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Double Balloon Endoscope Model EN-840T: This device is intended for the visualization of the upper and lower digestive tracts, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, duodenum, small intestine, large intestine and rectum. Never use this product for any other purposes.

Over-Tube TS-1214C: This product is intended to be used as an accessory with the FUJIFILM Double Balloon Endoscope cleared for use with an Over-tube is used to assist with the movement of the scope inside the upper or lower digestive tract. This product is not intended for use for any neonates, infants or children.

a. Double Balloon Endoscope Model EN-840T: The insertion portion of the device has a mechanism (hereinafter "the bends the tip from right to left and up and down, and a flexible tube (hereinafter") consists of the bending portion and operating portion with a knob which controls the bending portion. The forceps channel which runs through 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, Balloon air feed outlet , Distal cap, Objective lens, Air/water nozzle, Water jet nozzle, Instrument channel outlet, Objective lens, and Light guide. The bending portion is controlled by knobs on the control portion section to angulate the distal end to certain angles. The Flexible portion refers to the long insertion area between the Control portion (a part of Non-insertion portion). This portion contains light guides), air/water channels, a forceps/suction channel, a CMOS image sensor, and cabling. The class fiber bundles alow light to travel through the body cavity, thereby providing enough light to the CMOS 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 connects the endoscopes to the light source.

b. Over-tube TS-1214C: The over-tube TS-1214C is introduced in the patient's anatomy with the pairing endoscope. TS-1214C is assembled over the outer diameter of endoscope. The endoscope and the over-tube are not advanced both at the same time, but alternatingly and successively. TS-1214C is provided sterile and single-patient use only. This accessory is a Class 2 device.

The provided text is a 510(k) Summary for a medical device (Double Balloon Endoscope EN-840T and Over-tube TS-1214C). It describes the device, its intended use, and a comparison to predicate devices, and lists various non-clinical tests performed to demonstrate substantial equivalence. However, it does not include information about specific acceptance criteria, reported device performance in a table, sample sizes, ground truth establishment, expert qualifications, or any human reader studies (MRMC or standalone AI performance).

Therefore, based on the provided text, I cannot answer most of your detailed questions about acceptance criteria and the study proving the device meets those criteria. The document focuses on regulatory compliance through substantial equivalence, primarily established through non-clinical testing against recognized standards.

Here's what can be extracted and what cannot:

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

• Cannot be extracted. The document mentions various tests were conducted (EMC, Electrical safety, Biocompatibility, Endoscope specific testing, Sterility, Field of view, Bending capability, Rate of suction, Working length, Diameter of forceps channel, Viewing direction, Resolution, LG output) and states "The subject device met performance specifications" or "Bench testing data demonstrated that the subject devices are substantially equivalent in performance." However, it does not provide specific numerical acceptance criteria or reported performance values in a table format.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Cannot be extracted. The document mentions "Bench testing data" and "Endoscope specific testing" but does not specify the number of samples or units tested for any of these non-clinical tests, nor the data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. This device is an endoscope and over-tube, which are hardware devices for visualization and intervention, not an AI system that requires expert-established ground truth for diagnostic accuracy. The testing described is non-clinical (electrical, mechanical, biocompatibility, sterility).

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

• Not applicable. As above, this is for non-clinical hardware testing, not diagnostic AI performance assessment requiring expert adjudication.

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. The document describes a traditional medical device (endoscope and over-tube) and its non-clinical testing for safety and effectiveness, based on substantial equivalence to predicate devices. There is no mention of AI or assistant features, nor any MRMC studies.

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

• No. This device is not an algorithm or AI system.

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

• Cannot be extracted and not applicable in the usual sense. For non-clinical tests, "ground truth" would correspond to the established measurement standards and specifications (e.g., a caliper for diameter, a force gauge for bending, a flow meter for suction rate, etc.). The document indicates these tests were performed according to recognized consensus standards (e.g., ISO, AAMI).

8. The sample size for the training set

• Not applicable. This is not an AI/ML device requiring a training set.

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

• Not applicable. This is not an AI/ML device requiring a training set.

In summary, the provided FDA 510(k) summary focuses on demonstrating the substantial equivalence of the new endoscope and over-tube through engineering and biocompatibility testing against established standards and predicate devices. It does not contain the kind of performance data (e.g., sensitivity, specificity, AUC, or reader performance) typically associated with AI/ML-driven diagnostic devices.

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