(147 days)
The OptiOne Single-Head Contrast Delivery System is a contrast delivery system and is designed to inject radiopaque contrast media into a patient's vascular system to obtain diagnostic images with computed tomography (i.e. "CT") equipment.
The OptiOne Single-Head Contrast Delivery System (OptiOne) is intended to inject radiopaque contrast media into a patient's vascular system to obtain diagnostic images when used in conjunction with computed tomography equipment. Each injection is accomplished with a motor-driven syringe mechanism with microprocessor control of the flow rate, volume, pressure and timing. The OptiOne consists of the following key components: a Powerhead, a Console, and a Power Supply. The Power Supply delivers power to the Powerhead and Console. The Console provides remote control and programmability of the injection through a touch screen display system. The Powerhead contains the components to perform the actual injection such as motor control circuits, ball screw and syringe push ram.
The provided document is a 510(k) summary for the Liebel-Flarsheim Company LLC's OptiOne Single-Head Contrast Delivery System. It details the device's characteristics and its comparison to a predicate device, focusing on demonstrating substantial equivalence.
However, the document does not contain the specific acceptance criteria, reported device performance data, detailed descriptions of studies (sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance), or information on the ground truth establishment for either test or training sets as requested in your prompt.
The document states: "Extensive verification and validation activities were performed to ensure the OptiOne Single-Head Contrast Delivery System design outputs met all design inputs and the customer requirements were successfully met. The testing confirms the OptiOne Single-Head Contrast Delivery System meets the required specifications." And, "The OptiOne Single-Head Contrast Delivery System was developed under the Liebel-Flarsheim Company LLC Design Control processes. The verification and validation activities ensure the OptiOne meets all customer requirements and product specifications."
This indicates that internal testing was conducted to verify that the device met its specifications, but the specifics of those tests, their results against acceptance criteria, or the methodology of the studies are not included in this publicly available summary.
Therefore, I cannot provide the requested information from the given text.
§ 870.1650 Angiographic injector and syringe.
(a)
Identification. An angiographic injector and syringe is a device that consists of a syringe and a high-pressure injector which are used to inject contrast material into the heart, great vessels, and coronary arteries to study the heart and vessels by x-ray photography.(b)
Classification. Class II (special controls). The device, when it is a non-patient contacting balloon inflation syringe intended only to inflate/deflate balloon catheters and monitor pressure within the balloon, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.