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The Micro Catheter and Guidewire System is intended for the infusion of contrast media into the peripheral vessels. The Micro Catheter and Guidewire system is also infusion in intra-arterial therapy and the infusion of embolic materials for hemostasis. The system should not be used in cerebral vessels.

Micro Catheter and Guidewire System consists of a catheter, a guidewire, and accessories. The accessories include a flushing device, a shaping mandrel, an insertion tool, a torque device and a peel-able tube.

The catheter is consist of a hub, a stress relief tube and a catheter shaft. The catheter shaft has three layers. The inner layer is a PTFE tube, the middle layer is consist of stainless steel wire reinforce and platinum-iridium alloy radiopaque distal marker. And the outer layer is polyamide. There is also a hydrophilic coating on the catheter surface.

The guidewire is consist of a nitinol core, a polymer jacket with PVP hydrophilic coating over its entire surface, and a spring coil at distal. It has a white marker at the proximal to indicate the length inserted into human body and its relative position with the catheter.

The provided text is a 510(k) summary for the "Micro Catheter and Guidewire System" and predominantly focuses on the regulatory submission process, device description, and a comparison to a predicate device. It briefly mentions performance testing but does not provide the detailed acceptance criteria or the specific results required to fill out a table of acceptance criteria vs. reported device performance.

Therefore, I cannot fulfill the request to create a table of acceptance criteria and reported device performance or answer most of the questions about the study design, sample sizes, expert involvement, or ground truth establishment.

The document states that "Nonclinical tests demonstrate that the Micro Catheter and Guidewire System is substantially equivalent to the predicate device which is currently marketed for the same intended use." This indicates that the study was primarily a nonclinical (bench) testing and biocompatibility evaluation to demonstrate substantial equivalence, rather than a clinical study evaluating human-in-the-loop performance or diagnostic accuracy.

Here's what can be inferred or stated as "not provided" based on the text:

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

• Not provided in the document. The document lists types of tests (e.g., "Peak tensile force of catheter," "Coating test of guidewire," "Burst pressure under static conditions") under "Bench Testing", but it does not specify the quantitative acceptance criteria for these tests nor the numerical results achieved by the device.

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

• Sample size: Not provided. The document states that "Biocompatibility evaluation... was conducted in accordance with current standards" and lists various bench tests, but the number of units/samples tested for each is not specified.
• Data provenance: The tests are "Nonclinical tests," likely performed at Suzhou Hengrui Hongyuan Medical Co., Ltd. or a contracted lab in China, given the submitter's location. There is no mention of human subject data, so "retrospective or prospective" is not applicable in the typical sense of clinical studies.

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

• Not applicable. This device is a micro catheter and guidewire system, not a diagnostic AI device requiring expert interpretation for ground truth. The "ground truth" for this type of device would be established engineering specifications and material properties, against which the device's performance is measured in bench tests.

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

• Not applicable. This pertains to studies where human reviewers assess data, often clinical images. For bench testing of a micro catheter and guidewire, "adjudication" methods are not relevant. Test results are typically objective measurements.

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. This is a medical device, not an AI/CADe/CADx system for image interpretation. Therefore, an MRMC study comparing human readers with and without AI assistance was not performed.

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

• Not applicable. This is not an algorithm-based device. Its performance is intrinsic to its physical properties and design.

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

• For biocompatibility: Adherence to ISO standards (e.g., ISO 10993 series).
• For bench testing: Engineering specifications, industry standards, and predicate device performance. These would serve as the "ground truth" or acceptance criteria for mechanical and physical properties.

8. The sample size for the training set:

• Not applicable. This is not an AI/machine learning device that requires a training set.

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

• Not applicable. (See point 8).

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The Micro Catheter is intended for selective delivery of therapeutic devices and infusion of contrast media into the peripheral and neuro vasculature.

The proposed device Micro Catheter is a single-lumen catheter designed to be introduced over a steerable guidewire into the peripheral and neuro vasculature. The proximal end of the catheter incorporates standard Luer adapter to facilitate the attachment of accessories. The outer surface of the catheter has a lubricious coating at the distal end of the Micro Catheter has a radiopaque marker at the distal end to facilitate fluoroscopic visualization. The device is intended for single use and is provided sterile.

The provided document is a 510(k) Pre-market Notification for a medical device called "Micro Catheter". It details non-clinical performance and biocompatibility testing to demonstrate substantial equivalence to a predicate device.

