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Femoral artery Introducer Set: The Introducer set are intended to provide access and facilitate the introduction of guide wires, catheters and other accessory medical devices through the femoral artery while minimizing blood loss during interventional procedures.

Radial Artery Introducer Set: The Introducer set are intended to provide access and facilitate the introduction of guide wres, catheters and other accessory medical devices through the skin into the radial artery while minimizing blood loss during interventional procedures.

The Introducer Set is supplied with an introducer sheath, a dilator, a guidewire and an access needle. These devices will be manufactured in 5.0, 6.0, 7.0, and 8.0 French and in lengths of 5, 7 and 11 centimeters. The sets are compatible with the supplied 0.018", 0.021" guidewire and 21G needle in length of 7cm. The sets are supplied sterile and intended for single use.

The sheath shaft and hub are manufactured of Fluorinated ethylene propylene and copolyester; one-piece construction of the sheath shaft and hub allows smooth passage of medical devices. The hub, color-coded by French size, contains a hemostatic valve to prevent blood leakage during a procedure. A side tube equipped with a three-way stopcock is attached to the sheath hub. The side tube extension may be used for fluid and medication administration, as well as blood sampling.

The dilator is an open, tapered plastic tube with an integral luer hub for guidewire insertion. The guidewire is inserted into the introducer sheath to facilitate and support entry of the sheath into the patient's vasculature. The dilator is longer than the sheath with a rounded tapered distal tip. The dilator tubes are manufactured of polypropylene. Dilator tubes are press-fit into the dilator hub with a bushing. The sheath hub and dilator hub lock using a rotating motion.

Introducer Set is designed specifically to introduce therapeutic or diagnostic devices into the vasculature. Using the Seldinger technique, the physician gains percutaneous access to the vascular system and then employs the introducer sheath as a conduit for inserting diagnostic and/or interventional devices into the patient.

The provided text describes a 510(k) submission for the INT Introducer Set. This document is a regulatory submission for a medical device and, as such, focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing rather than proving performance against specific acceptance criteria for AI or diagnostic accuracy, which is what your request implies.

Therefore, many of the requested categories related to AI performance, expert ground truth, multi-reader studies, and training sets are not applicable to this type of device and document.

Below is a breakdown of the available information based on your request, with an explanation of why certain categories are not applicable.

Acceptance Criteria and Study Details for INT Introducer Set

1. Table of Acceptance Criteria and Reported Device Performance

For a traditional medical device like an introducer set, "acceptance criteria" are typically defined by engineering specifications and relevant ISO/ASTM standards, rather than diagnostic performance metrics. The "reported device performance" is the result of testing against these engineering criteria.

2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes (e.g., number of devices) used for each individual bench or biocompatibility test. It lists the tests performed, implying that appropriate sample sizes were used according to the referenced standards.
Data provenance is for the device being submitted (INT Introducer Set), manufactured by Shanghai Kindly Medical Instruments Co., Ltd. The studies are non-clinical (bench and lab-based biocompatibility studies).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable. The device is a physical medical instrument (introducer set), not an AI/diagnostic software. "Ground truth" in this context refers to objective measurements and adherence to engineering and biocompatibility standards, not expert consensus on diagnostic interpretations.

4. Adjudication method for the test set
This question is not applicable. Adjudication methods (like 2+1, 3+1) are used in studies involving human interpretation or AI output review. This document describes bench and biocompatibility testing of a physical device.

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 question is not applicable. This is a physical medical device, not an AI or imaging diagnostic software that would involve human readers or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used
The "ground truth" for this device's performance is established by adherence to recognized international standards (e.g., ISO, ASTM, USP) for physical and material properties, sterility, and biocompatibility. The tests performed are designed to objectively measure these properties against predefined specifications from these standards.

8. The sample size for the training set
This question is not applicable. There is no AI component or algorithms that require a training set for this device.

9. How the ground truth for the training set was established
This question is not applicable, as there is no training set for this device.

