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The Merit PreludeEASE Hydrophilic Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries, including but not limited to the radial artery, while maintaining hemostasis for a variety of diagnostic and therapeutic procedures.

The access needle with inner metal needle and outer plastic cannula is used to gain access to the vein or artery for placement of guide wires.

The 7F PreludeEASE™ 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. A sidearm is affixed to the sheath hub and has a 3-way stopcock at its proximal end. The 7F PreludeEASE Hydrophilic Sheath Introducer is available in 11cm, 16cm and 23cm lengths and is designed to accept 0.018", 0.021" and 0.035" diameter guide wires. The 7F PreludeEASE™ Hydrophilic Sheath Introducer is marketed with any of the following components, depending on the product configuration: guide wire, metal access needle, access needle with inner metal needle and outer plastic cannula, syringe, scalpel and BowTie™ guide wire insertion device.

Here's a breakdown of the acceptance criteria and study information for the PreludeEASE Hydrophilic Sheath Introducer, extracted from the provided text. Please note that the document primarily focuses on demonstrating substantial equivalence through performance testing rather than a comparative effectiveness study with human readers assisted by AI. Therefore, several requested sections (like MRMC study, human reader improvement, standalone algorithm performance, and training set details) are not applicable or cannot be found in this specific document.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria are "predetermined" and "applicable to the safety and efficacy of the device" guided by the referenced international and national standards. Specific numerical thresholds are not provided in this summary.

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

The document indicates "Performance testing of the subject 7F PreludeEASE Hydrophilic Sheath Introducer was conducted." However, it does not specify the sample sizes (number of devices tested) for any of the individual performance or biocompatibility tests.

The data provenance is not explicitly stated in terms of country of origin. The study appears to be a prospective performance evaluation of the manufactured device, conducted by the manufacturer, Merit Medical Systems, Inc. This is a premarket notification for a medical device cleared by the FDA, implying the tests were conducted to demonstrate the device meets specified standards for safety and effectiveness.

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

This document describes a series of engineering and biocompatibility tests for a physical device. It does not involve medical images or diagnostic interpretations requiring expert ground truth establishment for a test set in the context of an AI/algorithm. Therefore, this section is not applicable.

4. Adjudication method for the test set

As there is no "test set" in the context of diagnostic interpretation requiring expert consensus, adjudication methods are not applicable to this type of device 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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This document pertains to the regulatory clearance of a physical medical device (sheath introducer), not an AI algorithm. Therefore, details about human reader improvement with or without AI assistance are not relevant or present.

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

No, a standalone (algorithm-only) performance study was not done. This document is about a physical medical device, not an AI algorithm.

7. The type of ground truth used

The "ground truth" for the performance testing described here is the established performance requirements and specifications outlined in the referenced international (ISO) and national (ASTM, USP) standards, along with the device's risk analysis. For example, for "kink resistance," the ground truth would be a defined level of force or deformation the device must withstand without kinking, as specified by ISO 11070:1998. For biocompatibility tests, the ground truth is the absence of a toxic, inflammatory, or immune response as defined by the respective ISO 10993 standards.

8. The sample size for the training set

This document does not describe the development or evaluation of an AI algorithm, so there is no "training set" in this context. The tests are for verifying the physical properties and biological safety of a manufactured medical device.

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

As there is no training set for an AI algorithm, this question is not applicable.

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The Merit PreludeEASE™ Hydrophilic Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries, including but not limited to the radial artery, while maintaining hemostasis for a variety of diagnostic or therapeutic procedures.
The access needle with inner metal needle and outer plastic cannula is used to gain access to the vein or artery for placement of guide wires.

The PreludeEASE™ Hydrophilic Sheath Introducer consists of a sheath introducer with compatible vessel dilator that snaps securely into the sheath introducer hub. The sheath is coated with a hydrophilic coating and is equipped with a sidearm terminating in a 3-way stopcock. The sheath hub contains an integral hemostasis valve and suture ring. The access needle with inner metal needle and outer plastic cannula is an accessory device which is used to gain access to the vein or artery for placement of guide wires.
The PreludeEASE Hydrophilic Sheath Introducer is marketed with any of the following components, depending on the product configuration: guide wire, metal access needle, access needle with inner metal needle and outer plastic cannula, syringe, scalpel and BowTie™ guide wire insertion device.

