Griffin is an imaging system combining the acquisition of single photon nuclear medicine images and images from an x-ray computed tomography system. Griffin may produce non-attenuation corrected and attenuation corrected images of the distribution of radiopharmaceuticals in the body as well as x-ray transmission images. The CT transmission data may be used to produce attenuation corrected nuclear medicine images. The nuclear medicine images and the CT images may be registered and displayed in a fused format (overlaid in the same orientation) to provide combined single photon and anatomical data for anatomical localization of the nuclear medicine data. Griffin may be used either as a separate single photon system, a separate CT system or as a combined CT and single photon system. The nuclear medicine and CT images may be transferred to other systems such as a radiation therapy planning system. The Griffin Imaging System should only be used by trained healthcare professionals.

Device Description

The Griffin SPECT/CT Imaging System (Griffin) is a hybrid SPECT/CT system for performing CT studies, general nuclear medicine studies, or SPECT/CT scquentially (dual-modality studies) wherein the SPECT and CT studies may be automatically co-registered and displayed in fused form. Because the natures of the imaging modalities, they provide different information; the SPECT study yields functional information about metabolic processes and the CT study yields structural or anatomical information. As radionuctides become more tissue specific, diagnoses from nuclear images alone will be more difficult without the general anatomical detail less specific agents provide. Thus fused SPECT and CT images will provide the information required for accurate and comprehensive diagnoses. Griffin is constructed from two existing systems, the Skylight Imaging System (K031705) and the Brilliance CT (K012009). The Griffin has two acquisition consoles. One console is placed in the acquisition room itself, consistent with the SPECT convention, and the other console is placed in the shielded scanner control room, as required for CT. The acquisition stations provide a single user interface for both SPECT and CT patient acquisition set-up. The SK Ylight and Brilliance system gantries remain intact as major subsystem components located within a common integrated housing. The combined Griffin SPECT-CT Imaging System is designed so that the system can operate in three modes: CT only, SPECT only, and combined SPECT/CT performed sequentially. No modifications have been made to either system, which would affect system performance. Griffin is intended for use primarily as an imaging system combining the acquisition of single photon nuclear medicine images and images from an x-ray computed tomography system. The same clinical protocols and procedures are available on the Griffin Imaging System as in the predicate SPECT or CT systems. Acquired SPECT and CT images on the Griffin may be registered and displayed in a fused format (overlaid in the same orientation) to provide combined single photon and anatomical data to provide anatomical localization of the nuclear medicine image.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for the Griffin SPECT/CT Imaging System. It describes the device, its intended use, and comparison to predicate devices, but it does not contain a detailed study with specific acceptance criteria and reported device performance metrics in the format requested.

The document states that the system performance was tested in accordance with the NEMA-NU-1 standard and compliance with radiation safety standards (21 CFR 1020.30 and 21 CFR 1020.33). However, it does not provide the specific acceptance criteria derived from these standards or the quantitative results of these tests. Instead, it concludes that the device is "substantially equivalent" to predicate devices based on intended use, technological comparison, and system performance.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, nor the detailed information about sample sizes, experts, ground truth, or MRMC studies, as this information is not present in the provided text.

Based on the information available, here's what can be extracted regarding System Performance and Compliance:

System Performance and Compliance (as described in the document)

The document states compliance with general safety and performance standards, rather than presenting a performance study with specific acceptance criteria as you've requested.

Acceptance Criteria (Implied)	Reported Device Performance (Summary)
Radiation safety (21 CFR 1020.30 & 1020.33)	Compliance and certification to the performance standards for ionizing radiation emitting product was ensured. A radiation safety product report was to be filed.
Electrical & mechanical safety (IEC 60601-1 series)	Assured as the system is designed to applicable voluntary standards.
Image quality/performance (NEMA NU-1)	Device performance was measured in accordance with the NEMA-NU-1 standard. (Specific results not detailed)

Regarding the other requested information, the document does NOT provide the following:

Sample sizes used for the test set and the data provenance: No information on test sets, patient data, or data provenance is provided.
Number of experts used to establish the ground truth for the test set and qualifications: No information on expert review for ground truth is available.
Adjudication method for the test set: Not applicable as no specific test set or adjudication process is described.
Multi-reader multi-case (MRMC) comparative effectiveness study: No such study is mentioned. The document focuses on substantial equivalence to predicate devices, not improvement over human readers with AI assistance.
Standalone (algorithm only without human-in-the-loop performance) study: This device is an imaging system, not an AI algorithm. Its performance is inherent in its hardware and software for image acquisition and display, not a standalone AI algorithm.
Type of ground truth used: Not applicable as no specific performance study with a defined ground truth is described.
Sample size for the training set: Not applicable, as this is a hardware imaging system, not a machine learning algorithm requiring a training set in the typical sense.
How the ground truth for the training set was established: Not applicable for the same reason as above.

Conclusion:

The K041218 submission for the Griffin SPECT/CT Imaging System demonstrates substantial equivalence primarily by comparing its intended use, technology, and compliance with general performance and safety standards to predicate devices (Skylight Imaging System and MX8000 IDT CT System). It does not present a detailed study with quantitative acceptance criteria and results as typically found for novel diagnostic algorithms or AI-driven devices.

