(Division Sign-Off)
	Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number	K991896
Prescription Use	✓ OR Over-the-Counter Use ______(Per 21 CFR 801.109)

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.