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The EPX-4440FN Digital Video Processor with Light Source is used for endoscopic or laparoscopic observation, diagnosis, treatment, and image recording. It is intended to process electronic signals transmitted from a video endoscope or laparoscope (a video camera in an endoscope or laparoscope). This product may be used on all patients requiring endoscopic examination or laparoscopic surgical procedures and when using a FUJIFILM medical endoscope or laparoscope, light source, monitor, recorder and various peripheral devise. FICE (Flexible spectral-Imaging Color Enhancement) is an adjunctive tool for gastrointestinal endoscopic examination which can be used to supplement FUJIFILM white light endoscopy. FICE is not intended to replace histopathologic sampling as a means of diagnosis.

The EPX-4440FN Digital Video Processor with Light Source is comprised of:

• o VP-4440FN Video Processor with DK-4440E Data Keyboard
• o XL-4450FN Light Source
  The EPX-4440FN Digital Video Processor with Light Source consists of the VP-4440FN Video Processor and the XL-4450FN Light Source. The VP-4440FN Video Processor relays the image from a laparoscope or endoscope to a video monitor. The processor also controls the light projected to the body cavity. The XL-4450FN Light Source employs a Xenon lamp with an emergency back-up Halogen lamp. Brightness control is performed by the user.

The provided text is a 510(k) premarket notification for a medical device called the EPX-4440FN Digital Video Processor with Light Source. It does not include acceptance criteria for device performance in the form of specific metrics (e.g., sensitivity, specificity, accuracy for a diagnostic task), nor does it describe a study proving the device meets particular clinical or diagnostic performance criteria.

Instead, this document focuses on demonstrating substantial equivalence to predicate devices based on intended use, technological characteristics, and compliance with recognized consensus standards for safety and essential performance. The "Performance Data" section describes engineering-level bench testing to ensure the device's basic functionality, safety, and electromagnetic compatibility.

Therefore, I cannot fulfill the request as the necessary information (acceptance criteria for clinical performance and a study proving those criteria are met) is not present in the provided text.

The "Performance Data" section states:
"Additionally, performance testing showed that the EPX-4440FN Digital Video Processor with Light Source met all the acceptance criteria."

However, it does not list what those acceptance criteria were in terms of specific performance metrics relevant to an AI/diagnostic device (e.g., accuracy, sensitivity, specificity, positive predictive value, negative predictive value). It also doesn't describe any studies that would typically be associated with evaluating such criteria.

The studies mentioned are related to:

• Compliance with recognized consensus standards:
  • ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012 (Medical electrical equipment - General requirements for basic safety and essential performance)
  • IEC 60601-1-2:2007 (Electromagnetic compatibility)
  • IEC 60601-2-18 Edition 3.0 2009-08 (Particular requirements for endoscopic equipment)
  • ISO 14971:2007 (Medical Device Risk Management)
  • IEC 62471: 2006 (Photobiological safety of lamps and lamp systems)
  • AAMI ANSI IEC 62304:2006 (Medical device software - Software lifecycle processes)

These are primarily engineering and safety standards, not studies designed to assess clinical diagnostic performance or how an AI algorithm (if present as a core diagnostic component) performs against a clinical ground truth.

Regarding your numbered points, based on the provided text:

1. A table of acceptance criteria and the reported device performance: Not present. The document states "met all the acceptance criteria" but does not define these criteria or report specific performance values.
2. Sample size used for the test set and the data provenance: Not applicable, as no clinical performance study involving a test set is described. The "performance testing" referenced is likely bench testing for engineering compliance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical performance study involving ground truth establishment is described.
4. Adjudication method for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No. The device is a "Digital Video Processor with Light Source" and its FICE function is described as an "adjunctive tool... not intended to replace histopathologic sampling as a means of diagnosis." This indicates it's not a primary AI-based diagnostic tool requiring MRMC studies for comparative effectiveness of human readers with/without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No, this device is not presented as a standalone diagnostic algorithm.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable, as this device's description does not suggest a machine learning model that would require a "training set" in the sense of AI/diagnostic algorithm development.
9. How the ground truth for the training set was established: Not applicable.

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