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The Percutaneous Introducer is intended to allow for the percutaneous placement of devices, needles or probes, in close proximity to nerves and around or into surgical wound or non-surgical wound sites. It may be used to inject or aspirate the introduction area via the luer hub of the needle/introducer.

The Percutaneous Introducer is a single-use, disposable device consisting of a flexible polymer sheath with a molded plastic hub. The device incorporates a stainless steel needle inside the flexible cannula and is removed after the introducer is placed. The inserted stainless steel introducer needle has a sharp distal point. The flexible cannula acts as a conduit for percutaneous introduction of medical devices, such as catheters, needles, or probes. A stylet or porous plug (to prevent aspiration during insertion) comes seated in the standard 6 degree luer fitting of the proximal end of the needle hub. The Percutaneous Introducers are used for a short period of time and are supplied sterile and non-pyrogenic. The Percutaneous Introducer is available in four lengths and a 14 gauge.

This document is a 510(k) summary for a "Percutaneous Introducer" device. It outlines the device description, intended use, technological characteristics, and non-clinical testing performed to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" with quantitative targets and corresponding "reported device performance" in the way a clinical study might. Instead, it describes various tests performed and states that the device "meets the requirements" or "performs comparably" or has "successful results."

The tests and their reported outcomes are:

The study concludes that based on these results, the Percutaneous Introducer "performs comparably to, and is substantially equivalent to predicate device (K102460)."

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

The document does not specify the sample sizes used for any of the non-clinical tests (e.g., number of introducers tested for tensile strength, burst testing, etc.).
The data provenance is from non-clinical bench and laboratory testing, not human or animal studies. The data would originate from the manufacturing and testing facilities of Epimed International, Inc. or their contracted labs. It is inherently prospective in the sense that the tests were conducted specifically for this submission.

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

This section is not applicable in the traditional sense of clinical or diagnostic device ground truth. The "ground truth" for non-clinical performance and biocompatibility tests is established by adherence to recognized international standards (e.g., ISO, ASTM) and FDA guidance documents. The "experts" would be the qualified personnel within the testing laboratories who perform the tests according to these standards, generate the data, and interpret the results to ensure compliance. Their specific number or qualifications are not detailed here, as the focus is on adherence to standardized testing protocols.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving multiple human readers for diagnostic image interpretation or similar subjective assessments. The tests described are objective, standardized laboratory and bench tests where results are determined by measurement against specified criteria in the standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret results, and the AI's impact on their performance is being evaluated. This submission is for an interventional medical device (introducer) and focuses on its physical performance, material safety, and substantial equivalence, not diagnostic accuracy or human reader performance.

6. Standalone (Algorithm Only) Performance

No, a standalone (algorithm only) performance assessment was not done because the device is a physical medical instrument (a Percutaneous Introducer), not a software algorithm or AI-driven diagnostic tool. The concept of "algorithm only performance" does not apply to this type of device.

7. Type of Ground Truth Used

The "ground truth" for the non-clinical tests is based on established international standards and regulatory guidelines. For example:

• Mechanical properties: Defined by performance criteria within ASTM and ISO standards (e.g., specific force values, absence of collapse/peelback).
• Biocompatibility: Defined by the requirements and endpoints outlined in ISO 10993 series of standards (e.g., non-cytotoxic, non-sensitizing, non-irritating).
• Sterility and Packaging: Defined by standards like ASTM F1140, ASTM F1929, and general sterility assurance principles.
• Functional standards: Defined by the specific requirements of ISO 594-1, ISO 594-2, and ISO 10555-5.

Essentially, the "ground truth" is compliance with these widely accepted benchmarks for medical device safety and performance.

8. Sample Size for the Training Set

Not applicable. This device is a physical medical instrument, not an AI or machine learning model. Therefore, there is no "training set" in the context of an algorithm. The development and testing process involves engineering design, material selection, and verification/validation testing, not data-driven machine learning training.

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

Not applicable, as there is no training set for this type of device.

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Introducer for Endoscopic/Laparoscopic procedures.

