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The GORE Balloon Sheath is indicated for temporary occlusion, selective angiography, and/or facilitating the introduction and placement of intravascular devices into selected blood vessels in the peripheral and neurovascular systems.

The GORE Balloon Sheath consists of a dual lumen catheter shaft with a compliant balloon mounted at the distal-most tip of the shaft. The GORE Balloon Sheath is provided with compatible dilator which facilitates a gradual transition from the guide wire diameter to the sheath internal diameter. The first lumen acts as the inflation lumen while the second lumen acts as the working channel, accommodating diagnostic and therapeutic interventional devices. The sheath hub consists of four ports. The first port ("balloon inflation port") has a female luer thread, allowing assembly of a syringe and stopcock for balloon inflation. The second port ("fluid port") has a flexible tubing extension, which permits access to the working channel to subsequently allows fluid (e.g. contrast agent) injections and / or blood aspiration. The third port ("auxiliary port") allows side access to the working channel to introduce interventional devices. The fourth port ("main port") provides linear access to the working channel, functioning primarily as the delivery port for diagnostic and therapeutic devices.

The provided document is a 510(k) summary for the GORE Balloon Sheath and Dilator, focusing on establishing substantial equivalence to predicate devices for regulatory clearance. It does not contain information about a study proving the device meets specific performance acceptance criteria in the manner of a clinical trial or algorithm performance study.

Instead, the "Testing" section describes conformity to established standards for medical devices.

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

1. A table of acceptance criteria and the reported device performance

Note: The document states that testing was done "in accordance with ISO 10555" for several performance criteria and that the device "meets or exceeds the requirements of the standard." However, it does not provide specific numerical acceptance criteria or numerical reported device performance values for these tests. The standards themselves would contain the specific thresholds.

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

• Sample Size: Not specified for any of the performance tests.
• Data Provenance: Not specified. The testing seems to be internal verification by the manufacturer (W. L. Gore & Associates, Inc.) as part of the regulatory submission process. It is a pre-market submission, implying this testing was done before the device entered the market.

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

• This type of information is not applicable to the testing described. The "ground truth" here is defined by compliance with ISO standards for physical and biological characteristics, not expert interpretation of outputs like in a diagnostic AI study.

4. Adjudication method for the test set

• This is not applicable. No adjudication method involving human experts interpreting test results is described. The tests are standard engineering and biological performance evaluations.

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

• No, an MRMC comparative effectiveness study was not done. This document describes a medical device (balloon sheath and dilator), not an AI-powered diagnostic or assistive tool.

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

• This is not applicable. This device is a physical medical instrument, not an algorithm.

7. The type of ground truth used

• For biocompatibility: Ground truth is defined by the ISO 10993-1 standard and its associated testing methodologies.
• For performance characteristics (dimensional verification, force to break, freedom from leakage, balloon integrity): Ground truth is defined by the ISO 10555 standard and its associated testing methodologies.

8. The sample size for the training set

• This is not applicable. There is no "training set" as this is a physical medical device, not a machine learning model.

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

• This is not applicable. As above, there's no training set or machine learning model involved.

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