The VPC-94 high-energy (511 KeV) collimators and cart is an option for the Apex VariCam and Millennium VG gamma camera (K953801). It comprises two high-energy collimators and a collimator cart.

AI/ML Overview

The provided text describes a 510(k) submission for a medical device and its substantial equivalence to a predicate device. However, it does not contain specific details about acceptance criteria, a detailed study proving performance against those criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or how ground truth was established.

The document states: "Bench data and Clinical data show that the VPC-94 option achieves its intended use," but it does not elaborate on the nature or results of these studies.

Therefore, much of the requested information cannot be extracted from the provided text.

Here's a breakdown of what can be inferred or directly stated, along with what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not specified	"better at a comparable sensitivity" than the predicate device (Dyna Camera 2C 615-211) due to dual detector heads.
Intended Use: High-energy (511 KeV) NM imaging with Apex Varicam and Millennium VG Dual-Head Variable-Angle Gamma Cameras.	"Bench data and Clinical data show that the VPC-94 option achieves its intended use."

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

Sample Size (Test Set): Not specified.
Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The studies are referred to generally as "Bench data and Clinical data."

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

Number of Experts: Not specified.
Qualifications of Experts: Not specified.

4. Adjudication method for the test set

Adjudication Method: Not specified.

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

MRMC Study: Not mentioned or described. This submission is for a collimator for a gamma camera, not an AI-assisted diagnostic tool for human readers.

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

Standalone Performance: Not applicable/not discussed in the context of this device (a collimator). The device itself (collimator) is a physical component, not an algorithm.

7. The type of ground truth used

Type of Ground Truth: Not specified. The "Clinical data" would likely involve patient imaging but the method for confirming findings (e.g., pathology, other imaging modalities, clinical follow-up) is not detailed.

8. The sample size for the training set

Sample Size (Training Set): Not applicable/not specified. This device is a passive component (collimator), not a machine learning algorithm that requires a training set.

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

Ground Truth for Training Set: Not applicable.

Summary of what is known about the study:

The submission refers to "Bench data and Clinical data" as evidence that the device achieves its intended use.
The device (VPC-94 collimator) is stated to have "better" resolution at comparable sensitivity compared to its predicate device (Dyna Camera 2C - 615-211 high-energy collimator), partly because the VPC-94 uses two detector heads instead of one.
The overall conclusion is that the VPC-94 is "substantially equivalent" to the predicate device, has the "same intended use," and raises "no new safety or effectiveness concerns." This suggests the studies were primarily designed to demonstrate this equivalence rather than to establish new performance benchmarks against specified acceptance criteria.

Summary

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Image /page/0/Picture/0 description: The image shows the text "JUL 1 3 1998" on the top left corner. Below the date, the word "ELGEMS" is written in a stylized font. The letter "G" in "ELGEMS" has a circular design element incorporated into it.

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

K98/352

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

Device Name

VPC-94: High Energy (511 KeV) Collimator for Dual-Head Variable-Angle Gamma Camera.

Establishment Name and Registration Number of Submitter

ELGEMS Ltd.

Name: Registration Number: Corresponding Official:

9613299 Yair Friedman - VP, Quality and Regulatory Affairs ELGEMS Ltd. P.O. Box 170 Tirat Hacarmel 30200, ISRAEL

Device Classification

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Nuclear Medicine 90 123 KPS Panel Identification: Classification Code: (Radiology) Class II Product Classification Class:

Reason for 510(k) Submission

Modification of legally marketed device.

Identification of Legally Marketed Equivalent Devices

Dyna Camera 2C - no K number available, pre-amendment device. The Dyna Camera 2C is a single-head gamma camera. It can be equipped with the 615-211 High Energy Collimator, having an energy range of 44 - 525 KeV.

Device Description

The VPC-94 high-energy (511 KeV) collimators and cart is an option for the Apex VariCam and Millennium VG gamma camera (K953801). It comprises two high-energy collimators and a collimator cart.

Description of Change or Modification

The VPC-94 is equivalent to the Dyna Camera 2C 615-211 apart from the VPC-94 resolution, which is better at a comparable sensitivity, since two detector heads are used for the VariCam instead of one for the Dyna 2C.

Intended Use of Device

The VPC-94 collimators are designed for high-energy (511 KeV) NM imaging, with the Apex Varicam and Millennium VG Dual-Head Variable-Angle Gamma Cameras.

Summary of Studies

Bench data and Clinical data show that the VPC-94 option achieves its intended use.

Conclusion

In the opinion of ELGEMS Ltd., the VPC-94 is substantially equivalent to the Dyna Camera 2C 615-211 high-energy collimator. The VPC 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/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is a stylized eagle with three lines representing its wings and body. The eagle is facing to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 3 1998

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

Re:

K981352

VPC-94 High Energy (511 KeV) Collimator for Dual-Head Variable-Angle Gamma Dated: April 9, 1998 Received: April 14, 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 econvalent (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 (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 requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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 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 deving 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/dsmaldsmam.html".

Sincerely yours,

Kilian Yin

Lillian Yin, Ph.D. Director, Division of Reproductiv Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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CAKNOWN K981352 510(k) Number (if known): VPC-94: High Energy (511 KeV) Collimator for Device Name: Dual-Head Variable-Angle Gamma Camera

Indications For Use:

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To obtain Nuclear Medicine images based on high-energy photons from an administered positron-emitting radioactive agent in the human body.

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

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

Daniel A. Skym

(Division Sign-Off) Division of Reproductive, Abdominal, EN and Radiological Devic 8135c 510(k) Number

Prescription Use (Per 21 CFR 801.109)

Over-the-Counter Use OR

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.