The PMIPIN15 Percutaneous Introducer Needle is a single- use, disposable EO sterilized device made of 304 stainless steel with a luer hub made of polycarbonate. The introducer sheath is 5 Fr and manufactured from low density polyethylene. The device is manually inserted by the physician during endoscopic and/or laparoscopic procedures.

Here's an analysis of the provided text regarding the acceptance criteria and study for the PMIPIN15 Percutaneous Introducer Needle.

The document is a 510(k) summary for a medical device, which primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a novel device with extensive new clinical performance data. Therefore, the "acceptance criteria" here are largely derived from the performance and characteristics of the predicate device and relevant international standards.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) submission, the "acceptance criteria" are essentially demonstrating equivalence to the predicate device and compliance with relevant standards. The "device performance" is presented as meeting these standards and being similar to the predicate.

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

The document does not provide specific sample sizes for the individual tests (biocompatibility, sterilization, package, mechanical performance). It states "A series of preclinical tests were performed" and refers to ISO and ASTM standards, which would dictate appropriate sample sizes for each test.

• Test Set Sample Size: Not explicitly stated (implied by compliance with standards).
• Data Provenance: The tests are non-clinical (laboratory-based, material-based). There's no human clinical data presented, so country of origin and retrospective/prospective distinctions are not applicable in the typical sense. Physical measurements and performance evaluations were done on samples of the new device and the predicate device. Needle penetration testing was conducted by an "independent lab."

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

Not applicable. This device's evaluation is based on non-clinical engineering and materials testing, not on interpretation by clinical experts. The "ground truth" for these types of tests comes from the established scientific methods and standards (ISO, ASTM).

4. Adjudication Method for the Test Set

Not applicable. As described above, there is no clinical data or expert interpretation requiring adjudication. Performance is assessed against quantitative standards.

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-powered diagnostic or assistive device. It is a physical percutaneous introducer needle.

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

Not applicable. This is not an algorithm or AI device.

7. The Type of Ground Truth Used

For the non-clinical tests, the "ground truth" is based on:

• International Standards: ISO 10993 (biocompatibility), ISO 11135 (sterilization), ISO 11070 (needles), ASTM standards (packaging, shelf-life). These standards define acceptable methodologies and performance thresholds.
• Predicate Device Characteristics: For comparative aspects (design, materials, indications for use), the characteristics of the legally marketed predicate device (Ranfac Percutaneous Introducer PIN-15, K951090) serve as a de-facto "ground truth" for substantial equivalence.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable, as there is no training set for this type of device.

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This product is to assist in the introduction of diagnostic or therapeutic devices into a vessel.

Teleflex Medical OEM's Percutaneous Introducer and Kit is used to assist in the introduction of diagnostic or therapeutic devices into a vessel. These devices will be marketed in two configurations:

• Percutaneous Introducer only, or
• Percutaneous Introducer. Needle, Kit including Introducer Syringe and Guidewire

A description of each individual component is provided below:

Guidewire
The guidewire is designed to allow ease of movement through the vessels of the bodv.

18 Ga Needle
The 18 Ga Needle design allows the syringe to be attached to it and for the guidewire to be inserted through it.

Syringe
The 10ml syringe design allows for insertion into the needle.

Percutaneous Introducer
The Percutaneous Introducer uses a secure locking luer collar hub design and also incorporates an ergonomic handle design. This protects against separation of the dilator and sheath assembly during insertion. The introducer is designed to allow the dilator to be advanced over the guidewire into the vessel thus facilitating the introduction of the sheath into the vessel. This device design is such that after advancement into the vessel the dilator can be removed to allow access through the sheath of the customer's chosen device. For easy removal, the split sheath can be removed by breaking the hub and removing the two halves of the sheath while still within the vessel. The sheath hub is designed to snap cleanly. The sheath peels easily and evenly, thus reducing complications during the procedure.

The provided text describes a 510(k) summary for a medical device, the Teleflex Medical Percutaneous Introducer and Kit. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study of the device meeting specific acceptance criteria in the manner typically associated with an AI/algorithm-driven device.

