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The Momcozy Wearable Breast Pump (Model: BP334-, BP380-, BP420-, BP431-, BP400-, BP432-, BP434-) 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.

The Momcozy Wearable Breast Pump (Model: BP334-, BP380-, BP434-, BP420-, BP431-, BP432-, BP400-) is a wearable powered breast pump intended to be used by lactating women to express and collect milk from their breast. The device is a non-sterile reusable device to be used by single user. The breast pump stimulates lactation and extracts milk from the breasts by creating a seal around the nipple and applying and releasing suction to the breast. The milk is collected in a milk collector. The device is electrically powered through a rechargeable Lithium battery (3.7V) that can be charged using the USB cable provided with the device.

The subject device includes three operating modes, namely - stimulation mode, expression mode, and mixed mode, with 15 levels of operation within each mode and a maximum suction of -315mmHg. In stimulation mode, the breast pump begins with a quick and short sucking pattern to get the milk to start flowing. In expression mode, the breast pump begins with a slow and long sucking pattern for milk expression, sucking more deeply and more slowly. In mixed mode, the breast pump begins with a quick and short sucking pattern, followed by a slow and long sucking pattern. The device features a diaphragm-type vacuum pump driven by a microprocessor. The microprocessor provides control over vacuum pressure and cycle speed during milk expression.

The pump remembers the mode and suction level settings. When restarted, it will resume with the same mode and suction level as when it was last turned off. Each mode's suction level setting is also remembered individually and remains consistent during future use.

The device can be connected wirelessly to a mobile device through Bluetooth and be operated through a dedicated mobile application (Mobile flow). By using the application, users can either select one of three preset operating modes or define a personalized mode. The personalized mode supports personalized sessions, each of which can select its own mode, suction level, and duration. Users can also enable a milk overflow reminder function in the app. Pumping output can also be recorded and tracked by users in the app.

The device is available in one or two pumps in a pack to allow for single/double pumping. The subject device includes an LED display that displays information regarding working mode, running time, suction level, battery status, full milk indicator and Bluetooth indicator. The user interface includes on/off/pause switch, mode selection switch, decrease pumping level, increase pumping level and Toggle button to select breast pump direction to left or right. The subject device includes a diaphragm to prevent milk backflow into the vacuum system as well as software based overflow protection.

The device includes a milk collection set that consists of the following: double-sealed flange (Polyphenylsulfone (PPSU) + Silicone), flange insert, diaphragm assembly, duckbill valve assembly, milk collector (Tritan) and main unit pump motor. Each component can be purchased separately by the user if needed.

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The Momcozy Wearable Breast Pump (Model: BP223) 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.

The Momcozy Wearable Breast Pump is an electrically powered breast pump to be used in a home environment by a single user. It is intended to be used by lactating women to express and collect milk from their breast. The device is not sterile. The breast pump stimulates lactation and extracts milk from the breasts by creating a seal around the nipple and applying and releasing suction to the breast. The milk is collected in a milk collector.

The device includes stimulation mode, expression mode, and mixed mode with a maximum suction of -315mmHg. Each mode has multi-adjustable suction levels. In stimulation mode, the breast pump begins with a quick and short sucking pattern to get the milk to start flowing. In expression mode, the breast pump begins with a slow and long sucking pattern for milk expression, sucking more deeply and more slowly. In mixed mode, the breast pump begins with a quick and short sucking pattern, followed by a slow and long sucking pattern. The device features a diaphragm-type vacuum pump driven by a microprocessor. The microprocessor provides control over vacuum pressure and cycle speed during milk expression.

The pump remembers the mode and suction level settings. When restarted, it will resume with the same mode and suction level as when it was last turned off. Each mode's suction level setting is also remembered individually and remains consistent during future use.

BP223 can connect wirelessly to a mobile device and be operated through a dedicated mobile application (M9 Mobile flow).

By using the application, users can either select one of three preset operating modes or define a personalized mode. The personalized mode supports personalized sessions, each of which can select its own mode, suction level, and duration. Users can also enable a milk overflow reminder function in the app. Pumping output can also be recorded and tracked by users in the app.

To prevent milk from flowing into the vacuum system, the milk collection set includes a diaphragm that physically separates the milk-contacting pathway from the vacuum system. The motor unit operates on a rechargeable battery. The rechargeable battery can be charged from the external power adapter (not included in this device) through the provided charging cable. The user interface consists of buttons (On/off/Pause, Mode selection, Decrease pumping level Increase pumping level and Toggle button to select breast pump direction to left or right) and an LED display in which the user switches between modes and controls the vacuum pressure.

The device includes a milk collection set that consists of the following: double-sealed flange (Polyphenylsulfone (PPSU) + Silicone), flange insert, diaphragm assembly, duckbill valve assembly, milk collector (Tritan) and main unit pump motor. Each component can be purchased separately by the user if needed.

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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 (BP137); Momcozy Wearable Breast Pump (BP141) 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 document is a 510(k) clearance letter from the FDA for the Momcozy Wearable Breast Pump (BP137) and Momcozy Wearable Breast Pump (BP141).

This type of document does not contain the information requested regarding acceptance criteria and performance studies. 510(k) clearance letters primarily state that the FDA has determined the device is substantially equivalent to a legally marketed predicate device and outline regulatory requirements.

Information about specific performance studies, acceptance criteria, sample sizes, expert qualifications, and ground truth establishment is typically found in the 510(k) premarket notification submission itself, which is not included in this letter.

Therefore, I cannot provide answers to the questions based on the given text.

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