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FUJIFILM Endoscope Models EG-840T and EG-840TP is intended for the visualization of the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.

FUJIFILM Endoscope Model EG-840N is intended for the visualization of the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum. This product can be inserted orally or nasally.

Never use this product for any other purposes.

The insertion portion of the device has a mechanism (hereinafter "the bending portion") which bends the tip from right to left and up and down, and a flexible tube (hereinafter "the flexible portion") consists of the bending portion and operating portion with a knob which controls the bending portion. The forceps channel which runs through the operating portion to the tip is arranged inside the insertion portion for inserting the surgical instrument. The insertion portion of the endoscopes comes into contact with the mucosal membrane.

The tip of the insertion portion is called the "Distal end" which contains the Imaging section, Distal cap, Objective lens, Air/water nozzle, Water jet nozzle (Except EG-840N), Instrument channel outlet, and Light guide. The bending portion is controlled by knobs on the control portion/operation section to angulate the distal end to certain angles.

The Flexible portion refers to the long insertion area between the Bending portion and the Control portion (a part of Non-insertion portion). This portion contains light guides (glass fiber bundles), air/water channels, a forceps/suction channel, a CrOS image sensor, and cabling. The glass fiber bundles allow light to travel through the endoscope to illuminate the body cavity, thereby providing enough light to the CMOS image sensor to capture an image and display the image on a monitor. The forceps channel is used to introduce biopsy forceps and other endoscopic accessories, as well as providing suction.

The control portion/operating section provides a grip to grasp the endoscopes and contains mechanical parts to operate the endoscopes. This section includes a Forceps inlet, which allows endoscope accessories to be introduced. The Scope connector connects the endoscopes to the light source.

The provided FDA 510(k) clearance letter pertains to endoscopes, which are hardware devices, not AI/ML software. Therefore, the information requested regarding acceptance criteria, study details, and data provenance for an AI/ML device is not explicitly present in the provided text.

The document focuses on demonstrating substantial equivalence to a predicate device through various non-clinical tests (electrical safety, biocompatibility, endoscope-specific testing, software validation, and reprocessing validation) rather than a clinical effectiveness study involving human readers or AI performance metrics.

However, I can extract information about the device's performance specifications that were tested to prove its general functionality and safety, which can be interpreted as fulfilling certain "acceptance criteria" for a physical medical device.

Here's a breakdown of the available information based on your request, with the caveat that it does not directly address AI/ML performance:

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

The document lists various performance specifications that the device met. It does not provide specific numerical acceptance criteria alongside reported performance values in a table format. Instead, it states that "The subject device met performance specifications in the following additional testing." This implies that the device did meet predefined internal thresholds for these parameters.

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

• Sample Size: Not specified for any of the tests. The document mentions "testing" or "validation activities" without detailing the number of devices or trials involved.
• Data Provenance: Not specified. As this is a 510(k) for a physical medical device (endoscope), the testing would typically be conducted in a laboratory setting by the manufacturer, rather than involving patient data in the context of imaging performance.

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

Not applicable. The tests performed are engineering and safety validations. There is no mention of human expert involvement for establishing "ground truth" in the context of image interpretation or diagnosis, as this is not an AI/ML diagnostic tool.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is a concept typically used in clinical studies involving interpretation by multiple readers, which is not described here.

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. This is not an AI-assisted device. The document describes a traditional endoscope.

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

Not applicable. The device itself is an endoscope, not an algorithm. Software validation was conducted (IEC 62304:2015), but this relates to the software controlling the endoscope's functions, not a standalone diagnostic AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the listed performance specifications (field of view, resolution, etc.), the "ground truth" would be established by objective physical measurements using calibrated equipment and engineering standards. For biocompatibility, it's based on biological response to materials, and for reprocessing, it's based on sterility and decontamination efficacy. There is no "ground truth" in the diagnostic sense as there would be for an AI/ML algorithm.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable.

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