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To facilitate the placement of devices for diagnostic and interventional procedures. NOTE: These guidewires are not intended for PTCA use.

The Selective™ Guidewire is used to facilitate the placement of devices for diagnostic and interventional procedures. The shaft of the device is constructed of PES (polyethersulfone) coated Nitinol or stainless steel with a tapered distal end secured to a platinum or stainless steel helical coil. A selection of distal tapers imparts different tip flexibilities. The guidewire is coated with silicone fluid to improve lubricity. The Selectiva™ Guidewire will be offered in diameters of 0.018" - 0.035" and lengths of 60 cm - 260 cm. It will be supplied sterile, intended for one-time use.

The provided text describes a submission for a medical device (Selectiva™ Guidewire) to the FDA, seeking substantial equivalence to a predicate device. This document is a 510(k) Premarket Notification, a process used to demonstrate that a device is at least as safe and effective as a legally marketed predicate device. This type of submission relies on comparisons to an existing device rather than presenting novel clinical study data to establish acceptance criteria and performance against those criteria in the way one might for a new drug or an AI-powered diagnostic tool.

Therefore, many of the requested categories for AI/diagnostic studies are not applicable to this type of device submission. The "acceptance criteria" here are fundamentally about demonstrating equivalence to the predicate device in specific functional and safety aspects.

Here's an attempt to answer the questions based on the provided text, indicating "N/A" (Not Applicable) where the information is not present or relevant to a 510(k) submission for a guidewire, which is not an AI/diagnostic device.

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: Not specified for individual tests. The submission refers to a comparison of "all functional and safety tests."
• Data Provenance: Not specified. The testing was conducted by the submitter (NeoMetrics, Inc.) and potentially independent laboratories. The country of origin of the data is not mentioned, but the submitter is based in Plymouth, MN, USA.
• Retrospective or Prospective: Not explicitly stated, but device testing of this nature is generally prospective for the specific tests performed to support a 510(k).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

N/A. This type of information is not relevant to demonstrating substantial equivalence for a physical medical device like a guidewire. Ground truth is established by objective engineering and biocompatibility testing standards, not expert consensus on diagnostic images.

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

N/A. Adjudication methods are typically employed in clinical studies where subjective human interpretation or diagnostic accuracy is being assessed. For physical device performance tests, the results are typically objective measurements or pass/fail criteria against established specifications.

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

N/A. This context relates to AI-powered diagnostic tools. The Selectiva™ Guidewire is a physical device, not an AI or diagnostic tool, and therefore, an MRMC study is not relevant.

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

N/A. This applies to AI algorithms. The Selectiva™ Guidewire is a physical medical device.

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

The "ground truth" for this device's performance is established by:

• Pre-defined engineering specifications and performance standards for functional characteristics (e.g., tensile strength, flexibility, torqueability).
• Biocompatibility testing against ISO standards or equivalent for safety to demonstrate the device is non-toxic and compatible with the human body.
• Characteristics of the predicate device (Lake Region Manufacturing Mandrel Guidewire Assembly K011084) serve as the primary reference for demonstrating "substantial equivalence."

8. The sample size for the training set

N/A. There is no "training set" in the context of a 510(k) submission for a physical guidewire; this term refers to machine learning.

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

N/A. As there is no training set, this question is not applicable.

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