The WBR Xpress3.Cardiac and WBR Xpress.Cardiac including the Attenuation & Scattering Corrections 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 imaged organs

Device Description

The Xpress.cardiac & Xpress3.cardiac are image processing systems, which are interfaced to gamma cameras. Gamma camera cardiac, fast acquired, data are reconstructed by the devices, which utilize parallel and non - parallel beams and produce high resolution images. The images can be transferred to any other PACS device, which is DICOM or Interfile compatible. The devices have been modified by including Attenuation and Scattering Corrections (ACSC).

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and the study conducted for the K091073 submission:

Acceptance Criteria and Study Details for Xpress.cardiac & Xpress3.cardiac

Based on the provided 510(k) summary, the device is a modified version of previously cleared devices, with the addition of Attenuation and Scattering Corrections (ACSC). The core of the acceptance criteria and the study is demonstrating equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Stated Goal)	Reported Device Performance (Conclusion)
Reconstructed and ACSC corrected images are equivalent to images reconstructed and ACSC corrected by predicate Xeleris device.	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 Xeleris device.

Important Note: The provided text does not specify quantitative acceptance thresholds (e.g., "sensitivity must be >90%"). Instead, the fundamental acceptance criterion is a qualitative assessment of "equivalence" to a specific predicate device (Xeleris).

Detailed Study Information:

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

Test Set Sample Size: Not explicitly stated. The document mentions "bench and clinical data" but does not quantify the number of cases or images used in the clinical study.
Data Provenance: Not explicitly stated. The document does not specify the country of origin or whether the data was retrospective or prospective.

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

Not explicitly stated. The document does not provide details about experts or how ground truth was established for the clinical data.

4. Adjudication Method for the Test Set:

Not explicitly stated. The document does not mention any adjudication method (e.g., 2+1, 3+1).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size:

Not explicitly stated that an MRMC comparative effectiveness study was done. The summary mentions "clinical data" demonstrating equivalence, but it does not describe a study design where human readers evaluated both AI-assisted and non-AI-assisted cases to measure improvement. The focus appears to be on the device's output being equivalent to the predicate, rather than human performance with and without the device.
Effect Size: Not applicable, as an MRMC study with this objective is not described.

6. If a Standalone (algorithm only without human-in-the-loop performance) study was done:

Yes, implicitly. The statement "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 Xeleris device" implies a standalone assessment of the algorithmic output. The comparison is between the device's output and the predicate's output, suggesting the algorithm's performance without direct human intervention as the primary point of comparison.

7. The type of Ground Truth used:

Implicitly, the predicate device output. The ground truth for this equivalence study appears to be the images reconstructed and ACSC corrected by the predicate Xeleris device. The goal was for the new device's output to match or be equivalent to this established standard. There is no mention of pathology, long-term outcomes, or detailed expert consensus as the ground truth.

8. The Sample Size for the Training Set:

Not explicitly stated. The document focuses on validation/testing data ("bench and clinical data") but does not provide information about the training data used to develop the algorithms for Attenuation & Scattering Corrections.

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

Not explicitly stated. As the training set size is not mentioned, neither is the method for establishing its ground truth.

Summary of Limitations in Provided Detail:

The provided 510(k) summary is a high-level overview and lacks granular detail typically found in a full study report (e.g., number of subjects, specific metrics used for equivalence, reader qualifications, detailed study protocol). Its primary assertion is that the modified device's output (images) is equivalent to a legally marketed predicate, which is a common strategy for 510(k) clearances. The "acceptance criteria" here are qualitative in nature, focusing on the concept of "equivalence" rather than quantitative performance benchmarks against a gold standard.

Summary

{0}------------------------------------------------

K091073

MAY 14 2009

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

Device Name

Proprietary Device Name: Xpress.cardiac & Xpress3.cardiac including Attenuation & Scattering Corrections

Establishment Name and Registration Number of Submitter

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

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

Xpress.cardiac - K080784, Xpress3.cardiac - K081201 Xeleris - K051673

Device Description

Intended Use of Device

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 Xeleris device.

Substantial Equivalency

It is UltraSPECT opinion that the modified Xpress.cardiac & Xpress3.cardiac are substantially equivalent in terms of safety and effectiveness to the predicate devices.

{1}------------------------------------------------

Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human services.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

MAY 1 4 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

UltraSPECT Ltd. % Mr. Dan Laor Quality & Regulatory Advisor Quasar Quality Ltd 6 Sireni. Haifa 32972 İSRAEL

Re: K091073

Trade/Device Name: Xpress.Cardiac & Xpress3.cardiac including Attenuation & Scattering Corrections

Regulation Number: 21 CFR 892.1200

Regulation Name: Emission computed tomography system

Regulatory Class: II

Product Code: KPS and LLZ

Dated: April 12, 2009

Received: April 14, 2009

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.

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

{2}------------------------------------------------

Page 2

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

21 CFR 876.xxx	(Gastroenterology/Renal/Urology)	(240) 276-0115
21 CFR 884.xxx	(Obstetrics/Gynecology)	(240) 276-0115
21 CFR 892.xxx	(Radiology)	(240) 276-0120
Other		(240) 276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely wours,

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

Indications for Use

510(k) Number (if known):

K 09/1073

Device Name: Xpress.cardiac & Xpress3.cardiac including Attenuation & Scattering Corrections

Indications For Use:

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

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hubert Heme
(Division Sign-Off)

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number _

Page 1 of /

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.