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The Wearable Breast Pump, Model S18 is intended to express milk from lactating women in order to collect milk from their breasts. The device is intended for a single user.

The Wearable Breast Pump, Model S18 is an electrically powered breast pump to be used in home environment by a single user. The device is provided non-sterile and can be re-used by a single user. The device is electrically powered by an internal rechargeable Li-ion battery. It can be charged using 5V DC adaptor and the device is designed to be not used during charging. The device consists of the pump motor, milk collection parts, adjustment buckle and charging cable. The device functionality is controlled using an embedded firmware. The subject device has three modes of operation - Expression mode, Stimulation mode and Massage mode, and each mode of operation allows for switching between nine suction levels. The device has three buttons, a power button to turn the device on/off or switch between the modes, a '+ plus' button to increase the suction level and a '- minus' to decrease the suction level within a mode. The device includes an LED status display for the device operating mode and battery status indicator on the pump body. The operating mode LED changes to specific color based on the mode of operation. The device is designed to automatically shut down after 30 minutes of continuous operation. The device operates on a suction(vacuum) cycle that consists of an inhale (letting in air to release vacuum) and an exhaust (removal of air to create vacuum) process. When the breast pump is powered on, the vacuum pump exhausts the air inside the cavity. Once the suction strength reaches the set value, the vacuum pump stops and the valve for the milk opens and expressed milk flows into the bottle due to a pressure difference. All milk contacting components of the device are compliant with 21 CFR 177.

The provided document is a 510(k) Pre-Market Notification for a wearable breast pump (K232774). This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving the safety and effectiveness of a novel device through extensive clinical studies, especially those with AI components.

Therefore, the document does not contain the information requested regarding acceptance criteria and the study that proves a device with an AI component meets those criteria. Such information would be found in a submission for a device incorporating AI/ML, which would require performance data against defined metrics, often involving ground truth established by experts.

The document discusses performance testing relevant to a traditional electromechanical device (breast pump), such as:

• Biocompatibility Testing: Evaluating tissue-contacting components for cytotoxicity, irritation, and sensitization.
• Electrical Safety and Electromagnetic Compatibility (EMC): Compliance with recognized standards like IEC 60601-1.
• Software Verification and Validation Testing: This is to ensure the embedded firmware functions correctly according to its specifications, not to assess AI performance. The documentation level is "Basic Documentation Level," which is typical for non-AI software in medical devices.
• Performance Testing and Use Life Verification: This includes testing vacuum level and cycle frequency, backflow, battery capacity, button performance, and automatic shutdown function over the device's 3-year use-life.

None of these tests involve AI-specific acceptance criteria, ground truth establishment by multiple experts, MRMC studies, or standalone algorithm performance.

In summary, the provided text does not contain the information necessary to answer the questions about AI device acceptance criteria and study methodology because the device in question (a breast pump) is not an AI/ML medical device.

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