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INT Vacuum Locking Syringe is intended for use only by physicians for adult patients to inject fluids into, or withdraw fluids from the body. It can also be used in cases where a Vacuum Syringe is preferred (e.g., thrombus, abscess fluid, bile, urine, etc.)

The INT Vacuum Locking Syringe is used to inject or withdraw fluids from the body. It can also be used in cases where a vacuum syringe is preferred (e.g., thrombus, abscess fluid, bile, urine etc.). The Syringe consists of graduation lines, zero line, luer connector, nozzle lumen, seals, barrel, plunger, push-button, barrel flanges, locking column, locking piece and fiducial line. When the Syringe is used, it can be divided into two situations: normal suction in normal state and vacuum suction in locked state. Vacuum Locking Syringe is placed in a soft blister box which is composed of Tyvek 2FS and PE. The proposed device is sterilized by EO and intended for single use. The packaging form is sealed packaging and guarantees that the product is sterile until opening. The packaging can ensure the sterilized finished device during its shelf life of 3 years.

The provided text is a 510(k) summary for a medical device (INT Vacuum Locking Syringe) seeking FDA clearance. It describes non-clinical testing performed to establish substantial equivalence to a predicate device. However, it explicitly states "No clinical study is included in this submission."

Therefore, I cannot provide information regarding:

• Multi-reader multi-case (MRMC) comparative effectiveness study
• Effect size of human readers improving with AI vs. without AI assistance
• Standalone (algorithm only without human-in-the-loop performance) study

I can, however, extract information about the non-clinical acceptance criteria and testing that was performed.

Here's the breakdown of the information that can be extracted:

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

The document describes non-clinical performance testing conducted on the subject device against recognized standards. It states: "Results of the testing demonstrate that the subject device met the acceptance criteria sufficient for its intended use." However, the specific quantitative acceptance criteria and the exact reported performance values (e.g., specific force in N, leakage volume) are not detailed in this summary. The summary only lists the items tested and the methodology/standards used.

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

The document mentions "non-clinical bench performance testing was conducted on the subject device" and lists various tests. However, it does not specify the sample sizes used for any of these tests.
Regarding data provenance, the testing was performed by the manufacturer, Shanghai Kindly Medical Instruments Co., Ltd., based in China, as part of their 510(k) submission. This is retrospective testing done to support the premarket notification.

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 document explicitly states "No clinical study is included in this submission" and the testing described is non-clinical bench testing. Ground truth for clinical studies typically involves expert assessment of patient data.

4. Adjudication method for the test set:

This information is not applicable as it pertains to clinical studies and expert consensus, which were not part of this submission.

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 comparative effectiveness study was not done. The document explicitly states "No clinical study is included in this submission." The device is a physical medical instrument (syringe), not an AI-powered diagnostic tool.

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

No, a standalone study (in the context of AI algorithm performance) was not done. The device is a physical syringe, and the testing described is bench performance testing for a medical instrument, not a software algorithm.

7. The type of ground truth used:

For the non-clinical performance and biocompatibility testing, the "ground truth" is defined by the acceptance criteria specified within the referenced international standards (e.g., ISO 7886-1, ISO 80369-7, ISO 10993-1, ASTM standards, USP standards) and the manufacturer's own in-house standards. Compliance with these established technical specifications and biological safety requirements serves as the ground truth for device performance and safety.

8. The sample size for the training set:

This information is not applicable as there is no "training set" in the context of this device and the non-clinical testing performed. This usually refers to machine learning models, which are not involved here.

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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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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The inflation device is intended to be used in PTCA or PTA procedures to create and monitor pressure in the balloon and to deflate the balloon dilatation catheter.

The inflation device consists of barrel, threaded plunger assemble with a handle, a trigger, pressure gauge, an outer shell assembly that retains the internal components, and a pressure connecting tubing with rotating adapter. Also enclosed is a stopcock to aid in preparation and use of device. The inflation device is 20 mL disposable device capable of producing a maximum pressure of 30 atm.