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KDL Micro catheter is used to provide support, to facilitate the placement of guidewires in the peripheral and coronary vasculature, and can be used to exchange one guidewire for another. It is also intended to assist in the delivery of diagnostics, embolic, or therapeutic materials into peripheral and coronary vessels

The KDL Micro catheter is available in two French configurations, 2.3F (proximal)/1.6F (distal) and 2.5F (proximal) /1.8F (distal), 110cm, 130cm, 180cm of effective lengths. The proposed device consists of Hub with luer connector, strain relief, catheter shaft, a radiopaque marker and soft tip. The catheter shaft and radiopaque marker consist of 3 layers, an outer layer of Eurelon or pebax tube containing BaSO4, a middle layer of stainless steel braid mesh and an inner layer of PTFE tube, in addition, the middle layer of radiopaque marker consist of Platinoiridium. The radiopaque marker at the distal tip to facilitate fluoroscopic visualization. The soft tip consists of 2 layers, an outer layer of pebax tube containing BaSO4, an inner layer of PTFE tube. The outer surface of the micro catheter shaft is coated with a hydrophilic coating designed to facilitate the introduction of the micro catheter into the vasculature.

The distal tip of micro catheter is offered in straight (MCS) and swan neck (MCM) configurations.

All models of the catheter are designed to accept a maximum guidewire diameter of 0.010 inch or 0.014 inch.

The provided text is a 510(k) summary for the KDL Micro catheter. It describes the device, its intended use, comparison to predicate devices, and performance data from bench and biocompatibility testing. However, it does not contain information about an AI/ML powered device or a study involving human readers, expert ground truth adjudication, or statistical metrics like sensitivity, specificity, or AUC. Therefore, I am unable to fulfill the request based on the provided input.

The document pertains to a Class II medical device (percutaneous catheter) and its substantial equivalence determination to previously cleared predicate devices. The performance data presented are for the physical and biological characteristics of the catheter, not the performance of an AI/ML algorithm.

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KDL Angiography Catheter are intended for delivery of radiopaque contrast media to selected sites during the angiography procedure of the peripheral and coronary vascular system.

The proposed device consists of tube hub, strain relief, catheter shaft with stainless steel braid layer, soft extension and distal tip. The catheter shaft is made of Pebax contain Barium Sulfate that is radiopaque and a middle stainless steel braid layer. Soft extension and distal tip is made of Pebax contain Barium Sulfate without stainless steel braid layer that could prevent vascular injury when pushed into the blood vessel.

The distal tip of the catheter is available in 32 kinds tip shape configurations. The outer diameter is available in 4F, 5F, 6F, 7F sizes and the length is available in 100cm except for Pig angiography catheter in length of 110cm. The side hole on distal tip is used to disperse the contrast media and balance pressure.

The provided text is related to the FDA 510(k) premarket notification for a medical device: the KDL Angiography Catheter. This document demonstrates the substantial equivalence of the proposed device to legally marketed predicate devices, rather than proving the device meets specific acceptance criteria through a study involving AI-driven performance or human reader improvements.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets those criteria, specifically in the context of AI performance, human reader studies (MRMC), or a comprehensive ground truth establishment process for a diagnostic algorithm, is not contained within the provided document.

The document primarily focuses on:

• Device Description: Physical characteristics, materials, sizes, and configurations.
• Intended Use Statement: Delivery of radiopaque contrast media during angiography.
• Substantial Equivalence Comparison: A detailed table comparing the proposed device with predicate and reference devices across various parameters like product code, indications for use, principle of operation, design, dimensions, materials, and sterilization methods.
• Performance Data (Nonclinical Bench Testing): A list of physical and chemical tests performed to ensure the device meets engineering specifications (e.g., burst pressure, flexibility, guidewire compatibility).
• Biocompatibility Testing: Compliance with ISO 10993 standards, including in vitro and in vivo tests for hemolysis, toxicity, sensitization, etc.

