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The Supercath 5 is intended to access a vein or artery and to administer fluids and/or blood. The Supercath 5 is designed for single use, and is designed to minimize inadvertent needlesticks and to reduce accidental needlesticks. The 18 - 22 gauge catheters may be used with power injectors at a maximum pressure of 300 psi.

The Supercath 5 (Proposed) is intended to access a vein or artery and to administer fluids and/or blood. The Supercath 5 (Proposed) is designed for single use, and is designed to minimize inadvertent needlesticks and to reduce accidental needlesticks. The 18 - 22 gauge catheters may be used with power injectors at a maximum pressure of 300 psi. The Supercath 5 (Proposed) catheter hub has a built-in check valve which together with the healthcare professional's finger pressure on the blood vessel, assists to reduce blood flashback when the metallic introducer needle is withdrawn following blood vessel puncture. The built-in check valve is not intended to stop bleeding completely. Pressing the button on the needle hub activates the coiled spring in the hub, retracting the metallic introducer needle into the needle hub. The Supercath 5 (Proposed) introducer needle has a side-notch to provide rapid visual confirmation of vessel entry. When the introducer needle is inserted into the vein, blood flows up and through the side-notch and returns down along the inside of the catheter tube. The Supercath 5 (Proposed) is available in 14G, 16G, 18G, 20G, 22G, 24G and 26G.

The provided text is a 510(k) summary for the Supercath 5, an intravascular catheter. This document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device, rather than a clinical study evaluating the device's performance against specific acceptance criteria for diagnostic output.

Therefore, the document does not contain the information requested regarding:

• A table of acceptance criteria and reported device performance for an AI/diagnostic algorithm.
• Sample sizes used for a test set or data provenance for such a study.
• Number of experts or their qualifications for establishing ground truth for a test set.
• Adjudication methods for a test set.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness study results.
• Standalone (algorithm only) performance data.
• Type of ground truth used for an AI/diagnostic algorithm.
• Sample size for a training set.
• How ground truth for a training set was established.

The performance data mentioned in section "i. Performance data" (page 9) refers to engineering and biological performance tests for the catheter device itself, such as:

• Biocompatibility testing (e.g., hemocompatibility, according to ISO 10993-1).
• Catheter burst pressure test (according to ISO 10555-1).
• Vent fitting test for the needle hub (according to ISO 10555-5).
• Flow rate test (according to ISO 10555-1).
• Ease of assembly performance testing for the plunger (according to ISO 594-2).
• Tensile strength testing for the cap.
• Sterilization validation (according to ISO 11135) and shelf-life testing.

These tests are standard for medical device safety and functionality but are not related to the acceptance criteria or study design for an AI-powered diagnostic device as requested in the prompt.

In summary, the provided text does not contain the information required to answer the prompt because it pertains to the regulatory submission for a physical medical device (an intravascular catheter) and its engineering performance, not an AI/diagnostic software or algorithm.

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The Supercath 5 is intended to access a vein or artery and to administer fluids. The Supercath 5 is designed for single use, and is designed to minimize inadvertent needlesticks and to reduce accidental needlesticks.

The Supercath 5 (26G) is intended to access a vein or artery and to administer fluids. The Supercath 5 (26G) is designed for single use, and is designed to minimize inadvertent needlesticks and to reduce accidental needlesticks.

This device is a single-use and provided with ethylene oxide (EO) sterilization. Its shelf life is 3 years. The device is available in 26G and effective length of 19mm.

The introducer needle of the Supercath 5 (26G) has a side-notch to provide rapid visual confirmation of vessel entry. When the introducer needle is inserted into a vessel, blood passes through the side-notch and flows back along the inside of the catheter.

The Supercath 5 (26G) has a safety system. Pressing an activation button results in retracting the metallic introducer needle into a safety cover. This safety system enables to avoid needle-stick accident and further exposure of blood or body fluid attached to the introducer needle.

Some versions of the Supercath 5 (26G) have a built-in check valve which together with a healthcare professional's finger pressure on a blood vessel assists to reduce blood flashback during and after the retraction of the metallic introducer needle to the safety cover until the connection of an infusion or transfusion set to the catheter hub. The built-in check valve is not intended to stop bleeding completely.

The provided document is a 510(k) premarket notification for a medical device called "Supercath 5 (26G)", an intravascular catheter. This document does not describe a study involving an AI/algorithmic device, but rather a traditional medical device (a catheter). Therefore, the requested information about acceptance criteria for AI performance, study design, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, as well as the method for establishing ground truth for AI algorithms, cannot be extracted from this document, as it pertains to a different type of device evaluation.

The document focuses on demonstrating substantial equivalence to a predicate device (Supercath 5, K140419) based on design, materials, technological characteristics, sterilization, biocompatibility, and bench performance testing for the physical device.

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The SUPERCATH 5 is intended to access a vein or artery and to administer fluids. The SUPERCATH 5 is designed for single use and for short-term use (less than 30 days), is designed to minimize inadvertent needlesticks and to reduce accidental needlesticks.

