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The Surmodics Microcatheter is intended to provide support to facilitate the placement of guidewires in the coronary and peripheral vasculatures and can be used to exchange one guidewire for another. This microcatheter is also intended to assist in the delivery of contrast media into the coronary and peripheral vasculatures.

Do not use this microcatheter other than for use in the coronary and peripheral vasculatures.

The Surmodics Microcatheter is a sterile, single use, percutaneous device intended to provide support to facilitate the placement of guidewires in the coronary and peripheral vasculature. Additionally, the microcatheter can be used for contrast media injection.

The catheter is a single-lumen microcatheter with a 1.9 Fr distal outer diameter, a 2.6 Fr proximal outer diameter and is compatible with a 0.014" guidewire. The proximal end of the catheter shaft has a larger inner diameter, outer diameter and wall thickness and tapers to the distal end. The catheter is available in working lengths of 135 cm and 150 cm to facilitate access to various target sites.

The provided text is a 510(k) clearance letter from the FDA for a microcatheter, not an AI/ML device. Therefore, it does not contain any of the information requested regarding acceptance criteria, study details, sample sizes, expert ground truth, or MRMC studies for an AI/ML device.

The document states:

• The device is a "Microcatheter" (Trade/Device Name).
• Its classification is "Percutaneous catheter" (Regulation Name, Class II, Product Code DQY).
• It's a medical device for use in coronary and peripheral vasculatures.
• "No clinical studies were required for the Surmodics Microcatheter." (Section 8.5)
• Performance testing focused on "Coating Integrity (Particulate, Track Force), Simulated Use (part of track force testing), Pinch testing lubricity, and Biocompatibility." (Section 8.4)

Since this document pertains to a physical medical device (microcatheter) and explicitly states no clinical studies were required, the questions regarding AI/ML device performance, ground truth, expert adjudication, and comparative effectiveness studies are not applicable and cannot be answered from this source.

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The Surmodics Microcatheter is intended to provide support to facilitate the placement of guidewires in the coronary and peripheral vasculatures and can be used to exchange one guidewire for another. This microcatheter is also intended to assist in the delivery of contrast media into the coronary and peripheral vasculatures.

Do not use this microcatheter other than for use in the coronary and peripheral vasculatures.

The Surmodics Microcatheter is a sterile, single use, percutaneous device intended to provide support to facilitate the placement of guidewires in the coronary and peripheral vasculature. Additionally, the microcatheter can be used for contrast media injection.

The catheter is a single-lumen microcatheter with a 1.9 Fr distal outer diameter, a 2.6 Fr proximal outer diameter and is compatible with a 0.014" guidewire. The proximal end of the catheter shaft has a larger inner diameter, outer diameter and wall thickness and tapers to the catheter is available in lengths of 135 cm and 150 cm in length to facilitate access to various target sites.

The provided text describes a 510(k) premarket notification for a medical device called the "Surmodics Microcatheter." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting effectiveness studies akin to AI/ML device studies. Therefore, many of the requested elements for AI/ML device evaluations (such as human readers, ground truth establishment, training set details, or comparative effectiveness studies with AI assistance) are not applicable or not present in this document.

However, I can extract and structure the available information regarding acceptance criteria and testing:

Acceptance Criteria and Device Performance Study for Surmodics Microcatheter (K173560)

This submission establishes substantial equivalence to a predicate device (ASAHI Caravel, K152447) based on design, intended use, principles of use, materials, sizes, and sterility. The "acceptance criteria" here refer to the performance thresholds met during design verification and biocompatibility testing. The "study" refers to the conducted design verification tests and biocompatibility assessments.

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "All test results met documented acceptance criteria and did not raise new questions of safety or effectiveness." Specific quantitative performance values or detailed acceptance criteria are not provided in this regulatory document. The table below lists the types of tests performed.

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

The document does not specify the sample sizes for each individual test or the data provenance (e.g., country of origin, retrospective/prospective). These details are typically contained in the full test reports referenced in such a submission, but not in the summary provided.

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

Not applicable. For a 510(k) submission for a non-AI/ML device, "ground truth" as typically understood in AI/ML performance evaluation (e.g., expert consensus on medical images) is not established. Device performance is assessed against engineering specifications, material properties, and regulatory standards.

4. Adjudication Method for the Test Set

Not applicable. This is not an AI/ML device and does not involve adjudication of expert interpretations for a test set.

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

No, an MRMC comparative effectiveness study was not performed. This is a 510(k) submission for a microcatheter, not an AI/ML device, and thus does not involve human readers or AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the Loop Performance) Was Done

Not applicable. This is not an AI/ML algorithm. The device performance testing is akin to "standalone" in the sense that the device's physical and functional characteristics are tested directly without human intervention in the device's core function.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by engineering specifications, material science standards, and regulatory requirements (e.g., ISO standards) for medical devices. For example, a "tensile strength" test has a defined pass/fail criterion based on mechanical properties required for the device's intended use. Similarly, biocompatibility tests are assessed against established biological response limits.

8. The Sample Size for the Training Set

Not applicable. This is a conventional medical device; there is no "training set" in the context of machine learning. The device design is based on engineering principles and iterative development, 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 device.

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The Micro Catheter and Guidewire System is intended for the infusion of contrast media into the peripheral vasculature. The Micro Catheter and Guidewire system is also intended for drug infusion in intra-arterial therapy and the infusion of embolic materials for hemostasis.

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, and a torque device. The catheter is consist of a hub, a stress relief tube and a catheter body. The catheter body 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 polyamides of different hardness mixed with pigment. There is also a hydrophilic coating on the catheter surface. The guidewire is consist of a nitinol core, a polymer jacket with hydrophilic coating over its entire surface and a radiopaque distal marker. It has a white marker at the proximal end to indicate the length inserted into human body and its relative position with the catheter.

