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The Edwards eSheath Introducer Set is indicated for the introduction and removal of devices used with the Edwards SAPIEN 3 and the SAPIEN 3 Ultra transcatheter heart valves.

The Edwards eSheath Introducer Set contains two dilators and a sheath with hydrophilic coating, and loader packaged with an Edwards delivery system. It is available with inner sheath diameters of 14 French (model 914ES) and 16 French (model 916ES).

This document describes a 510(k) premarket notification for the Edwards eSheath Introducer Set. The review focuses on demonstrating substantial equivalence to previously cleared predicate devices and expanding the indications for use.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in a quantitative format for each test. Instead, it states that "all results were acceptable" for the design verification and validation tests and that "performance testing has demonstrated that safety and efficacy are not adversely impacted." The tests themselves act as the criteria to be met.

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

• Sample Size: The document does not specify the exact sample sizes used for each individual test. It mentions that "Performance Testing for the Edwards eSheath Introducer Set (model 914ES and 916ES) was previously provided in Section 14 of 510(k) K152225 and K162184" and "Performance Testing for the Edwards eSheath Introducer Set (model 914ES) indication expansion was previously provided in the FDA PMA140031/S088 and PMA140031/S091." The implication is that the sample sizes were sufficient for the original submissions and remain valid for this expanded indication.
• Data Provenance: The document does not state the country of origin of the data or whether the studies were retrospective or prospective. Given these are premarket submissions for a medical device in the US, the testing would typically be conducted under GLP (Good Laboratory Practice) guidelines and would be considered prospective for the purpose of demonstrating device performance against specific criteria.

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

This information is not applicable and not provided in the context of this device. The testing described is primarily mechanical, material, and biological performance testing, not diagnostic performance where expert ground truth is typically established (e.g., image interpretation). The "ground truth" for these tests would be the established scientific and engineering standards and methods.

4. Adjudication Method for the Test Set

Not applicable. The tests performed are objective measurements (e.g., dimensions, bond strength, particulate count) or standardized biological evaluations rather than subjective assessments requiring adjudication by multiple experts.

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

No. An MRMC study is not mentioned because this device is an introducer set, not a diagnostic or AI-driven imaging device that would typically involve human readers interpreting cases.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No. This device is a physical medical device (an introducer set), not an algorithm or AI software. Therefore, the concept of "standalone performance" for an algorithm is not applicable.

7. Type of Ground Truth Used

The "ground truth" for the tests performed can be categorized as:

• Engineering Specifications and Standards: For dimensional, mechanical (bond strength, kink resistance, lubricity, seam return, loader peel), and physical (radiopacity, guidewire compatibility, hemostasis, device interaction) tests.
• USP (United States Pharmacopeia) Standards: For particulate tests and physico-chemical tests for plastic closures.
• ISO/FDA Biocompatibility Guidelines: For biocompatibility tests (cytotoxicity, hemocompatibility, systemic toxicity, pyrogenicity, irritation, sensitization, chemical acceptability, thrombogenicity).
• Sterilization Industry Standards: For sterilization validation.
• Packaging and Shelf Life Standards: For packaging integrity and shelf life verification.

8. Sample Size for the Training Set

Not applicable. This device is a physical medical product, not an AI or machine learning model that requires a training set.

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

Not applicable, as there is no training set for a physical medical device.

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The Edwards eSheath Introducer Set is indicated for the introduction and removal of devices used with the Edwards SAPIEN 3 Transcatheter Heart Valve.

The Edwards eSheath Introducer Set consists of a sheath and two dilators packaged together, and one loader packaged with the Commander delivery system. The Edwards eSheath Introducer Set is available in two sizes: model 914ES (14F inner diameter) and model 916ES (16F inner diameter). The 14F eSheath introducer set is used to facilitate introduction of the 20mm, 23mm and 26mm SAPIEN 3 THV and Commander Delivery System into the vasculature, and the 16F eSheath introducer set is used to facilitate introduction of the 29mm SAPIEN 3 THV and Commander Delivery System into the vasculature.

The sheath shaft is comprised of 2 layers of material (HDPE/TecoFlex coextruded outer layer and PTFE liner). The outer and inner layer are folded, creating a seam which allows the distal region of the sheath to temporarily expand in diameter when a device is inserted. A tapered strain relief at the proximal end of the sheath shaft helps provide hemostasis when the sheath is inserted. The sheath shaft exterior includes a hydrophilic coating to facilitate introduction into the target vessel. The distal end of the shaft features a radiopaque marker, and the shaft mates proximally with a housing that contains three valves (seals) to provide hemostasis, an extension tube for flushing, and suture holes on the exterior.

Two dilators are provided to aid in the introduction of the sheath into the target vessel, and can also be used for dilation of the vessel prior to sheath insertion. The dilators are radiopaque and feature a tapered tip and guidewire lumen.

The loader features a disc valve within the loader cap assembly to help maintain hemostasis, and a scored perforation on the loader tube allowing the loader tubing to be "peeled away" and removed to utilize the full working length of the inserted device.

