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The imani i2 breast pump is a powered breast pump to be used by lactating women to express and collect milk from their breasts. The imani i2 breast pump is a single user device.

The imani i2 is a powered breast pump that is intended to express and collect mills from the breasts of lactating women. This breast pump is intended for use by a single user and can be used to pump breast milk from a single breast (single pumping). The imani i2 breast pump is a wearable breast pump comprised of a main body (pump), charqing cable, collection bottle, valve, diaphragm for backflow protection, and a breast funnel. It is designed to work in the user's nursing bra and is battery operated so it can be used hands-free without external power cords. The only user-contacting material is polypropylene (breast funnel). The device is provided non-sterile. The imani i2 breast pump allows the user to adjust the vacuum levels. Two suction patterns, massage and breast pumping mode, are pre-programmed with variable levels and cycle speeds. The subject device is powered by a rechargeable Li-polymer battery (3.7 VDC, 1400 mAh). The imani i2 provides the following user features: Two displays for level of vacuum and battery. Five buttons for power on/off, mode selection (Massage Mode, Pumping Mode), decrease vacuum, and increase vacuum Pumping Mode: This mode is used to express and collect milk from the breast. This mode includes five vacuum and cycle speed levels. Massage Mode: This mode is used to massage the breast before pumping. This mode includes five vacuum levels and a consistent single cycle speed across all vacuum levels.

The provided text is a 510(k) summary for the imani i2 breast pump, detailing its substantial equivalence to a predicate device. However, it does not contain any information regarding acceptance criteria, device performance metrics (like sensitivity, specificity, accuracy, etc.), or details of a study that would typically prove such criteria for a diagnostic or AI-driven device.

This document describes a medical device, specifically a powered breast pump, which is a mechanical device, not an AI or diagnostic device that would require the type of performance evaluation criteria you listed (e.g., sensitivity, specificity, accuracy, multi-reader multi-case studies, ground truth establishment, etc.).

The "Non-Clinical Test summary" section (page 6) describes bench performance testing related to:

• Electrical Safety/Electromagnetic Compatibility in accordance with various IEC and AAMI standards.
• Software Validation (for a "moderate level of concern" software, likely related to device control, not diagnostic algorithms).
• Biocompatibility of user-contacting materials (polypropylene).
• Bench Performance Testing of vacuum level settings, cycle speed settings, and backflow/cross-contamination protection.
• Battery Testing (use-life, charging time, indicator/operating time).
• Simulated Use Testing to confirm users can properly use the device and their satisfaction.

These are all standard engineering and safety performance tests for a mechanical/electrical medical device like a breast pump. They are not the types of studies or criteria used to validate AI or diagnostic performance in medical imaging or pathology.

Therefore, I cannot provide the requested table or answer the questions related to AI/diagnostic device validation based on this document. The document simply doesn't contain that information.

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