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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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