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The Hygeia Express Powered Breast Pump is a powered breast pump intended to express and collect milk from the breasts of a lactating woman. It is intended for a single user only.

The Hygeia Express Powered 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 a pump, Personal Accessory Set (PAS) pumping kit, and an AC adapter. The pump is also configurable with a wearable PAS kit which allows milk to flow into a cup pressed against the breast during use. It does not incorporate off-the-shelf (OTS) software or wireless technology/mobile app software functionality. The Hygeia Express Powered Breast Pump has a backlit LCD display, which shows pumping mode, suction level, timer, and battery level. The device also has four buttons allowing the user to power the device on/off, select between three pumping modes (massage, 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 breast pump uses cyclic negative pressure (suction) to mimic the suckling patterns of a feeding infant. A DC motor drives a membrane vacuum pump to generate the suction required to stimulate and express breast milk. The timing of this pattern is dependent upon the suction/speed settings selected by the user and is preprogrammed in the device. The device is capable of producing peak suction levels between -50 and -250 ± 25 mmHg in at speeds between 20 and 150 ± 5 cycles per minute. There are 3 available pumping modes with 9 distinct levels of vacuum and cycle speed. When connected to the pump, the PAS pumping kit transfers the vacuum generated by the powered pump to the breast, enabling expression and collection of milk. A diaphragm in the backflow protection assembly physically isolates pump and tubing from the space where milk is expressed and collected, protecting the breast milk from contamination. All other components (i.e., motor unit) of the subject device are not in contact with the breast. All milk contacting components are compliant with 21 CFR 174-179.

The provided text is a 510(k) summary for the Hygeia Express Powered Breast Pump, which is a medical device. This document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than providing a detailed study that proves the device meets specific acceptance criteria in the context of diagnostic or AI-powered devices.

Therefore, the requested information elements (acceptance criteria, study details, sample size, expert ground truth, MRMC study, standalone performance, training set details) are not applicable to this type of regulatory submission as they relate to the evaluation of a diagnostic or AI device's performance against clinical endpoints.

Instead, the document details non-clinical performance testing to ensure the device meets safety and functional requirements. Here's a breakdown of the relevant information provided:

1. A table of acceptance criteria and the reported device performance: This document does not present a table of specific acceptance criteria in the format usually seen for diagnostic performance (e.g., sensitivity, specificity, AUC). Instead, it describes general compliance with standards and successful completion of various engineering and safety tests.

   Reported Device Performance (Functional/Safety Aspects):

   • Vacuum Levels (Massage): 50-170 ± 25 mmHg
   • Vacuum Levels (Expression): 70-250 ± 25 mmHg
   • Vacuum Levels (Stimulation): 70-250 ± 25 mmHg
   • Cycles per minute (Massage): 70-150 ± 5 cpm
   • Cycles per minute (Expression): 36-136 ± 5 cpm
   • Cycles per minute (Stimulation): 20-33 ± 5 cpm
   • Overall Peak Suction: -50 to -250 ± 25 mmHg
   • Overall Speed: 20 to 150 ± 5 cycles per minute
   • Biocompatibility: Compliant with ISO 10993-1
   • Electrical Safety: Compliant with ANSI/AAMI ES60601-1:2005/A2:2010, IEC 62133-2:2017, and IEC 60601-1-11:2015
   • Electromagnetic Compatibility: Compliant with IEC 60601-1-2:2014
   • Software Evaluation: Evaluated at the Basic Documentation level per FDA guidance.
   • Vacuum level verification testing: Demonstrated that the devices meet mode/cycle specifications.
   • Backflow protection testing: Verified liquid does not backflow into the tubing.
   • Use life testing: Demonstrated that the device maintains its specifications throughout its proposed use life.
   • Battery performance testing: Demonstrated that the battery remains functional during its stated battery use-life.
   • Battery status indicator testing: Demonstrated that the battery status indicator remains functional during its stated battery life.

2. Sample size used for the test set and the data provenance: Not applicable. This document refers to non-clinical engineering and safety testing, not a test set of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth from experts is not established for an electrical breast pump's functional and safety testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

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: Not applicable. This is a breast pump, not an AI-assisted diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for this device's evaluation is primarily based on industry standards (e.g., electrical safety, biocompatibility, EMC) and the device's design specifications for vacuum levels and cycles. No clinical ground truth from patient outcomes or pathology is mentioned as this is a functional device, not a diagnostic one.

8. The sample size for the training set: Not applicable. This device does not use machine learning that requires a training set of data.

9. How the ground truth for the training set was established: Not applicable.

Summary of the Study that Proves the Device Meets the Acceptance Criteria:

The "study" described is a series of non-clinical performance tests conducted in accordance with recognized industry standards and FDA guidance documents. These tests evaluate the device's physical and electrical characteristics, its ability to function as intended, and its safety. The document states that "The results of the performance testing described above demonstrate that the Hygeia Express Powered Breast Pump is as safe and effective as the predicate device and supports a determination of substantial equivalence."

The specific non-clinical tests cover:

• Biocompatibility: To ensure materials in contact with the body are safe.
• Electrical Safety: To ensure the device operates safely electrically.
• Electromagnetic Compatibility (EMC): To ensure the device doesn't interfere with or is interfered by other electronic devices.
• Software Evaluation: To ensure the integrated software functions correctly and safely (evaluated at a "Basic Documentation level" as recommended for this type of device).
• Performance Testing (Specific to Breast Pumps):
  • Verification of vacuum levels at each mode/cycle (Massage, Expression, Stimulation) against specifications.
  • Backflow protection testing to prevent milk contamination.
  • Use life testing to demonstrate durability over its expected lifetime.
  • Battery performance and status indicator testing to ensure reliable power.

The overall "acceptance criterion" is demonstrated substantial equivalence to a legally marketed predicate device (Electric Breast Pump, K211024) by showing that the subject device's differences in technological characteristics (mainly vacuum/cycle specifications) "do not raise different questions of safety and effectiveness" and that it passes the specified non-clinical performance tests.

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