Search Results

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.

Ask a specific question about this device

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 designed for lactating woman to express and collect milk from the breast. It is an electrically powered, software-controlled, digital single user pump. The device consists of the following key components: flange, pump motor, silicone diaphragm, USB cable, milk collector, bra adjustment buckle, and valve. It is designed to work in the user's bra and has a rechargeable battery so it can be used hands-free without any external power cords.

There are two modes, with multiple suction levels for each mode, available for the device: Expression mode and Stimulation mode. Both modes consist of nine vacuum levels. Expression mode consists of pressures ranging from 120-245 mmHg and cycle speeds of 20-66 cycles/min and stimulation mode consists of ranges from 40-120 mmHg and cycle speeds of 69-92 cycles/min. There is an LED status display shown on the pump body, which displays the working mode and battery indicator.

The device may be operated as a single or double pumping system. For a user to pump both breasts simultaneously, they would need to use two devices at the same time, one on each breast. The pump is provided non-sterile and can be re-used by a single user. The device is powered by a Li-ion battery and charged using a 5V DC adaptor. The device should not be used while charging.

The device incorporates embedded software which controls all the features of the product.

All milk contacting components of the device are compliant with 21 CFR 177.

This document is a 510(k) premarket notification from the FDA regarding a Wearable Breast Pump (Model S18). While it confirms the device's substantial equivalence to a predicate device, it does not contain the level of detail typically found in a clinical study report for an AI/ML medical device regarding acceptance criteria and performance studies.

Therefore, I cannot extract the specific information requested about acceptance criteria and study details for an AI/ML device from this document. This document primarily focuses on regulatory approval based on comparison to a predicate device, rather than detailed performance metrics of a novel AI algorithm.

Here's what I can extract and infer from the provided text, acknowledging that it does not fully answer your request for AI/ML device study details:

Regarding the device: The device is a "Wearable Breast Pump (Model S18)". It is a Class II medical device, product code HGX. Its intended use is "to express milk from lactating women in order to collect milk from their breasts" and is "intended for a single user."

The acceptance criteria and reported device performance (based on the context of a breast pump, not an AI/ML device):

The "Performance Testing" section (Page 6) outlines general performance tests, not specific acceptance criteria in the format requested for an AI/ML model. These are more focused on mechanical and electrical function.

Missing/Not Applicable Information (as this is not an AI/ML device submission):

• Sample sized used for the test set and the data provenance: Not applicable/not provided. The performance tests are functional, not data-driven in the sense of AI/ML.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/ML medical device would typically involve expert annotations of medical images or data. For a breast pump, "ground truth" is its mechanical and electrical function.
• Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of AI/ML. The "ground truth" for this device's performance is whether it meets its mechanical and electrical specifications.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

Additional points mentioned in the document:

• Biocompatibility: Leveraged from the predicate device (K212180) because materials are identical.
• Electrical Safety and EMC: Tested according to ANSI/AAMI ES60601-1:2005 + A1:2012, IEC 62133-2:2017, IEC 60601-1-11:2015, and IEC 60601-1-2:2014.
• Software: Evaluated for a "moderate level of concern" as per FDA guidance (2005). The document states "The device incorporates embedded software which controls all the features of the product," but no detailed software performance validation or AI/ML specific details are provided.

In summary, this document establishes the substantial equivalence of a breast pump based on its design, materials, and functional performance tests compared to a previously cleared device. It does not provide the detailed AI/ML specific acceptance criteria and study information you requested.

Ask a specific question about this device