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The 9F Prelude IDeal Hydrophilic Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures.

The 9F Prelude IDeal Hydrophilic Sheath Introducer consists of a sheath introducer with compatible vessel dilator that snaps securely into the sheath introducer hub. The sheath hub contains an integral hemostasis valve. A rotating suture ring is affixed to the sheath hub. The sheath tubing is coated with a hydrophilic coating and incorporates a stainless steel braid. A sidearm is affixed to the sheath hub and has a 3-way stopcock at its proximal end. The 9F Prelude Ideal Hydrophilic Sheath Introducer is available in 11cm and 23cm lengths, (French size 9F) and is designed to accept 0.038" diameter guide wires. The 9F Prelude Ideal Hydrophilic Sheath Introducer is marketed with the following components: quide wire, metal access needle, quide wire insertion device.

This document describes the 510(k) summary for the 9F Prelude IDeal Hydrophilic Sheath Introducer, a medical device. It does not contain information about an AI/ML powered device, therefore, the requested information elements (1-9) which are related to AI/ML device studies and ground truth establishment are not applicable.

The document focuses on demonstrating the substantial equivalence of the 9F Prelude IDeal Hydrophilic Sheath Introducer to its predicate device (K173750 and K142829) through performance testing.

Here's the relevant information about the non-clinical performance and testing:

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists performance tests conducted, referencing applicable international and internal standards. It generally states that the device "met the predetermined acceptance criteria applicable to the performance of the device." However, specific numerical acceptance criteria and the exact reported device performance values are not provided in this summary. The table below outlines the tests performed:

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

• Sample Size: Not explicitly stated in the provided document for each specific test.
• Data Provenance: The tests are "Nonclinical performance data" and internal validation tests. The provenance is internal to the manufacturer, Merit Medical Systems, Inc.

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

• This is a non-clinical device filing, and expert adjudication for ground truth (as in a clinical study or AI/ML model evaluation) is not applicable or described. The tests are based on engineering and material science standards.

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

• Not applicable for non-clinical performance 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:

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

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

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

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

• The "ground truth" for this device's performance is established by meeting the requirements of recognized international and internal engineering, material, and sterility standards (e.g., ISO, ASTM). These standards define objective, measurable criteria for device functionality and safety.

8. The sample size for the training set:

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

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

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

Summary of Conclusions from the Document:

The 9F Prelude IDeal Hydrophilic Sheath Introducer demonstrated substantial equivalence to its predicate devices by meeting predetermined acceptance criteria in nonclinical performance tests. These tests included manual testing against international standards, coating adhesion and particulate testing, transportation integrity, biocompatibility, sterilization validation, and accelerated aging. The differences from the predicate (larger diameter, different hemostasis valve, colorants, tubing material, removal of compression sleeve, and dilator material change) and minor changes in indications for use (exclusion for radial artery use and specific access needle) were deemed not to raise new questions of safety or effectiveness.

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The Rosch-Uchida Transjugular Liver Access Set is intended for transjugular liver access in diagnostic and interventional procedures.

The Ring Transjugular Intrahepatic Access Set is intended for transjugular liver access in diagnostic and interventional procedures.

The Transjugular Liver Access Sets are comprised of various components that facilitate transjugular access to the liver for the purpose of performing diagnostic and interventional procedures. The sets are grouped into two basic types: the Ring Transjugular Intrahepatic Access Set and the Rösch-Uchida Transjugular Liver Access Set. Each set includes a core component comprised of a combination of either a stiffening cannula/Teflon catheter or needle stylet/Teflon catheter that facilitates access into the hepatic vasculature and the creation of a pathway into the portal vein. Other components included in some of these sets are a Check-Flo Introducer Set. selective catheters, and wire guides.

The Transjugular Liver Access Sets were evaluated through various performance and biocompatibility tests. The sections below outline the acceptance criteria and the study details.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the exact sample sizes used for each individual test. It mentions "all components of the subject device or on representative devices" for biocompatibility testing and refers to "the components in the subject device" and "the test articles" for performance testing. The provenance of the data (country of origin, retrospective or prospective) is not specified, but the tests were conducted by "Cook Incorporated" and referenced international standards (ISO, JIS, BS EN ISO) and FDA guidance.

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

This information is not applicable to the type of device and testing described. The tests performed are laboratory-based physical and chemical property assessments, not diagnostic or interpretive tasks requiring expert human readers to establish ground truth.

4. Adjudication Method for the Test Set

This information is not applicable. The tests are objective measurements against defined acceptance criteria, not subjective assessments requiring adjudication.

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

An MRMC comparative effectiveness study was not performed. The device is a medical instrument (catheter introducer set), and the testing focused on its physical properties and biocompatibility, not on a human-in-the-loop diagnostic or therapeutic performance.

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

This information is not applicable. The device is a physical medical instrument, not an algorithm or AI system.

