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The Momcozy Wearable Breast Pump (model: BP311) is a powered breast pump intended to express milk from lactating women in order to collect milk from their breasts. The device is intended for a single user.

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The provided FDA 510(k) clearance letter for the Momcozy Wearable Breast Pump (BP311) does not contain information about acceptance criteria, study design, or performance metrics that would typically be found in a submission for a device with complex algorithms or AI components.

The letter explicitly states:
"We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent... to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..."

This indicates a traditional 510(k) pathway where the device's substantial equivalence to a predicate is demonstrated, primarily through comparison of technological characteristics, materials, and intended use. Performance testing for breast pumps typically focuses on aspects like suction pressure, cycle rate, duration of use without overheating, and material biocompatibility, rather than AI-driven diagnostic accuracy or human-in-the-loop performance.

Therefore, I cannot provide the requested information regarding acceptance criteria, study data, ground truth establishment, or expert involvement as these details are not present in the provided document. The device in question, a wearable breast pump, does not appear to involve AI or complex algorithms that would necessitate such detailed performance studies as those typically seen for imaging or diagnostic AI/ML devices.

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The Momcozy Wearable Breast Pump (Model: BP311, BP223, BP334, BP334, BP430) is intended to express milk from lactating women in order to collect milk from their breasts. The device is intended for a single user.

Not Found

This document pertains to the FDA clearance of a medical device, specifically a breast pump. It does not contain information about the acceptance criteria or study details for an AI/ML-enabled medical device.

Therefore, I cannot provide the requested information regarding acceptance criteria and study details for an AI-enabled device based on the provided text. The document is a standard FDA 510(k) clearance letter for a non-AI medical device.

Ask a specific question about this device