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The FUJIFILM ultrasonic processor SP-900 is intended to be used in combination with FUJIFILM Ultrasonic Probe, video processor, light source, monitor, recorder, and various peripheral devices. The product is intended to provide ultrasonic images of the gastrointestinal tract, biliary and pancreatic ducts and surrounding organs, airways and tracheobronchial tree for observation, recording and to aid in diagnosis during endoscopic evaluation. Modes of Operation: B-mode

This product is a medical ultrasonic probe. It is intended for the observation and diagnosis of the gastrointestinal tract, biliary and pancreatic ducts and surrounding organs, airways and tracheobronchial tree under the management of physicians at medical facilities. Modes of Operation: B-mode

The FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M2 consists of five components: 1) processor (SP-900), 2) probe (PB2020-M2), 3) control pad (CP-900), 4) scanner (RS-900), and 5) power cord. SP-900 generates ultrasound waves into the body cavity by driving the ultrasonic transducer installed in PB2020-M2, which is inserted through the forceps channel of an endoscope. SP-900 processes the reflected ultrasound signals which PB2020-M2 receives in the body cavity and further converts the processed electrical signals to relay to a monitoring system. SP-900 can acquire and display real-time ultrasound data in B-mode. CP-900 is used to control operational features of SP-900. RS-900 provides the mechanical scanning for acquiring a two-dimensional image. The power cord supplies power to SP-900.

This FDA 510(k) summary describes the substantial equivalence of the FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M2 to their predicate devices. It focuses on the comparison of technological characteristics and safety testing, rather than an AI/ML-driven device's performance evaluation against specific acceptance criteria related to diagnostic accuracy or clinical outcomes.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" for an AI/ML device, such as those related to diagnostic performance (sensitivity, specificity, AUROC), expert ground truth establishment, MRMC studies, and training/test set details, are not applicable to this submission.

This submission is for a medical imaging device (ultrasound processor and probe), not an AI/ML diagnostic or assistive device. The "performance data" section focuses on electrical safety, EMC, biocompatibility, and reprocessing validation, which are standard for such hardware devices to demonstrate safety and effectiveness.

However, I can extract the information that is present and indicate where the requested information is not applicable (N/A) based on the provided document.

Device Name: FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M2

Device Type: Medical Ultrasonic Processor and Probe

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device (ultrasound hardware), the "acceptance criteria" are related to safety, electrical performance, biocompatibility, and reprocessing effectiveness, not diagnostic accuracy metrics typically seen with AI/ML algorithms. The document asserts that the device meets these criteria through various tests.

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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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SP-900:

The FUJIFILM Ultrasonic Processor SP-900 is intended to be used in combination with FUJIFILM Ultrasonic Probe, video processor, light source, monitor, recorder, and various peripheral devices. The product is intended to provide ultrasonic images of the gastrointestinal tract, biliary and pancreatic ducts and surrounding organs, airways and tracheobronchial tree for observation, recording and to aid in diagnosis during endoscopic evaluation.

PB2020-M:

This product is a medical ultrasonic probe. It is intended for the observation and diagnosis of the gastrointestinal tract, biliary and pancreatic ducts and surrounding organs, airways and tracheobronchial tree under the management of physicians at medical facilities.

The FUJIFILM Ultrasonic Processor SP-900 and Ultrasonic Probe PB2020-M consists of five components: 1) processor (SP-900), 2) probe (PB2020-M), 3) control pad (CP-900), 4) scanner (RS-900), and 5) power cord. The SP-900 generates ultrasound waves into the body cavity by driving the ultrasonic transducer installed in the PB2020-M, which is inserted through the forceps channel of an endoscope. The SP-900 processes the reflected ultrasound signals which the PB2020-M receives in the body cavity and further converts the processed electrical signals into video signals to relay to a monitoring system. The SP-900 can acquire and display real-time ultrasound data in B-mode. The CP-900 is used to control operational features of the RS-900 provides the mechanical scanning for acquiring a two-dimensional image. The power cord supplies power to the SP-900.

The provided document is a 510(k) summary for the FUJIFILM Ultrasonic Processor SP-900 and Ultrasonic Probe PB2020-M. It primarily focuses on demonstrating substantial equivalence to a predicate device, rather than proving that the device meets specific acceptance criteria through a clinical study or performance efficacy study with a test set, ground truth, or expert readers.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes for test/training sets, expert involvement, and ground truth establishment are not present in this document. The document outlines bench testing to ensure the device functions as intended and meets established specifications, particularly regarding image quality and performance, but it does not describe a study involving human readers or a defined set of diagnostic tasks.

