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The USGI TransPort Endoscopic Guide is intended to be used with an endoscope to facilitate intubation of the endoscope and as a guide for various flexible endoscopic instruments.

The TransPort Endoscopic Access Device is comprised of a flexible shaft that can be rigidized and locked into position, a steerable tip and multiple lumens that allow insertion and exchange of flexible instruments. It is supplied as two separately packaged components, i.e., a reusable, metal body and a strerile, single use disposable sheath.

The provided text describes a 510(k) summary for the USGI TransPort™ Endoscopic Access Device. This device is an "Endoscopic Overtube" and its submission focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through clinical studies. Therefore, much of the requested information regarding acceptance criteria and performance studies is not directly available in this document.

Here's a breakdown of what can be extracted and what is not applicable:

1. Table of acceptance criteria and the reported device performance

This information is not present in the provided 510(k) summary. The summary states: "Bench testing was conducted to ensure that the device performs as intended when used according to its instructions for use." However, it does not detail specific acceptance criteria or the reported performance metrics from this bench testing.

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

No test set data for performance evaluation (e.g., in a clinical study) is described in this 510(k) submission. The "bench testing" mentioned suggests in-vitro or simulated use, not a human-based test set from a specific country or retrospective/prospective data.

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

This information is not applicable as the summary does not describe a clinical study requiring ground truth establishment by experts.

4. Adjudication method for the test set

This information is not applicable as the summary does not describe a clinical study requiring adjudication.

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

This information is not applicable. The device is an endoscopic access device, not an AI-powered diagnostic tool. Therefore, MRMC studies or AI assistance are not relevant.

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

This information is not applicable as the device is not an algorithm or AI-powered.

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

This information is not applicable as the summary describes functional "bench testing" for a physical device, not a diagnostic or AI algorithm requiring ground truth.

8. The sample size for the training set

This information is not applicable as the device is not an AI algorithm requiring a training set.

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

This information is not applicable as the device is not an AI algorithm requiring a training set and ground truth establishment.

Summary of available information from the K072405 document:

• Device Name: USGI TransPort™ Endoscopic Access Device
• Intended Use: To be used with an endoscope to facilitate intubation of the endoscope and as a guide for various flexible endoscopic instruments.
• Comparison Basis: Substantially equivalent to predicate devices (USGI Medical TransPort™ Endoscopic Access Device K061216 and ShapeLock™ Endoscopic Access Device K033954) in terms of intended use, technology, and materials.
• Performance Claim: "Bench testing was conducted to ensure that the device performs as intended when used according to its instructions for use." (No specific criteria or results provided in this summary).

In conclusion, the provided 510(k) summary for K072405 focuses on demonstrating substantial equivalence through comparison and general bench testing, not on providing detailed acceptance criteria and performance data from a clinical or AI-centric study. Therefore, most of the requested fields are not applicable to the content of this specific document.

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