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Endoscope EN-580T: 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 and rectum. Never use this product for any other purposes.

Over-tube TS-1314B: This product is used in combination with a FUJIFILM Double Balloon Endoscope to assist the insertion of the Endoscope under the management of physicians in medical facilities. This product is used to assist with the movement of the scopes inside the upper or lower digestive tract. Do not use this product for any other purposes. This product is not intended for use for any neonates, infants or children.

Balloon BS-4: This product is used in combination with FUJIFILM Double Balloon Endoscopes at medical facilities under the management of physicians. Being attached to the endoscope, this product is inserted into the mouth or anus to stabilize the distal end of the endoscope to the digestive tract's mucous membrane. Do not use this product for any other purposes. This product is not intended for use for any neonates, infants or children.

Tube Kit TY-500D: This product is the tube kit used in combination with the compatible balloon controller in medical facilities. Do not use this product for any other purpose.

The endoscope EN-580T is inserted both perorally and transanally into the gastrointestinal tract during clinical use. The insertion of the device has a mechanism which bends the tip from right to left and up and down, and a flexible tube 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 over-tube TS-1314B is introduced in the patient's anatomy with the pairing endoscope. TS-1314B 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-1314B is provided sterile and single-patient use only.

The balloon BS-4 is attached to the balloon-compatible endoscope. The balloon air feed outlet should be contained inside BS-4. The accompanying fixing rubber is used to affix the scope balloon in place. The fixing rubbers are made specifically for BS-4 but should not be mixed with the fixing rubber of other scope balloons. BS-4 is provided sterile and single-patient use only.

The tube kit TY-500D consists of a set of two tubes connects the over-tube to the balloon controller by its air inlet. The other tube connects the same balloon controller to the endoscope by its balloon air feed inlet. TY-500D is only compatible with PB-30, cleared K153483. TY-500D is provided non-sterile. The tubes are not patient-contacting and reusable, but each filter is single-patient use only.

This document does not contain information about a study that proves the device meets specific acceptance criteria in the manner typically seen for AI/ML-driven devices. Instead, it describes a 510(k) premarket notification for updated medical devices (Endoscope and accessories) that aim to demonstrate substantial equivalence to previously cleared predicate devices.

The "acceptance criteria" here are inherent to the regulatory process of demonstrating substantial equivalence for traditional medical devices, focusing on safety and effectiveness compared to existing devices rather than a performance benchmark against a clinical gold standard using a specific test set.

Here's an breakdown based on the document's content:

1. Table of Acceptance Criteria and Reported Device Performance

Instead of a table with specific numerical performance metrics (like sensitivity, specificity, AUC), the "acceptance criteria" are compliance with relevant safety and performance standards for medical devices, and the "reported device performance" is the successful completion of testing to demonstrate this compliance and substantial equivalence to predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

This document does not describe a "test set" in the context of AI/ML evaluation (e.g., a set of medical images or patient cases). The performance data cited refers to standard engineering and biological testing (sterility, biocompatibility, endoscope-specific tests). Therefore, information on sample size or data provenance for such a "test set" is not applicable or provided here.

3. Number of Experts Used to Establish the Ground Truth and Qualifications of Those Experts

Not applicable. Ground truth, in this context, would imply expert annotations or diagnoses on patient data. This document describes the substantial equivalence of physical medical devices and their components, not an AI/ML algorithm's diagnostic performance. Therefore, no experts were used to establish ground truth for a test set in this manner.

4. Adjudication Method for the Test Set

Not applicable, as there is no diagnostic "test set" to adjudicate.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement with vs. without AI Assistance

No. This document does not pertain to AI or an AI-assisted device. Therefore, no MRMC study or AI-related effectiveness assessment was conducted or reported.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No. This document does not pertain to an algorithm or AI device.

7. The Type of Ground Truth Used

The "ground truth" for this submission is compliance with established international and FDA standards for medical device safety and performance. This is confirmed through laboratory testing for sterility, biocompatibility, and functional performance, rather than clinical outcomes or pathology data.

8. The Sample Size for the Training Set

Not applicable, as there is no AI/ML algorithm involved, and thus no "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no AI/ML algorithm and training set.

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