Therefore, many of the requested elements (e.g., sample size for test/training sets, experts for ground truth, MRMC study, standalone performance) are not applicable as this submission pertains to a traditional medical device, not an AI medical device.

Here's the information that can be extracted and a summary of why other points are not relevant based on the provided document:

Acceptance Criteria and Reported Device Performance

The document states that the device was subjected to performance testing with pre-determined acceptance criteria, and it met all acceptance criteria. However, it does not provide an explicit table of these criteria or specific quantitative results for each. It lists general categories of tests.

Study Proving Device Meets Acceptance Criteria:

The study consisted of "a full battery of performance testing." The document does not provide a specific name or detailed protocol for this study but indicates it was conducted by Teleflex Medical OEM.

Non-Applicable Information for this Device (as per the provided text):

Since this is a submission for a traditional medical device (percutaneous introducer kit) and not an AI/algorithm-driven device, the following points are not directly addressed or are not relevant to this type of 510(k) submission based on the provided document:

• Sample size used for the test set and the data provenance: Not applicable. Performance testing for this type of device typically involves laboratory-based tests on device samples, not patient data in the context of an AI model.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI test set is not relevant here.
• Adjudication method for the test set: Not applicable.
• 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-assisted diagnostic device.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for this device's performance would be the specifications and standards it must meet (e.g., material strength, dimension tolerances).
• The sample size for the training set: Not applicable. This device does not use an AI model that requires a training set.
• How the ground truth for the training set was established: Not applicable.

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The AngioDynamics, Inc. VenaCureEVLT Procedure Kit with Percutaneous Introducer is indicated for endovascular coagulation of the Great Saphenous Vein (GSV) in patients with superficial vein reflux, for the treatment of varicose veins and varicosities associated with superficial reflux of the Great Saphenous Vein (GSV), and for the treatment of incompetence and reflux of superficial veins of the lower extremity.

The AngioDynamics, Inc. VenaCureEVLT Procedure Kit is indicated for use with 810 nm and 980 nm Diode Lasers with SMA 905 connectors.

Not Found

I am sorry, but the provided text does not contain any information about acceptance criteria, device performance, or any studies conducted to prove the device meets specific criteria. The document is a 510(k) premarket notification letter from the FDA to AngioDynamics Inc. regarding their Percutaneous Introducer and VenCureEVLT Procedure Kit. It confirms the device's substantial equivalence to legally marketed predicate devices and outlines general regulatory provisions. The "Indications for Use" section describes what the device is intended for but does not provide performance metrics or study details.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the provided text.

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The AngioDynamics Inc. Percutaneous Introducers are intended for the introduction of balloon catheters, closed end catheters or angiographic catheters into the vasculature. AngioDynamics, Inc. Percutaneous Introducers are designed for use during interventional procedures and are not intended for critical care use.

Not Found

I apologize, but the provided text from the FDA 510(k) clearance letter for the AngioDynamics Percutaneous Introducer does not contain the detailed information necessary to answer your request in full.

Here's a breakdown of what can be extracted and what is missing, based on the input:

What can be extracted:

• Device Name: AngioDynamics, Inc. Percutaneous Introducer
• 510(k) Number: K040728
• Intended Use: "The AngioDynamics Inc. Percutaneous Introducers are intended for the introduction of balloon catheters, closed end catheters or angiographic catheters into the vasculature."
• Type of Study (Implied): A 510(k) clearance primarily relies on a demonstration of "substantial equivalence" to a legally marketed predicate device, rather than a clinical effects study. The letter states, "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent...". This means the submission likely focused on design, materials, and performance characteristics (e.g., mechanical testing) to show it performs as safely and effectively as an existing device, rather than proving novel clinical benefit through a detailed clinical trial.

