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This hood is intended to be used in combination with compatible endoscopes to maintain the field of view during endoscopic procedures such as mucosal resection.

This hood is intended to be used in compatible endoscopes to maintain the field of view during endoscopic procedures such as mucosal resection.

Principles of Operation: Align the objective lens of endoscope with the drain of the hood and attach the hood to the distal end of endoscope by pressing the hood until it stops. Securely attach the endoscope with sterile medical tape. Insert the endoscope equipped with the hood through the mouth. Perform the intended treatment. After completion of the examination, slowly withdraw the endoscope along with the attached hood. Peel the tape off the endoscope completely and remove the hood from the endoscope. Dispose of the hood and tape according to local laws and regulations.

The presented document is a 510(k) summary for the Hood (DH-083ST) by Fujifilm Corporation. It describes the device's intended use and performance testing conducted to demonstrate substantial equivalence to a predicate device.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only states that "performance testing was conducted, and the passed all test objectives."

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

This information is not provided in the document. The testing described focuses on physical dimensions and compatibility with endoscopes, rather than a clinical evaluation requiring expert ground truth for interpretation.

4. Adjudication Method for the Test Set

This information is not provided in the document. Given the nature of the tests (dimensional measurements and compatibility), an adjudication method as typically used in clinical studies with human interpretation is unlikely and not described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This information is not applicable and therefore not provided. The device is a physical hood for an endoscope, not an AI-powered diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable and therefore not provided. The device is a physical component (an endoscope hood), not an algorithm.

7. The Type of Ground Truth Used

For the described tests, the "ground truth" would be the engineering specifications and measurements of the device's dimensions and its fit with compatible endoscopes, along with compliance with the ISO 8600-1:2015 standard. There is no mention of expert consensus, pathology, or outcomes data as these types of ground truth are more relevant for diagnostic or therapeutic devices with clinical interpretation.

8. The Sample Size for the Training Set

This information is not provided and not applicable as this is not an AI/machine learning device that requires a training set.

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

This information is not provided and not applicable as this is not an AI/machine learning device.

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