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This product is intended for use to inject fluid into or withdraw fluids from parts of the surface of the skin.
Sterile single use needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub). The needle cap covers intended to provide physical protection to the needle tube. This product is packed by sterile paper and sterilized by EO gas.
The safety guard is placed around the needle after using the product for safety and to prevent reuse. EZ-Injec LDV Sterile Safety Needle helps to decrease fluid volume loss because of its smaller hub inner size.
The provided text describes a 510(k) premarket notification for a medical device, the EZ-Injec LDV Sterile Safety Needle. It details the device's characteristics, comparison to a predicate device, and the performance testing conducted to demonstrate substantial equivalence.
However, the information provided does not contain details about acceptance criteria, study methodologies, or performance results in the context of an AI/ML powered device. Specifically, it lacks:
- A table of acceptance criteria and reported device performance (in terms of AI metrics like sensitivity, specificity, AUC, etc.).
- Sample sizes for test sets, data provenance, ground truth establishment, expert qualifications, or adjudication methods for an AI/ML study.
- Any mention of Multi-Reader Multi-Case (MRMC) studies or standalone algorithm performance.
- Information on training set size or how its ground truth was established for an AI/ML model.
The document focuses on the physical and functional aspects of a hypodermic needle, including:
- Mechanical properties: Gauge, length, dead space, sharps prevention function.
- Material composition: Polypropylene, SUS304, Epoxy.
- Sterilization: EO gas.
- Biocompatibility testing: Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Material-Mediated Pyrogenicity, Hemocompatibility, Particulate Matter.
- Shelf-life validation.
The "Performance Testing" section refers to conformance with recognized ISO standards for hypodermic needles and tests for low dead space capability and sharps injury protection. These are engineering and safety standards for the physical device, not performance benchmarks for an AI/ML algorithm.
Therefore, it is not possible to provide the requested information regarding acceptance criteria, study details, and performance for an AI/ML device based on the provided text, as the device in question (EZ-Injec LDV Sterile Safety Needle) is a traditional medical device, not an AI/ML-powered one.
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).