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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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The Hitachi Aloka Medical, Ltd. Prosound F75 is intended for use by trained personnel (doctor, sonographer, etc.) for the diagnostic ultrasound evaluation of Fetal; Abdominal; Intra-operative (neurosurgery); Laparoscopic; Pediatric; Small Organ; Neonatal Cephalic; Trans-rectal; Trans-vaginal; TEE (non-cardiac); Musculo-skeletal; Cardiac Adult; Cardiac Adult - TEE; Cardiac Neonatal; Cardiac Pediatric - TEE; Peripheral Vascular; and Gynecological applications. The device is not indicated for Ophthalmic applications.

An ultrasound diagnostic system with the following features:

• Ultrasound transducer(s) = to generate the transmitted ultrasound energy and detect the reflected echoes
• Ultrasound transducer accessories (standard and optional) to maximize functional usage of transducer(s) in various modes of operation
• A computer system to control the transducer and analyze the signals resulting from the reflected echoes
• A video monitor with optional image recorder to display the computed image or derived Doppler data

This is not a study that proves a device meets acceptance criteria, but rather a 510(k) Premarket Notification from the FDA for a diagnostic ultrasound system. It declares the "Hitachi Prosound F75 Diagnostic Ultrasound System" substantially equivalent to a previously cleared predicate device (Hitachi Prosound F75 Diagnostic Ultrasound Scanner [K123828]).

Therefore, most of the requested information (acceptance criteria, reported device performance, sample size for test/training sets, data provenance, number and qualifications of experts, adjudication method, MRMC study, standalone performance, and ground truth type) is not applicable as this document is not a clinical or performance study of a device against specific acceptance criteria.

The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical testing and comparison of technical characteristics and intended use.

Here's the relevant information found in the document:

1. A table of acceptance criteria and the reported device performance
Not applicable. This document is a 510(k) submission asserting substantial equivalence, not a performance study against specific acceptance criteria. It focuses on comparing technical features with a predicate device.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. No clinical test set was used for this submission. The submission relies on non-clinical testing and comparison to an already cleared device.

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. No ground truth establishment by experts was mentioned as part of this 510(k) submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set requiring adjudication was used for this submission.

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 is not an AI-assisted device, and no MRMC comparative effectiveness study was done or mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a diagnostic ultrasound system, not an algorithm, and no standalone performance study was mentioned.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. No clinical ground truth was established or used for this 510(k) submission. The submission is based on substantial equivalence to a predicate device.

8. The sample size for the training set
Not applicable. No training set was used for this type of submission.

9. How the ground truth for the training set was established
Not applicable. No training set was used for this type of submission.

Summary of what is provided in the document:

• Device: Hitachi Aloka Medical, Ltd. Prosound F75 Diagnostic Ultrasound System
• Predicate Device: Hitachi Prosound F75 Diagnostic Ultrasound Scanner [K123828]
• Basis for Acceptance/Clearance: Substantial Equivalence to the predicate device.
• Testing Performed (Non-Clinical):
  • Acoustic output evaluation
  • Biocompatibility (in accordance with ISO 10993-1)
  • Cleaning & disinfection effectiveness
  • Electromagnetic compatibility
  • Electrical safety
• Findings: The device conforms to applicable medical device safety standards and is substantially equivalent in safety and effectiveness to the predicate device.
• Key points of equivalence (as stated in the document):
  • Same indications for diagnostic ultrasound imaging and fluid flow analysis.
  • Same gray scale and Doppler capabilities.
  • Same essential technology for imaging, Doppler functions, and signal processing.
  • Acoustic level below Track 3 FDA limits.
  • Manufactured in accordance with FDA 21 CFR 820 Quality System Regulations.
  • Designed and manufactured to the same electrical and physical safety standards.
  • Manufactured with biocompatible materials.
  • Provides instructions for cleaning, disinfection, and sterilization.
  • Additional functions are enhanced or blended versions of previously cleared features.

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