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The EXTesia Introducer Sheath Set is intended to be inserted percutaneously into a vessel to facilitate placing the interventional or diagnostic devices into a vein or artery.

The EXTesia Introducer Sheath Set is used to facilitate placing a catheter through the skin into a vein or artery. The set consists of an introducer (a sheath and a dilator) packaged together with an entry needle, guide wire, flushing syringe, and scalpel. The sheath and dilator contain a radiopaque material which makes these devices visible under fluoroscopy. In addition, the sheath is coated with hydrophilic coating to minimize frictional resistance when inserting or removing the sheath from the patient's blood vessel.

EXTesia Introducer Sheath Set is packaged in a Tyvek 1073B pouch, sealed, labelled and EtO sterilized. It is for single use only. The EXTesia Introducer Sheath Set is designed for 3 years shelf life.

This document is a 510(k) summary for the EXTesia Introducer Sheath Set, not a study report that details specific acceptance criteria and device performance in a clinical study with human data. Therefore, many of the requested details about acceptance criteria, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, training sets, and how ground truth was established for training sets cannot be extracted from this document.

However, based on the provided text, I can infer some information relevant to performance testing and the lack of clinical studies.

1. Table of acceptance criteria and the reported device performance:

The document broadly states that the device "meets the requirements for product specifications" but does not provide specific quantitative acceptance criteria or detailed performance results for each test.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• This document does not specify sample sizes for mechanical, functionality, biocompatibility, sterilization, or simulated usability tests.
• Data Provenance: Not specified, but these are typically in-house laboratory and engineering tests, not clinical studies with human data from specific countries. The testing would be prospective (designed and executed for this submission).

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):

• Not applicable for performance testing described. The "ground truth" for mechanical and functional tests is typically based on engineering specifications and validated test methods, not expert human assessment in the way clinical studies would require. Simulated usability implies expert observation or evaluation but details on the number or qualifications of "experts" are not provided.

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

• Not applicable for performance testing described. Adjudication methods like 2+1 or 3+1 are used in clinical studies where there's a need to resolve discrepancies in human expert interpretations of ground truth. The performance testing outlined here (biocompatibility, sterilization, mechanical, functionality, simulated usability) would follow pre-defined test protocols with objective pass/fail criteria, not consensus-based 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:

• No MRMC comparative effectiveness study was done. The document explicitly states: "No Clinical Testing was required for this product." This makes it clear that there was no study involving human readers/users in a comparative effectiveness setting as described for AI assistance.

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

• Not applicable. The EXTesia Introducer Sheath Set is a physical medical device (catheter introducer), not a software algorithm or AI-powered device. Therefore, the concept of "standalone (algorithm only)" performance does not apply. The performance testing focused on the physical characteristics and function of the device itself.

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

• For the performance testing mentioned (biocompatibility, sterilization, mechanical integrity, functionality, product specifications, simulated usability), the "ground truth" would be established by engineering specifications, international standards, and established laboratory test methods. For example, biomechanical tests would have defined load limits, and sterility tests would have defined microbial reduction rates. Outcomes data, pathology, or expert consensus (in a clinical sense) are not relevant to these types of bench and simulated tests.

8. The sample size for the training set:

• Not applicable. This product is a physical medical device, not an AI/ML algorithm that requires a training set.

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

• Not applicable. As above, no training set was used.

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