This document describes the Edwards eSheath Introducer Set, a medical device used for introducing and removing other devices in the vascular system, specifically with the Edwards SAPIEN 3 Transcatheter Heart Valve. The document is a 510(k) premarket notification summary submitted to the FDA, asserting substantial equivalence to a previously cleared device. Due to the nature of the device (a catheter introducer) and the provided document, the "acceptance criteria" and "study" are related to mechanical and material performance, not an AI/ML-based diagnostic or prognostic study. Therefore, many of the requested fields are not applicable in this context.

Here's the information extracted and interpreted based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified in terms of number of units tested for each test. The document states "Non-clinical testing was completed" and "design verification and validation testing was successfully completed."
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). This would generally be conducted in a laboratory setting by the manufacturer.

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

• This is not applicable as the device is a catheter introducer, not a diagnostic or AI/ML device requiring expert ground truth for classification. The "ground truth" here is the physical and biological performance adhering to established standards.

4. Adjudication method for the test set

• Not applicable for this type of device and testing. Performance standards are objective measurements, not subjective evaluations requiring 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

• Not applicable. This is not an AI/ML device, and no human reader study was conducted or is relevant.

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

• Not applicable. This is not an AI/ML device.

7. The type of ground truth used

• The "ground truth" for this device's testing is adherence to established engineering, material science, and biocompatibility standards and specifications. This includes:
  • Objective measurements: Force, strength, dimensional accuracy, flow rates, etc., for functional tests like "Loader Peel Test" and "Bond Strength Test."
  • Standardized biological assays: For biocompatibility tests (e.g., ISO 10993 series for cytotoxicity, sensitization, irritation, systemic toxicity, hemocompatibility).
  • Validated protocols: For sterilization, packaging integrity, and shelf-life verification.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device, so there is no training set in that context. The "training" for the device's design would be through iterative engineering development and testing.

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

• Not applicable. For a physical device, the "ground truth" for design and manufacturing is established through engineering specifications, material properties, and adherence to relevant industry and regulatory standards.

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The Edwards eSheath Introducer Set is indicated for the introduction and removal of devices used with the Edwards SAPIEN 3 Transcatheter Heart Valve.

The Edwards eSheath Introducer Set consists of a sheath and 2 introducers. It is available with inner sheath diameters of 14 French (model 914ES) and 16 French (model 916ES). The 14 French introducer set is used to facilitate introduction of the 23mm and 26mm SAPIEN 3 THV and Commander Delivery System into the vasculature, and the 16 French introducer set is used to facilitate introduction of the 29mm SAPIEN 3 THV and Commander Delivery System into the vasculature.

The sheath shaft is comprised of 2 layers of material (HDPE/TecoFlex coextruded outer layer and PTFE liner). The outer and inner layer are folded, creating a seam which allows the distal region of the sheath to temporarily expand in diameter when a device is inserted. A tapered strain relief at the proximal end of the sheath shaft helps provide hemostasis when the sheath is inserted.

A radiopaque marker on the distal end indicates the location of the sheath tip in the body and a hydrophilic coating on the sheath tubing exterior facilitates introduction into the vessel. The sheath tubing mates with a housing, which holds three seals (valves) to provide hemostasis: a duckbill seal, a disc seal, and a cross slit seal. The housing also includes flushport tubing and a stopcock to allow for flushing of the sheath.

Two introducers are provided to aid in the introduction of the target vessel, and can also be used for dilation of the vessel prior to sheath insertion. The introducers are radiopaque and feature a tapered tip and guidewire lumen.

Here's an analysis of the provided text regarding the Edwards eSheath Introducer Set, focusing on acceptance criteria and the study that proves the device meets them. Please note that the document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than a comprehensive "study" in the academic sense of proving efficacy through clinical trials. Therefore, some of the requested information may not be present as it pertains more to clinical studies of diagnostic AI devices.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of numerical acceptance criteria with corresponding performance metrics for the Edwards eSheath Introducer Set. Instead, it lists the types of non-clinical tests performed to demonstrate that "performance characteristics... are equivalent to the predicates, and to verify that design requirements are satisfied." The stated outcome for all tests is "successfully completed."

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

This document describes non-clinical (bench) testing, not a clinical study involving patient data. Therefore, the concept of a "test set" in the context of human data or AI algorithms is not applicable here. The data provenance is internal to Edwards Lifesciences, derived from various laboratory and engineering tests; it is not data from human subjects or from a specific country of origin in that sense. These were likely prospective tests performed on manufactured samples of the device.

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

Not applicable. Ground truth for non-clinical engineering tests (e.g., bond strength, dimensional accuracy, sterilization) is established through standardized methodologies, engineering specifications, and validated measurement equipment, not through expert human interpretation in the way a diagnostic imaging study would use radiologists.

4. Adjudication Method for the Test Set

Not applicable. Since the tests are objective, performance is measured against established specifications or standards. There is no human interpretation or adjudication required in the sense of resolving conflicting expert opinions.

