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Processor VP-7000:
The VP-7000 unit is used for endoscopic observation, diagnosis, treatment, and image recording. It is intended to process electronic signals transmitted from a video endoscope (a video camera in an endoscope).

This product may be used on all patients requiring endoscopic examination and when using a Fujinon/FUJIFILM medical endoscope and light source together with montor, recorder and various peripheral devices. BLI (Blue Light Imaging), LCI (Linked Color Imaging) and FICE (Flexible spectral-Imaging Color Enhancement) are adjunctive tools for gastrointestinal endoscopic examination which can be used to supplement Fujifilm white light endoscopy. BLI, LCI and FICE are not intended to replace histopathological sampling as a means of diagnosis.

The Image Processing Unit EX-0 is an optional module intended for use as an adjunctive monitor of the hemoglobin oxygen saturation of blood in superficial tissue of the endoscopic observation image area in patients at risk for ischemic states.

This product may be used on all patients requiring endoscopic examination when using a Fujinon/FUJIFILM medical endoscope, video processor and light source together with monitor, recorder and various peripheral devices.

The prospective clinical value of measurements made with OXEI has not been demonstrated in disease states.

Light Source BL-7000X:
The BL-700X Light Source is used for endoscopic observation, diagnosis, treatment, and image recording, It is intended to provide illumination to an endoscope. The light source also functions as a pump to supply air through the endoscope while inside the body to assist in obtaining clear visualization to facilitate diagnostic examination.

This product may be used on all patients requiring endoscopic examination and when using a Fujinon/FUJIFILM medical endoscope and video processor together with monitor, recorder and various peripheral devices.

Processor VP-7000 relays the image from the endoscope to a video monitor. Projection can be either analog or digital at the user's preference. VP-7000 also incorporates internal digital storage capacity. VP-7000 controls the light projected to the body cavity. VP-7000 provides for optional structural enhancement through user modes FICE (Flexible spectral-Imaging Color Enhancement), BLI (Blue Light Imaging), BLI-brt (Blue Light Imaging-Bright) and LCI (Linked Color Imaging) 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/60Hz, 0.8A. VP-7000 is housed in a steel-polycarbonate case measuring 390x485x110mm. Optional Image Processing Unit EX-0 receives image data from the VP-7000, and displays an OXEI image on a LCD monitor. The OXEI image is a color-coded digital image showing tissue oxygen saturation (StO2). EX-0 incorporates an internal digital storage capacity. The device is AC-operated at a power setting of 120V/60Hz, 1.0A. EX-0 is housed in a steel-polycarbonate case measuring 320x165x340 mm.

The Fujifilm endoscopes employ fiber bundles to transmit light from Light Source BL-7000X and subsequently to the body cavity. BL-7000X employs five LED lamps. Brightness control is performed by the user. The device is AC operated at a power setting of 120V / 60Hz 1.2A. BL-7000X is housed in a steel polycarbonate case measuring 395x485x155mm.

Processor VP-7000, Light Source BL-7000X, and Image Processing Unit EX-0 are used as a system in conjunction with a compatible video laparoscope or endoscope for visualization of tissue oxygen saturation (StO2) levels.

The provided document describes the Fujifilm Processor VP-7000, Light Source BL-7000X, and Image Processing Unit EX-0. The Image Processing Unit EX-0 is an optional module intended for use as an adjunctive monitor of hemoglobin oxygen saturation of blood in superficial tissue of the endoscopic observation image area in patients at risk for ischemic states.

Based on the provided information, the acceptance criteria and the study proving the device meets them can be summarized as follows:

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

2. Sample size used for the test set and the data provenance:

• Bench Testing: 7 different blood-based phantoms. Data provenance is not explicitly stated but implies laboratory (benchtop) testing.
• Animal Testing:
  • Study 1 (Laparoscopic): Number of animals not specified, but involved "a visualization study."
  • Study 2 (Endoscopic): 4 female Göttingen minipigs.
  • Study 3 (Open Surgery): 3 swine.
• Data Provenance (Animal Studies): Live animal studies, likely conducted in a controlled laboratory environment. No specific country of origin is mentioned for the animal studies, but the entire submission is to the U.S. FDA. The details provided (e.g., "female Göttingen minipigs at 11 months of age") suggest prospective data collection.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Bench Testing: A "dissolved oxygen meter" was used as the "gold standard" for StO2 measurements. This is an objective measurement tool, not human experts.
• Animal Testing: The document does not specify the use of human experts to establish ground truth for the StO2 measurements. The reference device (T-Stat 303 Microvascular Tissue Oximeter) served as a comparator, and the study focused on the comparability of the subject device's measurements to the reference device and, implicitly, to the physiological changes induced (e.g., decreased arterial oxygen saturation).

