The WBR- HR is indicated for the acquisition, formatting and storage of scintigraphy camera output data. It is capable of processing and displaying the acquired information in traditional formats, as well as in pseudo three dimensional renderings, and in various forms of animated sequences, showing kinetic attributes of the image organs.

Device Description

The WBR - HR is an image processing system, which is interfaced to gamma cameras. The camera-acquired data is reconstructed by the WBR - HR, which utilizes parallel and non - parallel beams and produces high resolution images. The images can be transferred to any other PACS device, which is DICOM or Interfile compatible.

AI/ML Overview

The provided text is a 510(k) summary for the WBR-HR device. It describes the device, its intended use, and claims substantial equivalence to a predicate device. However, it does not contain the specific details required to complete your request for acceptance criteria and a detailed study description.

The document states: "Bench and clinical data demonstrate that reconstructed images are equivalent or of better resolution comparing to the images of the predicate device. No adverse affects have been detected." This is a summary statement of the study's conclusion, not a detailed description of the study itself.

Therefore, I cannot provide the requested information in the format you specified. Here's why and what's missing:

Missing Information:

Acceptance Criteria: The document does not define specific performance metrics (e.g., resolution, signal-to-noise ratio, diagnostic accuracy) that the device needed to meet to be deemed "equivalent or of better resolution."
Reported Device Performance: While it states "equivalent or of better resolution," it doesn't provide quantitative results or specific measurements for the WBR-HR or the predicate device.
Sample Size for Test Set: No information is given about the number of images or patients used in the clinical or bench evaluations.
Data Provenance: The country of origin and whether the data was retrospective or prospective are not mentioned.
Number of Experts and Qualifications: No details on radiologists or other experts involved in evaluating the images or establishing ground truth.
Adjudication Method: Not specified.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No mention of such a study or any effect size related to AI assistance. The WBR-HR is an image processing system, not explicitly an "AI" device as understood today.
Standalone Performance: While it processes images, the context implies comparison to a predicate, not a standalone evaluation against a clinical gold standard in terms of diagnostic utility.
Type of Ground Truth: Not specified (e.g., pathology, clinical follow-up, expert consensus).
Sample Size for Training Set: The document is about a 510(k) submission, and the WBR-HR is described as an image processing system, not an AI/machine learning device that would typically have a "training set" in the modern sense.
Ground Truth for Training Set: Not applicable given the above.

Conclusion:

Based on the provided text, it is not possible to fill out the table and detailed study information as requested because the document is a high-level summary of a 510(k) submission, not the detailed study report itself. It simply states that data demonstrating equivalence or better resolution was provided to the FDA.

Summary

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APR 0 9 2003

510(k) Summary of Safety and Effectiveness (in accordance to 21 CFR 807.87(n))

Device Name

Proprietary Device Name : WBR -HR

Establishment Name and Registration Number of Submitter

Name: U.C.G. Technologies Ltd. Corresponding Official: Dan Laor Building 30, MATAM

Haifa, 31905 Israel

Device Classification

Classification Code: Panel Identification: Classification Name: Common Name: Classification Class:

KPS 90 FEZ Radiology 1200 Image processing (per 21CFR 892.2050 ) SPECT Imaging system Class II Product

Reason for 510(k) Submission

Fraditional 510(k) Submission

ission Special

Identification of Legally Marketed Equivalent Devices

K972886 Mirage system

Device Description

Intended Use of Device

The WBR- HR is indicated for acquiring gamma camera output data. It is capable of processing the acquired information, store it and display the resulted images in traditional formats.

Safety & Effectiveness

The device has been designed verified and validated complying to 21CFR 820.30 regulations. Bench and clinical data demonstrate that reconstructed images are equivalent or of better resolution comparing to the images of the predicate device. No adverse affects have been detected.

Substential Equivalency

It is U.C.G opinion that the WBR-HR is substantially equivalent in terms of safety and effectiveness to the predicate device.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing to the right, with flowing lines beneath them, possibly representing water or movement. The overall design is simple and conveys a sense of health and human well-being.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Dan Laor Ouality Manager U.C.G. Technologies, Ltd. P.O. Box 15010. MATAM Haifa, 31905 ISRAEL

Re: K030870

APR 0 9 2003

Trade/Device Name: WBR-HR Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: 90 KPS Dated: March 13, 2003 Received: March 19, 2003

Dear Mr. Laor:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

K030870

DEVICE NAME: WBR HR

INDICATION FOR USE: The WBR- HR is indicated for the acquisition, formatting and storage of scintigraphy camera output data. It is capable of processing and displaying the acquired information in traditional formats, as well as in pseudo three dimensional renderings, and in various forms of animated sequences, showing kinetic attributes of the image organs.

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

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

Prescription Use	✓
(Per 21 CFR 801.109)

OR Over-the-Counter Use

(Division Sign-Off)	Nancy C. Brogdon
Division of Reproductive, Abdominal, Radiological Devices
510(k) Number	K030800

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.