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The device is intended for the Optical visualization of the upper gastrointestinal tract. This includes the esophagus, stomach, duodenum, and small bowel. It is intended for the observation, diagnosis, and endoscopic treatment.

The small intestine is one of the most difficult organs to access in gastro-intestinal (GI) tract endoscopy. The Fujinon double balloon enteroscopy system facilitates diagnosis and treatment of the upper GI tract including the small intestine. The Fujinon double balloon enteroscopy system utilized balloons and over-tube to ensure complete positioning of the enteroscope in the small intestine. The tip of the scope can be smoothly inserted to reach the area of diagnosis. The Fujinon double balloon enteroscopy system includes the following: G5 endoscope / enteroscope (EN-450P5/20), Over-Tube (TS-12140), Balloon (BS-1), Balloon Pump Controller (PB-10). The subject device is used with the Fujinon Series 400 processor, the same processor used with the predicate device. The Fujinon double balloon enteroscopy system is used in conjunction with other peripherals specified in the Operation Manual such as: Light Source, Processor, Cart, Data Keyboard, Foot Switch, Monitor, Video Printer, Camera and Hard Copy Unit, VCR, ElectroSurgical Tastruments.

The provided text is a 510(k) summary for the Fujinon Double Balloon Enteroscopy System. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with detailed performance acceptance criteria and results.

Therefore, much of the requested information (such as specific performance criteria, detailed study design, sample sizes for test and training sets, expert qualifications, and adjudication methods) is not present in the provided document. The document emphasizes comparison to a predicate device and safety testing.

Here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria: The document does not explicitly state quantitative acceptance criteria for device performance. Instead, it relies on demonstrating substantial equivalence to a predicate device and passing general safety tests. The implicit acceptance criterion is that the new device performs at least as well as the predicate device and is safe for its intended use.

Reported Device Performance: The primary "performance" reported is compliance with regulatory standards and the device's physical specifications.

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

• Sample Size: Not specified. The document refers to "electrical safety, thermal, and EMC testing requirements" and "biocompatibility testing" but does not give sample sizes for these tests. There is no mention of a clinical test set to evaluate diagnostic or treatment performance compared to the predicate device in terms of image quality or efficacy in patient outcomes.
• Data Provenance: Not specified. The tests are general safety and performance tests typically conducted in a laboratory or engineering setting, not on patient data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

• Not Applicable. The document describes engineering and biocompatibility testing, not a study requiring expert readers to establish ground truth for a diagnostic outcome. The device's substantial equivalence is primarily based on technical specifications and safety profile compared to the predicate.

4. Adjudication Method for the Test Set

• Not Applicable. As no expert reading or diagnostic performance evaluation study is described, no adjudication method would be relevant.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

• No. The document does not describe an MRMC comparative effectiveness study. The focus is on demonstrating substantial equivalence through technical specifications and safety testing, not on measuring human reader improvement with or without AI assistance. The device itself is an endoscope system, not an AI-assisted diagnostic tool.

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

• Not Applicable. The Fujinon Double Balloon Enteroscopy System is a medical device (endoscope), not a standalone algorithm. Its performance is intrinsically linked to human operation.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

• Not Applicable / Implicit. For the engineering tests mentioned (electrical safety, thermal, EMC), the "ground truth" would be established by passing industry standards and internal specifications. For biocompatibility, the ground truth would be established by complying with recognized biocompatibility standards. There is no mention of ground truth related to diagnostic accuracy (e.g., pathology, outcomes data) because such a study is not described.

8. The Sample Size for the Training Set

• Not Applicable. This device is an endoscope system, not an AI model. Therefore, there is no "training set" in the context of machine learning.

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

• Not Applicable. As there is no training set for an AI model, this question is not relevant to the provided 510(k) summary.

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