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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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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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