D-SPECT is an emission computed tomography system intended to detect the location and distribution of gamma ray radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. The device includes display equipment, patient and equipment supports, component parts, and accessories. D-SPECT is primarily intended for cardiac applications. D-SPECT supports radionuclides within the energy range of 40 -170 keV.

Device Description

Spectrum Dynamics' D-Spect™ Cardiac Scanner System is a SPECT device, which is designed to perform myocardial perfusion imaging. The device is comprised of a detector head, gantry, and patient chair. Device operation is controlled from an acquisition station console. The system is supported by use of data-transfer accessories (RFID tags), which are attached to the patient's wrist and to the syringe containing the radiopharmaceutical agent, for patient and syringe positive identification. The cardiac gamma camera is designed such that there are no external moving parts that surround the patient. Detector boards rotate within the closed detector head. The special scanning geometry and detector technology, enable shorter scan times. In the modified D-Spect™ device, a Processing Station was added. The Processing Station, which is part of the display equipment, contains a software application with the Cedars Sinai Quantitative Perfusion SPECT (QPS) and Quantitative Gated SPECT (QGS) software that enables a review and quantification of cardiac SPECT data.

AI/ML Overview

This 510(k) summary describes a modification to an existing SPECT device, the D-Spect™ Cardiac Scanner System, with the primary change being the addition of a Processing Station that incorporates Cedars-Sinai Quantitative Perfusion SPECT (QPS) and Quantitative Gated SPECT (QGS) software. The submission focuses on demonstrating the substantial equivalence of the modified device to the predicate device.

Here's an analysis of the acceptance criteria and study details based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Software Validation: Each software application functions as per its specifications.	Functionality tests demonstrated that each software application (including QPS and QGS) performed according to its specifications.
Computer Platform Testing: QGS and QPS programs run on the proposed platform using gold standard test cases.	QGS and QPS programs were run on computer systems with the proposed platform using gold standard Cedars-Sinai test cases, and testing results demonstrated that the device performs according to its specifications.
Electromagnetic Compatibility/Electrical Safety Testing	Testing was performed (though specific results are not detailed, the implication is successful compliance).

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

Sample Size for Test Set: Not explicitly stated. The text mentions "gold standard Cedars-Sinai test cases" for computer platform testing but does not quantify the number of cases or patients.
Data Provenance: The "gold standard Cedars-Sinai test cases" suggest that the data was generated at Cedars-Sinai Medical Center. The text does not specify if the data was retrospective or prospective.

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

Number of Experts: Not explicitly stated.
Qualifications of Experts: Not explicitly stated.

4. Adjudication Method for the Test Set

Adjudication Method: Not explicitly stated. The term "gold standard Cedars-Sinai test cases" implies a pre-established, authoritative reference, but the method for their creation or any subsequent adjudication is not described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

MRMC Study: No, an MRMC comparative effectiveness study is not mentioned. The clinical validation was for the QGS and QPS programs themselves, conducted by Cedars-Sinai Medical Center, rather than a comparison of human reader performance with and without AI assistance. The QPS and QGS software modules are considered quantitative analysis tools within the SPECT system, not explicitly "AI assistance" in the context of improving human reader interpretation in a comparative study.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Standalone Performance: Yes, the performance testing described for the QGS and QPS programs ("Functionality tests" and "Computer platform testing... using gold standard Cedars-Sinai test cases") can be considered a standalone assessment of the algorithms' ability to process and quantify SPECT data according to their specifications. These tests focus on the software's output based on input data, without explicit human intervention in the interpretation loop during these specific validation steps.

7. The Type of Ground Truth Used

Ground Truth Type: "Gold standard Cedars-Sinai test cases" were used. While the specific nature of this "gold standard" isn't detailed, in the context of QPS and QGS (quantitative perfusion and gated SPECT), the ground truth would likely be established from well-characterized clinical datasets with confirmed diagnoses or outcomes, possibly correlated with other imaging modalities or invasive procedures to determine actual perfusion defects or cardiac function. It implies a high level of confidence in the accuracy of these reference cases.

8. The Sample Size for the Training Set

Training Set Sample Size: Not explicitly stated. The document focuses on the validation of existing software (QPS and QGS), which implies these programs were already trained prior to their integration into the D-Spect system. The FDA submission is about the device's substantial equivalence and the functionality of the integrated software, not the development or training of the QPS/QGS algorithms themselves.

