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The VP-4440HD unit is used for endoscopic observation, diagnosis, treatment, and image recording. It is intended to process electronic signals transmitted from a video endoscope). This product 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 gastromtestination which can be used to supplement FUJIFILM white light endoscopy. FICE is not intended to replace histopathological sampling as a means of diagnosis.

This system is intended to be used in coniunction with Fuiifilm endoscopes to provide illumination, visual display and data storage during endoscopic procedures.

The EPX-4440HD Digital Video Processor with FICE and light source consists of three components used in conjunction with one another:

The VP-4440HD Video Processor: 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 device is AC operated at a power setting of 120V/60MzJ0.8A. The Processor is housed in a steel-polycarbonate case measuring 390x105x460mm.

The XL-4450 Light Source: The Fujinon/Fujifilm endoscope employs fiber bundles to transmit light from the light source and subsequently to the body cavity. The Light Source employs a 300W Xenon lamp with a 75W emergency back-up Halogen lamp. Brightness control is performed by the user. The device is AC operated at a power setting of 120V/60MzJ3.3A. The Light Source is housed in a steel-polycarbonate case measuring 390x155x450mm.

The DK-4440E Keyboard: 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-4440HD Processor. The Keyboard resembles a standard computer keyboard in size and shape.

The VP-4440HD Digital Video Processor with FICE and light source is the same as the cleared EPX-4440HD Digital Video Processor and Light source (K102466) device, with the exception of the addition of the imaging algorithm termed "FICE" (Flexible spectral-Imaging Color Enhancement). As with the predicate device, the subject processor receives an image from the endoscope via a connector cable. The subject processor is capable of bi-directional communication that allows importation and exportation of various patient and procedural data between EMR (Electronic Medical Record) systems.

FICE is an image processing feature that a licensed medical practitioner (user) can utilize, as an adiunctive tool, to supplement the white light endoscopic examination. FICE extracts spectral images of specific wavelength components from the original full spectral (white light) image through an image processing algorithm that, assigns a spectral wavelength component in the Red (R), Green (G) and Blue (B) spectrum and displays the enhanced color image. FICE may enhance color contrast to improve visibility of the selected structures, borders of areas of interests.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Test Set (Clinical Study): Each subject underwent two (2) gastrointestinal endoscopic examinations during a single clinical procedure. The document doesn't explicitly state the total number of subjects or individual images in the test set.
• Data Provenance: Prospective clinical trial. The country of origin of the data is not specified.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Number of Experts: Multiple blinded investigators. The exact number is not specified.
• Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

• Adjudication Method: Images were analyzed independently by "multiple blinded investigators using a 4-point Likert scale." The document does not specify a formal adjudication method (e.g., 2+1, 3+1 consensus). It appears to rely on the "overall means between all readers."

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

• MRMC Study: Yes, a reader concurrence study was performed, which is a type of MRMC study comparing FICE (an AI/image processing feature) to optical filtering (NBI).
• Effect Size: The study aimed to establish "substantial equivalence of diagnostic visualization (e.g. image quality) to the predicate optical filtering method." The reported outcome is that "Overall means between all readers demonstrated at least comparable image quality of each FICE setting in one or more locations within the gastrointestinal tract." This indicates FICE performed similarly to or as well as NBI for image quality; a specific quantitative effect size of human reader improvement with AI assistance vs. without is not provided, as the study focused on comparability rather than improvement. The FICE feature itself is described as an "adjunctive tool," not necessarily a comprehensive AI diagnosis system.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Based on the provided text, the FICE feature is described as an "adjunctive tool for gastrointestinal endoscopic examination which can be used to supplement FUJIFILM white light endoscopy." The clinical study focused on readers evaluating image quality generated by FICE. There is no indication of a standalone performance study of the FICE algorithm without human interpretation.

7. The Type of Ground Truth Used

• Type of Ground Truth: The clinical study compared the "overall image quality" observed by multiple blinded investigators using a Likert scale. This suggests a form of expert consensus/reader perception for image quality as the ground truth. It's important to note that the FICE feature is "not intended to replace histopathological sampling as a means of diagnosis," indicating that the "ground truth" for diagnosis in a clinical sense would still be pathology. However, for the purpose of this study measuring the effectiveness of the FICE image processing, reader evaluation of image quality served as the primary measure.

8. The Sample Size for the Training Set

• The document describes performance testing for an image processing feature (FICE) which is integrated into a video processor. It does not explicitly mention a "training set" in the context of machine learning model development. This suggests the FICE algorithm might be based on pre-defined spectral filters or rule-based image processing rather than a deep learning model that requires a dedicated training set. If there was a training phase for the algorithm, its sample size is not disclosed.

9. How the Ground Truth for the Training Set Was Established

• As a dedicated "training set" is not mentioned and the FICE algorithm's nature isn't fully detailed as a deep learning model, the method for establishing ground truth for a training set is not applicable or not provided in this document.

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