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The device is intended for the visualization of the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenal bulb. The device can be inserted orally or trans nasally.

The device is intended for the visualization of the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenal bulb. The device can be inserted orally or trans nasally.

The EG-530N consists of the following portions / parts:

• Control portion to provide grip for holding the endoscope and for the operation of the endoscope.
• LG Flexible Portion - Contains the light guide, air/water supply tube, suction tube, and cables.
• Bending Portion
• Distal End - Contains objective lens, air/water nozzles, forceps channel.

The EG-530N is used with a Processor (4400) and other peripheral items such as VCR, Television Monitor, and Printers.

The provided text is a 510(k) summary for the Fujinon EG-530N Gastroscope. It describes the device, its intended use, comparison to a predicate device, and a conclusion on substantial equivalence. However, it does not contain information about specific acceptance criteria or a detailed study proving the device meets performance criteria in the way a clinical trial or algorithm validation study would.

The "Performance Data" section states: "The subject device has been subjected to and passed electrical safety, thermal, and EMC testing requirements. The materials in the endoscope are identical to the materials used in the predicate device." This indicates engineering and materials testing, but not clinical performance metrics like diagnostic accuracy, sensitivity, or specificity.

Therefore, many of your requested items cannot be extracted from this document, as it is a regulatory submission focused on substantial equivalence rather than a clinical performance study report.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. Table of acceptance criteria and reported device performance:

2. Sample size used for the test set and the data provenance: Not applicable. This document does not describe a test set or clinical study for evaluating diagnostic performance. The "testing" mentioned refers to engineering and safety tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No test set or ground truth establishment by experts for clinical performance is described.

4. Adjudication method for the test set: Not applicable.

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 device is a gastroscope, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is an endoscope, not an algorithm.

7. The type of ground truth used: Not applicable. The "ground truth" here is the device's adherence to engineering standards and technical specifications, not clinical outcomes or pathology.

8. The sample size for the training set: Not applicable. As this is not an AI/algorithm-based device, there is no training set in that context.

9. How the ground truth for the training set was established: Not applicable.

Summary of what the document implies about "meeting acceptance criteria":

The document effectively states that the Fujinon EG-530N Gastroscope meets its "acceptance criteria" by demonstrating substantial equivalence to existing legally marketed devices (predicates). This is the primary regulatory pathway used here. The criteria for acceptance by the FDA were that the device is as safe and effective as its predicates, which was argued based on:

• Similar indications for use.
• Identical material composition.
• Similar viewing direction, image size, bending, reprocessing/sterilization methods.
• Use of the same processor and peripherals.
• Minor differences (e.g., smaller diameter, field of view) were deemed not to raise new safety or effectiveness concerns.
• The addition of transnasal indication was supported by existing FDA clearance for similar devices.
• Passing of standard engineering safety tests (electrical, thermal, EMC).

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