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Endoscopic Seal is a self-sealing cap that is intended to prevent the backflow of fluid through the working channel of an endoscope.

The Endoscopic Seal is mounted to the proximal port of the endoscope working channel and intended to resist the backflow of distention fluid when the channel is not being used or when instruments are passed through the working channel.

The Endoscopic Seal consists of a silicone seal, an introducer, and an adapter with sealing ring (optional). The Introducer is used to enable improved access during endoscopic procedures. The Adapter and Sealing Ringare optional for Endoscopic Seal. They are used with the non-standard Luer endoscopes.

The silicone seal combined with introducer can be used with all endoscopes with the proximal port of the working channel between 6 mm to 9 mm in its largest outside diameter. Mount the silicone seal onto the working channel of the Endoscope. Make sure the connection is tight. Insert the introducer into the silicone seal.If using the WOLF endoscope, mount the adapter with sealing ring onto the endoscope working channel port first and then place the silicone seal and introducer onto the adapter.

The provided text is a 510(k) Summary for the Endoscopic Seal. This document focuses on demonstrating substantial equivalence to a predicate device through bench testing and comparisons, rather than providing details of a clinical study with acceptance criteria and device performance metrics in the way you've outlined for a typical AI/software device.

Therefore, for aspects related to clinical performance, ground truth, expert involvement, and AI-specific studies (MRMC, standalone), the information is not applicable as this device is a physical medical device (an endoscopic seal), not an AI/software as a medical device (SaMD).

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes various bench tests conducted to demonstrate the safety and performance of the Endoscopic Seal. It does not explicitly state "acceptance criteria" in a quantitative format for most tests, but rather implies that the device "meets the requirements" or is "identical to the predicated device."

2. Sample size used for the test set and the data provenance:

• Test Set Sample Size: Not explicitly stated. The tests are bench tests on the device hardware itself, not clinical data.
• Data Provenance: Not applicable in the context of clinical data. The tests were performed in a lab setting.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not Applicable. This is a physical device, and the "ground truth" is established by adhering to established engineering and biocompatibility standards.

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

• Not Applicable. This is a physical device.

5. If a multi-reader multicase (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:

• No. This is a physical device, not an AI/software.

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

• No. This is a physical device, not a standalone algorithm.

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

• For the physical and biocompatibility testing, the "ground truth" is defined by the acceptance criteria and methodologies specified in the cited ASTM and ISO international standards. Successful completion of these tests according to the standards serves as the evidence of compliance.

8. The sample size for the training set:

• Not Applicable. This device does not involve a training set for an algorithm.

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

• Not Applicable. This device does not involve a training set for an algorithm.

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