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The EPX-4400 and EPX-4400HD Digital Video Processors with FICE are used for endoscopic observation, diagnosis, treatment, and image recording. The devices are intended to process electronic signals transmitted from a video endoscope (a video camera in an endoscope). The devices may be used on all patients requiring endoscopic examination and when using a Fujinon/FUJIFILM medical endoscope, light source, monitor, recorder and various peripheral devices. FICE is an adjunctive tool for gastrointestinal endoscopic examination which can be used to supplement FUJIFILM white light endoscopy. FICE is not intended to replace histopathological sampling as a means of diagnosis.

The EPX-4400 and EPX-4400HD Digital Video Processor with FICE and light source consist of three components used in conjunction with one another: The VP-4400/4400HD Video Processor, The XL-4400/4400HD Light Source, and The DK-4400E Keyboard. The Processor relays the image from the endoscope to a video monitor. Projection can be either analog or digital at the user's preference. The Processor incorporates internal or external digital storage capacity. The Processor also controls the light projected to the body cavity. The Processor provides for optional structural enhancement at the user's option. Spectral and structural enhancements are achieved through proprietary software. The Light Source employs a 300W Xenon lamp with a 75W emergency back-up Halogen lamp. Brightness control is performed by the user. The Keyboard is used to enter pertinent procedural information (patient, physician, date, etc.) for display on the video monitor and digital/analog storage systems. The Keyboard is also used to control operational features of the VP-4400/4400HD Processor. Both EPX-4400 and EPX-4400HD contain FICE which is an image processing technology.

The provided text is a 510(k) summary for the FUJIFILM EPX-4400 and EPX-4400 HD with FICE. It describes the device, its intended use, and substantial equivalence to a predicate device. However, it does not contain the detailed information required to answer your questions about specific acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement for a comparative effectiveness study or a standalone performance study of FICE's diagnostic capabilities.

The document primarily focuses on demonstrating substantial equivalence in terms of safety and technical characteristics consistent with an endoscopic video processor, rather than a clinical diagnostic AI.

Here's a breakdown of what can be extracted and what cannot:

Information that can be extracted from the provided text:

• 1. A table of acceptance criteria and the reported device performance: This specific detail is not present. The document mentions that "All predetermined testing criteria were met, and in all instances the device functioned as intended" for the performance tests listed below, but it does not specify the actual criteria or the quantitative results against those criteria.
  • Performance Tests listed:
    • Contrast Enhancement
    • Resolution
    • Noise
    • Artifact
    • Color Reproduction
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The document states, "FUJIFILM has performed the same testing that was used to fully characterize the FICE feature as part of clearance with use with the EPX-4440HD system in K140149." The listed tests (Contrast Enhancement, Resolution, Noise, Artifact, Color Reproduction) are technical performance evaluations, which can be seen as a form of standalone performance assessment of the image processing itself. However, this is not a diagnostic standalone performance study measuring clinical endpoints like sensitivity/specificity.

Information that cannot be extracted from the provided text:

• 2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not mentioned. The testing described is technical characteristic validation, not a clinical trial with a test set of patient data.
• 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 mentioned. Ground truth for clinical diagnostic outcomes is not discussed.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not mentioned.
• 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: An MRMC comparative effectiveness study is not mentioned. The document describes FICE as an "adjunctive tool" and states it "is not intended to replace histopathological sampling as a means of diagnosis," which suggests it's a visualization aid rather than a primary diagnostic AI that would typically undergo MRMC studies for diagnostic improvement.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the technical performance tests, the "ground truth" would be the expected technical specifications or ideal image characteristics, but this is not defined in terms of clinical ground truth like pathology.
• 8. The sample size for the training set: The document discusses software validation and technical performance; it does not mention a "training set" in the context of machine learning or AI that learns from data.
• 9. How the ground truth for the training set was established: As no training set is discussed, this information is not present.

In summary:

This 510(k) pertains to the EPX-4400 and EPX-4400 HD with FICE as an endoscopic video processor and image processing technology to enhance visualization. The performance data provided are technical validations (software, electrical safety, contrast, resolution, noise, artifact, color reproduction) to ensure the device performs as intended and is safe, rather than clinical performance studies demonstrating diagnostic accuracy or improvement in human reader performance. The device is explicitly stated to be an "adjunctive tool" and "not intended to replace histopathological sampling."

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