The inflation device is sterilized by EO.

The provided text describes a 510(k) premarket notification for an "Inflation Device". This document focuses on demonstrating substantial equivalence to a predicate device through non-clinical bench testing, rather than presenting a clinical study with detailed acceptance criteria for diagnostic performance. Therefore, many of the requested elements are not applicable to this type of submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not present acceptance criteria in terms of diagnostic performance metrics (e.g., sensitivity, specificity, AUC) or a specific clinical outcome. Instead, it refers to compliance with established international standards for medical devices and device specifications.

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

• Sample Size: The document does not specify a "test set" in the context of clinical data. The tests performed are bench tests on the device itself (e.g., for mechanical properties, material testing). The number of units tested per bench test is not detailed.
• Data Provenance: Not applicable as no human data is used. The tests are performed on the manufactured device.

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

• Not applicable. There is no ground truth established by experts in this context as it's a device performance study, not a diagnostic accuracy study relying on human interpretation.

4. Adjudication Method

• Not applicable. No expert review or adjudication process is described as it's not a clinical study involving human assessment.

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

• No. This is a 510(k) submission for a physical medical device, not an AI software or diagnostic imaging tool. Therefore, a MRMC comparative effectiveness study is not performed or relevant.

6. Standalone Performance

• Yes, in a way. The "standalone" performance here refers to the device's ability to meet its technical specifications and regulatory standards independently. The non-clinical bench tests assess the device's functional and safety characteristics in a standalone manner.

7. Type of Ground Truth Used

• The "ground truth" for this device's performance is compliance with established international standards (ISO) and the manufacturer's own validated specifications. For example, for conical fittings, the ground truth is adherence to ISO 594-1 and ISO 594-2 standards. For biocompatibility, it's the outcome of tests against ISO 10993 standards.

8. Sample Size for the Training Set

• Not applicable. There is no "training set" as this is not an AI/machine learning model.

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

• Not applicable.

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The High Pressure Tubing is indicated for use as a connecting line for injection of contrast media or saline during coronary angiographic procedures.

The High Pressure Tubing is a sterile, single use device which can withstand injection pressure to 1200psi. The High Pressure Tubing is composed of tubing with connector at each end. The connector is a female-male combination and rotating adapter. The High Pressure Tubing is supplied sterile by Ethylene Oxide and disposable device. The material of tube is PU with polvamides liner, and the appearance is braided.

The provided document describes the 510(k) premarket notification for a medical device called "High Pressure Tubing." The submission argues for the substantial equivalence of the proposed device to a legally marketed predicate device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

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

The document does not explicitly present a table of "acceptance criteria" and "reported device performance" in the format typically associated with a clinical or analytical performance study of a diagnostic or AI device. Instead, it focuses on demonstrating substantial equivalence to a predicate device through non-clinical bench testing against established standards and a comparison of technological characteristics.

However, we can infer some criteria and reported performance from the "Non-clinical Test Conclusion" and the comparison table.

The document states: "Bench tests were conducted to verify that the proposed device met all device specification as were substantially equivalent (SE) to the predicate device. The test result demonstrates that the proposed devices comply with the following standards: ISO 594-1:1986, ISO 594-2:1998, ISO 8536-4:2010."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not provide details on the sample size used for the bench testing (e.g., number of tubing samples tested for pressure, luer compatibility, etc.). It only mentions that "Bench tests were conducted." The provenance of this test data (country of origin, retrospective/prospective) is also not specified beyond the fact that the manufacturer is "Shanghai Kindly Medical Instruments Co., Ltd."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable and not provided. The device is a piece of medical tubing, not a diagnostic or AI device requiring expert interpretation for ground truth establishment. The "ground truth" for this device relates to its physical and functional specifications meeting industry standards, which is assessed through engineering and materials testing, not expert clinical review.

