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The 14F 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 14F 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 14F 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 coatinq 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.

This is a submission for a medical device (14F iSLEEVE™ Introducer Set) and therefore doesn't involve AI/ML. The provided text describes a 510(k) submission for a non-AI medical device, focusing on its substantial equivalence to a predicate device based on physical and mechanical properties. Therefore, most of your requested information (acceptance criteria for AI performance, sample size for test/training sets, expert qualifications, adjudication, MRMC studies, standalone performance, ground truth types) is not applicable to this document.

However, I can extract information related to the device's performance testing given the provided text:

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

The rest of the requested information is not applicable to this 510(k) submission as it is for a physical medical device, not an AI/ML algorithm.

Here's why the other points are not applicable:

• 2. Sample size used for the test set and the data provenance: This relates to data for AI/ML validation, not physical device testing. The "test set" here refers to physical devices, not data.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for a physical device. Ground truth is usually established through engineering specifications and physical measurements.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for a physical device.
• 5. If a multi reader multi case (MRMC) comparative effectiveness study was done: MRMC studies are for AI-assisted image interpretation, not physical devices.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: "Standalone" in this context refers to the device itself, which performs its function physically, not an algorithm.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For physical devices, ground truth often comes from engineering specifications, material properties, and in vitro/in vivo measurements that are compared against predefined performance limits. For this specific submission, the "ground truth" for the tensile strength test would be the engineering specification for how much force the sheath-to-hub connection must withstand.
• 8. The sample size for the training set: Not applicable as there is no AI/ML algorithm to train.
• 9. How the ground truth for the training set was established: Not applicable.

In summary, this FDA clearance document pertains to a physical introducer set, and the "study that proves the device meets the acceptance criteria" refers to non-clinical performance data, specifically mechanical testing, rather than studies involving AI/ML performance metrics.

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The 14F 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 14F 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 14F 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 describes a 510(k) premarket notification for a medical device, the 14F iSLEEVE Introducer Set. It focuses on demonstrating substantial equivalence to a predicate device, specifically after a modification involving an alternative hydrophilic coating.

However, the document does not contain the level of detail typically found in a clinical study report or a robust performance study for an AI/ML medical device, which would include the specific acceptance criteria tables, sample sizes for test and training sets, expert qualifications, and adjudication methods for ground truth, and MRMC study details.

The provided information pertains to the acceptance criteria and study that proves the device meets the acceptance criteria for a medical device with a coating change, not an AI/ML algorithm.

Based on the provided text, here is an attempt to address your questions, while highlighting the limitations due to the nature of the document:

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

The document mentions that "Testing demonstrated that the modified 14F iSLEEVE Introducer Set met all previously established acceptance criteria." However, it does not provide a specific table of acceptance criteria with corresponding performance numbers. It lists the types of non-clinical tests performed:

Note: The "Reported Performance (Implied)" column is based on the statement "Testing demonstrated that the modified 14F iSLEEVE Introducer Set met all previously established acceptance criteria" and "Results confirm that the modified device remains biocompatible for its intended use." Specific quantitative results are not provided in this summary.

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

• Test Set Sample Size: Not explicitly stated for each non-clinical test. The document refers to "the modified device" meeting criteria. For the animal study, it mentions a "double-blinded animal study" in the "porcine model," implying a sample size of animals, but the exact number of animals or devices tested is not provided.
• Data Provenance:
  • Non-clinical testing: Performed internally by the manufacturer (Boston Scientific Corporation). The location of the testing is not specified, but it's presumed to be in a controlled laboratory environment.
  • Animal Study: Conducted in a "porcine model." No information on the country of origin or whether it was retrospective or prospective is given, though animal studies for device testing are typically prospective.

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

• Non-clinical tests: Ground truth is established by standard engineering and biocompatibility testing methodologies and validated equipment, not typically by human experts in the same way as medical image analysis.
• Animal Study: "Physicians were asked to separately evaluate the performance of the insertion and removal of the predicate and alternative hydrophilic coated device."
  • Number of experts: Not specified (e.g., "physicians" could be one or multiple).
  • Qualifications of experts: Only identified as "Physicians." No details on their specialty, experience level, or specific training are provided.

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

• Non-clinical tests: Not applicable in the context of human expert adjudication.
• Animal Study: The phrase "Physicians were asked to separately evaluate" suggests individual assessments, but it does not specify an adjudication method (e.g., consensus, majority vote) if multiple physicians were involved. It implies a comparative evaluation between the modified and predicate device's performance characteristics during insertion and removal.

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

• No MRMC study was performed. This document describes the testing for a physical medical device (introducer sheath) with a coating change, not an AI/ML algorithm. Therefore, the concept of human readers improving with AI assistance is not applicable here.

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

• Not applicable. This relates to a physical medical device, not an AI/ML algorithm.

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

• Non-clinical tests: Ground truth is established through physical measurements, chemical analyses, and standardized biological assays, adhering to relevant standards (e.g., ISO 10993-1 for biocompatibility).
• Animal Study: Ground truth was based on the "functional performance" assessed by "physicians" during the insertion and removal of the devices in the porcine model. This would involve qualitative and potentially some quantitative assessment of ease of use, resistance, and other performance characteristics directly observed during the procedure. It's a form of expert observation/assessment in a simulated use environment.

8. The sample size for the training set

• Not applicable. This device is not an AI/ML algorithm. It is a manufactured physical good, and as such, there is no "training set" in the context of machine learning. The design and manufacturing process would involve internal development and verification.

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

• Not applicable. See point 8.

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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 diameter.

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 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 Boston Scientific Corporation's iSLEEVE™ Introducer Set. It does not describe an AI medical device or a study proving its performance against acceptance criteria in the context of AI.

The document discusses medical devices classified as "Catheter Introducer," which are physical tools used to facilitate access to the vascular system. The review is based on "non-clinical performance bench testing data," not on computational analysis or AI model performance.

Therefore, I cannot provide the requested information about acceptance criteria and study details for an AI device. The input document pertains to a traditional medical device (a catheter introducer) and its regulatory clearance based on substantial equivalence to a predicate device, not an AI/ML device.

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