What is missing from the provided text:

The document is a clearance letter, not the actual 510(k) submission. Therefore, it does not include:

1. Acceptance Criteria Table and Reported Device Performance: This would be found in the performance testing section of the 510(k) submission itself, detailing specific metrics (e.g., tensile strength, burst pressure, lubricity, insertion force, etc.) and the results that met pre-defined criteria. The clearance letter only confirms that the FDA reviewed the submission and found the device substantially equivalent.
2. Sample Size Used for the Test Set and Data Provenance: This information would be specific to any non-clinical (e.g., benchtop, in vitro) or potentially limited clinical testing performed to support substantial equivalence. The letter does not specify this.
3. Number of Experts Used to Establish Ground Truth and Qualifications: This is typically relevant for studies involving subjective assessments (e.g., imaging interpretation), which is not the primary focus of an introducer substantial equivalence claim.
4. Adjudication method for the test set: Not applicable based on the available information.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Highly unlikely for an introducer device seeking 510(k) clearance, as these types of studies are typically for devices claiming improved diagnostic accuracy or clinical outcomes. The letter does not mention any such study.
6. Standalone (Algorithm Only) Performance: Not applicable as this is a physical medical device, not an AI algorithm.
7. Type of Ground Truth Used: For an introducer, "ground truth" would likely relate to objective physical and mechanical properties, not expert consensus on pathology or outcomes data in the way an AI diagnostic device would.
8. Sample Size for the Training Set: Not applicable as this is a physical device, and there is no "training set" in the context of machine learning unless an AI component was involved, which is not indicated.
9. How the Ground Truth for the Training Set was Established: Not applicable.

Conclusion:

The provided FDA clearance letter confirms that the AngioDynamics Percutaneous Introducer was found substantially equivalent to a predicate device based on a 510(k) submission (K040728). However, it does not contain the detailed technical data, study methodologies, or specific performance criteria and results that you are requesting. This information would be within the confidential 510(k) submission document itself, which is not publicly released in its entirety.

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The Percutaneous Introducer Set is intended for percutaneous introduction, manipulation, and removal of stimulation leads.

The Percutaneous Introducer Set is a single use device allowing for introduction, manipulation, and removal of stimulation leads after percutaneous entry is gained with a needle. The sheath is made of HDPE (High Density Polyethylene) with a HDPE hub. It is slightly tapered at the distal end to make a smooth transition to the dilator. The dilator is made of 304 stainless steel tubing tapered at the distal end for smooth insertion. It has a molded HDPE hub. The guidewire directional guide is made of 304 stainless steel wire with radiuses at each end. It has depth markings etched into the surface along the distal end.

This document, K013120, is a 510(k) summary for a Percutaneous Introducer Set. The device is intended for the introduction, manipulation, and removal of stimulation leads.

The document indicates that the device's substantial equivalence is based on its similarity to a predicate device, the MedAmicus Epidural Introducer (K994097), in terms of intended use, basic design, manufacturing methods, and materials.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document
does NOT list specific acceptance criteria with quantifiable metrics, nor does it provide a detailed table of reported device performance against such criteria.

Instead, it offers a general statement: "Performance data indicates that the Percutaneous Introducer Set meets the functional requirements and specifications for this device."

To infer potential "acceptance criteria" based on the provided information, we can consider the aspects of similarity to the predicate device and relevant material properties:

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

The document does not provide information on a specific "test set" with a defined sample size or data provenance (e.g., country of origin, retrospective or prospective). The submission relies on establishing substantial equivalence to a predicate device, and the "performance data" mentioned is a general statement, not a detailed study report.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided in the document. The submission focuses on device equivalence rather than a study requiring expert-established ground truth for a test set.

4. Adjudication Method

This information is not provided in the document. As no specific test set or expert ground truth establishment is described, neither is an adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A MRMC comparative effectiveness study was not performed or reported in this 510(k) submission. The document aims for substantial equivalence based on physical and functional characteristics, not on the impact of the device on human readers' performance with or without AI assistance.

6. Standalone Performance Study

A standalone (algorithm-only without human-in-the-loop performance) study was not performed or reported in this 510(k) submission. This is a medical device, not an AI/algorithm-based diagnostic tool. The "performance data" mentioned is a general statement about meeting functional requirements.

7. Type of Ground Truth Used

The concept of "ground truth" as typically used in the context of diagnostic performance studies (e.g., expert consensus, pathology, outcomes data) does not apply directly to this 510(k) submission. The "truth" for this submission is based on the demonstration of substantial equivalence to a legally marketed predicate device and the "identicality" of materials to those previously approved.

