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The Gator ClipSeal Plug is intended to be used with 12F to 24F introducer sheaths to maintain a hemostatic seal around 0.035" or 0.038" guidewires.

The Gator ClipSeal Plug (GATOR) is a flexible polymer plug used to seal against blood loss through the hemostatic valve of 12F - 24F introducer sheaths. The GATOR can be used with 0.035" or 0.038" guidewires.

This document contains a 510(k) summary for a medical device called the "Gator™ ClipSeal Plug." It is a traditional 510(k) submission, confirming substantial equivalence to a predicate device. This type of submission relies on bench testing and possibly animal studies (though not explicitly stated here) to demonstrate performance characteristics and safety, not clinical studies with human participants. Therefore, the device is not an AI/ML device, and many of the requested categories are not applicable.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document does not explicitly state a table of acceptance criteria or specific quantitative performance metrics for the Gator™ ClipSeal Plug, as would typically be found in a more detailed test report. Instead, it relies on the concept of "substantial equivalence" to a predicate device (K073620 Guardian Hemostasis Valve).

The summary states: "Technological differences in design and materials have been qualified through biomaterial assessments and verification testing, the results of which did not raise any new safety or performance questions." This implies that the device performed comparably to the predicate without introducing new risks or underperforming.

Without specific performance data, we can infer the acceptance criteria and performance are related to maintaining a hemostatic seal around guidewires of specific sizes, consistent with its intended use.

This indicates the device successfully met its intended function without issues. |
| Biocompatibility of materials (not explicitly stated as an AC but implied by "biomaterial assessments"). | Tested and found acceptable (implied by "biomaterial assessments"). |

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

The document does not specify a "test set" in the context of a clinical study or a labeled dataset for an AI model. This device is not an AI device. The "verification testing" mentioned would typically involve bench testing using a representative number of devices and conditions. The sample size for such tests is not provided in this summary. The data provenance would be from internal laboratory testing conducted by Vascular Solutions, Inc.

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

Not applicable. As noted above, this device is not an AI/ML device and does not involve a "test set" requiring expert ground truth labeling in the way an AI model would. Performance is established through physical and mechanical testing against design specifications and comparison to the predicate device.

4. Adjudication Method for the Test Set:

Not applicable. There is no "test set" requiring adjudication by experts for this type of device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. This device is not an AI-assisted diagnostic tool, and therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Not applicable. This is a physical medical device, not an algorithm, so "standalone performance" in the context of an AI algorithm is not relevant. Its performance is inherent in its design and materials.

7. The Type of Ground Truth Used:

The "ground truth" for this device's performance would be established through engineering specifications, material standards, and objective physical measurements during verification testing (e.g., flow rates, sealing integrity under pressure, durability tests). The comparison to the predicate device also forms a key part of the "truth" by demonstrating equivalent performance.

8. The Sample Size for the Training Set:

Not applicable. This device is not an AI/ML device, and therefore, it does not have a "training set."

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

Not applicable. As this is not an AI/ML device, there is no "training set" or "ground truth" established for it in the context of machine learning.

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