(133 days)
The Wearable Breast Pump (Model FS12A); Wearable Breast Pump (Model FS12B) are powered breast pumps intended to be used by lactating women to express and collect milk from their breasts. They are intended for a single user only.
The Wearable Breast Pump (Model FS12A); Wearable Breast Pump (Model FS12B) are powered breast pumps intended to be used by lactating women to express and collect milk from their breasts; they are intended for a single user. Both Wearable Breast Pump (Model FS12A) and Wearable Breast Pump (Model FS12B) are breast pumps powered by lithium battery, utilizing an embedded control program to manage all device functions. The main components of these pumps include: Pump, valve, control board, and milk collector. The user interface allows the user to switch from stimulation, expression, and auto modes and control the vacuum levels within those modes. All available modes consist of 12 vacuum levels. The Wearable Breast Pump (Model FS12A); Wearable Breast Pump (Model FS12B) are capable of providing vacuum levels from 40-160 mmHg with cycling rates from 75-133 cycles per minute in stimulation mode, vacuum levels from 120-245 mmHg with cycling rates from 21-98 cycles per minute in expression mode, and vacuum levels from 40-245 mmHg with cycling rates from 21-150 cycles per minute in auto mode. The Wearable Breast Pump (Model FS12A); Wearable Breast Pump (Model FS12B) is charged with a 5 V DC adaptor and powered by an internal rechargeable lithium-ion polymer battery. The motor unit operates on embedded software. Software updates by end-users are not supported. The subject devices are for repeated use by a single user in a home environment. The devices are provided non-sterile. The motor unit operates on a rechargeable battery and does not function when charging. The rechargeable battery can be charged from the external USB adapter if the motor unit is not in operation. The breast pump expresses milk by creating a seal around the nipple using the flange and applying and releasing suction to the nipple. The milk is collected in a milk collection container, which can be used for storage. To prevent milk from flowing into the vacuum system, a backflow protection membrane physically separates the milk-contacting pathway from the vacuum system. All other components (i.e., motor unit/housing) of the subject devices are not in contact with the breast. All milk contacting components are compliant with 21 CFR 174-179.
I am sorry, but the provided text is a 510(k) Clearance Letter for a wearable breast pump. It describes the device, its intended use, comparison to a predicate device, and summaries of non-clinical performance testing (biocompatibility, electrical safety, EMC, software, and general performance testing like vacuum level verification, backflow protection, use life, and battery performance).
However, this document does not contain any information about acceptance criteria or a study design that would prove a device meets acceptance criteria specific to an AI/ML powered device, especially concerning diagnostic performance metrics like sensitivity, specificity, or reader studies. The device described is a physical breast pump, not an AI/ML software device.
Therefore, I cannot extract the information required by your prompts, such as:
- A table of acceptance criteria and the reported device performance (for an AI/ML model)
- Sample size used for the test set and the data provenance (for an AI/ML model)
- Number of experts used to establish the ground truth (for an AI/ML model)
- Adjudication method (for an AI/ML model)
- MRMC comparative effectiveness study results (for an AI/ML model)
- Standalone performance (for an AI/ML model)
- Type of ground truth used (for an AI/ML model)
- Sample size for the training set (for an AI/ML model)
- How the ground truth for the training set was established (for an AI/ML model)
The document focuses on the mechanical, electrical, and material safety and performance of a physical pump. If you have a different document related to an AI/ML powered medical device, I would be happy to analyze it for the requested information.
§ 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).