(200 days)
The MV Flow Aspiration Pump is intended for general suction use in hospitals or clinics.
The MV Flow Aspiration Pump is an electrically powered (100 VAC/50 Hz, 240 VAC/60 Hz) device designed to generate vacuum pressure and serve as the vacuum source intended for general suction use in hospitals or clinics. The MV Flow Aspiration Pump is not intended for use in transport or field settings. The pump delivers 29 inHg of maximum vacuum pressure with a maximum flow rate of 36 L/min. The power button and vacuum-relief button provide pressure control. The brushless DC, dual-diaphragm pump design includes reverse-flow protection. Compatible pump accessories, supplied separately, include the MV Flow Canister. The MV Flow Canister consists of a single-use collection canister with integrated bacteria filter, overflow protection, and a pre-installed intermediate tubing.
The provided 510(k) clearance letter is for the MV Flow Aspiration Pump, which is a medical device, not an AI/ML-driven diagnostic or therapeutic device. As such, the information you've requested regarding acceptance criteria, study methodologies, and ground truth establishment (which are typically relevant for AI/ML device clearances) is not applicable to this particular device.
The clearance for the MV Flow Aspiration Pump focuses on demonstrating substantial equivalence to a predicate device (Penumbra Pump MAX) based on non-clinical performance testing, electrical safety, EMC/EMI compliance, and device-specific pump standards. There are no mentions of AI/ML components, image analysis, human reader studies, or complex ground truth establishment processes as would be found in clearances for AI-powered diagnostic tools.
Therefore, I cannot provide the requested information in the format of a table of acceptance criteria for AI performance, sample sizes for test/training sets, expert adjudication methods, or MRMC studies, as these types of studies were not conducted or required for the clearance of this specific device.
If you have a document related to an AI/ML medical device, I would be happy to analyze it according to your requested criteria.
§ 878.4780 Powered suction pump.
(a)
Identification. A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.(b)
Classification. Class II.