Summary

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K041218

Griffin 510(k) Premarket Notification Philips Medical Systems

Section B - A . ministrative Information

Inserted May 07, 2004

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

General Information

A.	Submitted By:	Contact: Coleen Coleman
	ADAC Laboratories540 Alder Dr.Milpitas, CA 95035	Tel: (408) 468-3051Fax: (408) 468-3050
B.	Device Trade Name:	Griffin SPECT/CT Imaging System
	Common Name:	Single Photon Emission Computed TomographyComputed Tomography X-Ray
	Classification Name:	System, Emission Computed Tomography, (892.1200)System, Computed Tomography X-Ray, (892.1750)
	Device Class:	21CFR 892.1200, Class II21 CFR 892.1750, Class II
	Product Code:	90 KPS and 90 JAK
C.	Date prepared:	April 26, 2004
D.	Predicate Device:	Skylight Imaging System (K031705)MX8000 IDT CT System (K012009)

MAY 2 4 2004

E. Performance Standards

21 CFR 1020.30 1020.33 as applicable for Ionizing Radiation Emitting . Products (Applicable Sections)
↓ NEMA NU-1

E. Intended Use:

নি। Device Description:

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Inserted May 07, 2004

specific agents provide. Thus fused SPECT and CT images will provide the information required for accurate and comprehensive diagnoses.

Griffin is constructed from two existing systems, the Skylight Imaging System (K031705) and the Brilliance CT (K012009). The Griffin has two acquisition consoles. One console is placed in the acquisition room itself, consistent with the SPECT convention, and the other console is placed in the shielded scanner control room, as required for CT. The acquisition stations provide a single user interface for both SPECT and CT patient acquisition set-up. The SK Ylight and Brilliance system gantries remain intact as major subsystem components located within a common integrated housing. The combined Griffin SPECT-CT Imaging System is designed so that the system can operate in three modes: CT only, SPECT only, and combined SPECT/CT performed sequentially. No modifications have been made to either system, which would affect system performance.

Griffin is intended for use primarily as an imaging system combining the acquisition of single photon nuclear medicine images and images from an x-ray computed tomography system. The same clinical protocols and procedures are available on the Griffin Imaging System as in the predicate SPECT or CT systems. Acquired SPECT and CT images on the Griffin may be registered and displayed in a fused format (overlaid in the same orientation) to provide combined single photon and anatomical data to provide anatomical localization of the nuclear medicine image.

G. Comparison to Predicate Device:

The Griffin SPECT/CT Imaging System, like the predicate devices, SKYlight Imaging System and the Brilliance CT are similar in that all the devices consist of a full functional SPECT and CT system. The patient may have a diagnostic SPECT and CT scan performed consecutively without having to move the patient. The Griffin provides a mean to reach the diagnostic decision faster than the conventional way of imaging patients with both SPECT and CT systems in separate locations. The differences are overall system dimensions, room size requirements, and ease of use.

The combined Griffin SPECT-CT Imaging System is designed so that the system can operate in three modes: CT only, SPECT only, and combined SPECT/CT performed sequentially. The major difference is that the Griffin system has a common integrated housing for the major subsystem components. Griffin also provides a new dedicated SPET/CT table to allow the patient to be scanned on both systems in a single acquisition session. The common table also allows for parametric registration.

le. System Performance Test:
- . Radiation safety by compliance and certification to the performance standards for ionizing radiation emitting product 21 CFR 1020.30 and 21 CFR 1020.3333. The radiation safety product report will be filed in accordance with 21 CFR 1002.10 with the Center for Device and Radiological Health.
- Electrical and mechanical safety is assured as the system is designed to applicable . voluntary standards in the IEC 60601-1 scries. The device performance was measured in accordance with the NEMA-NU-1 standard.

1. Conclusion:

The Griffin Imaging System is substantially equivalent to the predicate devices, the SK Ylight Imaging System (K031705) and Brilliance CT (K012009) based upon similar intended use, technological comparison, and system performance.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird-like figure, composed of three curved lines. The symbol is stylized and modern, representing the department's mission in a symbolic way.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 4 2004

ADAC Laboratories % Ms. Denise Leung Klinger Principal Reviewer Medical Device Services Underwriters Laboratories, Inc. 1655 Scott Boulevard SANTA CLARA CA 95050-4169 Re: K041218 Trade/Device Name: Griffin SPECT/CT Imaging System Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: 90 KPS and JAK Dated: May 7, 2004 Received: May 10, 2004

Dear Ms. Klinger:

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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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. Brydon

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

510 (k) NUMBER (IF KNOW

510 (k) NUMBER (IF KNOWN): K04/2/8

DEVICE NAME:

Griffin SPECT/CT Imaging System

SPONSOR NAME:

ADAC Laboratories

INDICATIONS FOR USE:

(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)

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

(Division Sign Off) Division of Reproductive, Abdomin 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.