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The Super Sheath Introducer Sheath is indicated for use in the introduction of diagnostic and interventional devices inserted into the human vasculature of adult and pediatric patients of all ages.

The Super Sheath Introducer Sheath (hereinafter referred to as the "Subject Device") is used to introduce diagnostic or interventional devices into a blood vessel. The Subject Device is available in two products: one consisting of a Sheath and Dilator (Super Sheath Introducer Sheath without Guidewire), and the other consisting of a Sheath, Dilator, and Guidewire (Super Sheath Introducer Sheath with Guidewire), similar to the Predicate Device K121504. These devices are provided sterile and intended for single use, and the shelf-life is three years.

The main component of the Sheath consists of a Sheath hub, a Sheath shaft connected to the Sheath hub, and a three-way stopcock valve connected to the hub with a side port tube. The Sheath shaft is 3.3 French size and available in 5cm and 7cm lengths. The Sheath hub contains a hemostatic valve and has a suture wing. The shape and dimensions of the three-way stopcock luer connector are modified to comply with the new applicable standard ISO 80369-7:2021.

The Dilator has an open, tapered plastic tube for Guidewire insertion. The Dilator tube is press-fit into the inner hub with a bushing. The length of the Dilator tube corresponds to the length of the Sheath shaft, which is longer and available in 10.5 cm and 12.5 cm.

The 0.018" Guidewire is the smallest size Guidewire and a 40 cm long, thin, flexible wire with a inserter attached to the tip. This Guidewire is a legally marketed product which is cleared by the Food and Drug Administration (K021990).

The upper cap and suture wing of the Sheath hub, and the Dilator hub are colored purple. The Dilator tube and the inserter are colored blue. And the unvented cap of the three-way stopcock is pink.

This document is a 510(k) premarket notification for a medical device called the "Super Sheath Introducer Sheath". This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific acceptance criteria through a clinical study or performance data like an AI/ML diagnostic device would.

Therefore, the provided text does not contain the information requested regarding acceptance criteria and a study to prove a device meets those criteria for an AI/ML-based device. The original request is formulated for a performance study of a diagnostic device (likely AI-powered), which requires metrics like sensitivity, specificity, or AUC, and details on clinical validation with ground truth.

The document describes a physical medical device (an introducer sheath), and its substantial equivalence is proven through:

• Bench Testing: Mechanical and physical properties (tensile strength, kink resistance, connection strength, pressure tests, lubricity, radiopacity, corrosion resistance).
• Biocompatibility Testing: Cytotoxicity, intracutaneous reactivity, sensitization, acute systemic toxicity, hemocompatibility, pyrogen test, LAL test.
• Comparison of Technological Characteristics: To a predicate device (K121504) across features like French sizes, indications for use, regulation numbers, components, sterilizations, and dimensional comparisons.

In summary, the provided document does not allow for a response to the specific questions regarding acceptance criteria and performance study details for an AI/ML device.

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The device is indicated for use in the introduction of diagnostic and interventional devices inserted into the peripheral and coronary vasculature.

Major components of the Super Sheath (Proposed) are a sheath and a dilator. In addition, a guidewire is covered under this premarket notification. The guidewire is placed in the guidewire case including the inserter. The sheath for the Super Sheath (Proposed) is named as the Super Sheath (Proposed) Introducer Sheath and is available in 4F- 9F diameters and in lengths ranging from 7 to 25 cm. Some types of sheaths have radiopaque markers. The Super Sheath (Proposed) are provided sterile and are intended for one procedure use only. The one-piece construction of the sheath shaft and hub allows smooth passage of concomitantly used interventional medical devices. The sheath shaft and hub are made from Ethylene Tetrafluoro ethylene (ETFE) and polyamide. The hubs contain a hemostatic valve to minimize 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. Some types of sheaths contain a marker band that is embedded in the shaft approximately 2.0 mm from the distal tip. The dilator is an open tapered plastic tube with an integral luer hub for guidewire insertion. The dilator is inserted into the introducer sheath. The dilator is longer than the sheath with a rounded tapered distal tip. The dilator facilitates and supports the entry of the sheath into the patient's vasculature. Once the sheath is in place, the dilator is removed. There are two different dilator distal tip sizes, 0.038" and 0.035" guidewire compatible. The 4F dilators are only available with a 0.035"guidewire lumen dilator. The 5-9F dilators are available with a 0.035" or 0.038" guidewire lumen. The 4-8F dilator tubes are made from Polypropylene (PP). The 9F dilator tubes are made from Fluorinated Ethylene Propylene. The dilator tubes are attached to the inner hub with a metal bush. The dilator is locked into the sheath by rotating motion. The Super Sheath (Proposed) has a polypropylene suture wing which is color coded by French size. The suture wing is a small projection near the hub with a hole in it for correct placement of the sheath using sutures. The uncoated guidewire is made of a stainless steel coil wrapped tightly around an inner mandrel that tapers at the distal tip. The flexible tip is J-shaped available in diameters of 0.035" and 0.038". The guidewire, with inserter, is available in 45 cm and 80 cm lengths. The inserter is used strictly for guiding the guidewire into a cannula or introducer.