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 introducer set, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and the concept of human readers improving with AI assistance are irrelevant to this submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a physical medical introducer set, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests is based on:

• Engineering Specifications: Predetermined design requirements and tolerances.
• International/National Standards: Adherence to standards like USP for particulates, ISO standards for sterilization, and specific test methods for biocompatibility (e.g., ISO 10993 series).
• Predicate Device Performance: The primary goal is to demonstrate equivalence in performance characteristics to the legally marketed predicate devices.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device requiring a training set. The "training" for such a device would be its design and manufacturing process, which is refined through iterative engineering development and testing.

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

Not applicable. As this is not an AI/ML device, the concept of a "training set" and associated ground truth establishment does not apply. The analogous process for a physical medical device involves:

• Defining design inputs and requirements based on intended use, user needs, and regulatory standards.
• Developing and manufacturing prototypes.
• Conducting iterative non-clinical testing (similar to the "Summary of Non-Clinical Testing" listed) to ensure the device meets those requirements.
• Refining the design based on test results.

Summary Takeaway:

The document is a 510(k) summary for a physical medical device (catheter introducer set). Its purpose is to demonstrate substantial equivalence to existing predicate devices through comprehensive non-clinical (bench) testing. The questions regarding AI acceptance criteria, training/test sets, expert ground truth, adjudication, and MRMC studies are not applicable to the nature of this particular device and its regulatory submission pathway. The acceptance criteria are implicitly met by "successfully completing" the listed non-clinical tests, which are designed to show that the device performs equivalently to its predicates and meets all relevant design requirements and safety standards.

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The Edwards eSheath Introducer Set is indicated for the introduction of the Edwards SAPIEN XT Transcatheter Heart Valve and associated devices into the vascular system.

The Edwards eSheath Introducer Set consists of a sheath, introducer, and loader. It is provided sterile for single use and is compatible with a standard 0.035" guidewire.

The sheath shaft is comprised of a PTFE inner liner and a HDPE/TecoFlex coextruded outer layer with a folded seam that can temporarily expand if a device is passed through that is larger than the sheath's inner diameter, and a TecoFlex outer cover that encapsulates the seam. The exterior includes a hydrophilic coating to facilitate introduction into the target vessel. The distal end of the shaft features a platinum/iridium radiopaque marker for visibility, and the sheath shaft mates proximally with a housing that contains an extension tube used for flushing of the sheath and three valves (seals) to provide hemostasis.

The introducer is made from polyethylene with barium sulfate for radiopacity, and features a hydrophilic coating to facilitate entry and trackability of the vessel. The introducer is tapered with an atraumatic distal tip and a lumen to accommodate a 0.035" guidewire.

The loader may be used to aid in the insertion of devices into the sheath and may be removed so that the entire working length of the inserted device can be utilized. The loader housing contains a valve (seal) to provide hemostasis.

This document is a 510(k) summary for the Edwards eSheath Introducer Set. It outlines the device's description, intended use, comparison to predicate devices, and a summary of non-clinical testing. However, it does not contain the specific details required to answer all the questions regarding acceptance criteria and a detailed study report. The document describes several tests performed, but it lacks specific acceptance criteria values and detailed study methodologies, sample sizes, and ground truth information for each test.

Here's an attempt to extract and format the available information, noting what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists various non-clinical tests performed to demonstrate performance. However, specific quantitative acceptance criteria and detailed reported performance values for each test are not provided in this 510(k) summary. The summary only states that these tests were "successfully completed" or that "performance testing has demonstrated that safety and efficacy are not adversely impacted."

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

• Sample Size for Test Set: The document does not specify the sample sizes used for any of the listed non-clinical tests.
• Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. Given that these are non-clinical (laboratory/bench) tests for a new device, they are inherently prospective.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This section is not applicable as the document describes non-clinical, bench testing of a medical device, not a study involving human-in-the-loop performance or expert interpretation of diagnostic data to establish ground truth.

4. Adjudication Method for the Test Set

This section is not applicable for the reasons stated above. Adjudication methods are typically relevant for studies involving human interpretation or clinical endpoint assessments, which are not detailed here.

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

An MRMC comparative effectiveness study was not performed or described in this document. The listed tests are non-clinical evaluations of the device's physical and functional properties, not a comparison of human reader performance with or without AI assistance.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

This section is not applicable. The device is a physical medical introducer set, not an algorithm or AI system. The tests described are for the physical device's performance.

7. Type of Ground Truth Used

For the non-clinical tests described, the "ground truth" would be established by:

• Engineering Specifications/Design Requirements: For tests like dimensional inspection, bond strength, kink resistance, etc., the ground truth is defined by pre-established engineering tolerances and performance specifications.
• Industry Standards (e.g., ISO, ASTM, USP): For tests like USP Particulate Test, Biocompatibility (following ISO 10993 series), Sterilization Validation, these standards define the methods and acceptance criteria that serve as the ground truth.
• Functional Demonstrations: For compatibility and hemostasis, the ground truth is successful operation and absence of leaks/issues under simulated use conditions.

The document does not explicitly state these ground truth sources for each test but implies their use through the nature of the tests.

8. Sample Size for the Training Set

This section is not applicable as the document describes non-clinical testing of a physical medical device, not an AI/algorithm that requires a training set.

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

This section is not applicable for the reasons stated above.

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