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The Sidecar External Working Channel is an external channel for an endoscope (8.6 to 12.8 mm in diameter) used to aid in the insertion, advancement, and removal of endoscopic devices during endoscopic procedures.

The Sidecar External Working Channel is an external channel for an endoscope used for inserting, advancing, and removing endoscopic devices during endoscopic procedures. It is supplied non-sterile and is intended to be a single-patient use device. It is designed to work with upper gastrointestinal diagnostic endoscopes with an outer diameter from 8.6 mm . It is attached to the distal and proximal ends of an endoscope and inserted with the endoscope.

This document is a 510(k) summary for the Sidecar External Working Channel and does not contain detailed information about acceptance criteria or specific study results that prove the device meets these criteria in the format requested. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed performance study with quantitative results and statistical analysis for acceptance criteria.

However, based on the provided text, I can extract information related to performance data in a general sense:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states: "Design verification and validation testing were performed on the Sidecar External Working Channel to evaluate physical, simulated use, reliability, and safety specifications." It then concludes: "The design verification test results demonstrate that the Sidecar External Working Channel should perform as intended in the specified use conditions and should perform comparably to the legally marketed predicate that is currently marketed for the same intended use."

This indicates that acceptance criteria would have been established for "physical, simulated use, reliability, and safety specifications," and the device's performance met these criteria. However, no specific quantitative criteria or reported performance values are provided in the document.

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 or prospective). It simply mentions "Design verification and validation testing."

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

Not applicable. The described testing refers to bench testing for physical and functional specifications of a medical device, not a diagnostic or AI-driven system requiring expert ground truth in the traditional sense.

4. Adjudication Method for the Test Set:

Not applicable, as this refers to bench testing of device specifications, not a scenario where expert adjudication is typically involved.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. The device is an "external channel for an endoscope," which is a physical accessory, not an AI-driven diagnostic tool that would typically involve human readers.

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

Not applicable. This device is a physical accessory, not an algorithm or software. The "performance" refers to its mechanical and functional integrity.

7. The Type of Ground Truth Used:

For the "physical, simulated use, reliability, and safety specifications" tested, the "ground truth" would be established engineering and safety standards, design specifications, and functional requirements. For example, a "physical specification" might have an acceptance criterion for tensile strength, and the device's measured tensile strength would be compared to that criterion.

8. The Sample Size for the Training Set:

Not applicable. This device is a hardware accessory; there is no "training set" in the context of machine learning or AI.

9. How the Ground Truth for the Training Set was Established:

Not applicable for the same reason as point 8.

Summary of what is available from the document:

• Acceptance Criteria & Reported Performance: General categories of "physical, simulated use, reliability, and safety specifications" were evaluated and met. Specific criteria and performance values are not detailed.
• Study Type: Bench testing and biocompatibility testing were performed.
• Focus: The focus of the 510(k) submission is on demonstrating substantial equivalence to a predicate device based on similar technological characteristics and performance through design verification and validation.

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