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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 PTFE Super Sheath Introducers are intended to obtain central venous access to facilitate catheter insertion or placing pacing leads into the central venous system.

The PTFE Super Sheath Introducer 2.1 is a catheter introducer. The sole difference between the predicate device (K130855; Super Sheath 2.0) and the proposed device is the material change to dilatory. The dilator material that was approved in the predicate 510K submission was nylon, the proposed has a dilator composed of a nylon/Pebax blend.

The provided text is a 510(k) premarket notification for a medical device (PTFE Super Sheath Introducer 2.1) and does not describe acceptance criteria or a study that proves the device meets specific performance criteria in the context of an AI/ML medical device.

The document discusses substantial equivalence to a predicate device (PTFE Super Sheath Introducer 2.0, K130855) for a physically manufactured medical instrument, not a software-based AI/ML device. The "Bench / Performance Data" section lists in-vitro tests performed, but these are for the physical properties of the introducer, such as liquid leakage, air leakage, force at break, simulated use, and equipment interaction. There is no mention of an algorithm, AI, or machine learning model.

Therefore, I cannot extract the requested information (acceptance criteria table, sample size for test/training sets, data provenance, number of experts, adjudication method, MRMC study, standalone performance, or ground truth details) because the provided text is not about an AI/ML medical device study.

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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 PTFE Super Sheath Introducers are intended to obtain central venous access to facilitate catheter insertion or placing pacing leads into the central venous system.

The PTFE Super Sheath Introducer with Sheath/Dilator assembly facilitates vasular access for placement of intravascular catheters. Inserting an introducer needle into the desired vessel allows for initial access to the vascular system. A guide wire is then placed into the vessel through the needle and the needle is then removed. The sheath/dilator assembly is then inserted over the guide wire and into the percutaneous opening to dilate the opening into the vessel. The dilator and guide wire are then removed leaving the sheath in place. A catheter can then be placed through the sheath. Breaking the sheaths hub and peeling the sheath away from the catheter then allows the sheath to be removed. Its frame is composed of Teflon, HDPE, and Nylon. The sheath hub and dilator hub all HPDE, while the sheath tube is PTFE (Teflon) and the dilator is either Nylon for the 3F through the 5.5F sizes or HDPE for the 6F through 9F sizes. The Super Sheath's sheath is gray in color, with either a Light Blue Nylon dilator (3F-5.5F) or gray HDPE dilator (6F-9F). The dilator hub is composed of a different color to identify each individual French size (3F Purple, 3.5F Pink, 4F Red, 4.5F Yellow. 5F Light Gray, 5.5F Dark Gray, 6F Green, 6.5F Light Green, 7F Orange, 8F Blue, and 9F White), The PTFE Super Sheath 2.0 is available in eleven (11) different French sizes ranging from 3F to 9F. The Introducers are available with 5cm, 7cm or 10cm length options.

Here's an analysis of the provided text regarding the acceptance criteria and study for the MARTECH MEDICAL PRODUCTS PTFE Super Sheath Introducer 2.0:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text lists the following in-vitro testing performed:

Note regarding the table above: The document states that these tests were performed "to assure reliable design and performance in accordance with ISO standards and/or internal procedures." It doesn't provide specific quantitative acceptance criteria or detailed numerical results for each test. Instead, it offers a general statement of compliance.

Study Details:

Based on the provided text, the "study" conducted for this medical device is a series of bench/performance data (in-vitro testing) and biocompatibility testing.

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

• Sample Size for Test Set: The document does not specify the sample size for individual tests (e.g., how many sheaths were tested for liquid leakage or force at break).
• Data Provenance: The data is generated from in-vitro testing. The country of origin is not explicitly stated for the data, but the submitter is based in Harleysville, PA, USA. The study is retrospective in the sense that these tests were conducted on the manufactured product to demonstrate compliance.

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

This information is not applicable as the study described is purely for a physical medical device and involves in-vitro (bench) testing and biocompatibility assessments, not the interpretation of human data or images requiring expert consensus for ground truth.

4. Adjudication Method for the Test Set

This information is not applicable for the reasons stated in point 3.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is typically relevant for diagnostic imaging or AI devices that interact with human readers, which is not the nature of the PTFE Super Sheath Introducer 2.0.

• Effect Size: Not applicable.

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

No, a standalone algorithm-only performance study was not done. This is not an AI/algorithm-driven device. The performance data is for the physical device itself.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established through:

• Physical measurement and observation against pre-defined engineering and safety specifications (for liquid leakage, force at break, simulated use, equipment interaction, surface examination).
• Chemical/biological testing against established international standards (ISO 10993 for biocompatibility).

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" as this is not a machine learning or AI device.

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

This information is not applicable for the reasons stated in point 8.

