The Fuji IP Cassette Type PC will be used as an accessory to megavoltage radiation therapy systems providing radiation therapy portal localization imaging and to aid in radiation therapy planning and quality control.

The Fuji IP Cassette Type PC and imaging plate is a digital replacement technology for conventional film/cassette imaging systems.

Device Description

The Fuji IP Cassette Type PC will be used as an accessory to medical charged particle radiation therapy systems providing radiation therapy (portal localization) imaging. The Fuji IP Cassette Type will be used with a FDA-cleared radiation treatment linear accelerator or cobalt 60 unit. The Type PC cassette is a digital replacement technology for conventional film/cassette imaging systems. This cassette is appropriate to accommodate energies up to 18 MV and higher.

Due to the high dose rates associated with this oncology indication, a 0.5 mm lead (Pb) absorber was added to the front of the cassette. In addition, a compression plate was added to the back of the cassette to place the imaging plate (IP) in contact with the lead cassette front during exposure. The compression mechanism was developed to maintain contact between the cassette front and IP during exposure to ensure maximum resolution and contrast.

Instead of film, a Fuji Imaging Plate (IP) is loaded into the cassette for exposure. Before exposure, the compression plate is engaged by moving the thumb sliders on the cassette to the EXPOSE position. After exposure, the compression plate is returned to its retracted position by moving the slide button from the EXPOSE position to the READER position. The cassette is then inserted into the appropriate Fuji image reader for scanning. After processing the IP in the CR reader, the IP is erased and returned to the cassette for reuse. No new software modifications to the CR reader or workstation are needed for this indication.

The imaging plate is processed in the CR reader according to exam and user-specified parameters. Images are processed using currently-cleared MFP image processing with FNC applied. The resulting image may be displayed on a cleared CRT or LCD monitor, printed by a hard copy device onto film, or output to a cleared diagnostic workstation, optical disk file, PACS or therapy planning workstations that accepts DICOM images. FDA has cleared Fuji's imaging plate, image readers, and image processing applications in previous 510(k)s.

Note: Fuji Imaging Plates (IP) belonging to the Type ST (Standard) family, are to be used for this product.

The Fuji IP Cassette Type PC is offered in three sizes: 14"x17" (35 x 43 cm), 14"x14" (35 x 35 cm), and 10"x12" (25 x 30 cm).

AI/ML Overview

The provided text describes the Fujifilm IP Cassette Type PC, an accessory for megavoltage radiation therapy systems, and its comparison to a predicate film/cassette system. However, it does not present acceptance criteria in a formal table or a study designed to explicitly prove the device meets pre-defined acceptance criteria with specific thresholds. Instead, the testing section describes a series of comparative performance assessments against a predicate device to demonstrate substantial equivalence.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

Formal acceptance criteria with numerical thresholds are not explicitly stated in the document. The study's objective appears to be a comparative assessment against a predicate device (Kodak EC-L Film Cassette) to demonstrate equivalent or superior performance, rather than meeting pre-defined specific clinical performance metrics. The "acceptance" is implied by the superior or equivalent scoring in the comparative tests.

Acceptance Criteria (Implied/Derived)	Reported Device Performance (Fuji IP Cassette Type PC)
Dose Linearity: Log-linear response between dose and mean pixel value, independent of energy between 6 and 18 MV.	Test result passed. Response is independent of energy between 6 and 18 MV.
Image Quality (Varian PortalVision™ Contrast-Detail phantom - 6MV): - Superior to or at least equal to predicate device (Kodak EC-L).	Superior: All three observers scored Fuji CR image higher than film image (14.83 vs. 13.33).
Image Quality (Varian PortalVision™ Contrast-Detail phantom - 18MV): - Superior to or at least equal to predicate device (Kodak EC-L).	Equal/Superior: Two out of three observers scored Fuji CR image equal to or superior to film image. Average score for both systems was the same (9.0).
Image Quality (Varian PortalVision™ Phantom with Anthropomorphic Phantom - 6MV): - Superior to or at least equal to predicate device (Kodak EC-L).	Equivalent/Slightly Superior: Judged equivalent (FCR slightly superior by 2 of 3 reviewers).
Image Quality (Varian PortalVision™ Phantom with Anthropomorphic Phantom - 18MV): - Superior to or at least equal to predicate device (Kodak EC-L).	Superior: Judged superior to Kodak film image.

