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The FUJIFILM ultrasonic processors SU-1 PLATINUM and SU-1 are intended to be used in combination with FUJIFILM ultrasonic endoscope, Video processor, light source, and various peripheral devices. The product is intended to provide ultrasonic images of the trachea, bronchial tree and surrounding organs, or submucosal and peribheral organs of the upper gastrointestinal tract for observation, recording and to aid in diagnosis during endoscopic evaluation.

The Fujifilm ultrasonic processors SU-1 PLATINUM and SU-1 are used with previously cleared ultrasonic endoscopes, EG-530UR2 & EG-530UT2 (K181763), EB-530US (K182825), EG-580UR and EG-580UT (K183433).

The Fujifilm ultrasonic processors SU-1 PLATINUM and SU-1 consist of two components, Processor and Keyboard, which are used in conjunction with one another. The SU-1 PLATINUM or SU-1 ultrasonic processors connect to an ultrasonic endoscope and transmit ultrasound waves into the body cavity by driving the transducer installed on the ultrasonic endoscope. The SU-1 PLATINUM or SU-1 ultrasonic processors process the reflected ultrasound signals received by the ultrasonic transducer in the body cavity and convert the electrical signals into image or video signals. The signals are displayed on the monitor or printer as ultrasonic images. The Keyboard, CP-1/CP-1TB, is used to control operational features of the SU-1 PLATINUM or SU-1 ultrasonic processor. Furthermore, the SU-1 PLATINUM and SU-1 system can be expanded by connecting additional devices. The system can optionally be used with a previously cleared FUJIFILM Ultrasonic Processor SP-900 (K171207).

The Fujifilm ultrasonic processor SU-1 PLATINUM and SU-1 can acquire and display real-time ultrasound data in different modes such as M, B, Color Doppler, F-Flow, Duplex and Triplex.

Additionally, SU-1 PLATINUM offers a feature/mode known as Elastrography, which is a medical imaging modality that maps the elastic properties of the target organs. Relative stiffness of the tissue is visualized as a color distribution map by a way of calculating the distortion of the tissue caused by external compression of inner vibration, and displaying disparities in stiffness levels as different colors.

The provided text describes a 510(k) summary for the Fujifilm Ultrasonic Processor, Model SU-1 PLATINUM and SU-1. It details the device's indications for use, technological characteristics, and performance data to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study information provided, structured as requested:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

• The document mentions "Doppler sensitivity for F-Flow mode performance testing" was conducted on the proposed device. However, it does not specify the sample size for this test.
• Data provenance is not explicitly stated. Given that it's a 510(k) submission by FUJIFILM Corporation, headquartered in Japan, and the submission is to the FDA for a device to be marketed in the US, the testing was likely conducted by the manufacturer, but the location of the test (e.g., country of origin of the data) is not detailed. The nature of the study (retrospective or prospective) is also not specified, though performance testing is typically prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• This information is not provided. The document focuses on technical performance testing rather than studies involving human expert interpretation.

4. Adjudication method for the test set:

• This information is not provided. As the testing appears to be technical performance testing (e.g., Doppler sensitivity), an adjudication method for ground truth establishment by experts is likely not applicable or was not part of this submission's provided details.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No MRMC comparative effectiveness study was done or reported. The submission describes modifications to an existing ultrasonic processor (software update for a new view mode, F-Flow, and compatibility with new endoscopes) and focuses on demonstrating equivalence through technical performance tests. There is no mention of AI assistance; the device is an ultrasonic processor.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

• The document describes performance testing for the "Doppler sensitivity for F-Flow mode." This is a standalone technical performance test of the device's imaging capability. However, it's a device that produces images for human interpretation, not an algorithm that makes diagnostic recommendations on its own.
• The "standalone" performance here refers to the device's ability to acquire and process signals as intended for the new F-Flow mode.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• For the "Doppler sensitivity for F-Flow mode performance testing," the ground truth would likely be technical measurements against a known standard or phantom, as part of validating the physical performance of the Doppler functionality, rather than a clinical ground truth like pathology or expert consensus. The description implies a technical verification of the device's output against expected performance for a particular imaging mode.

8. The sample size for the training set:

• This information is not applicable/not provided. The device is an ultrasonic processor, not a machine learning algorithm that requires a training set in the typical sense. The software updates mentioned relate to a new view mode and compatibility, not a trainable AI component.

9. How the ground truth for the training set was established:

• This information is not applicable/not provided for the same reason as point 8.

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