The device is an intravascular catheter known by the trade name SUPERCATH 5 (PROPOSED). It is available in four models, with a check valve, with a side-notch needle, with a check valve and a side-notch needle, and without both a check valve and a notched needle. The SUPERCATH 5 (PROPOSED) is intended to access a vein or artery and to administer fluids. The SUPERCATH 5 (PROPOSED) is designed for single use and for short-term use (less than 30 days), is designed to minimize inadvertent needlesticks and to reduce accidental needlesticks. The SUPERCATH 5 (PROPOSED) catheter hub has a built-in check valve which together with the healthcare professional's finger pressure on the blood vessel, assists to reduce blood flashback when the metallic introducer needle is withdrawn following blood vessel puncture. The built-in check valve is not intended to stop bleeding completely. Pressing the button on the needle hub activates the coiled spring in the hub, retracting the metallic introducer needle into the needle hub. The SUPERCATH 5 (PROPOSED) introducer needle has a side-notch to provide rapid visual confirmation of vessel entry. When the introducer needle is inserted into the vein, blood flows inside of the catheter and returns down along the inside of the catheter tube. The SUPERCATH 5 (PROPOSED) is available in 14G, 18G, 20G, 20G, 22G and 24G.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, 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

• Test Set Sample Size: Over 500 tests were performed across different test conditions and five different catheter sizes for the SUPERCATH 5 (PREDICATE). It is explicitly stated that these results are considered applicable to the SUPERCATH 5 (PROPOSED) due to the nature of the modifications not affecting the safety feature.
• Data Provenance: The study was a "simulated use clinical environment" test. The document does not specify the country of origin where the actual testing took place, but the manufacturer is Japanese (TOGO MEDIKIT CO., LTD.). It was a prospective study designed to evaluate the safety feature.

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

• Number of Experts: Eight (8) healthcare professional volunteers were recruited for the simulated clinical use study.
• Qualifications of Experts: The volunteers "routinely use this type of catheter in their clinical practice." No further specific qualifications (e.g., years of experience, specific medical specialty) are provided.

4. Adjudication Method for the Test Set

• The document does not describe a formal adjudication method (e.g., 2+1, 3+1). The evaluation parameter was whether the needle completely retracted. It appears to be a direct observation of a functional outcome rather than an interpretation requiring adjudication between experts. The "no failures" observation suggests a clear binary outcome.

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 study is focused on the mechanical safety feature of a medical device (intravascular catheter) and does not involve AI or human readers interpreting data.

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

• No, a standalone (algorithm-only) performance test was not done. This device is a physical medical instrument, not an algorithm, and the test involved human operation in a simulated environment.

7. The Type of Ground Truth Used

• The ground truth used was functional outcome observation. The primary evaluation parameter was a direct and observable physical event: whether the metal introducer needle completely retracted into the plastic needle hub after pressing the safety button.

8. The Sample Size for the Training Set

• This information is not applicable. There is no "training set" as this device is a physical medical instrument and not an AI/machine learning algorithm. The study described is a performance validation test for a safety feature.

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

• This information is not applicable, as there is no training set for this type of device.

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The SUPERCATH 5 is intended to access a vein or artery and to administer fluids. The SUPERCATH 5 is designed for single use and for short-term use (less than 30 days), is designed to minimize inadvertent needlesticks and to reduce accidental needlesticks.

The device is an intravascular catheter known by the trade name SUPERCATH 5. It is available in two models, with a check valve and without a check valve. The SUPERCATH 5 is intended to access a vein or artery and to administer fluids. The SUPERCATH 5 is designed for single use and for short-term use (less than 30 days), is designed to minimize inadvertent needlesticks and to reduce accidental needlesticks. The SUPERCATH 5 catheter hub has a built-in check valve which together with the healthcare professional's finger pressure on the blood vessel, assists to reduce blood flashback when the metallic introducer needle is withdrawn following blood vessel puncture. The built-in check valve is not intended to stop bleeding completely. Pressing the button on the needle hub activates the coiled spring in the hub, retracting the metallic introducer needle into the needle hub to prevent needlestick injury. The SUPERCATH 5 is available in 18G, 20G, 22G and 24G.

The provided document describes the safety and effectiveness testing for the SUPERCATH 5, an intravascular catheter with a sharp needle injury prevention feature.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for the Test Set: "No failures were observed in over 500 tests" for the needle injury prevention feature. This indicates at least 500 tests were performed.
• Data Provenance: The study was conducted by TOGO MEDIKIT CO., LTD., a Japanese company. The document does not specify the country of origin for the data collection itself, but it implies it was part of their internal testing for FDA submission. The study was a "simulated use clinical environment," suggesting prospective data collection for this specific evaluation.

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

• Number of Experts: Eight (8) healthcare professional volunteers.
• Qualifications of Experts: They were described as "health care professional volunteers who routinely use this type of catheter in their clinical practice." Specific qualifications like "radiologist with 10 years of experience" are not provided, but their routine use of such catheters implies relevant experience.

4. Adjudication Method for the Test Set

The document does not describe an explicit adjudication method (e.g., 2+1, 3+1). The primary evaluation parameter was a direct observation of whether the metal introducer needle completely retracted. Since "no failures were observed," it implies a clearpass/fail outcome where no adjudication among multiple observers was necessary for discrepant findings, or if multiple observers were present, they all agreed on the absence of failure.

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 document does not describe an MRMC comparative effectiveness study involving AI or human readers. The device is an intravascular catheter with a safety feature, not an AI-powered diagnostic tool. Therefore, these metrics are not applicable.

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

This document does not describe a standalone algorithm performance study. The device is a physical medical device, not a software algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the sharp needle injury prevention feature, the ground truth was direct observation by healthcare professionals in a simulated clinical environment. The success criterion was the physical complete retraction of the needle, which is an objective measurement verified by "expert" users. For compliance with ISO and USP standards, the ground truth was adherence to published technical specifications and testing protocols.

8. The Sample Size for the Training Set

The document does not mention a "training set" as this device is a physical medical device and not a machine learning model. Therefore, this metric is not applicable.

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

As no training set (in the context of machine learning) was used or described, this information is not applicable.

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