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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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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 sterile, non-pyrogenic, singleuse 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 device also has additional suture loops on the proximal end of the Introducer housing and a design that allows air to vent from the Introducer during insertion.

Here's a breakdown of the acceptance criteria and study information based on the provided text, focusing on the lack of information for a device like an introducer sheath:

Important Note: The provided document describes a medical device (introducer sheath), not an AI or software-based diagnostic tool. Therefore, many of the requested categories like "multi-reader multi-case study," "standalone algorithm performance," "sample size for training set," and "ground truth for training set" are not applicable or not present in this type of submission. Medical devices like this are typically evaluated based on engineering performance, biocompatibility, and manufacturing quality to demonstrate substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify the sample sizes used for each functional and safety test (e.g., how many sheaths were tested for tensile strength or leak). It only states that "All data met acceptance criteria."
• Data Provenance: Not specified. This type of submission for a physical medical device typically does not detail data provenance in the same way an AI/software device would. The tests are likely conducted in a controlled lab environment.
• Retrospective/Prospective: Not applicable in the context of this device's testing. These are laboratory-based engineering and biological tests, not clinical data collection.

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 a physical medical device like an introducer sheath, "ground truth" as it relates to expert consensus on diagnostic images or clinical outcomes is not relevant. The "ground truth" comes from objective measurements against engineering specifications and validated biological testing methodologies. The document does not mention the use of external experts for establishing this kind of ground truth. Internal quality control and R&D personnel are typically responsible for these measurements.

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

• Not Applicable: Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among multiple human readers in clinical studies or image interpretation. These are not relevant for the functional and safety testing of a physical medical device.

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

• Not Applicable: This device is a physical medical instrument (introducer sheath), not an AI or software-based diagnostic tool. Therefore, MRMC studies and AI assistance are irrelevant to its evaluation.

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, not an algorithm or software.

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

• Technical Specifications / Biocompatibility Standards: The "ground truth" for this device comes from established engineering specifications (e.g., tensile strength, leak rate limits) and widely accepted biocompatibility standards (e.g., ISO 10993 series). The device is tested against these predefined, objective criteria.

8. The sample size for the training set

• Not Applicable: This device is a physical medical instrument and does not involve AI or machine learning, which would require a training set.

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

• Not Applicable: This device is a physical medical instrument and does not involve AI or machine learning training data.

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