The provided text is a 510(k) summary for the Merit Medical Systems, Inc. PreludeEASE Hydrophilic Sheath Introducer. It details the device, its intended use, comparison to predicate devices, and outlines the safety and performance tests conducted.

However, it does not contain the specific acceptance criteria and reported device performance in a table format, nor does it describe a study using a test set with ground truth, experts, or a multi-reader multi-case comparison as requested in the input.

The document primarily focuses on demonstrating substantial equivalence to predicate devices through design characteristics, intended use, and the successful completion of a series of performance (bench) and biocompatibility tests against established international standards.

Therefore, I cannot fulfill all parts of your request based on the provided text. I can only report on what is present in the document.

Missing Information:

• A table of acceptance criteria and reported device performance. The document lists the types of tests performed (e.g., "Sheath Introducer Assembly Leak," "Hydrophilic Coating Lubricity") but does not provide specific pass/fail criteria or the quantitative or qualitative results of these tests.
• Sample size used for the test set and data provenance.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method for the test set.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size.
• If a standalone (algorithm only) performance study was done. (This device is a physical medical device, not an algorithm, so this is not applicable).
• The type of ground truth used.
• Sample size for the training set.
• How the ground truth for the training set was established.

Information from the document that is relevant to your request, but does not fully answer each point:

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

This information is not explicitly provided in the document in a table format with specific criteria and performance metrics. The document only lists the types of tests performed. It states "Performance testing of the subject PreludeEASE Hydrophilic Sheath Introducer was conducted based on the risk analysis and based on the requirements of the following international standard..." This implies that the acceptance criteria were defined by complying with these standards, but the specific values are not presented.

Types of Performance (Bench) Tests Performed:

• Surface
• Radiodetectability
• Size Designation
• Sheath Introducer Assembly Leak
• Sheath Introducer Hemostasis Valve 5.8 psi Leak
• Sheath Introducer Tubing Pull (Force at Break)
• Sheath Introducer Hub to Tubing Pull (Force at Break)
• Dilator Hub to Tubing Pull (Force at Break)
• Sheath / Dilator Tip Peel Back
• Hemostasis Valve Dislodgement
• Hemostasis Valve Vacuum
• Hemostasis Valve Low Pressure with Dilator Dwell
• Sidearm to Sheath Hub Pull (Force at Break)
• Sheath Hub to Cap Pull (Force at Break)
• Sheath Introducer Stiffness and Flex Modulus
• Sheath Introducer Kink Resistance
• Suture Ring Pull Test
• Dilator Stiffness and Flex Modulus
• Hydrophilic Coating Lubricity
• Hydrophilic Coating Coverage/Adherence and Length
• Two-Part Access Needle Metal Cannula to Hub Pull
• Two-Part Access Needle Plastic Cannula to Hub Pull
• Two-Part Access Needle Insertion and Withdrawal Test
• Particulate Evaluation
• Kink Resistance
• Torque Strength
• Packaging Testing
• Scalpel Flex Test

Types of Biocompatibility Tests Performed:

• Cytotoxicity
• Sensitization
• Intracutaneous Injection
• Acute Systemic Toxicity
• Pyrogenicity
• Genotoxicity
• Hemolysis
• Thrombogenicity
• Complement Activation
• Chemical Characterization

The document concludes that "the subject PreludeEASE Hydrophilic Sheath Introducer meets the requirements that are considered essential for its intended use and is substantially equivalent to the predicate devices..." This implies that all these tests passed their respective acceptance criteria, which were derived from the referenced international standards.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not provided in the document. The general statement is "Performance testing of the subject PreludeEASE Hydrophilic Sheath Introducer was conducted..." without specifying test sample sizes or data provenance.

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 as the device is a physical medical instrument, not an AI or diagnostic algorithm requiring expert "ground truth" for a test set in the traditional sense. Performance is assessed through physical and biological testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable for the reasons stated above.

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 as the device is a physical medical instrument, not an AI or diagnostic algorithm.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This information is not applicable as the device is a physical medical instrument, not an AI or diagnostic algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for this medical device's performance is established by compliance with recognized international standards (e.g., ISO 11070:1998 for catheter introducers, ISO 10993 for biocompatibility) and internal risk analysis. The physical and chemical properties are tested directly against defined specifications within these standards.

8. The sample size for the training set:
This information is not applicable as the device is a physical medical instrument and does not involve a "training set" in the context of machine learning or AI.

9. How the ground truth for the training set was established:
This information is not applicable for the reasons stated above.

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