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The Whisper Wear Powered Breast Pump is intended for use by lactating women to express and collect breast milk.

The Whisper Wear Breast Pump is a self-contained, battery-operated device that is worn under and held in place by everyday clothing. A DC motor imparts motion to a silicone diaphragm that develops a negative pressure that expresses milk from the breast to a collection bag.

The provided text describes the Whisper Wear Breast Pump and its regulatory submission, but it does not contain the detailed information requested regarding specific acceptance criteria and a study proving the device meets those criteria, particularly in the context of an AI/ML-driven device.

This document is a 510(k) premarket notification for a traditional medical device (a breast pump), and therefore, the typical performance criteria and study designs associated with AI/ML devices are not applicable. The core of this submission is demonstrating substantial equivalence to a predicate device, not establishing novel performance characteristics through a detailed clinical or algorithmic study as would be required for an AI/ML product.

Here's a breakdown of what the document does provide, and why it doesn't fit the requested format for acceptance criteria and dedicated studies:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria Mentioned: The document states the device "complies with the following standards, practices, and guidances:"
  • 10993-1, Biological Evaluation-Part 1: Guidance on Selection of Tests
  • 10993-5, Biological Evaluation-Part 5: Tests for Cytotoxicity: In Vitro Methods
  • 10993-10, Biological Evaluation-Part 10: Tests for irritation and sensitization
  • UL 1431, Personal Hygiene and Health Care Appliances
  • UL 2601-1, Medical Electrical Equipment, Part 1: General Requirements for Safety
• Reported Device Performance: The document vaguely states, "This has been demonstrated through a series of bench tests including vacuum and cycle rate performance." It also mentions, "The tissue contact and milk contact materials used to fabricate the Whisper Wear Breast Pump and Collection Bags have a long history of safe usage."
• Missing from the Request: The document does not provide specific quantitative acceptance criteria (e.g., "vacuum pressure must be > X kPa and

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