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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.

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).

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.

• 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.

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