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14F iSLEEVE Introducer Set: The 14F iSLEEVE Introducer Set is intended to facilitate femoral access to the vascular system for introduction and removal of the ACURATE TF Valve System and ancillary devices. The iSLEEVE Introducer Set is suitable for use in vessels ≥ 5.5 mm.

15F iSLEEVE Introducer Set: The 15F iSLEEVE Introducer Set is intended to facilitate femoral access to the vascular system for introduction and removal of the LOTUS Edge Valve System and ancillary devices. The iSLEEVE Introducer Set is suitable for use in vessels ≥ 5.9 mm.

The iSLEEVE™ Introducer Set is a sterile, single-use introducer catheter that provides percutaneous access to the femoral artery for introduction and removal of compatible valve systems and ancillary devices into the vascular system. The iSLEEVE Introducer Set is composed of a dilator and an introducer sheath with a three-way stopcock. The distal end of the introducer sheath is expandable which allows for transient sheath expansion when the compatible valve system is introduced through it. This reduces the time the access vessel is expanded. There is a hydrophilic coating on the introducer sheath which increases the lubricity of the surface to aid in delivery when activated.

The iSLEEVE Introducer Set is available in two sizes; 14F and 15F. The 14F iSLEEVE Introducer Set is for use with the ACURATE TF Valve System only and the 15F iSLEEVE Introducer Set is for use with the LOTUS Edge™ Valve System only. A product mandrel and flushing tube are also supplied with the iSLEEVE Introducer Set.

This document describes the performance testing for the iSLEEVE™ Introducer Set, but it does not present acceptance criteria or detailed results in a way that allows for a direct comparison as requested. The document states that the iSLEEVE Introducer Set conforms to certain standards and underwent various performance tests, but it does not provide specific numerical acceptance criteria or the reported device performance values for each criterion. It concludes that "No new safety or performance issues were raised during the testing" and "this device may be considered substantially equivalent to the predicate device."

Therefore, I cannot populate the table or provide detailed answers to most of the specific questions as the information is not present in the provided text.

Here's what can be extracted and what cannot:

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

This information is not provided in the document. The document lists the types of tests performed (e.g., Dimensional Verification, Device Deployment and Retraction, Catheter Bond Strength, etc.) and states that the device conforms to relevant sections of EN ISO 10555-1:2013 and EN ISO 11070:2014, and underwent biocompatibility testing in accordance with EN ISO 10993-1. However, it does not specify the numerical acceptance criteria for these tests nor does it report the specific performance values achieved by the device against these criteria.

2. Sample size used for the test set and the data provenance

The document mentions "a preclinical study was executed to support a determination of substantial equivalence. The study evaluated the performance of the iSLEEVE device through an acute animal assessment in a simulated use environment and bench testing under simulated use conditions." However, the sample sizes for these tests are not specified, nor is the exact data provenance (e.g., country of origin, retrospective/prospective). It only states it was an "acute animal assessment."

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

This information is not applicable to the type of performance testing described for a Class II medical device like an introducer set. The testing is primarily engineering and material performance-based, not reliant on expert medical interpretation of images or patient data to establish "ground truth."

4. Adjudication method for the test set

This information is not applicable for the same reasons as #3.

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 device is an introducer set, not an AI-powered diagnostic or assistive tool for human readers.

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

This information is not applicable. The device is an introducer set, not an algorithm.

7. The type of ground truth used

For the engineering and biocompatibility tests, the "ground truth" would be established by the specifications in the referenced ISO standards and internal design requirements. For the acute animal assessment, the "ground truth" would be the direct observation of device performance in the simulated use environment. However, this is not "expert consensus, pathology, outcomes data" in the typical sense for AI/diagnostic devices.

8. The sample size for the training set

This information is not applicable. The device is an introducer set, not an algorithm that requires a training set.

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

This information is not applicable. The device is an introducer set, not an algorithm that requires a training set.

In summary, the provided text from the 510(k) summary focuses on demonstrating substantial equivalence through standard device performance and biocompatibility testing, rather than studies involving ground truth establishment by experts, AI performance metrics, or clinical trial data with acceptance criteria for such metrics.

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