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Wearable Breast Pump is a powered breast pump to be used by lactating women to express and collect milk from their breasts. The device is intended for a single user

Wearable Breast Pump is a powered breast pump to be used by lactating women to express and collect milk from their breasts. The device is intended for a single user

I apologize, but the provided FDA 510(k) clearance letter for the "Wearable Breast Pump" does not contain any information about acceptance criteria or a study that proves the device meets those criteria.

The letter is a standard clearance notification that states the device is substantially equivalent to legally marketed predicate devices. It covers:

• The device name and model numbers.
• The regulation number and name.
• The regulatory class and product code.
• Dates of submission and clearance.
• General controls provisions of the Act that apply to the device.
• Links to FDA guidance documents and regulations (e.g., QS regulation, UDI rule, MDR).
• Contact information for FDA resources.
• The Indications for Use statement for the device.

There is no mention of performance studies, clinical trials, specific acceptance criteria, or data related to the device's functional performance (e.g., milk expression efficiency, comfort, battery life, etc.). The FDA's substantial equivalence determination for this type of device typically relies on demonstrating that the new device has the same intended use and similar technological characteristics to a predicate device, and does not raise different questions of safety and effectiveness. This often involves engineering bench tests and comparisons of specifications rather than detailed clinical performance studies, especially for well-established device types like breast pumps.

Therefore, I cannot fulfill your request for the specific points about acceptance criteria and study details because that information is not present in the provided document.

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