(102 days)
The Confluent Surgical Extended Tip Applicator is indicated for use in the simultaneous delivery of two non- homogenous solutions onto a surgical site.
The Confluent Surgical Extended Tip Applicator will be configured using a Y-Connector, a Malleable Shaft and three Spray Tip Assemblies.
The provided text details a 510(k) summary for the "Confluent Surgical Extended Tip Applicator." However, it does not describe acceptance criteria for a device, nor does it present a study proving the device meets acceptance criteria. Instead, it outlines the device's technical specifications, intended use, and claims of substantial equivalence to a predicate device.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and a study from the provided input.
Here's a breakdown of what the document does provide, and why it doesn't contain the requested information:
- Document Type: This is a 510(k) summary, which is a premarket notification to the FDA. It's a regulatory document demonstrating that a new device is as safe and effective as a legally marketed predicate device.
- Focus: The core of a 510(k) is to establish "substantial equivalence." This means the device has the same intended use and technological characteristics as a predicate device, or if it has different technological characteristics, it does not raise different questions of safety and effectiveness, and the device is as safe and effective as the predicate device.
- Instead of Acceptance Criteria and Studies: The document states: "Safety and effectiveness of the Confluent Surgical Extended Tip Applicator have been demonstrated in this submission. The biocompatibility and in vitro bench testing data provide support that the Extended Tip Applicator is substantially equivalent to the currently 510(k)-cleared Dual Liquid Applicator."
To reiterate, the requested information (acceptance criteria, study details, sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance, ground truth types, training set details) is not present in the provided 510(k) summary. These details would typically be found in a more comprehensive study report or a different section of a regulatory submission, not generally in the public 510(k) summary focused on substantial equivalence.
§ 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).