7. Type of Ground Truth Used

The "ground truth" for the acceptance criteria was established through:

• International Standards: ISO 10993-1, ASTM F640-12, ISO 10555-1:2013, BS EN ISO 9626, BS EN ISO 11070, ISO 11070:2014.
• FDA Guidance: General FDA guidance documents and specifically the FDA Coronary and Cerebrovascular Guidewire Guidance (1995).
• User-Defined Standards and Clinical Requirements: For tests like radiopacity (non-inferior to user-defined standard) and torque (within clinical requirement).
• Predefined Acceptance Criteria: For dimensional analysis and other performance tests.

8. Sample Size for the Training Set

This information is not applicable. The device is a physical medical instrument, not an AI or algorithm-based system that requires a "training set."

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

This information is not applicable as there is no training set for this device.

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The Micropuncture® Introducer Set is intended for the placement of wire guides up to 0.038 inch diameter into the peripheral vascular system when a small 21 gage needle stick is desired.

The Micropuncture® Introducer Set is intended for the placement of wire guides up to 0.038 inch diameter into the peripheral vascular system when a small 21 gage needle stick is desired. The device is utilized to gain access to the vasculature using the Seldinger technique. These introducer sets are comprised of either 4.0 French outer introducer and 3.0 French inner dilator coaxial pair, a 21 gage percutaneous entry needle, and a 0.018 inch mandrel wire guide with a distal coil tip. The dilator of these sets can come with a stainless steel stiffening cannula embedded in the shaft. These sets are supplied sterile and are intended for one-time use.

Here's a breakdown of the acceptance criteria and study information for the Micropuncture Introducer Set, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the exact sample sizes used for each individual test. It only states that "Testing verified..." and "The predetermined acceptance criteria were met."

The data provenance is from benchtop testing conducted by Cook Incorporated. The country of origin for the data is not explicitly stated, but Cook Incorporated is located in Bloomington, Indiana, USA, suggesting the testing likely occurred in the US or under the company's direct supervision. The studies are retrospective in the sense that they are laboratory tests performed on finalized device designs rather than prospective clinical trials.

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

This information is not provided in the document. The tests described are primarily engineering and material science tests, not clinical evaluations requiring expert interpretation of ground truth in the same way an AI diagnostic device would. The "ground truth" for these tests is based on established engineering standards and specifications.

4. Adjudication Method for the Test Set

This information is not applicable as the tests performed are objective physical and material performance tests, not subjective interpretations 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?

No, an MRMC comparative effectiveness study was not done. This document describes the clearance of a physical medical device (introducer set), not an AI diagnostic or assistive technology. Therefore, there is no discussion of human reader improvement with or without AI assistance.

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

No, a standalone algorithm performance study was not done. This device is a physical medical instrument, not a software algorithm.

7. The Type of Ground Truth Used

The ground truth used for these tests is based on established engineering standards, material specifications, and regulatory requirements (e.g., ISO standards). For example, for biocompatibility, the ground truth is conformance with ANSI AAMI ISO 10993-1. For leakage, it's conformance with BS EN ISO 11070:2014.

8. The Sample Size for the Training Set

This information is not applicable. This device is not an AI/ML product and does not involve a "training set" in the computational sense. The testing described is verification and validation for a manufactured product.

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

This information is not applicable for the same reason as point 8.

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The CXI TriForce is intended to be percutaneously introduced into blood vessels and support a wire guide while performing percutaneous peripheral intervention. The product is also intended for injection of radiopaque contrast media for the purpose of angiography.

The CXI™ TriForce Peripheral Crossing Set is an introducer set, supplied with a 5.0 French Flexor introducer sheath, a 4.0 French CXI Support Catheter and a peel-away sheath. The sets are compatible with the supplied 0.035" wire guide. The sets are supplied sterile and intended for one-time use.

The provided text is a 510(k) summary for the CXI TriForce Peripheral Crossing Set. It describes the device, its intended use, and the testing performed to demonstrate substantial equivalence to a predicate device. However, it does not contain the level of detail requested for a comprehensive acceptance criteria and study description as would be found for a novel AI/ML-based medical device.

Specifically, the document focuses on the mechanical and material performance of a physical medical device (a catheter and introducer set), not the performance of an AI/ML algorithm. Therefore, many of the requested points, such as "effect size of how much human readers improve with AI vs without AI assistance," "standalone (i.e. algorithm only without human-in-the-loop performance)," "number of experts used to establish ground truth," and "sample size for training set," are not applicable to this type of traditional medical device submission.

The document states that:

• "Acute Performance - Testing performed verified that performance parameters were acceptable for clinical use. The predetermined acceptance criterion was met."
• "Check-Flo valve liquid leakage testing -- Testing verified that the Check-Flo valve will not experience excessive leakage when utilized according to the device's intended use. The predetermined acceptance criteria were met."
• "Flow Rate Testing - Flow rates through the device were measured at designated injection pressures using saline and contrast."
• "Biocompatibility testing... The predetermined acceptance criteria were met."

Without specific numerical values for the acceptance criteria and performance (e.g., "leakage rate Y mL/sec"), and the exact methodology and sample sizes for these tests, it is impossible to construct the tables and detailed study information requested for a robust AI/ML device evaluation.

