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The iSLEEVE™ Introducer Set is intended to facilitate femoral access to the vascular system for introduction and removal of cardiovascular devices. The iSLEEVE™ Introducer Set is suitable for use in vessels > 5.5 mm diameter.

The iSLEEVE Expandable Introducer Set (iSLEEVE Introducer Set) is a sterile, single-use introducer catheter that provides percutaneous access to the femoral artery for introduction and removal of cardiovascular 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 passively expandable which allows for transient sheath expansion when the compatible valve system is introduced through it. Once expanded, this region of the introducer sheath is radially compliant, which allows it to expand and collapse as needed during device delivery and removal. This reduces the time the access vessel is expanded. A hydrophilic coating is applied to the working end of the iSLEEVE introducer sheath which increases the lubricity to aid in delivery when activated.

A product mandrel and flushing tube are also supplied with the iSLEEVE Introducer Set.

The provided text is related to a 510(k) premarket notification for a medical device called the "iSLEEVE Introducer Set." It describes the device, its intended use, and the regulatory process. However, it does not contain a detailed study with acceptance criteria and reported device performance in the format requested. The document focuses on regulatory approval based on substantial equivalence to a predicate device and mentions general categories of non-clinical performance data.

Therefore, I cannot provide the specific information requested in the format of a table of acceptance criteria and reported device performance, nor details about sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details as these are not present in the provided text.

The text does state:
"Testing demonstrated that the modified iSLEEVE Introducer Set met the previously established acceptance criteria."
And lists the types of non-clinical testing performed:

• Luer Connections
• Simulated Use Testing
• Dimensional Requirements
• Tensile Testing
• Packaging Testing
• Radiopacity
• Sterilization
• Usability

However, it does not provide the specific acceptance criteria values or the reported performance data against those criteria. It also doesn't contain the detailed study design elements you asked for, such as the number of experts, adjudication methods, or specific study types.

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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 transcatheter heart valve systems and ancillary devices into the vascular system. The iSLEEVE Introducer Set is composed of a dilator and an introducer sheath with a threeway stopcock.

The distal end of the introducer sheath is passively expandable which allows for transient sheath expansion when the compatible valve system is introduced through it. Once expanded, this region of the introducer sheath is radially compliant, which allows it to expand and collapse as needed during device delivery and removal. This reduces the time the access vessel is expanded. A hydrophilic coating is applied to the entire iSLEEVE introducer sheath which increases the lubricity to aid in delivery when activated.

The provided text is a 510(k) summary for the Boston Scientific iSLEEVE Introducer Set. It focuses on demonstrating substantial equivalence to a predicate device for regulatory clearance. Since this is a medical device, the acceptance criteria and study that proves the device meets the acceptance criteria are based on non-clinical performance (bench testing), as explicitly stated in the document.

The document does not describe:

• A table of acceptance criteria and reported device performance with specific numerical values beyond meeting general criteria for physical integrity, functionality, and performance.
• Sample sizes used for a "test set" in the context of an AI/human reader study.
• Data provenance, number of experts, adjudication methods, or MRMC studies, as these relate to AI/image-based diagnostic devices, not a catheter introducer.
• Standalone algorithm performance or details about training sets for an AI.
• Types of ground truth in a clinical sense (e.g., pathology), as the device's performance is assessed through bench tests.

Based on the provided text, here is the information that can be extracted, and where applicable, why certain information (relevant to an AI or diagnostic device) is not available:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a quantitative table of acceptance criteria with specific numerical performance values. Instead, it broadly states the categories of performance assessed through bench testing.

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

• Sample Size: Not specified in terms of a "test set" as would be relevant for an AI or diagnostic study. Performance was evaluated via bench testing, which typically involves a specified number of physical units, but this specific number is not provided in this 510(k) summary.
• Data Provenance: Not applicable in the context of clinical data for a "test set" as this is bench testing of a physical device.

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

• Not applicable. Ground truth for a physical catheter introducer is established by engineering specifications, material properties, and physical testing protocols, not by expert clinical review of images or data.

4. Adjudication Method for the Test Set

• Not applicable, as this refers to a process for resolving discrepancies in expert labeling or diagnoses for clinical data, which is not relevant for bench testing of this device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No, an MRMC study was not done. The document explicitly states: "Performance testing from clinical studies is not required to demonstrate substantial equivalence of the iSLEEVE Introducer Set." MRMC studies are typically performed for diagnostic devices (e.g., AI in radiology) to assess changes in human reader performance with and without AI assistance.

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

• Not applicable. This device is a physical catheter introducer, not an algorithm. Standalone performance refers to the performance of an AI algorithm on its own, which is irrelevant here.

7. The Type of Ground Truth Used

• Engineering Specifications and Benchmarking: The ground truth for this device's performance is established by pre-defined engineering specifications, functional requirements, and comparison to the performance of the predicate device (K191871) under controlled bench test conditions. For example, "dimensional requirements" means the device must meet specific size tolerances, which is a quantitative ground truth. "Visibility under fluoroscopy" would be assessed against a defined standard or observation.

