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The Angel Tip Safety Intravascular Needle Set is indicated to access the peripheral vascular system for hemodialysis. Additionally, after withdrawal of the needle from the patient's vein, the needle can be manually retracted within a safety enclosure to minimize the risk of an accidental needle stick.

The safety needle portion of the Angel Tip Safety Intravascular Needle Set will be available in diameters ranging from 14 to 18 Ga and lengths of 1.0 to 1.5 inches.

The Angel Tip Safety Intravascular Needle Sets are sterile, single use devices designed to access the peripheral vascular system for hemodialysis. Additionally, after withdrawal of the needle from the patient's vein, the needle can be manually retracted within a safety enclosure to minimize the risk of an accidental needle stick. The Angel Tip Safety Intravascular Needle Set consists of a needle attached to a winged hub, microbore or macrobore tubing, adapter and adapter cap and a safety enclosure that attaches to the winged hub.

As the needle is removed from the patient's vessel, the user's finger actively slides the safety enclosure until it latches onto the needle using a one- or two-handed technique. The user will know the needle is engaged based on the tethers being fully extended and hearing an audible click. The safety enclosure is designed to allow the user's fingers to remain behind the needle point so that the risk of needle stick injury is minimized. The enclosure is clear so the user has a visual means of knowing the needle is captured.

This document does not contain the information required to populate all sections of the request. It primarily pertains to a 510(k) premarket notification for a medical device, which focuses on demonstrating substantial equivalence to existing devices rather than presenting detailed clinical study data with acceptance criteria and reported performance metrics.

Specifically, the document focuses on non-clinical testing for performance aspects like tensile strength, leakage, Luer compatibility, corrosion, force to activate, and force to override, rather than clinical performance for diagnostic or therapeutic accuracy that would require an AI-driven device analysis.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

The document mentions "performance testing (tensile, leakage, Luer, corrosion, force to activate and force to override)" and states these tests "demonstrate that the Angel Tip Safety Intravascular Needle Set is as safe, as effective and performs comparably to the predicate devices." However, it does not provide specific acceptance criteria values or the reported performance data for these tests. Therefore, a table cannot be fully constructed.

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

This information is not present. The document mentions "nonclinical testing" but does not specify sample sizes for these engineering/material tests, nor does it refer to a "test set" in the context of human or patient data.

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

This information is not present. The approval is based on substantial equivalence to predicate devices, supported by non-clinical engineering tests, not on an evaluation by experts establishing ground truth for a diagnostic or therapeutic outcome.

4. Adjudication Method:

This information is not present. Adjudication methods are typically relevant for studies involving human interpretation or challenging cases, which is not the nature of the testing described here.

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

This information is not present. This type of study is for evaluating the impact of AI on human reader performance, which is not applicable to a physical medical device (needle set) that does not incorporate AI.

6. Standalone (Algorithm Only) Performance:

This information is not present. This device is a physical medical instrument, not an AI algorithm.

7. Type of Ground Truth Used:

For the non-clinical tests described, the "ground truth" would be the engineering specifications and established test methodologies (e.g., ASTM standards for tensile strength, ISO standards for Luer connections). However, the document does not explicitly state the specific standards or the "ground truth" labels. It implies compliance with predicate device performance.

8. Sample Size for the Training Set:

This information is not present. The device is not an AI/ML algorithm that requires a training set.

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

This information is not present as there is no training set for this device.

Summary of Available Information (from the document):

• Device Name: Angel Tip Safety Intravascular Needle Set
• Purpose of Review: 510(k) Premarket Notification for substantial equivalence.
• Tests Performed: Nonclinical tests including tensile, leakage, Luer, corrosion, force to activate, and force to override.
• Conclusion: The device is considered substantially equivalent to predicate devices based on "similar indications for use, intended use, fundamental scientific technology and similar design, materials, and manufacturing processes" and the results of the nonclinical testing, which demonstrated it "does not raise new issues of safety or effectiveness."

Conclusion based on the Request:

The provided document details a 510(k) submission for a physical medical device, not an AI or algorithm-driven device. As such, most of the requested information pertaining to acceptance criteria of an algorithm, studies involving human readers, ground truth establishment for AI, and training/test set sample sizes is not applicable or available in this type of regulatory document. The document focuses on demonstrating that the physical safety needle set is as safe and effective as pre-existing, legally marketed predicate devices through engineering and material performance tests, rather than clinical performance data with specific accuracy metrics.

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