The provided text is a 510(k) premarket notification for a medical device (Micro Catheter and Guidewire System). This type of document is primarily focused on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that the device meets a specific set of quantitative acceptance criteria through a clinical study or a study directly measuring performance against predetermined thresholds for an AI/software as a medical device.

Therefore, the information typically requested in your prompt regarding acceptance criteria, study design for AI/software, sample sizes, expert ground truth, MRMC studies, standalone performance, and training set details is not present in this document. This document details the physical characteristics, intended use, and bench testing for a physical medical device.

Here's why the information is not here, and what type of information is provided:

• Acceptance Criteria & Reported Device Performance (Table 1): The document does not provide a table of quantitative acceptance criteria for performance in the way you'd expect for, say, an AI diagnostic tool (e.g., "sensitivity > 90%"). Instead, it lists various bench tests conducted (e.g., Catheter Sizes, Coating Integrity, Peak tensile force, etc.) and states that "The data provided demonstrate that the Micro Catheter and Guidewire System is substantially equivalent to the predicate device." This implies the device passed these bench tests, but the specific numerical acceptance criteria and measured values are not detailed in this public summary.

• Sample size and data provenance for test set: Not applicable for this type of device and study. Bench testing is performed on physical samples.

• Number of experts and qualifications for ground truth: Not applicable. Ground truth for physical device bench testing is based on engineering specifications and direct measurement.

• Adjudication method: Not applicable.

• MRMC comparative effectiveness study: Not applicable. This is a physical device, not an AI or imaging diagnostic tool that assists human readers.

• Standalone performance: Not applicable in the context of AI performance. The document describes the standalone performance of the physical device through bench testing.

• Type of ground truth used: For this device, the "ground truth" is defined by engineering specifications, material properties, and physical testing standards (e.g., ISO 10555.1, ISO 11070).

• Sample size for training set & How ground truth for training set was established: Not applicable. This is not a machine learning/AI device.

What the document does provide in relation to "proving the device meets acceptance criteria":

The document focuses on demonstrating substantial equivalence to a predicate device, which is the primary regulatory pathway for 510(k) submissions. This is achieved by:

1. Indications for Use: Stating that the device has the same intended use as the predicate device (infusion of contrast media, drug infusion in intra-arterial therapy, infusion of embolic materials for hemostasis into peripheral vasculature).
2. Technological Characteristics: Highlighting similarities in design (catheter, guidewire, accessories, provided sterile, single use, hydrophilic coating, platinum-iridium alloy radiopaque marker).
3. Performance Data: Listing a comprehensive set of biocompatibility tests (e.g., Cytotoxicity, Sensitization, Hemolysis study) and bench tests (e.g., Catheter Sizes, Coating Integrity, Tensile force, Burst pressure, Guidewire Fracture test, Torque strength, Simulated use). These tests demonstrate that the device performs as intended and is safe, similar to the predicate. The implication is that the results of these tests met internal acceptance criteria to support the claim of substantial equivalence.

In summary, while the document indirectly "proves the device meets acceptance criteria" by stating its substantial equivalence based on safety and performance tests, it does not provide the detailed quantitative acceptance criteria and study particulars you've asked for, as those typically relate to AI/software performance rather than a physical medical device.

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The NMI Microcatheter is intended for use in small vessels and supreselective anatomy during diagnostic and interventional procedures in the peripheral vasculature. Upon access of the desired region, the microcatheter can be used for the controlled and selective infusion of diagnostic, therapeutic and embolic materials. All products delivered through the microcatheter must be used in accordance with the original manufacturer's instruction for use. The catheter is not intended for use in coronary or neuro- vasculature.

The proposed MC is offered in two French size configurations. The first configuration has an outside diameter of 3.0F/2.8F (tapers proximally to distally) and has a nominal inside diameter of 0.027" along the entire catheter length. The second configuration has an outside diameter of 3.0F/2.4F (tapers proximally to distally) and has a nominal insider diameter of 0.021" along the entire catheter length.

Both MC configurations consist of a shaft and proximal hub assembly. The radiopaque shaft transitions from a stiffer proximal region to a flexible 30cm distal end. A radiopaque marker is located 1mm from the catheter's distal end to identify the location of the distal tip under fluoroscopic visualization. The distal end of the catheter's outer surface is hydrophilic coated. The microcatheter is provided with a shaping mandrel and a rotating hemostatic valve. The microcatheter kit additionally includes a guidewire, a guidewire insertion tool and a torque device.

The provided document does not describe a study involving AI or machine learning. It pertains to a 510(k) premarket notification for a medical device called the "NMI Microcatheter" and focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance testing. Therefore, I cannot extract information related to AI acceptance criteria, sample sizes for training/test sets, expert adjudication, MRMC studies, or standalone algorithm performance.

However, I can provide the acceptance criteria and performance data for the physical device as described in the document.

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The document describes a series of non-clinical tests conducted to demonstrate that the NMI Microcatheter is "substantially equivalent" to specified predicate devices (Boston Scientific Renegade Hi-Flo Microcatheter K000177 and Boston Scientific Renegade STC Microcatheter K023861). The study's conclusion is based on "comparison of technological characteristics and the results of non-clinical tests."

Missing Information (Not applicable to this document as it's not an AI/ML study):

2. Sample size used for the test set and the data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
4. Adjudication method for the test set.
5. Multi-reader multi-case (MRMC) comparative effectiveness study.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) study.
7. Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for an AI/ML study.
8. Sample size for the training set.
9. How the ground truth for the training set was established.

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