The VTransACT attenuation correction system is an addition to the Apex VariCam and Millennium VG gamma cameras (K953801). It comprises additional hardware and software to generate corrected NM images for non-uniform attenuation.

AI/ML Overview

Here's a summary of the acceptance criteria and study information for the VTransACT: Attenuation Correction System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document does not explicitly state specific quantitative acceptance criteria (e.g., a specific percentage improvement, a threshold for uniformity). Instead, the "Summary of Studies" section provides a qualitative performance statement.

Acceptance Criteria	Reported Device Performance
Implicit Acceptance Criteria (inferred from "Summary of Studies"): - Ability to produce more uniform images than regular SPECT without attenuation correction. - Performance comparable to the predicate device (TransACT option for the CardiaL Gamma Camera).	- "Bench data and Clinical data show that the VTransACT option for the VariCam delivers more uniform images than regular SPECT without attenuation correction." - "Comparison to TransACT images shows no significant difference."

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

Sample Size: The document does not specify the sample size for the "Clinical data" or "Bench data" studies.
Data Provenance: The document does not specify the country of origin for the data or whether it was retrospective or prospective. It only states "Bench data and Clinical data."

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

The document does not provide information about the number of experts used to establish ground truth or their qualifications.

4. Adjudication Method for the Test Set:

The document does not specify any adjudication method.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done:

The document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. It states a comparison was made to the predicate device's images ("Comparison to TransACT images shows no significant difference"), but this is not described as an MRMC study and no effect size for human reader improvement is provided.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

The "Summary of Studies" focuses on the device's ability to "deliver more uniform images" and its "Comparison to TransACT images." This suggests the algorithm's performance in generating corrected images was assessed. While human interpretation of these images is the ultimate goal, the phrasing "delivers more uniform images" points to an evaluation of the algorithm's output itself, implying a standalone assessment of the image correction quality. However, it is not explicitly stated that this was a standalone performance study distinct from human interpretation.

7. The Type of Ground Truth Used:

The document does not explicitly state the type of ground truth used. Given the nature of an "Attenuation Correction System" and the performance reported ("delivers more uniform images"), the ground truth likely relates to objective measures of image uniformity or accuracy against a known physical phantom (for "Bench data") or clinical images where attenuation effects are understood/quantified. However, this is not specified as expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set:

The document does not provide information about the sample size for a training set. The device description mentions it "comprises additional hardware and software to generate corrected NM images," implying an algorithmic approach, but no details on training data are given.

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

The document does not provide information on how ground truth for any training set was established, as no training set is mentioned.

Summary

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Image /page/0/Picture/0 description: The image shows the date JUN 4 1998 and the word "ELGEMS" in a stylized font. The word "ELGEMS" is written in all capital letters, and the "G" has a curved line extending from the bottom of the letter. The date is written in a simple font, with the month abbreviated to "JUN".

EMS Ltd. • P.O. Box 170 • Tirat Hacarmel 30200 ISRAEL. 2-4-8310335/420 • FAX: 972-4-8310515

K980959

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

Device Name

VTransACT: Attenuation Correction System for the VariCam Gamma Camera.

Establishment Name and Registration Number of Submitter

Name: Registration Number: Corresponding Official: ELGEMS Ltd. 9613299 Yair Friedman ELGEMS Ltd. P.O. Box 170 Tirat Hacarmel 30200, ISRAEL

Device Classification

Classification Code: 90 IYX Classification Class: Class II Product Panel Identification: Nuclear Medicine

Reason for 510(k) Submission

Modification of legally marketed device.

Identification of Legally Marketed Equivalent Devices

TransACT option for the Apex CardiaL Gamma Camera K952674

Device Description

Description of Change or Modification

The VariCam (K953801) gamma camera has been modified to accommodate for the VTransACT attenuation correction system, by including an additional correction map for attenuation, obtained by two scanning line sources attached to the heads 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 VTransACT option for the VariCam delivers more uniform images than regular SPECT without attenuation correction. Comparison to TransACT images shows no significant difference.

Conclusion

In the opinion of ELGEMS Ltd., the VTransACT is substantially equivalent in terms of safety and effectiveness to the TransACT option for the CardiaL (K952674). The VTransACT has the same intended use as the predicate device and no new safety or effectiveness concerns are raised.

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Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping human profiles or a caduceus-like design.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 4 1998

Yair Friedman VP- Quality and Regulatory Affairs Elgems Ltd. P.O. Box 170 Tirat Hacarmel 30200 Israel

K980959 Re:

VTransACT: Attenuation Correction System for Dual-Head Variable-Angle Gamma Camera March 12, 1998 Dated: Received: March 16, 1998 Regulatory class: II 21 CFR 892.1200/Procode: 90 KPS

Dear Mr. Friedman:

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 Ouality System Regulation (OS) 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 result in reculatory 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 beein 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/odri/dsmaldsmamain.html".

Sincerely yours,

Kilian Yin

Lillian Yin, Ph.D.

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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510(k) Number (if known): UNKNOWN VTransACT: Attenuation Correction System Device Name: Indications For Use:

To obtain attenuation corrected Nuclear Medicine images.

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

( Concurrence of CDRH, Office of Device Evaluation (ODE) )

David A. Segmen
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological De 510(k) Number

Prescription Use_ -(Per 21 CFR 801.109)

OR 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.