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The Sequitor™ Steerable Guidewire is intended to facilitate the placement of catheters within the peripheral vasculature for various diagnostic and interventional procedures.

The Sequitor™ Steerable Guidewire (.014" or .018") is a stainless steel guidewire with a polymer distal tip and a radiopaque distal tip that is shapeable. The distal 50 cm is coated with a hydrophilic coating. The guidewire length is depicted on the product label.

The provided text is a 510(k) summary for the BioSphere Medical, Inc. Sequitor™ Steerable Guidewire. It describes the device, its intended use, predicate devices, and a general statement about performance testing. However, it does not include detailed information regarding specific acceptance criteria, study methodologies, sample sizes for test or training sets, expert qualifications, or ground truth establishment.

Therefore, most of the requested information cannot be extracted directly from the provided document.

Here's a breakdown of what can and cannot be provided based on the input:

1. Table of acceptance criteria and reported device performance:

• Cannot be provided. The document states, "In-vitro and in-vivo design verification and validation testing demonstrates that the Sequitor™ Steerable Guidewire fulfills design and performance specifications." However, it does not specify what those specifications are (i.e., the acceptance criteria) or what the quantitative performance results were against those criteria.

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

• Cannot be provided. The document mentions "in-vitro and in-vivo design verification and validation testing" but does not provide any details about the sample sizes used in these tests or the provenance of any data (e.g., country of origin, retrospective/prospective).

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

• Cannot be provided. This information is typically relevant for studies involving human interpretation (e.g., imaging devices with AI assistance). This document describes a guidewire, which is a physical device, and its testing would likely involve engineering and clinical performance evaluations, not expert-established ground truth in the context of diagnostic interpretation.

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

• Cannot be provided. Similar to point 3, adjudication methods are usually for resolving discrepancies in expert interpretations, which is not applicable to the type of device and testing described here.

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:

• Cannot be provided. An MRMC study is relevant for AI-assisted diagnostic tools. The Sequitor™ Steerable Guidewire is a physical medical device (a guidewire), not an AI diagnostic tool. Therefore, this type of study is not applicable.

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

• Cannot be provided. This question is also relevant for AI algorithms. The device described is a physical guidewire, so the concept of an "algorithm only" performance doesn't apply.

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

• Cannot be provided. As a physical guidewire, its performance would be assessed against engineering specifications (e.g., flexibility, torque transmission, coating integrity, tensile strength) and possibly clinical outcomes related to its safe and effective use (e.g., successful catheter placement, lack of vessel damage). The document only vaguely refers to "design and performance specifications" without detailing them or the ground truth against which they were measured.

8. The sample size for the training set:

• Cannot be provided. This concept is specific to machine learning/AI models. The guidewire is a physical device and doesn't involve a "training set."

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

• Cannot be provided. As explained in point 8, this is not applicable to the described device.

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