The Forte Gamma Camera System is intended to produce images depicting the anatomical distributions of single photon and positron emitting radioisotopes within the human body for interpretation by medical personnel.

Device Description

The modified Forte Gamma Camera System offers all the features of the existing Forte Gamma Camera System (K982911) while expanding the Concurrent Imaging feature for Multi-Energy/Multi-Isotope Imaging and the addition of DICOM to the acquisition system. The basic underlying algorithms for concurrent imaging remain the same. Software modifications to the Multi-Energy/Multi-Isotope application extend the current functionality to include acquisition of more image events simultaneously. Acquisition data can be exported to the Pegasys or any other processing station via DICOM by translating image data from the native XML format to a DICOM 3.0 complaint format. The addition of DICOM to the acquisition software will enhance workflow by providing DICOM Worklist and the capability to import patient information for scheduling purposes. The DOS-based user interface in Atlas acquisition system (predicate) is replaced by a Java based graphical user interface JETStream™. The Java graphical user interface provides a modern graphics presentation as opposed to the DOS text based interface of the predicate. In addition, P-scope (patient positioning/count rate) and gantry display information are now available on a touch screen for easy accessibility.

The Forte is designed to provide extended imaging functionality relative to a ring style gantry. The Forte is designed for single or dual detector nuclear imaging accommodating a broad range of emission computed tomography (ECT) studies. The device includes a gantry frame, display panel, two detectors, a collimator storage structure with an acquisition computer unit, a patient imaging table, and a remote hand controller. The gantry is "open" so that a high degree of imaging flexibility is available to image patients sitting, standing or lying down, with or without the included patient imaging table. The patient imaging tables are mechanized to allow for patient loading access and then raised to an imaging height. The imaging pallet includes removable arm, leg, breast, and headrest supports for patient positioning during studies that require support.

The Forte is designed to allow acquisition of a broad range of imaging studies using single or dual detectors. When using either a single detector or dual detectors placed in a relative 90-degree or relative 180-degree positions (as study appropriate), Forte can be used to perform static, dynamic, gated, total body, circular-orbit and non-circular orbit SPECT studies, coincidence studies, gated SPECT (circular and non-circular) studies, computerprogrammed protocol strings, and reference scans (dual detectors only). SPECT and total body acquisitions are routinely acquired with two detectors. There are some planar procedures such as bone statics and lung scan that also use two detectors. There are many additional nuclear medicine procedures that only use one detector at a time. These single detector procedures are typically renal, gastric emptying, hepatobiliary, flow studies, GI bleed, thyroid, and delayed static views.

AI/ML Overview

This 510(k) submission (K033254) from ADAC Laboratories for the Forte™ Gamma Camera System focuses on modifications to an existing device (K982911), primarily in software, rather than presenting a de novo device with new acceptance criteria. Therefore, the traditional elements of acceptance criteria and a study proving a device meets them, particularly for performance metrics like sensitivity, specificity, accuracy, or reader improvement in AI contexts, are not present.

The submission claims substantial equivalence based on identical indications for use, technological comparison, and overall system performance. This implies that the device is expected to perform at least as well as the predicate device.

Here's an analysis based on the provided text, addressing the points where information is available or implicitly understood due to the nature of a 510(k) for a modified device:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) for device modifications, specific quantitative acceptance criteria (e.g., minimum sensitivity/specificity thresholds) and detailed performance data (e.g., clinical study results with these metrics) are not provided nor typically required in this format for substantial equivalence of software updates to an existing gamma camera. The focus is on demonstrating that the modifications do not adversely affect safety and effectiveness and that the overall system performance remains equivalent to the predicate.

The "performance" demonstrated for this type of submission is typically through:

Verification and Validation Activities: (Implied) Ensuring the new software features function as intended and do not introduce new risks. These would likely include functional testing, performance testing (e.g., speed, data integrity, DICOM compliance), and possibly phantom studies to confirm image quality is maintained.
Technological Comparison: The submission explicitly states: "The modified Forte™ Gamma Camera System and existing Forte Gamma Camera System have identical intended use and indications for use. The modified Forte and the existing Forte are technologically equivalent. They have the same main mechanical and electrical components. All the features provided on the existing Forte are provided on the modified Forte."

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

Sample Size: Not applicable/not provided in this document as it's not a clinical trial for diagnostic performance. The "test set" would refer to testing environments for software and system functionality.
Data Provenance: Not applicable.

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

Not applicable/not provided. Ground truth in the context of a 510(k) for software updates to an imaging system usually relates to functional correctness and image quality, often verified by engineers and potentially nuclear medicine physicians during internal testing, rather than complex diagnostic ground truth.

4. Adjudication Method for the Test Set

Not applicable/not provided.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study was done. This is not an AI-assisted diagnostic device where human reader improvement would be measured. It's a gamma camera system with software updates.

6. Standalone Performance Study (Algorithm Only)

No standalone performance study of an algorithm was done in the context of comparing diagnostic accuracy. The "algorithms for concurrent imaging remain the same." The software modifications are largely about extending functionality (e.g., more simultaneous image events) and user interface (Java GUI, DICOM). The performance metrics would be related to the proper functioning of these software features and maintenance of image acquisition quality, not diagnostic accuracy of an AI algorithm.

7. Type of Ground Truth Used

Functional correctness and image acquisition quality. For a gamma camera, ground truth would relate to the physical properties of the acquired images (e.g., spatial resolution, energy resolution, uniformity) using phantoms, and the correct operation of the software interface and data export. It's not typically "expert consensus" on disease diagnosis, pathology, or outcomes data for this type of submission.