8. The Sample Size for the Training Set

• Not applicable. The concept of a "training set" applies to machine learning algorithms. This document describes a physical medical device submitted for 510(k) clearance based on substantial equivalence to a predicate, primarily through non-clinical bench testing.

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

• Not applicable. As there is no training set for an algorithm, there is no "ground truth" to establish for it in this context. The "ground truth" for the device's design and manufacturing is based on established engineering principles, material science, and regulatory standards for medical devices.

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INTENDED USE:

The iSLEEVE Introducer Set is intended to facilitate femoral access to the vascular system.

INDICATIONS FOR USE:

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

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 transcatheter heart valve systems and ancillary devices into the vascular system. The iSLEEVE Introducer Set is composed of a dilator and an introducer sheath with a threeway stopcock.

The distal end of the introducer sheath is passively expandable which allows for transient sheath expansion when the compatible valve system is introduced through it. Once expanded, this region of the introducer sheath is radially compliant, which allows it to expand and collapse as needed during device delivery and removal. This reduces the time the access vessel is expanded. A hydrophilic coating is applied to the entire iSLEEVE introducer sheath which increases the lubricity to aid in delivery when activated.

A product mandrel and flushing tube are also supplied with the iSLEEVE Introducer Set.

This document is a 510(k) Pre-Market Notification from the FDA regarding the "iSLEEVE™ Introducer Set". It's a regulatory clearance document, not a study report detailing acceptance criteria for an AI/ML device. Therefore, the requested information about acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not applicable to this document. The document describes a medical device (catheter introducer), not an AI system.

However, I can extract the information that is present about the device's technical specifications and the testing performed, acknowledging that it's "non-clinical performance data" for a physical device, not an AI model.

Here's an analysis based on the provided text, explicitly stating where the requested AI/ML-related details are not available or not applicable:

1. Table of Acceptance Criteria and Reported Device Performance:

   Acceptance Criteria (General)	Reported Device Performance (General)
   Physical integrity	Bench testing was performed to evaluate physical integrity, functionality, and performance.
   Functionality	Bench testing was performed to evaluate physical integrity, functionality, and performance. The distal end of the introducer sheath is passively expandable, radially compliant, expands and collapses as needed, and has a hydrophilic coating to increase lubricity.
   Performance	Bench testing was performed to evaluate physical integrity, functionality, and performance. Performance criteria includes dimensional requirements, visibility under fluoroscopy, and interface with compatible devices. The proposed 14F iSLEEVE Introducer Set has a modified distal tip design to enhance robustness and ease of vessel insertion compared to the predicate.
   Usability (ease of use)	The modified distal tip design enhances robustness and ease of vessel insertion.
   Compatibility (interface with other devices)	Evaluated interface with compatible devices. Intended to facilitate introduction and removal of the ACURATE TF Valve System and ancillary devices.
   Radiographic visibility	Evaluated visibility under fluoroscopy.
   Dimensional requirements	Evaluated dimensional requirements. Suitable for use in vessels ≥ 5.5 mm diameter.
   Substantial Equivalence to Predicate K180785	The device incorporates substantially equivalent design, packaging, fundamental technology, manufacturing processes, sterilization process and intended use as the predicate. Based on indications for use, technological characteristics, and performance testing, the iSLEEVE Introducer Set is considered substantially equivalent to the iSLEEVE Introducer Set, K180785. The 14F iSLEEVE Introducer Set has a modified distal tip design compared to the predicate.

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

   • Sample Size: Not specified for any specific test. The document generally refers to "bench testing."
   • Data Provenance: The testing appears to be "non-clinical performance bench testing" conducted by Boston Scientific Corporation. This is likely internal testing, not patient data (retrospective or prospective). Country of origin is not specified, but the applicant (Boston Scientific) is based in the USA.

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

   • N/A. This is a physical medical device, not an AI/ML system requiring expert-established ground truth from medical images or data. The "ground truth" for a physical device would typically be its adherence to engineering specifications and performance standards established through bench testing.

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

   • N/A. Not applicable to a physical medical device's bench testing.

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:

   • N/A. This device is a catheter introducer, not an AI imaging or diagnostic tool. No MRMC study was conducted or is relevant.

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

   • N/A. This is a physical device, not an algorithm.

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

   • For a physical device, the "ground truth" for performance would be its adherence to established engineering specifications and performance standards as measured by various bench tests (e.g., dimensional accuracy, material properties, functional movements, compatibility with other devices). No medical "ground truth" types like pathology or expert consensus on clinical findings are applicable here.

8. The sample size for the training set:

   • N/A. This is a physical medical device, not an AI/ML system that uses training data.

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

   • N/A. Not applicable.

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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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