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The Evenflo Premium Double Electric Breast Pump (Model 4018) is an electrically powered suction device intended to express and collect milk from a lactating woman's breasts. It is intended for a single user.

The Evenflo Electric Breast Pump (Model 4018) is an electrically powered breast pump to be used in a home environment by a single user. The device is provided non-sterile and should be cleaned and disinfected prior to first use according to the instructions for use. The breast pump can be used on one breast (single pumping) or on both breasts at the same time (double pumping).

The device consists of a pump unit, AC power adapter, power cable, AdvancedFit flange kit and bottle kit. The AdvancedFit flange kit consists of a flange body, flange insert, check valve (valve and membrane), diaphragm, diaphragm cap, and tubing for each breast, a tubing adapter to connect the kit to the pump unit and a tubing adapter plug to convert for single pumping. It does not incorporate off-the-shelf (OTS) software or wireless technology/mobile app software functionality. 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 mmHg in double pumping mode and between -85 and -250 mmHg in single pumping modes at speeds between 30 and 80 cycles per minute. There are 9 distinct levels of suction and 6 speeds available for each suction level.

The breast pump expresses breast milk by creating a seal around the nipple using a flange and applying and releasing suction to the nipple. The milk is collection container, which can be used for storage. To prevent milk from flowing into the vacuum system, a backflow protection membrane physically separates the milk-contacting pathway from the vacuum system.

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 Evenflo Premium Double Electric Breast Pump (Model 4018). It focuses on demonstrating substantial equivalence to a predicate device based on similar intended use and technological characteristics, and non-clinical performance testing.

However, the document does NOT contain information about acceptance criteria for a device that uses AI/algorithm or a study involving human readers or expert consensus for ground truth establishment, which are typical for AI/ML-enabled medical devices.

Based on the provided text, I can answer some of your questions, but many will be marked as "Not applicable" or "Not provided" because the device is a breast pump, not an AI/ML diagnostic tool, and the summary focuses on equivalence to a predicate device rather than de novo performance studies as would be seen for an AI/ML device.

Here's the breakdown of the information from the document in response to your questions:

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

The document does not present acceptance criteria for AI model performance (e.g., sensitivity, specificity, AUC) or human reader performance. Instead, it describes performance testing for a breast pump, focusing on engineering specifications.

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

• Sample Size for Test Set: Not explicitly stated in terms of number of devices tested for each performance criterion. The document refers to "testing" conducted.
• Data Provenance: Not specified directly for the testing. It's implied that the testing was conducted by Evenflo Feeding, Inc. or their designated testing facilities.
• Retrospective or Prospective: Not applicable or specified for this type of device testing.

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

Not applicable. Ground truth as understood for AI/ML clinical studies (e.g., radiologist reads) is not relevant for the testing of a breast pump's mechanical and electrical performance. The "ground truth" here is the design specification or established engineering standard.

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

Not applicable. Adjudication methods are typically used in clinical studies with human readers or image analysis, not for mechanical/electrical testing of a breast pump.

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 device is a breast pump, not an AI system intended to assist human readers in, for example, diagnosing medical conditions from images.

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

Not applicable. The device does not contain an AI/ML algorithm for diagnostic purposes. Its software is for operational control (e.g., suction/speed settings).

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

Not applicable. The "ground truth" for this device's performance testing is based on engineering specifications, adherence to international standards (e.g., ISO, IEC), and functional requirements for a breast pump (e.g., vacuum levels, backflow prevention).

8. The sample size for the training set

Not applicable. This document is for a physical medical device (breast pump), not an AI/ML model that requires training data.

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

Not applicable. (See #8)

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