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

This information is not applicable and not provided. As explained above, the assessment is based on objective measurements against engineering standards, not subjective expert judgment 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

This information is not applicable and not provided. The device is medical tubing, not an AI or diagnostic tool. Therefore, MRMC studies involving human readers and AI assistance are not relevant.

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

This information is not applicable and not provided. The device is medical tubing, not an algorithm. Standalone algorithm performance studies are not relevant.

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

The "ground truth" for this device is based on established engineering and medical device standards (ISO standards) and the device's own predetermined specifications (e.g., withstand 1200psi). It's essentially "compliance with specified physical and performance characteristics."

8. The sample size for the training set

This information is not applicable and not provided. The device is medical tubing; there is no "training set" in the context of machine learning or AI that would be relevant here.

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

This information is not applicable and not provided. As there is no training set for this type of medical device, the establishment of ground truth for such a set is not relevant.

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The Angiography syringe is used to inject contrast media into the heart, great vessels, and coronary arteries during angiographic procedures.

The Angiography Syringe are plastic , single-use, disposable syringes to be offered in 6ml, 8ml, 10ml, 12ml size. As manual control syringe, each configuration includes bilateral, external finger rings located on the proximal barrel shaft. The proximal thumb rings located on the plunger, in tandem with the external finger rings on the barrel, allows for single handed movement to create aspiration and/or expulsion of fluids. The angiography syringe has two tip fitting: fixed adapter and rotating adapter

The provided text is a 510(k) summary for a medical device (Angiography Syringe) and does not describe the specific type of study, acceptance criteria, or expert involvement typically associated with AI/ML-based medical devices or diagnostic tools.

The document discusses "acceptance criteria of design verification and validation as specified by applicable standards, guidance, and test protocols," but these are for the mechanical and material properties of the syringe itself, not for diagnostic performance in the way a clinical study for AI would be evaluated.

Therefore, many of the requested details cannot be extracted from this document, as they are not applicable to the type of device and study presented.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

The document lists standards that the device complies with, which implicitly serve as acceptance criteria for those specific tests. However, it does not provide quantitative "reported device performance" against these criteria in a table format, other than stating compliance.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Sample Size: Not specified for non-clinical bench tests. The document states "Bench tests were conducted."
• Data Provenance: Not applicable. These are laboratory bench tests, not clinical data. The manufacturer is Shanghai Kindly Medical Instruments Co., Ltd., China.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

• Not applicable. This is a medical device (syringe), not an imaging or diagnostic AI/ML device requiring expert ground truth for its performance evaluation. The ground truth for its mechanical and biological safety is established by adherence to engineering and biocompatibility standards.

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

• Not applicable. There is no human interpretation or adjudication involved in the performance testing of a syringe against engineering or 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

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

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

• Not applicable in the context of diagnostic performance. The "ground truth" for this device's performance is established by the specifications in the cited ISO standards for its physical and material properties (e.g., fit of luer connections, sterility, biocompatibility).

8. The sample size for the training set

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

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

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

Summary of the Study Proving the Device Meets Acceptance Criteria (as described in the document):

The study to prove the device meets acceptance criteria was primarily non-clinical bench testing. The manufacturer conducted various tests to verify that the Angiography Syringe met all device specifications and was substantially equivalent (SE) to a predicate device.

• Tests Performed:

  • Compliance with ISO 594-1:1986 (Conical Fittings)
  • Compliance with ISO 594-2:1998 (Lock Fittings)
  • Compliance with ISO 7886-1:1993 (Sterile Hypodermic Syringes)
  • Biocompatibility Testing (referencing ISO 10993 standards):
    • In Vitro Hemolytic Properties
    • In Vitro Cytotoxicity
    • Skin Irritation
    • Skin Sensitization
    • Acute Systemic Toxicity
    • Pyrogenicity

• Conclusion: The test results demonstrated that the proposed devices comply with the listed standards, indicating that they met the predetermined acceptance criteria for design verification and validation. The document explicitly states, "Clinical Test: It is not applicable."

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