4. Adjudication method for the test set:

Not applicable. The ground truth for StO2 measurement was established by an objective "gold standard" (dissolved oxygen meter in bench testing) or by comparison to a legally marketed predicate/reference device and physiological changes in animal models. No human adjudication is mentioned for the StO2 measurements.

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, an MRMC comparative effectiveness study was not done. The device (Image Processing Unit EX-0) acts as an "adjunctive monitor" of StO2. The studies described focus on the device's ability to measure StO2 accurately and comparably to a reference device, not on improving human reader performance in interpreting images with AI assistance versus without it. This device itself is an "adjunctive tool," not specifically an AI assisting human interpretation of images for diagnosis, but rather providing a quantifiable physiological parameter (StO2).

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

Yes, the performance testing of the StO2 measurement function appears to be a standalone evaluation of the device's capability to measure and display StO2 levels. The bench testing directly compared the device's output to a gold standard, and the animal studies evaluated the device's measurements against a reference device's measurements and induced physiological states. The language suggests the device outputs StO2 values or color-coded images autonomously, without direct human intervention in the measurement process itself, though a human interprets the displayed information.

7. The type of ground truth used:

• Bench Testing: Dissolved oxygen meter (objective measurement, considered a "gold standard").
• Animal Testing:
  • Comparison to a legally marketed reference device (T-Stat 303 Microvascular Tissue Oximeter).
  • Induced physiological states (e.g., decreasing arterial oxygen saturation (SpO2) to simulate ischemic states). These physiological changes and the measurements from the reference device serve as the de-facto ground truth for evaluating the subject device's performance in a living system.

8. The sample size for the training set:

Not applicable. The document describes performance testing for a 510(k) submission, which focuses on demonstrating substantial equivalence to a predicate device. This typically involves verification and validation testing, not the development and training of an AI algorithm from a training set. The Image Processing Unit EX-0 processes existing endoscopic image data to display StO2; it is not presented as a machine learning or AI-driven diagnostic tool that requires a training set in the conventional sense.

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

Not applicable, as no training set is described for this device in the provided document.

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Processor VP-7000

The VP-7000 unit is used for endoscopic observation, diagnosis, treatment, and image recording.

It is intended to process electronic signals transmitted from a video endoscope (a video camera in an endoscope). This product may be used on all patients requiring endoscopic examination and when using a Fujinon/FUJIFILM medical endoscope and light source together with monitor, recorder and various peripheral devices.

BLI (Blue Light Imaging), LCI (Linked Color Imaging) and FICE (Flexible spectral-Imaging Color Enhancement) are adjunctive tools for gastrointestinal endoscopic examination which can be used to supplement Fujifilm white light endoscopy.

BLI, LCI and FICE are not intended to replace histopathological sampling as a means of diagnosis.

Light Source BL-7000

The BL-7000 Light Source is used for endoscopic observation, diagnosis, treatment, and image recording, If is intended to provide illumination to an endoscope.

The light source also functions as a pump to supply air through the endoscope while inside the obtaining clear visualization to facilitate diagnostic examination.

This product may be used on all patients requiring endoscopic examination and when using a Fujinon/FUJIFILM medical endoscope and video processor together with monitor, recorder and various peripheral devices.

VP-7000 and BL-7000 are intended to be used in conjunction with Fujinon/FUJIFILM endoscopes for endoscopic observation, diagnosis, treatment, and image recording. The description for each of the components of the subject device is below:

The VP-7000 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 digital storage capacity. The Processor also controls the light projected to the body cavity. The Processor provides for optional structural enhancement through user modes FICE. BLI. BLI-bright and LCI. Spectral and structural enhancements are achieved through proprietary software. The device is AC operated at a power setting of 100-240V/50-60Hz/0.8-0.5A. The Processor is housed in a steelpolycarbonate case measuring 390x110x485mm.

The DK-7000E Keyboard is a standard accessory of VP-7000. It 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-7000 Processor. The Keyboard resembles a standard computer keyboard, and is provided with an instruction label attached to it.