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The PTFE Super Sheath Introducers are intended to obtain central venous access to facilitate catheter insertion or placing pacing leads into the central venous system.

The PTFE Super Sheath Introducer with Sheath/Dilator assembly facilitates vascular access for placement of intravascular catheters. Inserting an introducer needle into the desired vessel allows for initial access to the vascular system. A guide wire is then placed into the vessel through the needle and the needle is then removed. The sheath/dilator assembly is then inserted over the guide wire and into the percutaneous opening to dilate the opening into the vessel. The dilator and guide wire are then removed leaving the sheath in place. A catheter can then be placed through the sheath. Breaking the sheaths hub and peeling the sheath away from the catheter then allows the sheath to be removed. Its frame is composed of mostly HDPE, as the sheath hub, dilator and dilator hub are all HPDE. The sheath tube is composed of PTFE (Teflon). The Super Sheath if gray in color with the exception of the dilator hub which is composed of a different color to identify each individual French size (3F Purple, 3.5F Pink, 4F Red, 4.5F Yellow, 5F Light Gray, 5.5F Dark Gray, 6F Green, 6.5F Light Green, 7F Orange, 8F Blue, and 9F White). The PTFE Super Sheath is available in eleven (11) different French sizes ranging from 3F to 9F. The Introducers are available 3F-7F with a Scm length or 3F-9F in the 10cm length option.

The medical device in question is the "PTFE Super Sheath Introducer" manufactured by MARTECH MEDICAL PRODUCTS. This device is intended to obtain central venous access to facilitate catheter insertion or placing pacing leads into the central venous system.

Based on the provided text, the acceptance criteria and the study that proves the device meets these criteria can be summarized as follows:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document does not specify the exact sample sizes used for each in-vitro test. It only states that "in-vitro testing was performed." The provenance of the data is not explicitly mentioned (e.g., country of origin), nor whether the tests were retrospective or prospective, though in-vitro tests are inherently experimental and controlled, rather than observing pre-existing data.

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. The device is a medical introducer sheath, and the testing described is primarily mechanical and material performance (in-vitro bench testing) and biocompatibility, not diagnostic or clinical performance that would require expert-established ground truth.

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

This information is not applicable as the testing involves objective measurements against predefined ISO standards and internal procedures, not subjective human assessment needing 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. The device is a physical medical instrument (introducer sheath), not an AI-powered diagnostic tool, and therefore MRMC studies with human readers are not relevant.

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

This information is not applicable. The device is a physical medical instrument; there is no algorithm or AI component involved.

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

For the in-vitro bench testing, the "ground truth" would be the specifications and requirements outlined in the applicable ISO standards and the manufacturer's internal procedures for device design and performance. For biocompatibility, the ground truth is established by ISO 10993 standards. For the substantial equivalence claim, the ground truth is the performance and characteristics of the legally marketed predicate devices.

8. The sample size for the training set

This information is not applicable as the device is not an AI/machine learning system that requires a "training set." The performance is validated through physical and chemical testing.

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

This information is not applicable for the same reason as above; there is no training set for this 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 Medikit 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.

The Medikit Super Sheath Introducer XL Sheaths and Super Sheath XL Introducer Sheath Sets are similar to the 4-9F sheaths with the addition of four French sizes to the sheath line. The Super Sheath XL Introducer Sheaths are available in 10F, 11F, 12F and 14F sizes and available in lengths ranging from 11 to 25 cm. The devices are provided sterile and are intended for one procedure use only. The Medikit Super Sheath XL Introducer Sheath is packaged with a dilator. The Super Sheath Introducer XL Sheath Set consists of a sheath, a dilator and a mini guidewire, with inserter. The mini guidewires with inserter were cleared to market in K052557 (January 17, 2006). The construction of the sheath shaft and hub allows smooth passage of medical devices. The sheath shaft and hub are made of polyamide and fluorinated ethylene propylene FEP (Teflon). The hubs, color-coded by French size, contain 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 and facilitates and supports the entry of the sheath into the patient's vasculature. The dilator is longer than the sheath with a rounded tapered distal tip. Once the sheath is in place the dilator is removed. The dilators are 0.038" and a 0.035" guidewire compatible. The dilator tubes are made of fluorinated ethylene propylene (FEP). The dilator tubes are attached to the dilator hub using an epoxy resin. The sheath hub and the dilator hub lock using a rotating motion.

The provided text is a 510(k) premarket notification for a medical device (introducer sheaths) and does not describe acceptance criteria or a study that proves a device meets those criteria in the context of an AI/ML clinical validation study. Instead, it details the non-clinical (bench) testing performed to demonstrate substantial equivalence to a predicate device.

Therefore, many of the requested categories are not applicable to the provided document.