9. How the Ground Truth for the Training Set Was Established

Training Set Ground Truth Establishment: Not explicitly stated. As mentioned above, the focus is on the validation of pre-existing QPS/QGS software. The methodology for establishing ground truth during the original development and training of these Cedars-Sinai algorithms is not part of this 510(k) submission.

Summary

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OCT 1 2007

SECTION 6 – 510(k) SUMMARY

072468
(Premarket Notification [510(k)] Number)

1. Applicant

Spectrum Dynamics Ltd. 22 Bareket St. North Industrial Park POB 3033 Caesarea 30889 ISRAEL Tel: +972-73-7374500 Fax: +972-73-7374501

Corresponding Official:

Ahava M. Stein, Consultant A. Stein - Regulatory Affairs Consulting Beit Hapa'amon (Box 124) 20 Hata'as St. 44425 Kfar Saba ISRAEL Tel: +972-9-767 0002 Fax: +972-9-766 8534

Device Name:	D-Spect™ Cardiac Scanner System
Device trade/proprietary name:	D-Spect™ Cardiac Scanner System
Common Name:	SPECT system
Classification Name:	Emission Computed Tomography System (product code KPS, class II, classification section 892.1200).

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3. Predicate Devices

The modified D-Spect™ system is substantially equivalent to the following device:

Device	Manufacturer	510(k) No.
D-Spect™ Cardiac Scanner System	Spectrum Dynamics Ltd.	K062450
ADAC AutoQuant	ADAC	K980715
ADAC JETStream Workspace	ADAC	K061029

4. Intended Use

The D-Spect™ is an emission computed tomography system intended to detect the location and distribution of gamma ray radionuclides in the body and produce crosssectional images through computer reconstruction of the data. The device includes display equipment, patient and equipment supports, component parts, and accessories. D-Spect™ is primarily intended for cardiac applications. D-Spect™ supports radionuclides within the energy range of 40 -170 keV.

5. Description of the Device

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(QPS) and Quantitative Gated SPECT (QGS) software that enables a review and quantification of cardiac SPECT data.

6. Technological Characteristics Compared to Predicate Device

The technological characteristics, e.g., overall design, materials, mechanism of action, mode of operation, performance characteristics, etc., and the intended use of the D-Spect™ device are substantially equivalent to the predicate devices cited above.

7. Performance Testing

The following performance testing activities were performed for the modified D-Spect™ device:

A. Software Validation
Electromagnetic Compatibility/ Electrical Safety Testing B.

Functionality tests were performed as part of the software validation testing to demonstrate that each software application functioned as per its specifications. Computer platform testing was performed by running QGS and QPS programs on computer systems with the proposed platform using gold standard Cedars- Sinai test cases.

Testing results for all validation tests demonstrated that the D-Spect™ device performs according to its specifications.

Clinical validation for the QGS and QPS programs was conducted by Cedars-Sinai Medical Center.

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Image /page/3/Picture/0 description: The image shows a circular logo with text around the perimeter and a symbol in the center. The text reads "U.S. DEPARTMENT OF HEALTH & HUMAN SERVICES". The symbol in the center appears to be three curved lines forming a stylized representation of a person or figure. The logo has a simple, clean design and is rendered in black and white.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

Spectrum Dynamics Ltd % Ms. Ahava Stein Regulatory Consultant A. Stein Regulatory Affairs Consulting 20 Hata'as St., Kfar Saba, 44425 ISRAEL

2007

Re: K072468

Trade/Device Name: D-Spect Cardiac Scanner System Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: KPS Dated: August 17, 2007 Received: September 4, 2007

Dear Ms. Stein:

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 (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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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closing and Promoting Public Hoalth

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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.

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 this letter:

21 CFR 876.xxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 894.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). 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/cdrl/industry/support/index.html.

Sincerely vours.

Nancy Crogdon

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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Indications for Use Statement

Page 1 of 1

510(k) Number (if known): K072468

Device Name: D-Spect Cardiac Scanner system

Indications for use:

Prescription Use V (Per 21 C.F.R. 801.109) OR

Over-The-Counter Use (Optional Format 1-2-96)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Arnie M. Whay

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

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.