(145 days)
The Safety Insulin Pen Needle is intended for use with pen injector devices for the subcutaneous injection of insulin. The attached safety shield automatically locks after injection and reduces the occurrence of accidental needle sticks from the patient end of the needle.
The Safety Insulin Pen Needle consists of hub, spring, needle tube, safety shield, housing, safety seat, outer container and sealed paper. The sharps protection feature can be passively activated to cover the needle immediately after use to minimize risk of accidental needle sticks.
The provided document is a 510(k) summary for a medical device (Safety Insulin Pen Needle), not a study report for an AI/ML-based medical device. Therefore, it does not contain the information required to answer the prompt regarding acceptance criteria and studies proving the device meets those criteria for an AI/ML device.
The document discusses:
- Device Type: A physical medical device (pen needle).
- Regulatory Pathway: 510(k) clearance based on substantial equivalence to a predicate device.
- Testing: Primarily non-clinical performance and safety testing (e.g., biocompatibility, sterility, mechanical properties, sharps injury protection).
- No AI/ML Component: There is no mention of any artificial intelligence, machine learning, or software algorithm that would require a ground truth, expert review, or MRMC study.
Therefore, I cannot extract the requested information such as acceptance criteria for AI performance metrics (sensitivity, specificity), sample sizes for AI test/training sets, expert qualifications for ground truth establishment, or details of an MRMC study.
To answer your request, I would need a document describing the regulatory submission and study for an AI/ML-based medical device.
§ 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).