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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 Coaxial Introducer Set is indicated for percutaneous introduction of up to a 0.038 inch guidewire or catheter into the vascular system following a small 21 gauge needle stick. The Coaxial Introducer Set is not intended for use in the coronary or cerebral vasculature.

The Coaxial Introducer Set is designed to provide dilation of the initial entry point and provide a channel for attaining vascular access. The coaxial introducer consists of an inner dilator within a slightly shorter outer sheath. The kit contains a 21 gauge introducer needle, a .018" diameter guidewire, and a 4F or 5F coaxial introducer. The coaxial introducer is offered in a standard and stiff version. The Coaxial Introducer Set is provided in sterile and non-sterile configurations.

The provided document is a 510(k) summary for a medical device (Coaxial Introducer Set) and does not describe acceptance criteria or a study proving that the device meets those criteria in the context of an AI/ML medical device. Instead, it details in-vitro bench testing conducted to assure reliable design and performance in accordance with ISO standards and/or internal procedures for a physical medical device. It also includes information about biocompatibility testing.

Therefore, many of the requested categories for AI/ML device studies cannot be populated from the given text.

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

1. Table of Acceptance Criteria and Reported Device Performance:

The document mentions in-vitro testing but does not provide specific acceptance criteria or quantitative performance metrics for each test. It only lists the types of tests performed.

2. Sample size used for the test set and the data provenance: Not applicable. This refers to physical device testing, not data for an AI/ML model.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This pertains to AI/ML model evaluation, not physical device testing.

4. Adjudication method for the test set: Not applicable. This pertains to AI/ML model evaluation.

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 document describes a physical medical device, not an AI-powered system.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This document describes a physical medical device, not an AI algorithm.

7. The type of ground truth used: For the bench testing, the "ground truth" would be objective measurements and observations against established engineering specifications and ISO standards. For biocompatibility, it's compliance with ISO 10993 standards.

8. The sample size for the training set: Not applicable. This pertains to AI/ML model training.

9. How the ground truth for the training set was established: Not applicable. This pertains to AI/ML model training.

Summary based on the provided text:

The Coaxial Introducer Set underwent in-vitro bench testing for:

• Guidewire Passage
• Air Leakage
• Liquid Leakage
• Force at Break
• Simulated Use

These tests were performed "to assure reliable design and performance in accordance with ISO standards and/or internal procedures." The specific acceptance criteria and the quantitative results (e.g., "passed 100/100 guidewire passages," or "leakage rate was X") are not provided in this summary.

Additionally, biocompatibility testing was performed, and the results demonstrated that the materials used meet the requirements of ISO 10993.

The conclusion states that the proposed devices meet the performance criteria of design verification as specified by ISO standards and test protocols, and are substantially equivalent to the legally marketed predicate devices.

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The Martech Endoscopic Injection Needle is indicated for use as an accessory for currently marketed endoscopes to provide for delivery of injectable materials into tissues during endoscopic procedures.

As with currently marketed endoscopic injection needles, the Martech Endoscopic Injection Needle may be used in a variety of endoscopic procedures for the delivery of a variety of injectable materials which have received approval for use by the FDA. The type of material to be injected will be dependent on the nature of the endoscopic procedure, but such materials may include for example: delivery of collagen during cystoscopic procedures; delivery of sclerosing agents during esophagoscopic and gastroscopic procedures; delivery of local anesthetics during cystoscopic procedures; or delivery of saline or contrast media during colonoscopic procedures.

The Martech Endoscopic Injection Needle fits within various endoscopes with working channels having a 5 French or larger inner diameter and extends beyond the proximal end of the endoscope. The Endoscopic Injection Needle is sterile, disposable and nonpyrogenic. It consists of a non-coring, 23 gauge stainless steel needle attached to a flexibe, 5 French polycarbonate catheter with luer lock hub. The luer lock hubs are designed to meet the "American National Standard for Medical Material, Luer Taper Fittings and Performance' (ANSI/HIMA MD70. i-1983). Moreover, these luer lock hubs are designed to accommodate standard syringes. To allow for smooth passage of the device through the endoscope's instrument channel, the transition between the needle and catheter assembly is tapered.

The Endoscopic Injection Needle will be provided in a variety of lengths, up to 200 cm, in order to accommodate for different length instrument channels. The needle length will be specified on the device's unit label. In general, the shorter needles with shorter endoscopes such as bronchoscopes and the longer needles may be used with longer endoscopes such as flexible gastroscopes and colonoscopes.

This is a 510(k) summary for a medical device (Martech Endoscopic Injection Needle), not a study analyzing AI/algorithm performance. Therefore, most of the requested information (acceptance criteria, study details, sample sizes, expert qualifications, etc. related to AI or algorithm performance) is not applicable and cannot be extracted from this document.

The document describes the device, its intended use, and claims substantial equivalence to predicate devices (Bard Endoscopic Injection Needle and Mill-Rose Endoscopic Injection Needle).

Here's what can be extracted based on the nature of the document:

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

• Acceptance Criteria for the device itself (not an AI/algorithm): The document implies performance criteria related to its physical characteristics and functionality. These are not explicitly stated in a quantitative table but are inferred from the description and comparison to predicate devices.
  • Fits within various endoscopes with working channels having a 5 French or larger inner diameter.
  • Extends beyond the proximal end of the endoscope.
  • Sterile.
  • Disposable.
  • Nonpyrogenic.
  • Non-coring, 23 gauge stainless steel needle.
  • Flexible, 5 French polycarbonate catheter with luer lock hub.
  • Luer lock hubs meet "American National Standard for Medical Material, Luer Taper Fittings and Performance' (ANSI/HIMA MD70. i-1983).
  • Luer lock hubs accommodate standard syringes.
  • Tapered transition between needle and catheter assembly for smooth passage.
  • Available in various lengths up to 200 cm.
• Reported Device Performance (as implied by the 510(k) summary): The document asserts that the device meets these implied criteria by claiming substantial equivalence to predicate devices that have already demonstrated safety and effectiveness for these functions. The 510(k) process relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device. There are no specific quantitative performance metrics reported in this summary that would typically be found in an algorithm performance study (e.g., sensitivity, specificity, accuracy).

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

• Not applicable. This is not an AI/algorithm performance study. The 510(k) summary does not detail a "test set" in this context.

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

• Not applicable. This is not an AI/algorithm performance study.

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

• Not applicable. This is not an AI/algorithm performance study.

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/algorithm performance study.

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

• Not applicable. This is not an AI/algorithm performance study; it's a physical medical device.

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

• Not applicable in the context of an algorithm. The "ground truth" for this device's safety and effectiveness is established through adherence to standards (ANSI/HIMA MD70. i-1983) and comparison to predicate devices for which safe and effective use has already been demonstrated in clinical practice.

8. The sample size for the training set

• Not applicable. This is not an AI/algorithm development.

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

• Not applicable. This is not an AI/algorithm development.

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