The provided text describes a 510(k) submission for a medical device called "Super Sheath" (Proposed), which is a vessel dilator for percutaneous catheterization. The submission aims to demonstrate substantial equivalence to a predicate device, also named "Super Sheath" (K141070).

This document does not include information about AI/ML algorithms, human-in-the-loop performance, or the establishment of ground truth by expert consensus. Therefore, many of the requested elements for describing the acceptance criteria and study proving device performance will be inapplicable. The study's focus is on non-clinical performance testing to support changes in materials and an extended shelf-life for a physical medical device.

However, I can extract the relevant information regarding the acceptance criteria and the performance testing conducted for this traditional medical device.

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

The document details performance testing for the "Super Sheath" (Proposed) to support modifications from the predicate device, specifically for an extended shelf-life and changes to the 8F dilator. The acceptance criteria are described as "established methods and acceptance criteria in conformity with ISO 11070:2014 and the submission under the predicate device without deviation."

Table: Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify exact sample sizes for each test. It refers to "testing" performed.
• Data Provenance: The testing was conducted by Togo Medikit Co., Ltd. in Japan. The data is likely from prospective testing, as it was performed to support design modifications and an extended shelf-life for the proposed device before its market introduction.

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

• Not Applicable. This is a physical device with performance testing based on established engineering standards (e.g., ISO 11070:2014) and direct measurements, not expert human interpretation (like radiology image analysis).

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

• Not Applicable. As mentioned above, this is non-clinical performance testing of a physical device against engineering standards, not a study involving human adjudication of clinical output.

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, nor does it involve human readers or image analysis.

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

• Not Applicable. This is not an AI/ML algorithm.

7. The type of ground truth used:

• The "ground truth" for this device's performance is established by engineering standards, material specifications, and physical measurements (e.g., tensile strength, dimensional accuracy, leak integrity, biocompatibility test results). It is based on a comparison to the predicate device's performance and compliance with relevant ISO standards (ISO 10993 for biocompatibility, ISO 11070 for catheter/dilator performance).

8. The sample size for the training set:

• Not Applicable. This is not an AI/ML device that requires a training set.

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

• Not Applicable. No training set was used.

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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 6 is intended to access a vein or artery and to administer fluids. The SUPERCATH 6 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 18 -22 gauge catheters may be used with power injectors at a maximum pressure of 300 psi.

The SUPERCATH 6 is intended to access a vein or artery and to administer fluids. The SUPERCATH 6 is designed for single use and for short-term use (less than 30 days) 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 6 has technological characteristics as follows;

Its 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 introducer needle of the SUPERCATH 6 has a side-notch to provide rapid visual confirmation of vessel entry. When the introducer needle is inserted into the vein, blood flows upward into side-notch and returns down along the inside of the catheter tube.

The SUPERCATH 6 has a slide in order to assist insertion of the catheter. The user can choose either to push the catheter hub forward or push the slide forward to insert the catheter. When pushing the slide, the slide is stopped 12 mm forward by a stopper.

The SUPERCATH 6 is available in 14G, 16G, 18G, 20G, 22G and 24G.

