Search Results

This device is intended for the visualization of the duodenum and upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.

FUJIFILM Duodenoscope Model ED-580XT is comprised of three general sections: a control portion, an insertion portion and an umbilicus. The control portion controls the angulation of the endoscope. This portion also controls the flexibility of the distal end in the endoscope. The insertion portion contains glass fiber bundles, several channels and a complementary Charge-Coupled Device (CCD) image sensor in its distal end. The channels in the insertion portion assist in delivering air/suction as well as endoscope accessories, such as forceps. The glass fiber bundles allow light to travel through the endoscope and emit light from the tip of the insertion portion to illuminate the body cavity. This provides enough light to the CCD image sensor to capture an image and display it on the monitor. The umbilicus consists of electronic components needed to operate the endoscope when plugged in to the video processor and the light source. The endoscope is used in combination with FUJIFILM's video processors, light sources and peripheral devices such as monitor, printer, foot switch, and cart.

Based on the provided text, the document describes the substantial equivalence of the FUJIFILM Duodenoscope Model ED-580XT, not a study evaluating an AI-powered diagnostic device. Therefore, the requested information about acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment, which are typical for AI/ML device studies, are not present in this document.

The document mainly focuses on the physical and functional aspects of the duodenoscope and its safety and performance standards.

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

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

The document lists performance specifications that were tested and states the device met the "pre-defined acceptance criteria for the test." However, the specific numerical or descriptive acceptance criteria themselves are not provided, nor are the reported raw performance values.

Information NOT available in the document:

2. Sample sizes used for the test set and the data provenance: Not applicable as this is not an AI/ML study with a "test set" in that context. The "tests" refer to engineering performance validations.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/ML algorithm is not established for this type of device.
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, as this is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a 510(k) summary for a medical device (a duodenoscope) and details its engineering performance, biocompatibility, and sterilization, rather than the clinical performance of an AI/ML-powered diagnostic tool.

Ask a specific question about this device