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The Hydrophilic Coating Guide Wire is designed to direct a catheter to the desired anatomical location in the peripheral and coronary vasculature during diagnostic or interventional procedures. This device is not intended for neurovascular interventions.

The Hydrophilic Coating Guide Wire consists of a Nickel-Titanium alloy core wire; a polymer jacket (Polyurethane containing Tungsten for X-Ray visibility); and a hydrophilic coating applied to the entire wire. There are two shaft configurations: standard and stiff. There are two distal tip shapes: straight and angled. The guide wire is provided sterile (EtO) and is intended for single use only.

This document is a 510(k) Premarket Notification from Suzhou Hengrui Disheng Medical Co., Ltd. for their "Hydrophilic Coating Guide Wire." It seeks to demonstrate substantial equivalence to legally marketed predicate devices, rather than proving the device meets specific performance criteria for an AI/ML algorithm.

Therefore, the requested information regarding acceptance criteria, study design for AI/ML performance, ground truth establishment, expert adjudication, and sample sizes for training/test sets (as they pertain to AI/ML) is not available in this document.

This submission is for a medical device (a guide wire) and primarily focuses on its physical characteristics, materials, intended use, and non-clinical performance testing to show it's equivalent to existing devices. It does not involve any AI/ML component.

Consequently, I cannot fill in the table or answer the questions related to AI/ML performance. The document only reports on the substantial equivalence of the physical guide wire device to predicate devices.

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The SUPERPIPE Angiographic Catheter is intended for use in angiographic procedures. It delivers radiopaque media, guide wires, catheters, and therapeutic agents to selected sites in the vascular system.

Angiographic Catheter consists of a catheter hub, a strain relief tubing, catheter shaft (including braided section and non-braided section) and catheter tip. It is comprised of a two-layer construction featuring stainless steel mesh sandwiched between layers of polyamide elastomers of the catheter braided section. The non-braided section is comprised of layers of polyamide elastomers. And the soft catheter tip is comprised of the mixture of polyurethane and polyamide elastomers. The device is offered in lengths of 80cm, 100cm and 110cm.

This is a 510(k) summary for the SUPERPIPE Angiographic Catheter, which is a medical device for delivering radiopaque media, guide wires, catheters, and therapeutic agents to selected sites in the vascular system. The document focuses on demonstrating substantial equivalence to a predicate device, not on proving device performance against specific acceptance criteria in a study involving AI or human readers for diagnostic tasks.

Therefore, most of the requested information regarding acceptance criteria and a study proving the device meets them, especially in the context of AI and human reader performance, is not available in this document. This document details the engineering and biocompatibility testing performed to demonstrate that the device is safe and effective for its intended use, mainly comparing it to a predicate device.

Here's a breakdown of the available information based on your request:

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

The document lists performance tests conducted, but it does not explicitly state specific quantitative acceptance criteria or the numerical results/performance metrics for each test. Instead, it states that "Performance (bench) testing and biocompatibility testing were performed to demonstrate that the proposed device performs as intended and does not raise new questions of safety or efficacy compared to the predicate devices."

The tests performed include:

• Non-Clinical Performance Testing (per ISO 10555-1):

  • Catheter Sizes
  • Catheter Surface
  • Catheter Color
  • Side Holes
  • Catheter Hub
  • Distal Tip
  • Distal Shape
  • Freedom from Leakage
  • Peak Tensile Force of Catheter
  • Burst Pressure under Static Conditions
  • Radio-detectability
  • Torsion Transmissibility
  • Torque strength
  • Kink test
  • Push and withdrawal Ability
  • Simulated Use
  • Flow rate
  • EO and ECH Residual
  • Sterile
  • Bacterial Endotoxin
  • Visual Inspection test of the inner pouch
  • Sealing-strength of the Inner Pouch
  • Dye Leakage Test of the Inner Pouch

• Biocompatibility Testing:

  • Cytotoxicity study
  • Sensitization study
  • Intracutaneous study
  • Acute systemic toxicity study
  • Pyrogen study
  • Hemolysis study
  • In-vivo thromboresistance study
  • Complement activation assay

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The testing described is bench testing and biocompatibility testing, not clinical studies involving patient data or test sets in the context of AI performance evaluation.

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 and not provided. The device is an angiographic catheter, and the evaluation is based on engineering and biocompatibility tests, not diagnostic accuracy requiring expert interpretation or ground truth establishment in a clinical imaging context.

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

This information is not applicable and not provided.

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 information is not applicable and not provided. This document does not describe an AI medical device.

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

This information is not applicable and not provided. This document does not describe an AI medical device.

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

This information is not applicable and not provided. The "ground truth" for the performance tests would be the established engineering standards (e.g., ISO 10555-1) and biocompatibility test methods, not clinical outcomes or expert consensus.

8. The sample size for the training set

This information is not applicable and not provided. This document does not describe an AI medical device requiring a training set.

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

This information is not applicable and not provided.

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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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