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EC-760S-V/L is intended for the visualization of the lower digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the rectum and large intestine.

FUJIFILM Endoscope Model EC-760S-V/L is comprised of three general sections: a control portion, an insertion portion and an umbilicus. The control portion controls the anqulation of the endoscope. This portion also controls the flexibility of the distal end in the endoscope. The insertion contains glass fiber bundles, several channels and a complementary metal-oxide-semiconductor (CMOS) 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 CMOS 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.

The provided text is a 510(k) Summary for the FUJIFILM Endoscope Model EC-760S-V/L. It describes the device, its intended use, and its comparison to a predicate device to establish substantial equivalence.

Based on the information provided, here's an analysis of the acceptance criteria and study data:

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

The document explicitly states: "Fujifilm conducted the following performance testing on the proposed device EC-760S-V/L to ensure that the modified device performs equivalently to the predicate device:

• Field of view
• Bending capability
• Rate of air supply
• Rate of water supply
• Suction rate
• Working length
• Forceps channel diameter
• Viewing direction
• Resolution
• LG output

In all cases, the device met the pre-defined acceptance criteria for the test."

However, the document does not provide the specific acceptance criteria values for each of these performance metrics, nor does it provide the measured performance values for the proposed device or the predicate device. It only states that the device "met the pre-defined acceptance criteria."

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

The document mentions "Bench testing was conducted on the subject device to validate the Advanced Force Transmission, Adaptive Bending features" and lists other performance tests. These are bench tests and thus do not involve human subjects or clinical data in the traditional sense. The sample size for these engineering/performance tests (e.g., number of endoscopes tested) is not specified. Data provenance related to country of origin or retrospective/prospective is not applicable as it's not a clinical study.

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)

This is a technical device performance study, not a perception or diagnostic accuracy study requiring expert human readers to establish ground truth. Therefore, this information is not applicable. The ground truth is based on engineering specifications and measurements.

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

Not applicable as this is not a study involving human adjudication of results.

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 a 510(k) for an endoscope itself, comparing its performance characteristics to a predicate endoscope. It does not involve AI or human reader performance comparisons.

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

Not applicable, as this device is an endoscope, not an AI algorithm. Its performance is measured directly through physical and optical characteristics.

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

The ground truth for these performance tests (e.g., field of view, bending capability, resolution) are established based on engineering specifications, industry standards, and the performance characteristics of the predicate device. For instance, the "acceptance criteria" would be a defined range or value for a characteristic that the device must meet to be considered functional and equivalent to the predicate.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device, so there is no "training set."

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

Not applicable, as there is no training set for this type of device.

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