Based on the information provided, here's what can be extracted and what is missing:

Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in terms of specific performance metrics for diagnostic accuracy (e.g., sensitivity, specificity) against a ground truth. Instead, it focuses on demonstrating substantial equivalence to an existing predicate device (Olympus EU-ME2 and UM-S20-17S). The "performance" reported is primarily the device's conformance to safety and performance standards, and its ability to produce images and function as intended during bench testing.

Table of Acceptance Criteria and Reported Device Performance:

Study Details (Based on available information):

1. Sample size used for the test set and the data provenance:
   This document describes bench testing and software validation, not a clinical or performance study with a "test set" of patient data in the typical sense for evaluating diagnostic accuracy. No sample size for a patient data test set is mentioned. The data provenance is not applicable in the context of device function testing rather than diagnostic performance evaluation.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   Not applicable. No "ground truth" establishment for diagnostic accuracy is described, as the evaluation was of device functionality and safety, not diagnostic performance on patient cases.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   Not applicable. There was no test set requiring expert adjudication for diagnostic ground truth.

4. 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. This document does not mention any MRMC study or AI assistance. The device is an ultrasonic processor and probe, not an AI-powered diagnostic tool requiring human-in-the-loop performance studies.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   Not applicable. The device is hardware (ultrasonic processor and probe), not an algorithm that performs standalone diagnostic functions. Its performance was tested as a system.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
   Not applicable. No ground truth for diagnostic accuracy was used. The "ground truth" for the engineering tests would be the established performance specifications and safety standards defined in the relevant IEC and ISO standards (e.g., acoustic output limits, electromagnetic compatibility, software integrity).

7. The sample size for the training set:
   Not applicable. There is no mention of machine learning or an AI model requiring a training set.

8. How the ground truth for the training set was established:
   Not applicable, as there was no training set for an AI/ML model.

In summary: This 510(k) summary focuses on demonstrating the substantial equivalence of a new ultrasonic imaging device to existing legally marketed devices, primarily through engineering and safety testing. It attests that the device meets relevant performance and safety standards and its functionality is comparable to its predicate. It does not include details about clinical performance studies, diagnostic accuracy, or human reader involvement, as these types of studies are typically required for devices with more subjective or interpretative outputs, or for AI-based diagnostic tools.

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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, monitor, recorder, and various peripheral devices. The product is intended to provide ultrasonic images of the trachea, bronchial tree and surrounding organs, or submucosal and peripheral organs of the upper gastrointestinal tract for observation, recording and 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 (K120446) and EB-530US (K121035) to provide ultrasonic images of the trachea, bronchial tree, and surrounding organs, or submucosal and peripheral 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 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, is used to control operational features of the SU-1 PLATINUM or SU-1 ultrasonic processor.

The Fuifilm 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, Pulse Doppler, 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.

This is a device that processes ultrasound images, not an AI / ML device. Hence most of the questions are not applicable to the context.

Here's an analysis of the provided text in relation to your request about acceptance criteria and a study proving device conformance:

The document describes a medical device submission (K153206) for Fujifilm Ultrasonic Processors SU-1 PLATINUM and SU-1. It is a 510(k) submission, meaning the device is seeking clearance by demonstrating substantial equivalence to a legally marketed predicate device, not by proving efficacy through a comprehensive clinical trial.

Therefore, there is no mention of "acceptance criteria," "device performance," "sample size for test set," "data provenance," "number of experts," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," "type of ground truth," "sample size for training set," or "how ground truth for training set was established" in the context of an AI/ML device or a traditional clinical study with outcome-based performance metrics.

Instead, the document focuses on demonstrating substantial equivalence through:

• Comparing technological characteristics.
• Compliance with recognized performance and safety standards.
• Bench testing.

Here's an attempt to extract relevant information given the nature of the document:

1. A table of acceptance criteria and the reported device performance

The document does not present acceptance criteria in a typical AI/ML or clinical study format (e.g., target sensitivity/specificity). Instead, equivalence is demonstrated by meeting technical specifications and safety standards.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not applicable in the context of clinical data for performance evaluation. The "Performance Data" section refers to software validation and EMC safety/performance testing. These are engineering/device-level tests, not imaging-data-based performance studies with a "test set" of patient data.
• Data Provenance: Not applicable. The "Performance Data" section describes engineering and safety testing of the device hardware and software.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This is not a study involving expert readers and establishing ground truth for diagnostic accuracy.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable.

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

Not applicable. This device is an ultrasonic processor, not an AI-assisted diagnostic tool.

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

Not applicable. This is not an algorithm, but a hardware device with embedded software for image processing.

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

Not applicable. The "ground truth" here pertains to the device meeting engineering specifications and safety standards, confirmed through various tests (e.g., electrical safety, electromagnetic compatibility, software validation).

8. The sample size for the training set

Not applicable. This is not an AI/ML device that undergoes training on a dataset.

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

Not applicable.

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