(109 days)
The Wearable Breast Pump (Model S21) is a powered breast pump intended to be used by lactating women to express and collect milk from their breasts, it is intended for a single user.
The Wearable Breast Pump (Model S21) is a powered breast pump intended to be used by lactating women to express and collect milk from their breasts, it is intended for a single user. The Wearable Breast Pump (Model S21) is a breast pump powered by lithium battery, utilizing an embedded control program to manage all device functions. The main components of this pump 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 S21) is capable of providing vacuum levels from 40-120 mmHg with cycling rates from 62-104 cycles per minute in stimulation mode, vacuum levels from 120-245 mmHg with cycling rates from 22-86 cycles per minute in expression mode, and vacuum levels from 40-120 mmHg with cycling rates from 22-104 cycles per minute in auto mode.
The Wearable Breast Pump (Model S21) 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 device is for repeated use by a single user in a home environment. The device is provided not 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 device are not in contact with the breast. All milk contacting components are compliant with 21 CFR 174-179.
It appears there has been a misunderstanding in the request. The provided FDA 510(k) clearance letter for the "Wearable Breast Pump (Model S21)" does NOT contain information about an AI/Algorithm-driven device or an associated study that proves the device meets acceptance criteria related to AI performance.
The document outlines the regulatory clearance process for a physical medical device (a breast pump) and focuses on its electrical safety, biocompatibility, electromagnetic compatibility, and mechanical performance verification. It does not involve any artificial intelligence, machine learning, or software functions that would require a ground truth, expert adjudication, or MRMC studies for accuracy.
Therefore, I cannot provide the requested information regarding acceptance criteria for an AI/Algorithm, data provenance, expert qualifications, or MRMC studies, as these concepts are not applicable to the content of the provided document.
If you have a different document related to an AI/Algorithm-driven medical device, please provide it, and I will be happy to extract the relevant 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).