Therefore, I will explain why this document does not contain the requested information and provide a general structure of what such a response would look like if the relevant information were available.

Explanation of Missing Information and Why:

The provided document (K170931) is a 510(k) summary for a physical medical device (CXI TriForce Peripheral Crossing Set), which is a catheter and introducer set. It is not an AI/ML-driven device. The regulatory submission for such a device focuses on:

• Mechanical performance: How well the device functions physically (e.g., acute performance, leakage, flow rates).
• Biocompatibility: Ensuring the materials are safe for contact with the human body.
• Sterility: Ensuring the device is free from microorganisms.
• Material compatibility: With other fluids or devices.

Consequently, the types of "acceptance criteria" and "study data" presented are related to these physical and material characteristics, and not to diagnostic accuracy, sensitivity, specificity, reader performance, or multi-reader multi-case studies, which are pertinent to AI/ML devices.

What a complete answer for an AI/ML device would look like (if the information were available):

Based on the provided document, the device is a physical medical device (catheter and introducer set), not an AI/ML-driven device. Therefore, the detailed criteria related to AI/ML algorithm performance, such as sensitivity, specificity, inter-reader variability, human reader improvement with AI assistance, and specific data provenances for AI model training/testing, are not applicable to this submission and are not present in the provided text.

The document generally states that "predetermined acceptance criteria were met" for various physical and material tests, but it does not provide the specific numerical acceptance criteria or the reported performance values.

Below is a template of how such an answer would be structured if the device were an AI/ML product and the necessary information was available.

Acceptance Criteria and Device Performance (Hypothetical for an AI/ML Device):

(1) A table of acceptance criteria and the reported device performance

Study Details (Hypothetical for an AI/ML Device):

(2) Sample size used for the test set and the data provenance

• Test Set Sample Size: [e.g., 500 cases (images/studies)]
• Data Provenance: [e.g., Multi-center retrospective study from hospitals in the USA, UK, and Germany. Data collected between 2018-2022.]

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

• Number of Experts: [e.g., 3-5 independent experts]
• Qualifications: [e.g., Board-certified Radiologists with >10 years of experience in [specific domain, e.g., chest radiography, mammography, etc.], specializing in [specific sub-specialty if applicable].]

(4) Adjudication method for the test set

• Adjudication Method: [e.g., 2+1 (two experts review independently, and if they disagree, a third senior expert adjudicates). OR Majority vote (if >3 experts). OR Consensus meeting. OR None (if a single definitive ground truth like pathology was used).]

(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

• MRMC Study Done: [e.g., Yes]
• Effect Size: Human readers improved [e.g., sensitivity by X%, specificity by Y%, or overall accuracy by Z%] when assisted by the AI device compared to reading without AI assistance. [e.g., Mean AUC for readers increased from 0.85 to 0.91 when using AI, a statistically significant improvement (p

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The Indy OTW™ Vascular Retriever is intended to snare a foreign body and withdraw it to a peripheral vascular location.

The Indy OTW™ Vascular Retriever consists of a 4-loop nitinol wire snare attached to an inner catheter (which is attached proximally to a metal cannula) and includes an outer Flexor sheath. The device is compatible with a 0.035 inch wire guide for over-the-wire introduction. The Flexor sheath has a radiopaque band incorporated within the sheath material to identify the location of the sheath's distal tip.

The provided text describes the Cook Incorporated Indy OTW™ Vascular Retriever, a medical device for snaring and retrieving foreign bodies in the vascular system. However, it does not contain the specific information requested about the acceptance criteria or a study proving the device meets those criteria, particularly in the context of an AI/human-in-the-loop system.

The document is a 510(k) summary for a medical device cleared by the FDA. It focuses on demonstrating substantial equivalence to a predicate device through manufacturing and performance testing, not on the performance of a software algorithm or AI.

Therefore, I cannot fulfill your request for the specific points listed (AI performance, sample sizes for test/training sets, ground truth establishment, MRMC studies, standalone performance) based on the provided text.

The closest information related to "acceptance criteria" and "device performance" in this document is in Section VII, "PERFORMANCE DATA". It lists various types of engineering and materials testing performed, but these are for the physical device itself, not an AI component.

Here's what can be extracted from the provided text regarding "acceptance criteria" and "device performance" for the physical device, recognizing it does not apply to an AI system:

1. Table of Acceptance Criteria and Reported Device Performance (as much as can be inferred from the text):

Regarding the other requested information (which is specific to AI/software performance):

• 2. Sample sized used for the test set and the data provenance: Not applicable to the provided document, as it describes a physical medical device, not an AI system.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 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.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
• 8. The sample size for the training set: Not applicable.
• 9. How the ground truth for the training set was established: Not applicable.

The document details the evaluation of a physical vascular retriever based on mechanical, material, and simulated use tests designed to establish its safety and effectiveness and substantial equivalence to a predicate device. It does not involve any artificial intelligence or machine learning components.

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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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