(199 days)
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.
| Acceptance Criteria (Inferred from Performance Tests) | Reported Device Performance (Inferred) |
|---|---|
| Device meets mode/cycle specifications for vacuum levels. | Verified at each mode/cycle. |
| Liquid does not backflow into the tubing. | Backflow protection testing conducted and verified. |
| Device maintains specifications throughout proposed use life. | Use life testing conducted and verified. |
| Battery remains functional during stated battery use-life. | Battery performance testing conducted and verified. |
| Battery status indicator remains functional during stated battery life. | Battery status indicator testing conducted and verified. |
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.
§ 884.5160 Powered breast pump.
(a)
Identification. A powered breast pump in an electrically powered suction device used to express milk from the breast.(b)
Classification. Class II (performance standards).