2. Sample Size and Data Provenance for the Test Set

Sample Size (Test Set):
- Dose Linearity Bench Test: Not specified, but involved testing with 6 MV and 18 MV energies.
- Varian PortalVision™ Contrast-Detail phantom Test: One phantom was used, generating images at 6MV and 18MV for both cassettes.
- Varian PortalVision™ Phantom with Anthropomorphic Phantom Test: One phantom was used with an anthropomorphic phantom, generating images at 6MV and 18MV for both cassettes.
Data Provenance: The tests were performed "at West Virginia University Hospitals Radiation therapy department." The data is prospective, generated specifically for these comparison tests. The country of origin is the USA.

3. Number of Experts and Qualifications for Ground Truth

Number of Experts: Three independent observers.
Qualifications of Experts: Not specified beyond "independent observers." It's highly probable these were medical physicists, dosimetrists, or radiation oncologists due to the nature of the testing (portal imaging, phantom assessment in a radiation therapy department), but this is not explicitly stated.

4. Adjudication Method for the Test Set

The review process involved "three independent observers" scoring images. The scoring results were then compared (e.g., "All three observers scored...", "Two out of three observers scored...", "average score"). This suggests a form of consensus or majority rule, but no formal adjudication method like 2+1 or 3+1 is described.

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

No, a typical MRMC comparative effectiveness study was not explicitly stated or performed in the context of human readers with AI vs. without AI assistance.
- The device itself is not an AI algorithm but a digital imaging cassette, a replacement for a film cassette. The comparison is between the digital cassette system and a traditional film cassette system, with human observers evaluating image quality.
- The study compares the performance of the imaging system (Fuji IP Cassette Type PC + CR reader) against a predicate imaging system (Kodak EC-L film cassette). It assesses human observers' ability to interpret images from these two systems.
Effect Size of Human Readers Improving with AI: This is not applicable as the device is not an AI system, and the study does not involve human readers comparing AI-assisted vs. non-AI-assisted interpretations.

6. Standalone (Algorithm Only) Performance Study

No. The device is a physical cassette, not a standalone algorithm. The performance evaluation is inherently tied to the entire imaging chain (cassette, CR reader, display) and the human interpretation of the resulting images.

7. Type of Ground Truth Used

Expert Consensus on Image Quality: The ground truth for evaluating images from the Varian PortalVision™ phantom was established by the subjective scoring and consensus (or comparison of scores) of the three independent observers. The phantom itself provides a known structure for assessing resolution and contrast.

8. Sample Size for the Training Set

Not Applicable / Not Specified. This device is a hardware component (cassette) designed to capture images for an existing FDA-cleared CR reader and image processing pipeline. The document states, "No new software modifications to the CR reader or workstation are needed for this indication" and "Images are processed using currently-cleared MFP image processing with FNC applied." Therefore, there is no mention of a specific training set for a new algorithm developed for this cassette. Any "training" for the existing image processing algorithms would have occurred prior to the development of this specific cassette.

9. How Ground Truth for the Training Set Was Established

Not Applicable / Not Specified. As there is no new algorithm or training set discussed for this specific device, this information is not provided.

Summary

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

510(k) Summary

Date Prepared March 29, 2007

Submitter's Information

FUJIFILM Medical Systems U.S.A., Inc. 419 West Avenue Stamford, Connecticut 06902 Telephone: (203) 602-3774 Facsimile: (203) 363-3813 Debra A. Peacock Contact:

Trade Name, Common Name, Classification

The device trade name is: Fuji IP Cassette Type PC

Common or classification names:

Classification Name: An accessory to a medical charged particle radiation therapy system.

Common Name: Portal imaging cassette or radiographic cassette.

Predicate Device

Fuji identifies the predicate devices as follows:

Device	510(k)
Agfa CR RT1.0 Low Dose Cassette	K042779
Kodak EC-L Film Cassette	K960834

Description of the Device

MAY 2 2 2007

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

FUJIFILM Medical Systems, USA, Inc. Fuji IP Cassette Type PC 510(k)

CR reader, the IP is erased and returned to the cassette for reuse. No new software modifications to the CR reader or workstation are needed for this indication.

Note: Fuji Imaging Plates (IP) belonging to the Type ST (Standard) family, are to be used for this product.

