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The Approach Hydro ST Wire Guide is indicated for use in facilitating delivery of percutaneous catheters into the peripheral vasculature.

The Approach Hydro ST Wire Guide is manufactured using a stainless steel wire with a PTFE coating and a stainless steel and platinum distal tip. The wire guide has a hydrophilic coating. The maximum outside diameter is 0.0142 inches and will be available in 135, 190 and 300 centimeter lengths. It will be supplied sterile, intended for one-time use.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Approach Hydro ST Wire Guide, structured to answer your questions:

The provided text outlines the declaration of substantial equivalence for the "Approach Hydro ST Wire Guide" based on various tests. However, it does not explicitly state specific numerical acceptance criteria for each test. Instead, it states that "The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a wire guide."

Therefore, for aspects requiring quantitative acceptance criteria or detailed study specifics beyond what's directly stated, I must indicate that the information is "Not provided in the document."

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

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Sample size for test set: Not provided in the document.
• Data provenance: Not provided in the document. These are product performance tests, likely conducted in a controlled laboratory setting (e.g., Cook Incorporated's facilities) rather than clinical data from a specific country. They are inherently prospective in the sense that they are tests performed on newly manufactured devices.

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

• Number of experts: Not applicable. The "ground truth" for engineering performance tests like tensile strength, flexibility, etc., is established by validated testing methodologies and instrumentation, not expert consensus in the medical sense.
• Qualifications of experts: Not applicable.

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

• Adjudication method: Not applicable. These are objective engineering tests; results are determined by measurement and adherence to pre-defined test protocols, not by human adjudication of qualitative data.

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

• MRMC study: No. This document describes the testing of a physical medical device (wire guide), not an AI-powered diagnostic or assistive tool.
• Effect size: Not applicable.

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

• Standalone performance: Not applicable. This document is about a physical medical device, not an algorithm.

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

• Type of ground truth: The "ground truth" for these tests are the established engineering specifications, material properties, and performance standards relevant to wire guides for facilitating catheter delivery into the peripheral vasculature. These standards would be derived from industry guidelines, regulatory requirements (e.g., FDA guidance documents, ISO standards), and internal company performance benchmarks for the device's intended use.

8. The sample size for the training set

• Sample size for training set: Not applicable. This refers to the testing of a physical device, not an AI model requiring a training set.

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

• How ground truth for training set was established: Not applicable.

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