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The eufy Wearable Breast Pump S1 is a powered breast pump intended to be used by lactating women to express and collect milk from their breasts. It is intended for a single user.

The eufy Wearable Breast Pump E10 is a powered breast pump intended to be used by lactating women to express and collect milk from their breasts. It is intended for a single user.

The eufy Wearable Breast Pump is an electrically powered wearable single breast pump. There are two models, eufy Wearable Breast Pump S1 (T8DO2) and eufy Wearable Breast Pump E10 (T8DO3). S1 consists of a Pump Hub, Diaphragm, Milk Container, Pouring Spout, Heating Pins, Flange, Duckbill Valve and charging pins. E10 consists of Pump Hub, Diaphragm, Milk Container, Pouring Spout, Flange and Duckbill Valve.

The differences between S1 and E10 are as follows:

1. E10 has no heating function (S1 has a heating function);
2. The charging method is different (S1 for magnetic charging, E10 for Type-C charging).

The eufy Wearable Breast Pump is powered by an internal rechargeable lithium-ion polymer battery (3.7V 1460mAh). The eufy Wearable Breast Pump cannot be operated while it is being charged.

The eufy Wearable Breast Pump operates on embedded software, and software updates by end-users are supported. The subject device is intended for use in a home healthcare environment. An optional smartphone app may be used with the Breast Pump. The app may be used to control the operation of The Breast Pump (select mode and vacuum level, start and stop pumping), save pumping session history and display the quantity (in ml) of milk in the bottle on the user's smartphone. Use of the app is not mandatory to operate the Breast Pump.

The eufy Wearable Breast Pump is a closed-system breast pump with an anti-backflow diaphragm which physically separates the air-pumping system from the milk-flow system.

The eufy Wearable Breast Pump allows the user to power the breast pump on and off, and to operate the breast pump in two modes (stimulation, expression) and to control the vacuum settings within these modes. Each mode consists of 7 vacuum levels, capable of providing suction from -75 to -292.5mmHg, with cycle speeds ranging from 71 to 110 cycles/minute in stimulation mode and 39 to 60 cycles/minute in expression mode.

The provided FDA 510(k) clearance letter and summary for the eufy Wearable Breast Pumps (S1 and E10) do not contain information about a clinical study involving human subjects or AI components that would require acceptance criteria related to accuracy, sensitivity, or specificity.

The document describes non-clinical performance testing for the device, which primarily focuses on:

• Electrical Safety, Electromagnetic Compatibility: Compliance with standards like ANSI AAMI ES60601-1, IEC 60601-1-2, HA60601-1-11, and IEC 62133-2.
• Performance testing: Verification of vacuum suction pressure & cycle speed, backflow protection, battery capacity, operating time/charging time, and use life testing. "Device specifications were met for all tests conducted." This statement indicates internal acceptance criteria were met, but the specific numerical criteria are not detailed in this summary.
• Packaging simulation testing: Compliance with ISTA 3A: 2018.
• Biocompatibility: Compliance with ISO 10993-1, 10993-5, 10993-10, and 10993-23. "The user-contacting materials were shown to be non-cytotoxic, non-irritating, and non-sensitizing." These are the acceptance criteria.
• Software: Evaluation based on FDA guidance documents for device software functions.
• Cybersecurity: Evaluation based on FDA guidance for cybersecurity in medical devices.

Therefore, I cannot provide a table of acceptance criteria and reported device performance in the way you've requested (e.g., accuracy, sensitivity, specificity), nor can I answer questions about sample size for a test set, data provenance, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment for clinical data, as this information is not present in the provided text.

The provided document indicates that the device has "embedded software" and an "optional smartphone app," but there's no mention of these software components being AI-driven in a way that would necessitate performance metrics like those typically seen for AI/ML devices (e.g., for diagnosis, prediction, or image analysis). The app primarily controls the pump and displays basic information like milk quantity.

Based on the provided text, the device is a powered breast pump, and its clearance is based on demonstrating substantial equivalence to a predicate device through non-clinical performance and safety testing.

To summarize what can be inferred from the provided text regarding acceptance and testing:

Acceptance Criteria and Study for eufy Wearable Breast Pump

The acceptance criteria and study detailed in the provided 510(k) summary are focused on the safety and performance of the electromechanical device as a powered breast pump, rather than on diagnostic or AI-powered functions requiring clinical accuracy metrics.

1. Table of Acceptance Criteria and Reported Device Performance

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

• The document describes non-clinical performance testing on the device itself (e.g., how many units were tested for vacuum, battery life, etc.). The sample sizes for these engineering or lab tests (e.g., number of breast pumps tested) and their provenance (e.g., manufactured in China, tested in specific lab environments) are not detailed in this 510(k) summary. There is no mention of a clinical test set involving human subjects for performance evaluation.

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

• Not applicable. This information pertains to studies where expert interpretation (e.g., for medical images) forms the ground truth. The acceptance criteria here relate to physical device performance and safety standards, which are evaluated by engineers and lab technicians against predefined specifications.

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

• Not applicable. Adjudication methods are typically used in clinical studies involving multiple human readers or interpretations.

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:

• No. An MRMC study was not conducted as this device is a breast pump, not an AI-driven diagnostic or interpretative tool for which human readers would interact.

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

• Not applicable. This applies to AI/ML algorithms, not the core function of a breast pump.

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

• For the performance testing, the "ground truth" or reference was engineering specifications and recognized international consensus standards (e.g., specified vacuum ranges, cycle speeds, battery capacities, biocompatibility definitions by ISO standards).

8. The sample size for the training set:

• Not applicable. This device is not described as involving machine learning from a training set for its core function. The embedded software and app are for control and display, not for learning or prediction based on large datasets.

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

• Not applicable. (See point 8).

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