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The EMBOL-X Introducer Sheath is indicated for use in procedures requiring the introduction of EMBOL-X Intra-Aortic Filters.

Edwards Lifesciences' EMBOL-X Introducer Sheath is a 17 Fr, sterile, non-pyrogenic, single-use introducer made of flexible and non-flexible polymeric materials. It consists of a single lumen housing and a removable, snap-lock obturator. The housing has a flexible suture flange for attachment to the vessel and orientation markings on the shaft and suture flange to assist in the placement of the EMBOL-X Introducer Sheath. Inside the housing is an internal valve to prevent backbleeding. The housing also has suture loops on the proximal end of the Introducer housing, and vent grooves, vent holes, and a central lumen in the obturator that leads to the vent plug to assist in venting air from the Introducer.

Here's a breakdown of the acceptance criteria and the study details for the EMBOL-X Introducer Sheath, based on the provided text:

Edwards Lifesciences LLC Special 510(k) Premarket Notification EMBOL-X Introducer Sheath (K140398)

1. Acceptance Criteria and Reported Device Performance

The document states that the functional and accelerated aging bench testing was performed to support a specification change and a shelf life increase. It also emphasizes that all data met acceptance criteria, demonstrating that the device is as safe and effective as the predicate device. However, the exact quantitative acceptance criteria for each test (e.g., maximum allowable leak rate, minimum tensile strength) are not explicitly stated in the provided text. The tables below summarize the tests performed and the general reported outcome.

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

The document does not specify the exact sample sizes used for each of the functional/safety tests. It only states that "All data met acceptance criteria." The provenance of the data is not explicitly mentioned (e.g., country of origin). Since these are bench tests and surgeon evaluations, the data would be considered prospective as it's generated specifically for this submission.

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

For "Design Validation," the document mentions "surgeon evaluation."

• Number of experts: Not specified (simply "surgeon evaluation" implies at least one, but the exact number is not given).
• Qualifications of experts: Explicit qualifications are not provided, other than being "surgeons."

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for establishing ground truth, particularly for the surgeon evaluation mentioned under design validation. The bench testing would likely rely on direct measurement against predefined specifications, rather than expert adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was mentioned or performed. The submission relies on bench testing and a general "surgeon evaluation" for design validation, not a comparative study of human readers with vs. without AI assistance. This device is an introducer sheath, not an AI-assisted diagnostic tool.

6. Standalone (Algorithm Only) Performance Study

This question is not applicable. The EMBOL-X Introducer Sheath is a physical medical device, not an algorithm or AI system. Therefore, there is no "standalone" algorithm-only performance to assess.

7. Type of Ground Truth Used

For the bench tests, the "ground truth" would be the predefined engineering specifications and performance targets for each test (e.g., a specific leak rate, tensile strength, or force range). For the "Design Validation," the ground truth was established through surgeon evaluation (user feedback/opinion on device design and functionality) and the results of a benchtop study.

8. Sample Size for the Training Set

This question is not applicable. As the EMBOL-X Introducer Sheath is a physical medical device and not an AI/ML algorithm, there is no concept of a "training set" in this context.

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

This question is not applicable for the same reasons as #8.

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