The WBR Xpress.PET including the Attenuation & Scattering Corrections is indicated for the acquisition, formatting and storage of scintigraphy 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 imaged organs

Device Description

The WBR Xpress.PET is image processing system, which is interfaced to PET/CT. Fast acquired, data are reconstructed by the device, which utilizes parallel and non - prrallal beams and produce high resolution images. The images can be transferred to any other PACS device, which is DICOM compatible. The device includes Attenuation and Scatterng Corrections (ACSC).

AI/ML Overview

The provided text is a 510(k) summary for the WBR Xpress.PET device, which is an image processing system for PET/CT. It details the device's classification, predicate devices, description, and intended use, along with a statement on safety and effectiveness. The FDA's letter granting substantial equivalence is also included. However, the document does not contain specific acceptance criteria, a detailed study description with performance metrics, sample sizes for test or training sets, information about experts, adjudication methods, or MRMC study results.

Therefore, I cannot fulfill most of the requested points as the information is not present in the provided text.

Here's what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not provided in the document. The document states: "Bench and clinical data demonstrate that reconstructed and ACSC corrected images are equivalent in comparison to images that are reconstructed and ACSC corrected by predicate CT/PET device." This is a general statement of equivalence, not a specific performance metric or acceptance criterion.	Not provided in the document. The document states that performance is "equivalent" to predicate devices, but no specific metrics are given.

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

Sample Size for Test Set: Not specified in the provided document.
Data Provenance (e.g., country of origin, retrospective or prospective): Not specified in the provided document. The submitter's address is Haifa, Israel.

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 in the provided document.
Qualifications of Experts: Not specified in the provided document.

4. Adjudication method for the test set

Adjudication Method: Not specified in the provided document.

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 specified or implied in the provided document. The focus is on the device's technical equivalence in image reconstruction and correction, not on human reader performance improvement with AI assistance.

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

Standalone Performance: The document states "Bench and clinical data demonstrate that reconstructed and ACSC corrected images are equivalent in comparison to images that are reconstructed and ACSC corrected by predicate CT/PET device." This implies an evaluation of the device's output, which is a standalone assessment of its image processing capabilities, but no further details on the study's design are provided.

7. The type of ground truth used

Type of Ground Truth: Not explicitly stated. The comparison is made against "images that are reconstructed and ACSC corrected by predicate CT/PET device," suggesting the predicate device's output serves as a reference for "equivalence."

8. The sample size for the training set

Sample Size for Training Set: Not specified in the provided document.

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

Ground Truth for Training Set: Not specified in the provided document. The document refers generally to "Bench and clinical data," but does not elaborate on how ground truth was established for any internal development or training purposes.

Summary

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

Device Name Proprietary Device Name: WBR Xpress.PET

Establishment Name and Registration Number of Submitter

Name: UltraSPECT Ltd. Corresponding Official: Dan Laor Sireni 6, Haifa 32972, Israel TEL: 972-4-8246632

JAN 1 9 2011

103710

Device Classification

Product Code:	KPS
Subsequent Product Code	LLZ
CFR section:	892.1200
Panel Identification:	Radiology
Device Description:	Emission computed tomography system
Classification:	Class II Product

Reason for 510(k) Submission

Special 510(k) Submission

Identification of Legally Marketed Predicate Devices

WBR Xpress. Bone - K040370 & K080784 WBR Attenuation and Scattering Correction - K091073 Work station of the GE Discovery LS - K040172

Device Description

Intended Use of Device

The WBR Xpress.PET including the Attenuation & Scattering Corrections is indicated for the acquisition, formatting and storage of scintigraphy output data. They are capable of processing and displaying the acquired information in traditional formats, as well as in psevodo proc dimensional renderings, and in various forms of animated sequences, showing kinetic attributes of the imaged organs

Safety & Effectiveness

The device has been designed, verified and validated complying to 21CFR 820.30 regulations. Bench and clinical data demonstrate that reconstructed and ACSC corrected images are equivalent in comparison to images that are reconstructed and ACSC corrected by predicate CT/PET device.

Substantial Equivalency

It is UltraSPECT opinion that the modified Xpress.PET is substantially equivalent in terms of safety and effectiveness to the predicate devices.

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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 features a stylized eagle with three wavy lines representing its body and wings. The eagle faces right and is positioned in the center of a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the upper half of the circle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Mr. Dan Laor Quality & Regulatory affairs Advisor UltraSpect Ltd. 6 Sireni Haifa 32972 ISRAEL

JAN 19 201

Re: K103710

Trade/Device Name: WBR Xpress.PET Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: KPS Dated: December 13, 2010 Received: December 20, 2010

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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

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Page 2

medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours,

Mary S. Postel

Mary Pastel, ScD. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K103710 Device Name: WBR Xpress.PET

Indications for Use:

Prescription Use _____________________________________________________________________________________________________________________________________________________________ X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

(Division Sign-Off)

Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

K103710
510K

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.