8. Sample Size for the Training Set

Not applicable/not provided. This is not a machine learning or AI device that requires a training set.

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

Not applicable. As above, no training set for an AI algorithm is mentioned or implied.

Summary of Acceptance Criteria and Reported Performance (Based on Implied Substantial Equivalence):

Acceptance Criteria (Implied for Substantial Equivalence)	Reported Device Performance (as stated in submission)
1. Identical Intended Use & Indications for Use: The modified device must serve the same clinical purpose as the predicate.	"The modified Forte™ Gamma Camera System and existing Forte Gamma Camera System have identical intended use and indications for use." "The Forte Gamma Camera System is intended to produce images depicting the anatomical distributions of single photon and positron emitting radioisotopes within the human body for interpretation by medical personnel." (Same as predicate)
2. Technological Equivalence: Changes (software, UI, features) do not alter the fundamental technological principles or raise new questions of safety/effectiveness.	"The modified Forte and the existing Forte are technologically equivalent. They have the same main mechanical and electrical components. All the features provided on the existing Forte are provided on the modified Forte." "Acquisition software changes consist of: replacement of the predicate Atlas with the JETStream, the expanded feature of Concurrent Multi-Energy/Multi-Isotope Imaging, and DICOM Export/Worklist." "The basic underlying algorithms for concurrent imaging remain the same."
3. Overall System Performance Equivalence: The modified device performs at least as well as the predicate device, especially regarding image quality and functionality.	"The modified Forte™ Gamma Camera System is substantially equivalent to the predicate device Forte based upon... overall system performance." (Implied by substantial equivalence claim, supported by technological comparison and maintaining core algorithms). This means image quality, acquisition capabilities, and data integrity (including DICOM export) are expected to be maintained or improved without degradation.
4. Safety Profile Maintained: No new safety concerns are introduced by the modifications.	(Implied by FDA's substantial equivalence finding, suggesting that the modifications passed internal risk assessments and verification activities.)

In conclusion, the K033254 submission is a demonstration of substantial equivalence for software and user interface modifications to an existing gamma camera system. It does not contain the typical "acceptance criteria" and detailed study results found in submissions for novel AI/CAD devices or devices with novel diagnostic claims. Instead, the "study" is the comparison against the predicate device to ensure that the modifications do not negatively impact the established safety and effectiveness of the device.

Summary

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K033254

OCT 2 2 2003

510(k) SUMMARY SAFETY AND EFFECTIVENESS

A.	Submitted By:ADAC Laboratories540 Alder Dr.Milpitas, CA 95035	Contact: Joy M. SacmarTel: (408) 468-3053Fax: (408) 468-3050
B.	Device Trade Name:Common Name:Classification Name:Device Class:Product Code:	Forte™ Gamma Camera SystemGamma Camera SystemsEmission Computed Tomography System21 CFR 892.1200, Class II90 KPS
C.	Date prepared:	September 18, 2003
D.	Predicate Device:	Forte™ Gamma Camera System (K982911)
E.	Intended Use:

The Forte Gamma Camera System is intended to produce images depicting the anatomical distributions of single photon and positron emitting radioisotopes within the human body

F. Device Description:

for interpretation by medical personnel.

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an imaging height. The imaging pallet includes removable arm, leg, breast, and headrest supports for patient positioning during studies that require support.

G. Technological Comparison:

The modified Forte™ Gamma Camera System and existing Forte Gamma Camera System have identical intended use and indications for use. The modified Forte and the existing Forte are technologically equivalent. They have the same main mechanical and electrical components. All the features provided on the existing Forte are provided on the modified Forte. Acquisition software changes consist of: replacement of the predicate Atlas with the JETStream, the expanded feature of Concurrent Multi-Energy/Multi-Isotope Imaging, and DICOM Export/Worklist. In addition, the P-scope (patient positioning/count rate) and gantry display information shall be available on a touch screen.

H. Conclusion

The modified Forte™ Gamma Camera System is substantially equivalent to the predicate device Forte based upon identical indications for use, technological comparison and overall system performance.

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Image /page/2/Picture/1 description: The image shows a circular logo for the Department of Health & Human Services. The logo features a stylized bird in flight, composed of three curved lines, symbolizing health and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged around the top half of the circle, framing the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 2 2003

ADAC Laboratories % Ms. Denise Leung Klinker Reviewer, Medical Device Services Underwriters Laboratories, Inc. 1655 Scott Boulevard SANTA CLARA CA 95050-4169

Re: K033254

Trade/Device Name: Forte™ Gamma Camera System Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: 90 KPS Dated: October 6, 2003

Received: October 8, 2003

Dear Ms. Klinker:

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 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 vours.

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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INDICATIONS FOR USE STATEMENT

510 (k) NUMBER (IF KNOWN):

510 (k) NUMBER (IF KNOWN): K033254

DEVICE NAME:

Forte™ Gamma Camera System

SPONSOR NAME:

ADAC Laboratories

INDICATIONS FOR USE:

The Forte™ Gamma Camera System is intended to produce images depicting the anatomical distributions of single photon and positron emitting radioisotopes within the human body for interpretation by medical personnel.

Darcy K Hayden

(Division Sign-Off) Division of Reproductive, Abdo and Radiological Devices 510(k) Number ..

(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-Use (Optional Format 1-2-96)

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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.