8. Sample Size for the Training Set

This information is not applicable and therefore not provided. This is not an AI/machine learning device that requires a training set.

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

This information is not applicable and therefore not provided. As there is no training set for an AI/machine learning model, there is no ground truth establishment for such a set.

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Datascope's 10 Fr. FlexiSheath™ Percutaneous Introducer is intended for the percutaneous introduction of Datascope's 9.5Fr. Intra-Aortic Balloon Catheters.

Datascope's 10 Fr. FlexiSheath™ Percutaneous Introducer is intended for the percutaneous introduction of Datascope's 9.5 Fr. Intra-Aortic Balloon Catheters.

The provided text describes a 510(k) premarket notification for Datascope's 10 Fr. FlexiSheath™ Percutaneous Introducer. In the context of 510(k) submissions, the concept of "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the traditional sense of a clinical trial with predefined performance metrics and statistical endpoints is generally not applicable for devices seeking substantial equivalence.

Instead, the submission aims to demonstrate that the new device is "substantially equivalent" to predicate devices already on the market. This is done by showing that the new device has similar technological characteristics and performance, and does not raise different questions of safety and effectiveness.

Here's an analysis of the provided text based on your request, interpreting "acceptance criteria" as the demonstration of substantial equivalence and "study" as the non-clinical testing performed:

1. Table of Acceptance Criteria (Substantial Equivalence Pillars) 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)

• Sample Size for Test Set: The document mentions "in-vitro tests" but does not specify the sample size used for these tests.
• Data Provenance: The document does not specify the country of origin of the data or whether the tests were retrospective or prospective. Given that this is an in-vitro study for a US submission, it's highly likely the tests were conducted in a US-based lab, but this is not explicitly stated. The tests are prospective in nature as they evaluate the device's characteristics.

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 or provided in the context of this 510(k) submission. For in-vitro tests demonstrating substantial equivalence, "ground truth" is typically established by engineering specifications, validated test methods, and comparison against the performance of predicate devices, not by expert consensus on clinical data. No human experts evaluating test results for "ground truth" are mentioned.

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

• This information is not applicable or provided. Adjudication methods are typically used in clinical studies involving interpretation of medical images or patient outcomes, not for in-vitro engineering tests.

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 type of study is relevant for AI-powered diagnostic devices, which is not the nature of Datascope's 10 Fr. FlexiSheath™ Percutaneous Introducer.
• The device is a medical introducer sheath, a physical medical device, not an AI or imaging diagnostic tool. Therefore, the concept of human readers improving with AI assistance is not applicable.

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

• No, a standalone (algorithm only) study was not done. As mentioned, this is a physical medical device, not an algorithm or software. Its performance is evaluated through physical and material properties, and functionality in a lab setting.

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

• For the non-clinical tests, the "ground truth" would be established by engineering specifications, validated test methods, and direct comparison of performance metrics (e.g., tensile strength, flexibility, lubricity, burst pressure, flow rates, etc.) against the established performance of the predicate devices. It is not based on expert consensus, pathology, or outcomes data.

8. The sample size for the training set

• This information is not applicable or provided. The concept of a "training set" and "validation set" is relevant for machine learning algorithms. This submission is for a physical medical device and relies on engineering and material characteristic tests rather than data-driven model training.

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

• This information is not applicable or provided as there is no "training set" in the context of this device and its substantial equivalence submission.

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The Braun Percutaneous Introducer Kits are designed to facilitate percutaneous introduction of devices into the vasculature.

Braun Percutaneous Introducer Kits consist of an introducer sheath packaged with a corresponding dilator. A guidewire and introducer needle may also be packaged with the sheath and dilator.

This document is a 510(k) premarket notification for a medical device (Braun Percutaneous Introducer Set) and primarily focuses on demonstrating substantial equivalence to previously cleared devices. It does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically found in clinical trial reports for AI/ML devices.

Therefore, I cannot provide the requested information. The provided text is a regulatory submission for a traditional medical device, not an AI/ML powered device, and thus does not contain the specific study design elements you've asked for.

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