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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 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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