However, the document does not contain any information about a study proving the device meets acceptance criteria related to an AI/Machine Learning model, nor does it discuss human reader performance, AI assistance, or the establishment of ground truth for such models. The document focuses on the physical and biological performance of a catheter device through standard engineering and biocompatibility tests.

Therefore, I cannot fulfill your request for the following sections as the information is not present in the provided text:

• A table of acceptance criteria and the reported device performance: The document provides a table of test methods and results for non-clinical performance and biocompatibility, but these are for the physical device, not an AI model.
• Sample sized used for the test set and the data provenance: Not applicable as no AI/ML model testing is described.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• Adjudication method: Not applicable.
• If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used: Not applicable.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

The document pertains to the regulatory clearance of a physical medical device (a micro catheter) and its performance is evaluated through standard engineering and biological compatibility tests, not through the evaluation of an AI or machine learning algorithm.

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The Plato MICROCATH® 27 Microcatheters are intended to assist in the delivery of diagnostic and/or therapeutic agents to the peripheral and neurovascular systems.

The Plato MICROCATH® 27 Microcatheters are single lumen catheters designed to be used with a guiding catheter and a steerable guidewire for accessing the vasculature. The microcatheter contains a metal hypotube reinforced shaft with a maximum diameter of 3.7F, tapering to a distal end of 3.3F, which can be inserted into a 6F guide catheter. The inner diameter is constant throughout the shaft length and accommodates up to a 0.025" guidewire. The catheter is 150 cm in length with two tip configurations; straight and 45°. All have steam shapeable tips, hydrophilic coating and a radiopaque marker at the distal tip. The devices are marketed with an accessory mandrel which allows the catheter tips to be steam-shaped to the doctor's preferred shape when desired.

The provided text describes the "SCIENTIA VASCULAR LLC PLATO MICROCATH® 27 MICROCATHETER". It does not describe a study involving acceptance criteria related to an AI/ML device, but rather the non-clinical performance data for a microcatheter device. Therefore, I will extract information relevant to the device's performance against non-clinical acceptance criteria.

Here's the breakdown of the information as per the request, adapted for a non-AI/ML medical device:

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

The document lists "Non-Clinical Performance Data" which served as the basis for demonstrating substantial equivalence. These can be considered the acceptance criteria for functional and safety aspects of the device.

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 the non-clinical bench testing, specific sample sizes are not provided in the document. The tests likely involved multiple units of the Plato MICROCATH 27 Microcatheter.
  • For the simulated use testing, an "anatomical model" was used. The number of models or tests conducted is not specified.
  • For the human cadaver model, the term "a human cadaver model" is used, implying at least one but the exact number of cadavers or trials is not specified.
• Data Provenance: The tests are explicitly described as "Non-Clinical Performance Data" and include "bench testing," "simulated-use testing," and testing in a "human cadaver model." This indicates the data is from controlled laboratory and simulated environments. The country of origin of the testing is not specified, but the submission is to the FDA (United States). This testing would be considered prospective, as it was conducted specifically to evaluate the device.

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 section is not applicable as the document describes non-clinical and simulated-use testing of a physical medical device, not an AI/ML system requiring expert ground truth for interpretation. The evaluation was based on engineering specifications, standardized test methods (ISO 10993, ISO 10555-1), and performance in physical models.

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

This is not applicable. The device's performance was evaluated against physical and functional criteria, not expert interpretations requiring 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 is not applicable. The document describes a physical medical device (microcatheter), not an AI-assisted diagnostic or therapeutic system that would involve human readers.

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

This is not applicable. This document is about a physical medical device, not an algorithm.

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

The "ground truth" for the device's performance was established through:

• Compliance with international standards (ISO 10993, ISO 10555-1).
• Demonstration of expected functional performance in various bench tests (e.g., kink resistance, tensile strength, burst pressure, coating lubricity).
• Comparative performance to a predicate device in simulated anatomical and human cadaver models for key operational aspects like maneuverability and advancement.

8. The sample size for the training set

This is not applicable. This document describes a physical medical device, not an AI/ML system that requires a training set.

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

This is not applicable. This document describes a physical medical device, not an AI/ML system.

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The Marksman™ Catheter is indicated for the introduction of interventional devices and infusion of diagnostic or therapeutic agents into the neuro, peripheral and coronary vasculature.

