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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 Slip-Cath® Beacon® Tip Catheter and Shuttle® Select Slip-Cath® Catheter are intended for use in angiographic procedures by physicians trained and experienced in angiographic techniques.

The Slip-Cath® Beacon® Tip Catheters and Shuttle® Select Slip-Cath® Catheters are visually identified by a distal radiopaque tip bonded onto a stainless steel braided catheter shaft. Slip-Cath® Beacon® Tip Catheters and Shuttle® Select Slip-Cath® Catheters are manufactured in lengths of 40. 60. 65. 75. 80. 90. 100. 125. 135 and 150 centimeters and have no distal sideports. Each catheter is manufactured with either a plastic winged hub. mounted on the proximal end of the catheter, indicating the catheter French size and relative endhole diameter, or a translucent hub with a strain relief. The catheters are manufactured with a 4.0, 4.1, 4.5, 5.0, 5.5 or 6.5 French catheter shaft that is designed with an inner lumen tapered to a 0.035 or a 0.038 inch endhole diameter. These catheters. are manufactured in a variety of distal tip configurations.

The provided document is a 510(k) summary for a medical device modification, specifically for the Slip-Cath® Beacon® Tip Catheter and Shuttle® Select Slip-Cath® Catheter. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive clinical study data.

Therefore, many of the requested items related to clinical studies (e.g., sample size, data provenance, number of experts, adjudication methods, MRMC studies, standalone AI performance, training set details) are not applicable as this document describes physical performance testing, not a clinical study.

Here's the information that can be extracted:

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)

• Not applicable for this submission type. The document describes physical and biocompatibility testing, not clinical data from a "test set" of patients. The tests mentioned are laboratory-based engineering and biological evaluations.

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. Ground truth in the context of clinical expert consensus is not relevant for the physical and biocompatibility tests performed. Standards (ISO 10555-1, ISO 10993-1) define the "ground truth" for acceptance.

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

• Not applicable. Adjudication is relevant for interpreting clinical data, not for the straightforward physical and biocompatibility tests described.

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 device is a catheter, not an AI-powered diagnostic tool. No MRMC study was conducted.

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

• Not applicable. This device is a catheter, not an algorithm.

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

• For Tensile Strength and Leakage: The ground truth is defined by the technical specifications and performance limits set forth in ISO 10555-1 (Intravascular catheters - Sterile single-use catheters - Part 1: General requirements).
• For Biocompatibility: The ground truth is defined by the toxicological and biological safety requirements outlined in ISO 10993-1 (Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process).

8. The sample size for the training set

• Not applicable. This document describes physical testing of a medical device, not a machine learning model, so there is no training set.

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

• Not applicable. As above, no training set or machine learning model is involved.

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