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An electrically powered breast pump with adjustable vacuum and massage settings and 2 funnels for expressing milk from the breasts of a lactating woman.

The Gerber Double Electric Breast Pump is a simple and effective system for expressing milk from a lactating women's breast(s). The device includes the following components: a pump base, flexible tubing, a funnel assembly, a carrying bag, and accessories (e.g. bottles, nipples, and disposable nursing pads). The device is powered by a variable speed power supply that drives a diaphragm pump creates the negative pressure required to extract breast milk. The breast pump is capable of providing a variable vacuum and massage like motion. A maximum vacuum of 240 mm Hg can be applied to one or both breasts.

The provided document is a 510(k) premarket notification for the Gerber Double Electric Breast Pump, seeking substantial equivalence to existing predicate devices. It does not contain information about the acceptance criteria and a study proving device performance in the context of an AI/ML medical device.

The document discusses "non-clinical tests" as "Bench testing of the device has demonstrated that the Gerber Double Electric Breast pump meets established requirements when used in the manner and environment specified in product labeling." It explicitly states, "No clinical tests have been conducted on this device."

Therefore, I cannot provide the requested information as it pertains to a medical device that is not an AI/ML product and does not involve the types of studies described in your request. The device is a traditional medical device (breast pump), and its clearance is based on substantial equivalence to predicate devices rather than complex performance studies against specific acceptance criteria for an AI/ML algorithm.

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