(126 days)
VACUETTE® PREMIUM Safety Blood Collection Set is used in routine venipuncture procedures. It is used for blood collection. The safety shield is activated automatically to cover the needle immediately following blood collection thus preventing accidental needlestick injury.
The Vacuette Premium Safety Blood Collection Set is a single use, individually wrapped, sterile winged blood collection needle with an integrated needle and safety shield bonded to a flexible tubing with a female luer adapter allowing the set to be used with a luer system (e.g. Holdex®). It is available with optional Luer Adapter and / or Luer Adapter + Holder. The device is free of PVC, DEHP, Latex.
The provided document describes the VACUETTE® PREMIUM Safety Blood Collection Set, but it does not contain detailed acceptance criteria and a study proving the device meets those criteria in a format applicable to AI/ML device performance.
The document discusses substantial equivalence to predicate devices based on design and safety features. It mentions "Simulated Use Testing" and "Material Testing" but does not provide the quantitative acceptance criteria or the study results of these tests in a way that would allow filling out the requested table and detailed information about AI/ML device performance.
Therefore, I cannot fulfill your request as the necessary information (explicit acceptance criteria, detailed study methodology, sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance) is not present in the provided text for an AI/ML device.
The document primarily focuses on the physical design, intended use, and demonstration of substantial equivalence for a medical device (a safety blood collection set), not an AI/ML system.
§ 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).