The provided text describes a 510(k) premarket notification for a medical device called SUPERCATH 6, an intravascular catheter. The submission argues for substantial equivalence to a predicate device (SUPERCATH 5) and a reference device (Introcan Safety® 3 Closed IV Catheter).

However, the document does not contain information about a study proving the device meets acceptance criteria in the context of an AI/algorithm-based diagnostic or assistive device. Instead, it outlines the bench testing, biocompatibility testing, and comparison of technological characteristics to demonstrate substantial equivalence to its predicate device, which is a requirement for 510(k) clearance for medical devices.

Therefore, most of the requested information regarding acceptance criteria, sample sizes, expert ground truth, adjudication, MRMC studies, and standalone performance is not applicable to this document as it does not describe an AI/algorithm-based study.

Here's a breakdown of the relevant information from the document that can be mapped to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document describes several bench tests with their corresponding standards or in-house criteria. The "reported device performance" is generally stated as "meets acceptable minimum force," "meets allowable limits," "exceeds peak pressure," or "is impervious to air/liquid infiltration." Specific quantitative values for acceptance criteria or performance numbers are largely absent.

Information Not Found or Not Applicable (N/A) to this document:

2. Sample sizes used for the test set and data provenance: N/A. The document describes bench testing on the device itself, not a clinical test set with data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A. No expert-based ground truth is established for this type of device testing.
4. Adjudication method: N/A.
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: N/A. This is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A. This is not an algorithm.
7. The type of ground truth used: For the bench tests, the "ground truth" is determined by the physical properties of the device meeting pre-defined engineering and safety standards (e.g., tensile strength, leakage, flow rate). For biocompatibility, it's the absence of adverse biological reactions.
8. The sample size for the training set: N/A. This document does not describe an AI/algorithm.
9. How the ground truth for the training set was established: N/A.

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The device is indicated for use in the introduction of diagnostic and interventional devices inserted into the peripheral and coronary vasculature.

Major components of the SUPER SHEATH (PROPOSED) are a sheath and a dilator. In addition, a guidewire is covered under this premarket notification. The guidewire is placed in the gudiewire case including inserter. The sheath for the SUPER SHEATH (PROPOSED) is named as the SUPER SHEATH (PROPOSED) Introducer Sheath and is available in 4F- 9F diameters and in lengths ranging from 7 to 25 cm. Some types of sheaths have radiopaque markers. The SUPER SHEATH (PROPOSED) are provided sterile and are intended for one procedure use only. The one-piece construction of the sheath shaft and hub allows smooth passage of concomitantly interventional medical devices. The sheath shaft and hub are made of Ethylene Tetrafluoro ethylene (ETFE) and polyamide. The hubs, color-coded by French size, contain a hemostatic valve to minimize 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. Some types of sheaths contain a marker band that is embedded in the shaft approximately 2.0 mm from the distal tip. The dilator is an open tapered plastic tube with an integral luer hub for guidewire insertion. The dilator is inserted into the introducer sheath. The dilator is longer than the sheath with a rounded tapered distal tip. The dilator facilitates and supports the entry of the sheath into the patient's vasculature. Once the sheath is in place the dilator is removed. There are two different dilator distal tip sizes, 0.038" and 0.035" guidewire compatible. The 4F dilators are only available with a 0.035" guidewire lumen dilator. The 5-9F dilators are available with a 0.035" or 0.038" guidewire lumen. The 4bes are made from Polypropylene (PP). The 9F dilator tubes are made of Fluorinated Ethylene Propylene (FEP). The dilator tubes are attached to the inner hub with a metal bush. The sheath hub and the dilator hub lock using a rotating motion. The SUPER SHEATH (PROPOSED) has a polypropylene suture wing which is color coded by French size. The suture wing is a small projection near the hub with a hole in it for correct placement of the sheath using sutures. The uncoated guidewire is made of a stainless steel coil wrapped tightly around an inner mandrel that tapers at the distal tip. The flexible tip is J-shaped available in diameters of 0.035" and 0.038". The guidewire, with inserter, is available in 45 cm and 80 cm lengths. The inserter is used strictly for guiding the guidewire into a cannula or introducer.

