The WBR - thr, wBR - wb are indicated for the acquisition, formatting and storage of scintigraphy camera output data. They are 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 -- fHR and the WBR -- fWB are image processing systems, which are interfaced to gamma cameras. Camera- fast acquired data is reconstructed by the WBR - FHR or processed by the WBR - fWB, which utilize parallel and non parallel beams and produce high resolution images. The images can be transferred to any other PAC'S device, which is DICOM or Interfile compatible.

AI/ML Overview

The provided text is a 510(k) Summary and FDA clearance letter for the WBR-fHR and WBR-fWB devices. It asserts that the devices are substantially equivalent to a predicate device (K031874 WBR-WB) and mentions "Bench and clinical data demonstrate that reconstructed images are equivalent or of better resolution comparing to the images that are back projection reconstructed." However, it does not provide detailed acceptance criteria or a comprehensive study plan with the specific information requested in your prompt.

Therefore, much of the requested information cannot be extracted directly from this document.

Here's an attempt to answer based only on the provided text, with clear indications of what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not explicitly stated in the document. The document generally states "equivalent or of better resolution comparing to the images that are back projection reconstructed."	Reconstructed images are equivalent or of better resolution compared to images that are back projection reconstructed.

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

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

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 (e.g. 2+1, 3+1, none) 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 explicitly mentioned as an MRMC study. The document mentions "clinical data" but does not detail a comparative effectiveness study involving human readers with and without AI assistance, nor does it quantify an effect size for human reader improvement. The device is described as an image processing system, not an AI assistance tool for human readers in this context.

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

Standalone Performance: The study description is too brief to confirm if a standalone algorithm-only performance assessment was done. It states "reconstructed images are equivalent or of better resolution," suggesting an evaluation of image quality produced by the algorithm itself.

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

Type of Ground Truth: Not specified. The comparison is made against "images that are back projection reconstructed," implying a comparison of image quality or resolution, but not against a definitive ground truth of patient pathology or outcomes.

8. The sample size for the training set

Sample Size (Training Set): Not specified.

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

Ground Truth Establishment (Training Set): Not specified. It is unclear if a "training set" in the modern AI sense was used, as this document is from 2004 and the device is described as an "image processing system" rather than a machine learning algorithm.

Summary of Limitations:

This 510(k) summary provides a high-level overview of the device and its intended use, focusing on demonstrating substantial equivalence to a predicate device. It indicates that "Bench and clinical data" were reviewed but does not elaborate on the specific methodology, sample sizes, expert involvement, or statistical outcomes that would typically be found in a detailed study report for AI/ML-driven devices following current regulatory guidance. The information provided is insufficient to answer most of your detailed questions regarding acceptance criteria and study particulars.

Summary

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MAR 1 1 2004

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

Device Name

Proprietary Device Name : WBR - fHR , WBR - fWB.

Establishment Name and Registration Number of Submitter

Name: UltraSPECT Ltd. Corresponding Official: Dan Laor Building 30, MATAM Haifa, 31905 Israel

Device Classification

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

90 KSP Radiology Image processing (per 21CFR 892.1200 ) SPECT Imaging system Class II Product

Reason for 510(k) Submission

Special 510(k) Submission

Identification of Legally Marketed Equivalent Devices

K031874 WBR - WB

Device Description

Intended Use of Device

The WBR- fHR and the WBR - fWB are 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 that are back projection reconstructed. No adverse affects have been detected.

Substantial Equivalency

It is UltraSPECT opinion that the WBR- fHR and the WBR -- fWB are substantially equivalent in terms of safety and effectiveness to the above predicate device.

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Image /page/1/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the edge. In the center of the seal is a stylized image of three human profiles facing right, with flowing lines extending from their heads. The seal appears to be a government or official emblem.

Food and Drug Administration 9200 Corporate Boulevard · Rockville MD 20850

MAR 1 1 2004

Mr. Dan Laor Quality Manager UltraSPECT, Ltd. P.O. Box 15010, MATAM Haifa, 31905 ISRAEL

Re: K040370

Trade/Device Name: WBR-fHR, WBR-fWB Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II

Product Code: 90 KPS Dated: February 8, 2004 Received: February 17, 2004

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 such 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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Page 2

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):

DEVICE NAME: WBR - fHR, WBR - fWB

INDICATION FOR USE: The WBR - thr, wBR - wb are indicated for the acquisition, formatting and storage of scintigraphy camera output data. They are 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

Nancy C Brogdon

(Division Sign-Off)

Division of Reproductive, Abdominal,

and Radiological Devices

510(k) Number: K040370

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.