Here's a breakdown of what can be extracted and what cannot:

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

The document describes several non-clinical tests but does not explicitly state acceptance criteria in a quantitative format or report performance against specific thresholds. It generally states that "Test results verified that the Super Sheath XL Introducer Sheaths and Super Sheath XL Introducer Sheath Sets are adequate for their intended use."

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

• Sample Size: Not specified for individual non-clinical tests.
• Data Provenance: N/A (non-clinical bench testing, not human data).

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

N/A. Ground truth in this context would be test standards/specifications, not expert interpretation of data.

4. Adjudication method for the test set:

N/A. This is relevant for diagnostic studies, not bench testing.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

N/A. This document describes a medical device, not an AI/ML diagnostic system, and no MRMC study was conducted.

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 non-clinical tests, the "ground truth" would be the established engineering specifications and performance standards for introducer sheaths, which are not detailed in this summary but are referred to as "product specification."

8. The sample size for the training set:

N/A. No training set is applicable as this is not an AI/ML device.

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

N/A. No training set.

Summary of Device-Specific Information from the Text:

The document describes the Super Sheath XL Introducer Sheaths and Super Sheath XL Introducer Sheath Sets, which are indicated for the introduction of diagnostic and interventional devices into the human vasculature.

Study Type: Non-clinical (bench) testing was performed to verify that the device met product specifications and to establish substantial equivalence to a predicate device (Medikit Super Sheath Introducer Sheaths and Super Sheath Introducer Sheath Sets, K052557).

Tests Performed:

• Sheath Shaft Tensile test
• Sheath Kink Test
• Sheath Hub to Shaft Tensile Test
• Hemostatic Valve Integrity/Sheath Pressure Test
• Sheath Valve Integrity/Sheath Pressure Test
• Dilator Shaft Tensile Test
• Dilator Hub to Shaft Tensile Test
• Real Time Product Shelf Lift Testing
• (Also referenced from predicate device testing: Lubricity, radiopacity, sheath/dilator corrosion resistance testing, biocompatibility, and package test reports).

Conclusion of Testing: "Test results verified that the Super Sheath XL Introducer Sheaths and Super Sheath XL Introducer Sheath Sets are adequate for their intended use. Based on a comparison of intended use, design and the results of bench testing, Medikit 10F, 11F, 12F, and 14F Super Sheath XL Introducer Sheaths and Super Sheath XL Introducer Sheath Sets have been shown to be substantially equivalent to the predicate (K052557) device."

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Introducer Sheaths and Introducer Sheath Sets are intended for use in the introduction of diagnostic and interventional devices into the human vasculature.

The Super Sheath Introducer Sheaths are available in-4F-Device Description 9F diameters and available in lengths ranging from 7 to 25 cm. Some sheaths may be ordered with a suture wing and some sheaths have radiopaque markers. The devices are provided sterile and are intended for one procedure use only.

The Medikit Super Sheath Introducer Sheath is packaged with a dilator. The Super Introducer Sheath Sets consists of a sheath, a dilator and a mini guidewire, with Inserter, as described in this submission or a US commercially available mini guidewire meeting Medikit specifications. The one-piece construction of the sheath shaft and hub allows smooth passage of medical devices. The sheath shaft and hub are made of polyamide and Ethylene shart and mac mac the (Teflon). Some sheaths have radiopaque markers that are embedded into the shaft 1.5 mm from the distal tip. The hubs, color-coded by French size, contain 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 sidetube extension is used for site management.

The dilator is an open tapered plastic tube with an integral luer hub for guidewire insertion. It is inserted into the introducer sheath and facilitates and supports the entry of the sheath into the patient's vasculature. The dilator is longer than the sheath with a rounded tapered distal tip. Once the sheath is in place the dilator is removed. There are two different dilators, 0.038" and a 0.035" guidewire compatible. The 4-8F-dilator tubes are made from Polypropylene (PP). The 9F dilator tubes are made of Fluorinated Ethylene Propylene (FEP). The dilator tubes are pressed into the dilator hub with a bushing. The sheath hub and the dilator hub lock using a rotating motion.

Super Sheaths can be ordered with a Polypropylene suture wing 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 mini 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 mini guidewire (with Inserter) is available in 45cm and 80cm lengths. The Inserter does not contact blood and is used strictly for guiding the guidewire into a cannula or introducer. A US commercially available mini guidewire (meeting Medikit specifications) may be used in the sets or the mini guidewire that is described in this submission.

This is a medical device submission for a "Super Sheath Introducer Sheath" which is a physical device, not an AI/ML powered device. Therefore, the questions regarding acceptance criteria and study details for an AI/ML device are not applicable to this document. The document describes functional testing of the physical device to demonstrate substantial equivalence to a predicate device, as opposed to performance metrics for an AI/ML algorithm.

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