Search Results

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.

Ask a specific question about this device

The Balloon Guiding Catheter is intended to assist intravascular catheterization and guidance of an intravascular catheter into a selected vessel in the neuro or peripheral vascular system. The balloon can provide temporary vascular occlusion during angiography.

The proposed device, Balloon Guiding Catheter, is a braid-reinforced, variable stiffness catheter designed for use in facilitating the guidance of an intravascular catheter into a target vessel in the neuro or peripheral vascular system. A radiopaque marker is included on the distal end for angiographic visualization. A compliant balloon is mounted on the distal end to provide temporary vascular occlusion during angiographic procedures. The proposed device is divided into the S and S+ types with different effective lengths, the difference between S type is the size of the catheter.

The provided document is a 510(k) summary for a medical device called a "Balloon Guiding Catheter." It describes the device, its intended use, a comparison to a predicate device, and the non-clinical testing performed to establish substantial equivalence.

Here's an analysis of the acceptance criteria and study information, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not specify the exact sample sizes used for each individual non-clinical test. It generally states that "Non-clinical tests were conducted to verify that the proposed device met all design specifications."

• Sample Size: Not explicitly stated for each test.
• Data Provenance: The tests are non-clinical (benchtop and in vitro/in vivo biocompatibility). The document does not specify country of origin for the data; however, the manufacturer is Shanghai Heartcare Medical Technology Co., Ltd. in China, implying testing was likely conducted or commissioned by them. The studies are retrospective in the sense that they are conducted on finished or pilot-production devices to demonstrate performance against specifications.

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

Not applicable. This device is a physical medical instrument, not an AI/software device requiring expert consensus for ground truth on a dataset. The "ground truth" for the non-clinical tests is established by objective measurements against established engineering specifications and recognized international standards (e.g., ISO, ASTM, USP).

4. Adjudication Method for the Test Set:

Not applicable. As described above, this is not a study requiring human adjudication of results in the traditional sense of medical image or clinical outcome interpretation.

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 is not an AI/software device. No MRMC study was performed.

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

Not applicable. This is not an AI/software device. No standalone algorithm performance study was performed.

7. The Type of Ground Truth Used:

The "ground truth" for this device's acceptance criteria are based on:

• Engineering Specifications: Defined dimensional tolerances, mechanical properties (tensile strength, burst pressure, kink resistance), and functional performance (balloon expansion, torque, anti-collapse).
• International Standards: Adherence to ISO (e.g., ISO 10993 for biocompatibility, ISO 11135 for sterilization, ISO 594 for connectors, ISO 10555-1 for leakage), ASTM (e.g., for seal strength, dye penetration, hemolysis), and USP (for pyrogen and endotoxin testing) standards.
• Benchtop Test Results: Objective measurements and observations from physical testing in controlled laboratory environments.
• Biological Test Results: In vitro and in vivo testing (on study animals, e.g., for systemic toxicity, thromboresistance) according to ISO standards.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/software device. There is no "training set."

9. How the Ground Truth for the Training Set Was Established:

Not applicable. This is not an AI/software device.

Ask a specific question about this device