(100 days)
The TriboGlide™ Lubricated Silicone-Free Syringe when combined with an appropriate gauge needle is used to inject fluids into, or withdraw fluids from, the body.
The TriboGlide™ Silicone-Free Syringes are sterile and disposable (single use) standard polypropylene piston syringes without permanently attached needles. They consist of a polypropylene syringe barrel and plunger. Various syringe sizes include 0.5ml, 1ml, 3ml, 6ml, 10ml, 12ml, 60ml and 140ml. The lubricant used in the TriboGlide syringe is a fluorocarbon based non-silicone lubricant. The TriboGlide™ Silicone-Free Syringes, when combined with an appropriate gauge needle, are used to inject fluids into, and withdraw fluids from, the body.
The provided text describes a 510(k) summary for TriboGlide™ Silicone-Free Syringes and outlines the testing conducted to demonstrate substantial equivalence to predicate devices. However, the document does NOT contain information pertaining to a study involving AI, or any advanced computational device that would typically have an acceptance criteria table, sample sizes for test/training sets, expert involvement for ground truth, or MRMC studies.
The provided acceptance criteria and study information pertain to the performance of the syringe itself (biocompatibility, sterilization, luer taper compliance, etc.), not the performance of an AI or computational device in a medical imaging or diagnostic context.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and the reported device performance (in the context of an AI device)
- Sample sized used for the test set and the data provenance
- Number of experts used to establish the ground truth
- Adjudication method
- If a multi reader multi case (MRMC) comparative effectiveness study was done
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- The type of ground truth used
- The sample size for the training set
- How the ground truth for the training set was established
The document describes a traditional medical device (a syringe) and its validation through compliance with established standards and physical/biological testing, not a study of an AI algorithm's performance.
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).