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The introducer sheath is used to facing a catheter through the skin and into a vein or artery, including, but not limited to, the radial artery. The micropuncture needle or IV catheter is used to gain access to a vein or artery, including, but not limited to, the radial artery, for placement of the mini-guidewire is used for placement of the sheath into a vein or artery, including, but not limited to, the radial artery.

Medtronic's InTRAkit™ device is a Catheter Introducer (PCI) which is intended to facilitate percutaneous vascular access into a vein or artery, performed as part of the Cardiac catheterization procedure. The InTRAkit™ Catheter Introducers are designed to facilitate access into the vasculature from different access sites including but not limited to the radial arteries. InTRAkit™ Catheter Introducers are single-use use devices sold in a sterile condition. The InTRAkit™ Access Kit includes four main type of components required for percutaneous vascular access procedure: 1) Needles 2) Mini-Guidewires 3) Introducer Sheath 4) Dilator

The provided text describes a 510(k) premarket notification for the InTRAkit™ Access Kit, a medical device. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific performance acceptance criteria through the kind of study typically associated with AI/ML-based devices.

Therefore, the requested information elements (acceptance criteria, device performance, sample sizes for test/training sets, ground truth establishment, expert adjudication, MRMC studies, standalone performance) are not applicable in the context of this 510(k) submission as it is presented. This submission relies on non-clinical (bench) testing and biocompatibility testing to show that engineering differences do not raise new safety or effectiveness concerns compared to a legally marketed predicate device.

Here's an analysis based on the provided document:

1. A table of acceptance criteria and the reported device performance:

• Not applicable. This document does not present quantitative performance metrics against pre-defined acceptance criteria in the manner one would expect for an AI/ML device (e.g., sensitivity, specificity, AUC). Instead, it states that "Design Verification (DV) testing was completed on the InTRAkit™ device in accordance with the requirements of the ISO 11070: 2014" and that "bench testing qualification and biocompatibility testing demonstrated that InTRAkit™ is substantially equivalent to the predicate device." The "performance" is implicitly tied to meeting the standards of ISO 11070:2014 and the biocompatibility requirements, which are typically pass/fail for specific tests rather than reported as continuous performance metrics.

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

• Not applicable. No test set (in the context of AI/ML evaluation) is mentioned. "Non-clinical testing" was performed, which refers to bench testing and biocompatibility testing. The sample sizes for these types of engineering and biological tests are not specified in this summary.

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

• Not applicable. There is no "ground truth" establishment in the AI/ML sense mentioned. The evaluation is based on engineering standards and biological safety tests.

4. Adjudication method for the test set:

• Not applicable. No test set or related adjudication process is described.

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:

• No. The document explicitly states: "No clinical investigation was performed on the subject device (InTRAkit™)." Therefore, no MRMC study, AI assistance, or human reader improvement data is present.

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

• Not applicable. This device is a physical medical instrument (catheter introducer) and does not involve an algorithm or AI component.

7. The type of ground truth used:

• Not applicable. For this type of physical device, "ground truth" would relate to meeting engineering specifications (e.g., dimensional accuracy, material strength, fluid flow rates) and biological safety standards. The document states that testing was done in accordance with ISO 11070:2014 and ISO 10993-1:2009. These standards define the "truth" or acceptance criteria for the respective tests.

8. The sample size for the training set:

• Not applicable. There is no training set mentioned, as this is not an AI/ML device.

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

• Not applicable. There is no training set mentioned.

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