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The mechanical guidewire is intended for complex diagnostic and interventional procedures where increased body. flexibility, and low surface friction of the wire guide are needed. The guidewire is intended for perpheral vasculature use only, not intended for coronary or neurovascular use.

The Mechanical Guidewire consists of a stainless-steel core wire with a flexible, J-tip stainless steel distal tip. A green polytetrafluoroethylene (PTFE) coating is present on the entire length of the guidewire and provides a lubricious surface for tracking through compatible ancillary devices. The distal curve allows visualization under appropriate imaging guidance during diagnostic and interventional procedures. The device is offered in a 180 cm length, with two outside diameters (0.032″ and 0.035″), and one distal curve shape (1-tip). The tip curve radius for the Mechanical Guidewire measures 3 mm.

The provided text is a 510(k) Summary for a medical device called the "Mechanical Guidewire." This document focuses on demonstrating substantial equivalence to a predicate device, not on proving that a new AI/Software device meets specific acceptance criteria through a study.

Therefore, the input does not contain the information necessary to answer the questions about acceptance criteria for an AI/Software device, its performance, a test set, ground truth establishment, MRMC studies, or training sets. The document describes standard performance testing for a physical medical device (guidewire), such as mechanical testing, biocompatibility, sterilization, and packaging.

Specifically:

• 1. A table of acceptance criteria and the reported device performance: This document lists various mechanical, physical, biocompatibility, and sterilization tests performed on the guidewire. It states "All test requirements were met as specified by applicable standards and test protocols." However, it does not provide a table of specific acceptance limits and the quantitative results for each test. More importantly, these are physical device tests, not acceptance criteria for an AI/software device.
• 2. Sample sizes used for the test set and the data provenance: Not applicable. This document describes testing of a physical medical device, not an AI/software device with a "test set" of data.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/software device is not relevant to the testing described here for a mechanical guidewire.
• 4. Adjudication method for the test set: Not applicable.
• 5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No, an MRMC study is not mentioned as this relates to human reader performance with AI assistance, which is not relevant to a mechanical guidewire.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• 7. The type of ground truth used: Not applicable.
• 8. The sample size for the training set: Not applicable.
• 9. How the ground truth for the training set was established: Not applicable.

In summary, the provided text describes the regulatory clearance process for a physical medical device (a guidewire) by demonstrating substantial equivalence to a predicate device through various physical, mechanical, and biological tests. It does not pertain to the evaluation of an AI or software device, and thus the questions regarding acceptance criteria, test sets, ground truth, and human reader studies for AI/software are not answerable from this document.

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