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The Selector Angiographic Catheter is intended to deliver contrast medium during angiography as well as to provide a conduit for various diagnostic and therapeutic procedures. Selector Angiographic Catheters are intended for single-patient use only.

The Selector Angiographic Catheter consists of a radiopaque shaft with an attached molded female luer lock hub. The shaft of the catheter includes a flexible section and an optional soft distal tip. The Selector Angiographic catheter may vary with respect to length, diameter, curve style, and the number of side holes present. Selector Angiographic Catheters can be introduced into the selected blood vessel by either cutdown or percutaneous entry techniques.

Here's a breakdown of the acceptance criteria and study information for the Selector Angiographic Catheter based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size for Test Set and Data Provenance:

The document does not explicitly state the sample sizes used for the non-clinical performance testing. It also does not specify the country of origin for the data or whether the study was retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

This information is not applicable. The device is a physical medical device (catheter), and its performance is evaluated through physical and material property testing, not through expert review of data like an AI algorithm would be.

4. Adjudication Method for the Test Set:

This information is not applicable, as the evaluation involves non-clinical performance testing of a physical device, not subjective expert assessment requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not done. This type of study is typically conducted for AI/software devices to assess the impact of AI assistance on human readers' performance. This document describes a physical medical device.

6. Standalone Performance Study:

Yes, a standalone performance study was done in the sense that the device's physical and material properties were tested independently against pre-defined performance criteria. The description "non-clinical performance testing to provide data supporting the safety and effectiveness of the device" indicates a standalone evaluation of the device itself.

7. Type of Ground Truth Used:

The "ground truth" for this device's performance is based on engineering specifications and established performance criteria for medical devices that ensure safety and effectiveness. This includes measurements of tensile strength, dynamic pressure, flow rate, diameters, radiopacity, and biocompatibility, as determined by laboratory testing.

8. Sample Size for the Training Set:

This information is not applicable. The device is a physical medical device, not an AI algorithm that requires a training set.

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

This information is not applicable, as there is no training set for a physical medical device.

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The HEMO-Valve is recommended for use in angiographic procedures involving blood or other potentially infectious materials, so that the procedure can be performed in such a manner as to minimize blood loss and patient/user exposure to these substances. The HEMO-Valve is intended for use in intra-arterial and intravenous administration of fluids, including radiographic contrast media.

The HEMO-Valve consists of an elastomeric valve located between male and female luer lock fittings. The valve may be opened by connecting a male luer lock (the luer fitting pushes the gland out of the way) or may be opened by introducing a guidewire in a forward or backloading manner.

This document describes a premarket notification for the "NAMIC HEMO-Valve." However, the provided text does not contain any information about acceptance criteria or a study proving that the device meets specific performance criteria related to AI or any advanced algorithmic analysis.

Instead, the document focuses on:

• Device Description: What the HEMO-Valve is and how it functions.
• Intended Use: The medical procedures it's designed for.
• Predicate Devices: Comparison to similar, already marketed devices.
• Performance Testing: A general statement about non-clinical performance testing for "functional claims," hemostasis, and pressure testing.
• Biocompatibility: Stating that predicate devices have undergone this testing and there are no material changes.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, AI study details, sample sizes, ground truth establishment, or expert involvement, as this information is not present in the provided text.

If you have a different document that details an AI device and its validation study, please provide that text, and I will do my best to extract the requested information.

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Ask a specific question about this device