(79 days)
The Auto-Fill™ Syringe Kit is indicated for the introduction of dilute lidocaine solutions into subcutaneous tissues for the purposes of tumescent local anesthesia.
The Auto Fill Syringe Kit consists of a control syringe and fluid administration set with check valve.
The provided text does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria regarding its performance. This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance study results against specific criteria.
Here's why the requested information cannot be extracted from the given text:
- No Acceptance Criteria or Device Performance Table: The document explicitly states "No performance standards have been developed under section 514 for this device." and only mentions "Testing has been conducted to verify the integrity and strength of the bond used to attach the check valve to the tubing." It does not provide any specific "acceptance criteria" (e.g., a certain burst pressure, flow rate, or maximum leakage) nor does it report "device performance" against such criteria in a quantitative manner.
- No Clinical Study Details: The summary is entirely focused on non-clinical testing ("Summary of Non-Clinical Testing: Testing has been conducted to verify the integrity and strength of the bond used to attach the check valve to the tubing.") and comparison to predicate devices. There is no mention of a clinical study, human readers, or any of the other elements typically associated with a medical image analysis or diagnostic device study (e.g., sample size for test set, data provenance, expert ground truth, MRMC study, stand-alone performance, training set details).
- Device Type: The device is a "Fluid Administration Set" and "Auto Fill Syringe Kit," used for introducing lidocaine solutions. This is a mechanical device, not an AI/software-based diagnostic tool, which is what most of the specific questions (like MRMC studies, ground truth establishment, training sets) pertain to.
In summary, the provided 510(k) document is for a fluid administration syringe kit and does not contain the detailed performance study information, acceptance criteria, or AI/software validation details requested in your prompt.
§ 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).