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The Lucina-Melodi Advance Breast Pump is intended to express and collect milk from the breast of lactating women. This device may be used by more than one user if the collection kit is changed.

The Lucina Melodi Advanced Breast Pump is a battery powered breast pump powered by a smart software. It has a 2 phase suction cycle. Phase 1 runs at a higher speed than phase 2. It is portable and is battery powered, with a rechargeable battery build in the system. It weighs less than 1 kg. it is intended for continuous usage from User A to User B to User C etc. It can be use on both breasts at the same time as well as single breast one at a time. The device has a build in color LCD screen, and east to use buttons and graphic user interface. The device can be run on battery power and also while plugged in to the AC adapter. Internally it gets its suction from a diaphragm motor. The PCB board will control the speed and the suction of the motor to provide optimal suction or based on the settings that the user sets at.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Important Note: The provided document is a 510(k) summary for a breast pump. This type of submission generally focuses on demonstrating substantial equivalence to a predicate device rather than conducting extensive clinical studies with specific performance metrics like those for diagnostic AI devices. Therefore, many of the requested fields regarding AI performance, expert ground truth, and clinical efficacy studies will not be applicable or directly addressed in this document. The "study that proves the device meets the acceptance criteria" largely refers to bench testing and comparison to predicate devices, not clinical trials for performance metrics.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not describe a "test set" in the context of a clinical performance study with human subjects or a dataset for AI evaluation. The "testing" mentioned refers to bench tests performed on the device itself.

• Sample Size: Not applicable in the context of clinical or AI performance evaluation. Bench testing data volume is not specified beyond "continuous usage test," "post testing for consistency to measure pressure over time," and "microbiological tightness validation test."
• Data Provenance: Not applicable. The testing is device-centric bench testing presumably performed by the manufacturer.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts

Not applicable. Ground truth as typically understood for diagnostic device performance (e.g., disease presence/absence) is not relevant for this breast pump's safety and effectiveness demonstration, which relies on engineering specifications and equivalence to predicate devices. There's no mention of experts establishing a "ground truth" for the bench tests; these tests follow established engineering protocols.

4. Adjudication Method for the Test Set

Not applicable. No "test set" requiring adjudication (like expert consensus on medical images) is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of AI vs. Without AI Assistance

Not applicable. This device is a powered breast pump and is not an AI diagnostic or assistance tool. Therefore, no MRMC study or AI-related effectiveness metrics are relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for this device's safety and effectiveness is established by:

• Engineering specifications and regulatory standards: Compliance with standards like IEC 60601-1-2, FCC part 15 Class B, EN 55011, IEC 61000-4-2, IEC 61000-4-3.
• Bench test results: Demonstrating the device meets its design requirements (e.g., consistent pressure, durability, microbiological tightness).
• Predicate device comparison: The specifications and performance of the predicate devices (Medela Symphony Powered Breast Pump K020518 and Lucina-Melodi Powered Breast Pump K102516) serve as benchmarks for demonstrating substantial equivalence.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI algorithm that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable. (See #8)

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