(194 days)
The TSK Syringe is a low dead volume syringe intended for use in patients that need injection and withdrawal of substances for examination, treatment, diagnosis or prevention.
The TSK Syringe is a syringe intended for use with a needle to inject or withdraw substances, for general use. The TSK Syringe leaves a low volume of fluid when the plunger is fully depressed.
There are two model numbers for the TSK Syringe. The technological differences are as follows:
| Number | Syringe Nominal Capacity (mL) |
|---|---|
| TSY-0071P | 0.7 |
| TSY-0101Y | 1.0 |
The provided text is a 510(k) Clearance Letter and 510(k) Summary for the TSK Syringe. It details the device's characteristics, indications for use, and a comparison to a predicate device. However, it does not contain the specific information required to answer your request about acceptance criteria and a study proving device performance in the context of an AI/human reader study.
This document describes a physical medical device (syringe), not a software or AI-powered medical device that would involve AI performance metrics, human reader studies, ground truth establishment, or training/test set sample sizes in the way you've outlined.
Therefore, I cannot provide the requested information from this document. The details about acceptance criteria and study design for AI-based performance evaluation are not present.
§ 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).