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The Duo Hands-Free breast pump is an electrically powered breast pump to be used in a home environment by a single user. The device is provided non-sterile and can be used on one breast (single pumping) or on both breasts at the same time (double pumping).

The device consists of the pump unit, two Hands-free Collection Cups (breast shields, membranes, outer shells), and tubing. The breast pump provides wireless connectivity via a Bluetooth Low Energy (BLE) 4.2 compliant protocol and is compatible with the Medela Family mobile application. The BLE component does not offer control of the breast pump and is only meant to store the information sent from the breast pump (such as session length, phases and vacuum intensity levels) and log additional information related to their pumping session. The device has four buttons allowing the user to power the device on/off, select between two pumping modes (expression, and stimulation), and control vacuum strength within each mode (9 levels of vacuum strength in each mode). The pump is powered by an internal, non-replaceable, rechargeable lithium-ion battery which is charged using the included AC power supply and cable. The subject device can be operated while plugged into AC power.

The Duo Hands-free breast pump utilizes a microcontroller executing embedded software to interpret user inputs and modulate the voltage applied to a DC motor and a solenoid to produce a negative vacuum pressure applied to the user. The vacuum is generated by turning on the motor, incrementally drawing air out of the pump set on each rotation and expelling it into the atmosphere. When the cycle is complete, the solenoid valve is opened, relieving the vacuum. Vacuum generated by the breast pump unit is applied to the membrane in the Hands-free Collection Cup pump set causing it to displace away from the breast and to apply vacum to the breast. Vacuum applied to the breast will cause milk to be expressed and to accumulate on the milk valve. Once the vacuum is relieved by the solenoid valve, milk will fall through the milk valve into the outer shells, and the cycle is repeated.

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

AI/ML Overview

The Duo Hands-Free Breast Pump, described in the provided 510(k) summary, is a Class II medical device, and the information provided does not directly detail a clinical study involving human patients or complex AI algorithms requiring extensive acceptance criteria beyond basic device functionality and safety. The document focuses on bench testing and regulatory compliance.

However, based on the non-clinical performance testing conducted, we can infer some "acceptance criteria" related to the device's functionality and safety, and the "study" that proves it.

Here's the breakdown of the available information:

1. A table of acceptance criteria and the reported device performance

Since specific numerical acceptance criteria (e.g., "vacuum level must be within +/- 5 mmHg") are not explicitly stated in the summary, we will infer the performance criteria from the types of tests conducted and their stated purpose. The "reported device performance" is essentially that the device "meets its design requirements and performs as intended."

Acceptance Criteria (Inferred from Test Type)	Reported Device Performance
Biocompatibility: Materials in contact with milk are safe for use.	Compliant with 21 CFR 174-179. Information provided in accordance with ISO 10993-1 guidance.
Electrical Safety: Device operates safely without electrical hazards.	Tested in accordance with IEC 60601-1 Ed 3.2, IEC 62133-2:2017, and IEC 60601-1-11 Ed 2.1.
Electromagnetic Compatibility (EMC): Device does not interfere with or is affected by other electronic devices.	Tested in accordance with IEC 60601-1-2 Ed 4.1.
Software Functionality: Embedded software operates correctly.	Evaluated at the Basic Documentation level as recommended by FDA guidance.
Cybersecurity: Device is protected against cybersecurity risks.	Documented in accordance with FDA Guidance document, "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions."
Vacuum Level Accuracy: Delivers specified vacuum levels in each mode/cycle.	Met mode/cycle specifications during vacuum level verification testing.
Backflow Protection: Prevents milk from entering the tubing/pump mechanism.	Verified liquid does not backflow into the tubing during backflow protection testing.
Use Life Durability: Maintained specifications throughout its proposed lifespan.	Maintained specifications throughout its proposed use life during use life testing.
Battery Performance & Indicator Functionality: Battery operates as expected and indicator works correctly.	Battery remains functional during its stated battery use-life, and the battery status indicator remains functional during its stated battery life.

2. Sample size used for the test set and the data provenance

The document does not provide details on the specific sample sizes for the non-clinical tests (e.g., how many units were tested for vacuum level, how many cycles for use-life, etc.). These are typically bench tests conducted on a sufficient number of manufactured units as determined by the manufacturer's internal quality assurance procedures and risk management. The data provenance is internal manufacturer testing (Medela LLC). These are prospective tests conducted on the manufactured device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This section is not applicable in the context of this device and its testing. The "ground truth" for non-clinical performance and safety tests is established by recognized international standards (e.g., IEC, ISO) and the device's design specifications. The experts involved would be the engineers and quality assurance personnel at Medela LLC, qualified in electrical engineering, mechanical engineering, software development, and quality systems, who designed, built, and tested the device against these standards and specifications. No external expert panel was used to establish a "ground truth" in the way it might be for an AI-powered diagnostic device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable. Adjudication methods like 2+1 or 3+1 are used for clinical studies involving interpretation of medical images or data by multiple readers to establish a consensus "ground truth." The tests described are objective, non-clinical performance tests against pre-defined specifications and standards.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable. The device is a breast pump, not an AI-assisted diagnostic tool. No MRMC study was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable. The device is a breast pump, not an AI algorithm. While it contains embedded software to control its operation, there's no "standalone algorithm" performance assessed in the context of diagnostic accuracy.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical performance tests, the "ground truth" is defined by:

International Standards: e.g., IEC 60601 series for electrical safety and EMC, ISO 10993-1 for biocompatibility.
Device Design Specifications: Internal specifications set by Medela LLC for vacuum levels, cycle rates, battery life, and durability.
Regulatory Requirements: 21 CFR 174-179 for milk-contacting materials.

8. The sample size for the training set

This is not applicable. This device does not use machine learning or AI that requires a "training set" of data.

9. How the ground truth for the training set was established

This is not applicable, as there is no training set for this device.

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