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Non-powered Breast Pump to express milk from the breast.

Easy Comfort ™ Deluxe Manual Breast Pump

This document is a 510(k) premarket notification letter from the FDA for a nonpowered breast pump. It does not include information about acceptance criteria or a study proving device performance in the way described in your request (e.g., performance metrics, sample sizes, expert ground truth).

Therefore, I cannot extract the requested information from this document. The document primarily focuses on:

• Device Identification: Easy Comfort™ Deluxe Manual Breast Pump, Regulation Number 21 CFR 884.5150 (Nonpowered breast pump).
• Regulatory Determination: Substantially equivalent to legally marketed predicate devices, allowing it to proceed to market.
• General Controls: Reference to general controls provisions of the Act (registration, labeling, good manufacturing practice, etc.).
• FDA Contact Information: For questions regarding labeling, promotion, and general responsibilities.
• Indications for Use: "Non-powered Breast Pump to express milk from the breast."

There is no mention of "acceptance criteria" for performance, specific metrics like sensitivity or specificity, or details of any clinical or performance study conducted to establish these.

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