The Marksman™ Catheter is a variable stiffness, single lumen catheter designed to access small, tortuous vascular areas. The outer surface of the catheter's distal segment is coated with a hydrophilic material to provide lubricity during use. The catheter also incorporates a PTFE liner to facilitate movement of introduction devices passed through its lumen. The Marksman™ Catheter has a radiopaque marker at the distal tip to facilitate fluoroscopic visualization. The distal tip of the catheter is shapeable. The Marksman™ Catheter is provided with various working lengths. The Marksman™ Catheter is for single use only.

This is not an AI/ML device. This is a medical device, a catheter, for which the manufacturer is seeking approval for a modified version with a different coating. Therefore, the questions related to AI/ML device performance metrics, such as accuracy, AUC, F1 score, expert consensus for ground truth, training/test set sizes, and MRMC studies, are not applicable here.

The submission is a Special 510(k) for the Marksman™ Catheter, focusing on demonstrating substantial equivalence to a predicate device after a change in the hydrophilic coating. The safety and performance verification is based on engineering and biocompatibility testing, not on AI/ML performance evaluation.

Here's how the provided information relates to the general concept of acceptance criteria and proving device meets them, adapted for a non-AI/ML medical device:

1. A table of acceptance criteria and the reported device performance
   • Acceptance Criteria/Performance Metrics: The primary "acceptance criteria" here is substantial equivalence to the predicate device, specifically demonstrating that the new Biocoat™ coating does not introduce new risks and that the device maintains its existing safety and performance characteristics.
   • Reported Device Performance: The submission states:
     • Biocompatibility: "The Marksman™ Catheter with Biocoat™ coating meets the requirements for biocompatibility." and "All test results obtained were acceptable for the device's intended use."
     • Safety and Performance Verification Tests: "These tests yielded acceptable results substantially equivalent to the predicate device."
   • Table: While not presented in a formal table in the provided text as numerical values for specific performance metrics (which are typical for AI/ML devices), the key areas of evaluation and their "performance" are summarized as "SAME" or "acceptable results".

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

   • This question is not applicable in the context of an AI/ML system evaluating data. For a physical medical device, testing typically involves a sufficient number of device units or components to ensure statistical confidence in the results for the specific tests performed (e.g., biocompatibility on samples, mechanical stress tests on multiple catheters). The document doesn't specify the exact number of units tested for each physical or biological test, but it indicates the tests were performed.
   • Provenance: The biocompatibility testing was performed by Toxikon (Bedford, MA), a certified laboratory. The nature of testing is likely prospective in that the new coating was specifically manufactured and then tested according to predetermined protocols.

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

   • This is not applicable to this type of device submission. There is no concept of "ground truth" established by experts in the context of evaluating the performance of a physical catheter with a new coating; rather, it relies on standardized physical, chemical, and biological testing methods.

4. Adjudication method

   • This is not applicable.

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 is not applicable.

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

   • This is not applicable.

7. The type of ground truth used

   • This is not applicable. For this device, "ground truth" is analogous to established scientific and engineering principles, material standards, and biological responses as measured by validated laboratory tests and existing clinical knowledge of similar devices and materials.
   • Specifically, biocompatibility relies on standardized in vitro and in vivo biological tests (e.g., per EN ISO 10993-1: 2009 for biocompatibility). Physical performance validation uses engineering and material testing methods.

8. The sample size for the training set

   • This is not applicable. There is no "training set" for this type of medical device.

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

   • This is not applicable.

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The MTI Echelon™ Micro Catheter is intended for the controlled selective infusion of physician-specified therapeutic agents or contrast media into the vasculature of the peripheral and neuro anatomy.

The MTI Echelon™ Micro Catheter is an end-hole, single-lumen catheter designed to be introduced over a steerable guidewire into the vasculature. The catheter has a semi-rigid proximal shaft which transitions into the flexible distal shaft to facilitate the advancement of the catheter in the anatomy. Dual radiopaque markers at the distal end facilitate fluoroscopic visualization. The outer surface of the catheter is coated to increase lubricity.

The provided text describes a Special 510(k) submission for the Echelon™ Micro Catheter, which is a modification to the previously cleared Rebar® Micro Catheter (K993672). As such, the submission focuses on demonstrating substantial equivalence to the predicate device through performance testing rather than establishing de novo clinical efficacy for a novel device. Therefore, many of the requested categories related to clinical studies, AI performance, and expert ground truth are not applicable to this type of submission.

Here's a summary of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission describes in-vitro performance testing and biocompatibility testing. The "acceptance criteria" themselves are not explicitly detailed as quantitative thresholds in the provided text, but rather implied by successful completion of these tests to demonstrate substantial equivalence to the predicate device.

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