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The Wearable Breast Pump (Model S1DW) 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 S1DW) is an electrically powered wearable single or double breast pump consisting of the following key components: a flange, linker, silicone diaphragm, pump motor, USB charging cable, silicone tubing, valve, milk collector, and bra adjustment buckle. 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. The motor unit includes a press-button user interface, pump body, and LED display. Pumping can be performed on one breast (single pumping) or two breasts (double pumping). The user interface allows the user to switch from stimulation to expression mode and control the vacuum levels within those modes. Both stimulation and expression mode consist of 9 vacuum levels. The S1DW model is capable of providing vacuum levels from 40-120 mmHg with cycling rates from 38-51 cycles per minute in stimulation mode and vacuum levels from 120-245 mmHg with cycling rates from 19-40 cycles per minute in expression mode. The model SIDW Wearable Breast Pump is charged with a 5 V DC USB 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 non-sterile.

The breast pump expresses breast milk by creating a seal around the nipple using the flange and applying and releasing suction to 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) of the subject device are not in contact with the breast.

The motor unit operates on a rechargeable battery and does not function when charging. The rechargeable battery can be charged using the external USB adapter if the motor unit is not in operation.

The subject device components are made of the following materials:

• · Motor unit: acrylonitrile-butadiene-styrene (ABS) plastic
• · Flange, tubing, valve, diaphragm: Silicone
• · Linker, milk collection container: Polypropylene

All milk contacting components are compliant with 21 CFR 174-179.

The provided text is a 510(k) Summary for a Wearable Breast Pump (Model S1DW). This document outlines the device's characteristics, its comparison to a predicate device, and the non-clinical performance testing conducted to demonstrate substantial equivalence.

However, the provided text DOES NOT contain information regarding:

• Acceptance Criteria for a "device" in the context of an AI/ML medical device where performance metrics like sensitivity, specificity, or AUC are typically used. The "acceptance criteria" discussed in the document are about the breast pump meeting its design specifications (e.g., vacuum levels, cycle speeds).
• A "study that proves the device meets the acceptance criteria" in the sense of a clinical or standalone performance study involving human subjects or a large test set evaluated against a ground truth for a diagnostic or prognostic AI/ML algorithm. The performance testing mentioned is for the mechanical and electrical functions of the breast pump, not for an AI/ML component.
• Sample sizes used for a test set (for AI/ML).
• Data provenance.
• Number of experts used to establish ground truth.
• Qualifications of experts.
• Adjudication method for a test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study.
• Effect size of human reader improvement with AI vs. without AI assistance.
• Standalone (algorithm-only) performance.
• Types of ground truth (expert consensus, pathology, outcomes data).
• Sample size for the training set.
• How ground truth for the training set was established.

The document discusses "software" and says it was "evaluated as recommended in the 2005 FDA guidance document Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." This suggests that the software in this breast pump is likely for controlling the pump's mechanical functions (e.g., motor speed, vacuum control) and user interface, rather than an AI/ML algorithm performing a diagnostic or prognostic function.

Therefore, based only on the provided text, it's not possible to extract the information requested as it pertains to AI/ML device performance studies. The device is a physical breast pump, and the "performance testing" described relates to its mechanical and electrical specifications, not to an AI model's diagnostic or predictive capabilities.

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