The BL-7000 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 79.2W 4 LED lamps. Brightness control is performed by the user. The device is AC operated at a power setting of 100-240V/50-60Hz/1.2-0.7A. The Light Source is housed in a steel-polycarbonate case measuring 390x155x485mm.

The provided document describes the FUJIFILM Processor VP-7000 and Light Source BL-7000 and its substantial equivalence to predicate devices, particularly focusing on the performance data for its new imaging features (BLI and BLI-bright).

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" with quantitative metrics for the clinical performance of the device's enhanced imaging modes (BLI, BLI-bright). Instead, it states that "All testing criteria were met" for non-clinical functional tests and for clinical evaluation, "The clinical study established that BLI and BLI-bright demonstrated substantial equivalence of diagnostic visualization (e.g. image quality) to the predicate FICE."

The primary goal of the clinical study was to demonstrate substantial equivalence of diagnostic visualization (image quality) compared to the FICE predicate. While a specific numerical acceptance criterion isn't given, the statement implies that the image quality was not worse than FICE, which was already a cleared device.

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

• Sample Size: The document does not specify the exact number of subjects (patients) or images in the clinical study's test set. It mentions each subject underwent an endoscopic examination using the VP-7000, BL-7000, and FUJIFILM's video endoscopes.
• Data Provenance: The study was a "prospective clinical trial." The country of origin for the data is not explicitly stated, but given the FDA filing, it is likely that parts, if not all, of the data were collected in the United States or under similar clinical standards.

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

• Number of Experts: The clinical study involved "multiple blinded investigators." The exact number is not specified.
• Qualifications of Experts: The qualifications of these "investigators" are not detailed in the provided text. It can be inferred they are medical professionals qualified to interpret endoscopic images, but specific credentials (e.g., gastroenterologists, radiologists) or years of experience are not mentioned.

4. Adjudication Method for the Test Set

• The study design was a "reader concurrence study." Images were "analyzed independently by multiple blinded investigators." It is not explicitly stated how discrepancies among readers were resolved or if a formal adjudication process (e.g., 2+1, 3+1) was used to establish a final ground truth for each image, beyond simply analyzing reader agreement (concurrence).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance

• An MRMC-like study was performed in the sense that multiple readers evaluated multiple cases. However, this study was not a comparative effectiveness study designed to assess how much human readers improve with AI vs. without AI assistance.
• The BLI, LCI, and FICE features are described as "adjunctive tools for gastrointestinal endoscopic examination which can be used to supplement Fujifilm white light endoscopy." They are image processing features, not necessarily "AI" in the modern sense (e.g., providing diagnostic suggestions).
• The study's goal was to establish "substantial equivalence of diagnostic visualization (e.g. image quality) to the predicate FICE," not an improvement in human reader performance or diagnostic accuracy per se. Therefore, no effect size for human reader improvement with AI assistance is reported.

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

• No standalone performance was reported in this document. The BLI, LCI, and FICE features are image processing enhancements intended to be used by a "licensed medical practitioner (user)" as "adjunctive tools" to "supplement" white light endoscopy. They are not presenting a standalone diagnostic output that would require a separate "algorithm only" performance evaluation.

7. The Type of Ground Truth Used

• The document states that the clinical study evaluated "overall image quality" and "diagnostic visualization."
• The images were analyzed independently by multiple blinded investigators using a "4-point Likert scale." This suggests that the ground truth for image quality/diagnostic visualization was established through expert consensus/opinion based on their scoring.
• The document explicitly states: "BLI, LCI and FICE are not intended to replace histopathological sampling as a means of diagnosis." This indicates that histopathology was not the ground truth against which the image enhancements were directly evaluated for diagnostic accuracy outcomes.

8. The Sample Size for the Training Set

• The document does not specify a separate training set. The BLI, LCI, and FICE enhancements are described as "achieved through proprietary software" and based on "signal processing" and manipulation of LED light intensity ratios. This suggests these are pre-defined image processing algorithms rather than machine learning models that require a distinct training set in the typical sense of AI development.

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

• As no explicit training set for a machine learning model is mentioned, the concept of "ground truth for the training set" does not directly apply in the context of the information provided for these specific image processing features. The development of these enhancements would likely have involved engineering and optical principles to achieve desired visual effects, rather than a data-driven training process with established clinical ground truth labels.

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