(227 days)
The Ardo Alyssa is a powered breast pump to be used by lactating women to express and collect milk from their breasts. The Ardo Alyssa is intended for a single user.
The Ardo Alyssa is a powered breast pump that generates negative pressure to express millt from the breasts of lactating women. It is intended for a single user and can be used in professional healthcare and home environments. The pump can be used for single or double breast pumping. To operate as a single or double pumping system, the pump needs to be connected to a single or double pump sets to be provided with the Ardo Alyssa are identical to those cleared in K141742 for the Ardo Calypso Powered Breast Pump. The Ardo Alyssa has two operational modes (stimulation and expression), with eight vacuum levels in each mode. The device comprises an ON/OFF button and two +/- buttons for independently adjusting (increasing or decreasing) vacuum and cycle. The user also has an option to operate the device via the mobile app, MyArdoApp. A memory function enables storing and replaying a pump session, and a power pumping button enables execution of a predefined pump-pause program. The pump can be powered using the supplied power adapter or by an integrated rechargeable battery.
The provided text is a 510(k) summary for the Ardo Alyssa powered breast pump. It details the device, its intended use, comparison to a predicate device, and the results of non-clinical performance testing.
However, the questions posed relate to the acceptance criteria and study proving a device meets acceptance criteria, specifically in the context of AI/ML performance metrics like sensitivity, specificity, or AUC, and the human expert involvement in ground truth establishment and MRMC studies. The Ardo Alyssa is a powered breast pump, not an AI/ML powered device, and the provided document does not contain information about AI-related performance metrics or studies involving human readers/experts in the way your questions imply.
Therefore, I cannot provide a table of acceptance criteria and reported device performance from this document in the format you expect for an AI/ML device. The "performance testing" section in the document refers to engineering and safety performance testing (e.g., vacuum pressure, electrical safety, battery life), not diagnostic performance based on AI algorithms.
The questions regarding sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, and training set details are not applicable to the information provided in this 510(k) summary for a powered breast pump.
To reiterate, the provided document does not contain the type of AI/ML-related study information needed to answer most of your detailed questions. The acceptance criteria listed are primarily for physical and electrical performance, and the "study" is a series of non-clinical engineering and safety tests rather than a clinical performance study involving AI analysis of medical images or data.
§ 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).