(290 days)
The Gemini family infusion devices are intended for intravascular administration of fluids, of medications, blood, and blood products into a patient in a controlled manner.
The IMED GEMINI PC-1TX Volumetric Infusion Pump/Controller is a single channel linear peristaltic infusion device. PC-1TX incorporates the same general safety features exhibited in the Models PC-1, PC-2, PC-2TX, and PC-4. The PC-1TX has been designed as a fail-safe device which utilizes state-of-the-art microprocessor circuitry to monitor the operation of the device and to alarm visually and/or audibly whenever assigned parameters have been exceeded, resulting in shutdown until corrective actions, as indicated, have been completed by the user. The PC-1TX displays information relative to operations including advisories, prompts, alarms, and malfunctions.
I am sorry, but the provided text is a 510(k) K960512 Premarket Notification for the IMED GEMINI PC-1TX Volumetric Infusion Pump/Controller, dated February 2, 1996.
This document describes a medical device, specifically an infusion pump, and focuses on its safety, effectiveness, and functional similarity to previously cleared devices. It does not contain information related to:
- Acceptance criteria and reported device performance in the context of a study as you've requested (e.g., sensitivity, specificity, AUC). The performance stated is an accuracy of ±5%, which is a technical specification for the device's function in delivering fluids, not a "performance" metric in the AI/diagnostic imaging sense.
- Sample sizes used for test sets or data provenance.
- Number or qualifications of experts for ground truth establishment.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance.
- Type of ground truth used (pathology, outcomes data, etc.).
- Sample size for training sets.
- How ground truth for training sets was established.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets them, based solely on the provided text, as this information is not present in the document. The document pertains to hardware device regulatory approval, not a clinical or AI performance study.
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).