The provided text describes a 510(k) premarket notification for a medical device called "SUPER SHEATH (PROPOSED)," a catheter introducer. The submission aims to establish substantial equivalence to previously marketed predicate devices, "SUPER SHEATH (K052557)" and "3.3F SUPER SHEATH (K121504)."

The acceptance criteria are not explicitly stated as numerical performance targets (e.g., "sensitivity of 90%"). Instead, the acceptance criteria are implicitly met by demonstrating that the "SUPER SHEATH (PROPOSED)" device is substantially equivalent to its predicate devices through various bench tests and biocompatibility testing. The study's goal was to ensure the proposed device's safety and effectiveness amidst material changes to the sheath shaft and packaging modifications.

1. Table of acceptance criteria and the reported device performance:

Since specific numerical acceptance criteria (e.g., target tensile strength, specific kink resistance values) are not provided in the document, the table below lists the types of tests performed and the general findings as the "reported device performance." The acceptance criteria, in this context, were that the proposed device would perform comparably to its predicate device or meet international/in-house requirements without raising new safety or effectiveness concerns.

Regarding the study proving the device meets the acceptance criteria:

The study described is a series of bench tests and biocompatibility tests designed to demonstrate that the "SUPER SHEATH (PROPOSED)" is substantially equivalent to its predicate devices, despite a material change in the sheath shaft and changes in packaging.

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

  • Sample Size: The document does not specify the exact number of devices or samples used for each bench test or biocompatibility test. It simply states that "bench testing" and "biocompatibility testing" were performed.
  • Data Provenance: The tests were conducted by TOGO MEDIKIT CO., LTD., a Japanese company. The data would therefore originate from their internal testing processes. The document does not specify if the tests were retrospective or prospective, but typically such verification tests are performed prospectively on newly manufactured devices or components.

• 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 to this type of submission. This premarket notification is for a physical medical device (catheter introducer) and its performance is evaluated through objective physical and chemical testing (bench tests, biocompatibility tests). There is no "ground truth" established by human experts in the way that an AI diagnostic device would require (e.g., radiologist consensus on images). The "ground truth" for these tests are objective measurements against established engineering standards or comparative performance against predicate devices.

• 4. Adjudication method for the test set:

  • This question is not applicable for the reasons stated above. There is no human interpretation or adjudication of "cases" as would be seen in an AI study. The results of the physical and chemical tests are objectively measured.

• 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 not an AI/software device that involves human interpretation of diagnostic data. It is a physical medical device.

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

  • This question is not applicable. This is not an AI/software device. The performance is of the physical device components.

• 7. The type of ground truth used:

  • The "ground truth" in this context refers to the objective performance criteria derived from engineering specifications, international standards, and the established performance of the predicate devices. For biocompatibility, the ground truth is the absence of adverse biological reactions/toxicity as defined by ISO standards for biocompatibility.

• 8. The sample size for the training set:

  • This question is not applicable. This submission does not involve an AI algorithm; therefore, there is no "training set." The device is a physical product.

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

  • This question is not applicable. As there is no AI algorithm, there is no training set or associated ground truth.

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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 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 up and through the side-notch and returns down along the inside of the catheter tube. The SUPERCATH 5 (PROPOSED) is available in 14G, 18G, 20G, 20G, 22G and 24G.

This document, K140419, is a 510(k) premarket notification for a medical device, specifically an "Intravascular Catheter" named SUPERCATH 5. The submission focuses on demonstrating substantial equivalence to previously marketed predicate devices (K093546 and K112290) rather than proving performance against specific acceptance criteria for a novel AI/ML device. Therefore, the requested information related to AI/ML device performance (acceptance criteria, study details, human reader improvement, standalone performance, ground truth, and training set details) is not applicable to this 510(k) submission.

This submission is for a conventional medical device, an intravascular catheter, and the evidence provided is primarily through bench testing, biocompatibility testing, and a comparison to predicate devices, not an AI/ML effectiveness study.