The Fuji IP Cassette Type PC is offered in three sizes: 14"x17" (35 x 43 cm), 14"x14" (35 x 35 cm), and 10"x12" (25 x 30 cm).

Intended Use

The Fuji IP Cassette Type PC and imaging plate is a digital replacement technology for conventional film/cassette imaging systems.

Technological Characteristics

The subject device is an accessory to a medical charged particle radiation therapy system. The concept of radiographic cassettes and digital imaging are not new; there are several cleared digital imaging cassettes used for this indication on the market. The radiographic technique is unchanged from that of a film/screen based portal imaging application.

In addition, the proposed device has the same technological characteristics as the above-listed predicate device.

Testing

The following tests were performed at West Virginia University Hospitals Radiation therapy department to compare Fuji's IP Cassette Type PC (digital) to Kodak's EC-L (screen film cassette).

Dose Linearity Bench Test: Testing was performed to confirm that the Fuji IP Cassette Type PC (Portal Imaging Cassette) has the desired log-linear response between dose and mean pixel value. Test result passed. The results also indicate that the response is independent of energy between 6 and 18 MV.

Varian PortalVision™: Contrast-Detail phantom Test Bench testing was performed on both cassettes to assess image quality through the use of a Varian PortalVision™ Phantom. Images were scored by three independent observers with the following results:

. 6MV- All three observers scored the Fuji CR image higher than the film image at the 6 MV energy range with a total score of 14.83 for the Fuji CR image vs. a 13.33 score for the Kodak film image.

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

FUJIFILM Medical Systems, USA, Inc. Fuji IP Cassette Type PC 510(k)

18MY- Two out of three observers scored the Fuji CR image equal to or superior to the . film image, with one observer scoring the Kodak film image 0.5 higher than the Fuji CR image. The average score for both systems is the same (9.0).
Varian Portal Vision™ Phantom with Anthropomorphic Phantom Test: Clinical testing was performed by placing the Varian PortalVision™ Phantom underneath the anthropomorphic phantom to obtain images in order to compare the standard port film cassette with Fuji's IP Cassette Type PC (portal imaging cassette).

Images were scored by three independent observers with the following results:

Under the same exposure conditions at 6 MV. the Fuji CR image was scored equivalent . (FCR judged slightly superior by 2 of 3 reviewers) to the Kodak film image when scoring the Varian Portal Vision™ phantom with the superimposed anthropomorphic image.
. Under the same exposure conditions at 18 MV, the Fuji CR image is judged superior to the Kodak film image when scoring the Varian Portal Vision™ phantom with the superimposed anthropomorphic image.

Sample images are enclosed in this 510(k) in Attachment 1.

Conclusion

This 510(k) premarket notification submission has demonstrated Substantial Equivalence as defined and understood in the Federal Food Drug and Cosmetic Act and various guidance documents issued by the Center for Devices and Radiological Health. We conclude the subject device to be as safe and effective as the predicate devices.

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

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wavy lines representing the bird's body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

MAY 2 2 2007

Ms. Debbie Peacock Regulatory Coordinator FUJIFILM Medical Systems USA, Inc. 419 West Avenue STAMFORD CT 06902

Re: K070920

Trade/Device Name: Fuji IP Cassette Type PC Regulation Number: 21 CFR §892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: March 29, 2007 Received: April 4, 2007

Dear Ms. Peacock:

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.

Image /page/3/Picture/10 description: The image is a circular logo or emblem. The central element is the acronym "FDA" in bold, stylized letters, with the word "Centennial" written below it in a smaller font. Above the "FDA" acronym, the years "1906-2006" are displayed, indicating a centennial celebration. The entire design is encircled by text that follows the curve of the circle, and there are star symbols interspersed within the text.

Protecting and Promoting Public Health

{4}------------------------------------------------

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 mumber at the top of this letter:

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

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours.

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

{5}------------------------------------------------

SECTION 4

INDICATIONS FOR USE SUMMARY

Indications for Use

510(k) Number (if known):	K070920
Device Name:	Fuji IP Cassette Type PC

Indications for Use:

The Fuji IP Cassette Type PC and imaging plate is a digital replacement technology for conventional film/cassette imaging systems.

Prescription Use (Part 21 CFR 801 Subpart D)

AND

AND OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C Brogdon
Division Sign-Off

Division of Reproductive. Abdominal, an Radiological Devices 510(k) Number

00 18

Regulation Number and Section

N/A