Since the request is about AI performance, human reader studies, and related metrics for a diagnostic device, and the provided document describes an Angiography Catheter (a physical medical instrument for delivering contrast), the requested information as described (AI performance, MRMC study, ground truth for AI, training set, etc.) is not applicable to this submission.

The document is a regulatory submission for a physical device, not a diagnostic algorithm or AI product.

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The Medical Face Masks are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids and particulate material.

Not Found

This document is a 510(k) premarket notification for a Medical Face Mask. It primarily covers regulatory information and does not contain details about acceptance criteria or a study proving the device meets those criteria in the context of AI/ML or diagnostic performance. Instead, it speaks to the masks' intended use for protection against microorganisms, body fluids, and particulate matter, and confirms its classification as a Class II device.

Therefore, I cannot provide the information requested in your prompt as it is not present in the provided text.

Specifically, there is no mention of:

1. A table of acceptance criteria and reported device performance related to a study.
2. Sample sizes for test sets or data provenance.
3. Number of experts, their qualifications, or adjudication methods for ground truth establishment.
4. Multi-reader multi-case (MRMC) comparative effectiveness studies.
5. Standalone algorithm performance.
6. The type of ground truth used (expert consensus, pathology, outcomes data).
7. Sample size for the training set or how its ground truth was established.

This document is a regulatory clearance letter, not a study report or a technical performance specification document.

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Guidewire is intended to be used in the coronary and/or peripheral vascular system to introduce and position catheters to desired anatomical location during diagnostic or interventional procedures.

The Guidewire are designed to facilitate the placement of interventional devices. The guidewire has two models. PTFE coating type and hydrophilic coating type. The two models have the different material for wire and coating. PTFE guidewire consists of stainless steel spring coil wire, inside core wire and a safety wire. The guidewire is placed inside a loop flush dispenser, also as a hoop. Hydrophilic guidewire consisits of nickel titanium alloys core wire with a jacket that has a hydrophilic coating. The guidewire is placed inside a spiral hoop. The Guidewire is radiopactitive under fluoroscopy. The wire will be offered in straight, angle, J-tip configuration . All guidewires are available in five nominal outer diameter of 0.025", 0.028", 0.032", 0.038"inches and nominal lengths of 100cm, 150cm, 180cm, and 260cm.

The provided document is a 510(k) summary for a guidewire device and specifically states that no clinical tests were performed (Section 8. Clinical Test: "It is not applicable"). Therefore, there is no study described that involves AI or human readers for diagnostic purposes. The acceptance criteria and testing detailed relate to the physical and biocompatibility performance of the guidewire itself.

Based on the provided text, here's a breakdown of the requested information, focusing on the non-clinical performance and a clear indication where information is not available or applicable:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that for each performance test, "The predetermined acceptance criteria was met." Specific numerical thresholds for these criteria are not provided in this summary.

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

The document does not specify the exact sample sizes for each test in the acceptance criteria, nor does it detail the provenance of any data beyond indicating "in-house standard" for some tests. It mentions testing on "non-aged and aged to 3 years sample," implying samples were physical guidewire units. This is a medical device, not a diagnostic AI product, so "data provenance" as it relates to patient data is not applicable here.

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

Not applicable. This device is a physical medical instrument (guidewire) and not a diagnostic tool requiring expert interpretation or ground truth establishment in the traditional sense of an AI study.

4. Adjudication method for the test set

Not applicable. There is no human interpretation or adjudication described for the performance tests of the guidewire.

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. The document explicitly states "Clinical Test: It is not applicable." This is a guidewire, not an AI-assisted diagnostic tool.

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

No. This is a guidewire, not an algorithm or AI product.

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

For the physical and biological tests of the guidewire, the "ground truth" or reference points are defined by the standards themselves (e.g., ISO, ASTM, FDA guidance, USP) and "in-house" specifications. These standards provide the objective criteria against which the device performance is measured.

8. The sample size for the training set

Not applicable. This is a physical medical device. There is no AI model requiring a training set.

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

Not applicable. There is no AI model requiring a training set or ground truth in that context.