Here's an analysis of the provided text, focusing on the information that is present regarding device evaluation:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes several bench tests and their general acceptance criteria rather than presenting them in a formal table with specific quantitative pass/fail values. The "reported device performance" is a general statement that the device "meets" or "is impervious to" the criteria.

Biocompatibility Testing:
The acceptance criterion for biocompatibility tests is the absence of concerns. The reported performance is a general statement that "no biocompatibility concern was raised."

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

• Test Set Sample Size: For the bench testing, specific sample sizes are not explicitly stated in the provided text for each test. For biocompatibility, the 14G SUPERCATH 5 (PROPOSED) was used as a sample, noted as being the "largest size."
• Data Provenance: The document implies that the testing was conducted by TOGO MEDIKIT CO., LTD. in Japan, as they are the listed owner/company. The data is prospective, generated specifically for this submission.

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

Not applicable. This is a conventional medical device undergoing physical and chemical property testing and biocompatibility assessments, not a diagnostic AI/ML device requiring expert-established ground truth on a test set.

4. Adjudication Method for the Test Set:

Not applicable. As described above, the tests are objective measurements of physical and chemical properties and biological reactions, not subjective interpretations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

Not applicable. This type of study is relevant for AI/ML diagnostic tools that assist human readers. The SUPERCATH 5 is an intravascular catheter.

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

Not applicable. This device is not an algorithm.

7. The Type of Ground Truth Used:

For the bench tests, the "ground truth" is defined by the objective measurement standards (e.g., ISO 10555-1, ISO 10555-5, or in-house standards) and the physical properties of the device. For biocompatibility, it's about the absence of adverse biological reactions, confirmed by standard biological testing protocols.

8. The Sample Size for the Training Set:

Not applicable. This device does not involve machine learning; therefore, there is no training set in the context of AI/ML.

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

Not applicable. No training set exists for this type of device.

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The Super Sheath Introducer Sheaths and Super Sheath Introducer Sheath Sets are indicated for use in the introduction of diagnostic and interventional devices inserted into the human vasculature of adult and pediatric patients of all ages.

The Super Sheath Introducer Sheaths and Super Sheath Sets are similar to the 4F-9F with the addition of the 3.3 French sheath, compatible dilator and guidewire to the sheath line. The Super Sheath Introducer Sheath is available in 3.3F and lengths of 5 cm and 7 cm. The device is provided sterile and intended for one procedure use only.

The Super Sheath Introducer Sheath is packaged with one dilator. The Super Sheath Introducer Sheath Set consists of one sheath, one dilator, and one guidewire with inserter. The sheath shaft and hub are manufactured of polyamide and ethylene tetrafluoro ethylene; 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 3.3F Super Sheath Introducer Sheaths and provided dilator are compatible with a maximum recommended 0.025" guidewire. 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.

The provided text describes a medical device (Super Sheath Introducer Sheaths and Sets) and its equivalence to a predicate device, rather than the acceptance criteria and study results for a new AI or diagnostic device. As such, most of the requested information (sample sizes, expert qualifications, MRMC studies, ground truth types, training data, etc.) is not applicable or present in this document.

However, I can extract the information related to the functional testing conducted to establish the performance of this medical device.

Acceptance Criteria and Device Performance (Functional Testing)

The document states that "Functional testing was conducted to verify the 3.3F Super Sheath Introducer Sheaths and Super Sheath Introducer Sheath Sets met product specification." While specific numerical acceptance criteria are not provided, the types of tests performed indicate the performance characteristics that were evaluated and met.

Study Details (for a medical device, not AI)

1. Sample size used for the test set and the data provenance: Not explicitly stated. The testing was functional/engineering testing of the device itself, not patient data. Therefore, "data provenance" in terms of country of origin or retrospective/prospective is not applicable.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. These were non-clinical, functional tests performed according to protocols. "Ground truth" in this context would refer to engineering specifications and international standards, not expert medical opinion.
3. Adjudication method for the test set: Not applicable. Results would be compared against established product specifications and standards.
4. If a multi reader multi case (MRMC) comparative effectiveness study was done: No, not applicable. This is not an AI or diagnostic imaging device.
5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No, not applicable.
6. The type of ground truth used: Product Specifications, International Standards (e.g., ISO 11135-1:2007 for sterilization), and in-house requirements.
7. The sample size for the training set: Not applicable. This document describes the testing of a physical medical device, not a machine learning model.
8. How the ground truth for the training set was established: Not applicable.

