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To facilitate the introduction of other diagnostic and treatment devices used in gastroenterology and urology procedures.

The guidewire is made of an uncoated Nitinol or Stainless Steel core wire that is tapered at the distal tip where a coil is secured over the core. The wire can have a distal coil or a full length coil that is made of Stainless Steel. The guidewire may contain proximal markers. The PREDICATE™ III GUIDEWIRE family is bound by the following parameters: Lengths: 30cm – 500cm, Outside Diameter: 0.018" to 0.038", Tips: Straight or Shaped with various flexibilities, Coil Length: Full length, 2cm to 30cm.

The provided text describes a 510(k) premarket notification for the Predicate III Guidewire. Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document mentions that the acceptance criteria were met, but it does not explicitly list the specific quantitative acceptance criteria for each test. Instead, it states that "all verification and validation activities resulted in the ability to demonstrate that the predetermined acceptance criteria were met."

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document does not specify the exact sample size for the test set (number of guidewires tested). It refers to "Test devices" being manufactured and inspected.
• Data Provenance: The study was conducted by Lake Region Medical for their Predicate III Guidewire. The document does not provide details on the country of origin of the data or whether it was retrospective or prospective, as this is a bench and biocompatibility study of a medical device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable as the evaluation primarily involved bench testing and biocompatibility analysis, not expert-based assessment for ground truth.

4. Adjudication Method for the Test Set

This information is not applicable as the evaluation primarily involved bench testing and biocompatibility analysis, not expert-based assessment requiring adjudication.

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

This information is not applicable. The document describes the premarket notification for a physical medical device (guidewire), not an AI-based diagnostic tool. Therefore, an MRMC study related to human reader performance with AI assistance was not conducted.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable for the same reason as point 5. This is a physical guidewire, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by the design input summary requirements and applicable standards (e.g., ISO for biocompatibility and specific tests). For bench testing, the ground truth would be the expected physical, mechanical, and material properties of the guidewire. For biocompatibility, the ground truth is adherence to established biological safety limits.

8. The Sample Size for the Training Set

This information is not applicable. This is a physical medical device and does not involve AI or machine learning algorithms that require a "training set."

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reason as point 8.

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