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Femoral artery Introducer Set: The Introducer set are intended to provide access and facilitate the introduction of guide wires, catheters and other accessory medical devices through artery while minimizing blood loss during interventional procedures.

Radial Artery Introducer Set. The Introducer set are intended to provide access and facilitate the introduction of guide wires, catheters and other accessory medical devices through the skin into the radial artery while minimizing blood loss during interventional procedures.

This set classifies two types: Femoral Artery and Radial Artery. The Femoral Artery introducer set consist of a sheath introdcuer, dilator, needle, Guidewire. The Radial Artery introducer set consist of a sheath introdcuer lubricated with/without hydrophilic coating, dilator, I.V. cannula /Introducer needle,Guidewire (with/without hydrophilic coating).

The Introducer Set consists of sheath introducer, each packaged in a set to together with a dilator, introdcuer needle, and guidewire. The introducer sheath is fitted with a hemostasis valve to minimize blood loss during catheter introduction and/or exchange. A side port with tubing connected to a 3-way stopcocks is used for injection contrast medium. The dilator is provided to aid in the introduction of sheath to the target vessel. The Introducer needle/I.V. Cannula is provided a conduit for insertion of the guidewire into the vascular system. The guidewire is utilized as a guiding mechanism for the introducer sheath into the vascular system.

The provided document is a 510(k) premarket notification summary for a medical device (KDL Introducer Set). It outlines the device's technical specifications, intended use, and comparison to a predicate device. However, this document describes a Class II medical device (a catheter introducer) and not an AI/ML-driven device. Therefore, the information typically requested in your prompt regarding acceptance criteria and studies for AI/ML device performance (such as sample size for test sets, data provenance, expert ground truth adjudication, MRMC studies, standalone algorithm performance, training set details, etc.) is not applicable to this type of traditional medical device.

Instead, the document details non-clinical performance testing and biocompatibility testing to demonstrate substantial equivalence to a predicate device.

Here's a breakdown of the relevant information provided in the document concerning how the device meets acceptance criteria:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present a single table with "acceptance criteria" and "reported device performance" in the way one might for an AI/ML diagnostic output (e.g., sensitivity, specificity thresholds). Instead, it lists various "Testing item" and "Reference Standard/Guidance" for different components of the Introducer Set. The document then states:

"All sample tested met the standard applicable to each test." and "Base on the result of the performance and biocompatibility testing, the proposed device, Introducer Set, met all the predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, and test protocols."

Here's a re-composition of this information into a table format based on the supplied text:

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

• Sample Size: The document does not specify the exact sample size for each test. It states "The performance tests were performed on the non-aged and ages to 3 years sample." This implies that samples were tested for immediate performance and also after accelerated aging simulating 3 years of shelf life. Specific lot sizes or number of units tested per parameter are not disclosed in this summary.
• Data Provenance: Not explicitly stated, however, the manufacturer is Shanghai Kindly Medical Instruments Co., Ltd. in Shanghai, China. The testing would have been conducted by or for them, likely in China. The study is a non-clinical performance testing and biocompatibility assessment, rather than a clinical study with patient data.

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

• This question is not applicable as this is a traditional medical device undergoing physical and biological performance testing, not an AI/ML device relying on interpretation of medical images or data by experts to establish ground truth. The "ground truth" here is defined by the technical specifications and standards (e.g., ISO, ASTM).

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

• This question is not applicable for the same reason as point 3. Testing involves objective measurements against established engineering and biocompatibility standards.

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 question is not applicable as the device is not an AI-driven product nor does it involve human readers interpreting medical cases.

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

• This question is not applicable as the device is not an algorithm.

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

• The "ground truth" for this device is based on engineering specifications, established international standards (ISO, ASTM), and FDA guidance documents for medical devices (specifically catheter introducers and guidewires). For biocompatibility, it's based on standard biological test methods outlined in ISO 10993 and ASTM F756.

8. The sample size for the training set:

• This question is not applicable as this is a manufactured medical device, not an AI/ML model that requires a training set.

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

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

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