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The SUPERCATH Z3V is intended to access a vein or artery and to administer fluids. The SUPERCATH Z3V is designed for single use, is intended for short-term use (less than 30 days), and is intended to minimize inadvertent needlesticks and to reduce accidental needlesticks.

The SUPERCATH Z3V (PROPOSED) is an intravascular catheter and is available in following eight models.

1. with a check valve
2. with a wing
3. with a filter adapter
4. with a check valve and a wing
5. with a check valve and a filter adapter
6. with a wing and a filter adapter
7. with a check valve, a wing, and a filter adapter
8. without a check valve, a wing, or a filter adapter
   The SUPERCATH Z3V (PROPOSED) is intended to access a vein or artery and to administer fluids. The SUPERCATH Z3V (PROPOSED) is designed for single use, is intended for short-term use (less than 30 days), and is intended to minimize inadvertent needlesticks and to reduce accidental needlesticks by the safety system. In the safety system, the metallic introducer needle is retracted into the extendable needle casing.
   The SUPERCATH Z3V (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.
   Some of the SUPERCATH Z3V (PROPOSED) has a filter adapter. The filter adapter can be removed and the SUPERCATH Z3V (PROPOSED) can be connected to a syringe in place of the filter adapter, under negative pressure and assist visual confirmation of blood access.
   The SUPERCATH Z3V (PROPOSED) is available in 14G, 18G, 20G, 22G, and 24G.

The provided text is a 510(k) summary for a medical device (intravascular catheter) and focuses on demonstrating substantial equivalence to predicate devices, rather than an AI/ML device with specific performance metrics and a clinical study as typically described for such products.

Therefore, many of the requested categories (e.g., number of experts for ground truth, adjudication method, MRMC study, training set details) are not applicable to this document as it describes a non-AI/ML medical device.

I will extract the relevant information available for this type of device (bench testing and a simulated clinical study for a sharps injury prevention feature).

Here's the analysis of the provided text, focusing on the available information regarding acceptance criteria and studies:

1. Table of Acceptance Criteria and Reported Device Performance

For non-AI/ML devices like this catheter, performance is typically demonstrated through compliance with established international standards (e.g., ISO) and in-house standards through bench testing. The document lists several bench tests and their outcomes.

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

• Bench Testing: The document states "All SUPERCATH Z3V (PROPOSED) samples were compliant..." but does not specify the sample size for each bench test.
• Simulated Clinical Study (Sharps Injury Prevention Feature): The document mentions a "Simulated Clinical Use of Study" was performed to confirm a statistically significant safety feature. However, no specific sample size or data provenance (country of origin, retrospective/prospective) is provided for this study.

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

• Not Applicable. For a medical device like an intravascular catheter, "ground truth" established by experts in the context of clinical interpretation (e.g., reading images) is not relevant. The performance is assessed via engineering tests and biological safety tests.

4. Adjudication Method for the Test Set

• Not Applicable. See point 3.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size

• No. An MRMC study is relevant for diagnostic imaging devices where multiple readers interpret cases. This document describes an intravascular catheter, not an AI/ML diagnostic system.

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, so there is no "algorithm only" performance to evaluate. The device is a physical, mechanical product.

7. The Type of Ground Truth Used

• For Bench Testing: The "ground truth" is typically defined by the ISO standards or in-house engineering specifications that dictate acceptable performance limits (e.g., minimum tensile strength, maximum leakage).
• For Biocompatibility Testing: The "ground truth" reflects the absence of adverse biological reactions as assessed by standard biological safety tests (e.g., cytotoxicity, irritation).
• For Sharps Injury Prevention Feature: The "ground truth" would be the quantifiable reduction in simulated needlesticks compared to a control or a defined safety threshold. The study confirmed a "statistically significant safety feature."

8. The Sample Size for the Training Set

• Not Applicable. This is not an AI/ML device that requires a training set.

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

• Not Applicable. See point 8.

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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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