Search Results

The electric breast pumps are intended to be used by lactating women to express and collect milk from their breasts. They are intended for a single user. The electric breast pumps are intended for at home use.

The Youha, Bebebao, and Yiyadodo electric breast pumps are single-user, powered breast pump intended to be used by lactating women to express and collect milk from their breasts. THE ONE, YH-8012, BB-5020 and YY-5030 have both single (pumping from one breast) and double pumping (pumping from both breasts) configurations. YY-8011 and YH-8019 have a single pumping configuration only. A reciprocating diaphragm vacuum pump, driven by a microprocessor, generates the suction to extract the milk at vacuum levels up to 280 mmHg. The user interface for the THE ONE, YH-8012, BB-5020 and YY-5030 models consists of a front panel keypad and LCD display or LED display in which the user switches between modes and controls the vacuum pressure. The YY-5030 model does not have any visual indicators on the pump housing. The device has three modes of operation: Massage mode: Suction patterns with fast cycles and low vacuum to start milk flowing; Low expression mode: Suction patterns with slow cycles and high vacuum to express more milk gently and efficiently; High expression mode: Suction patterns with slower cycles and higher vacuum to express more milk efficiently. THE ONE, YH-8012 and BB-5020 have 3 modes including massage mode, low expression mode and high expression mode. YY-5030, YH-8011, and YH-8019 have 2 modes including massage mode and high expression mode. The device is electrically powered from either an internal lithium ion rechargeable battery or an external AC power adapter. The external adapter also charges the battery.

Here's an analysis of the acceptance criteria and study information provided in the document for the Youha Electric Breast Pump (and related models):

Important Note: The provided document is a 510(k) Summary for a powered breast pump. It is not a document for an AI/ML-driven device. Therefore, many of the requested categories related to AI/ML device studies (e.g., expert adjudication, MRMC study, training set ground truth, effect size) are not applicable to this type of medical device. The information below will focus on the applicable criteria and studies described for a non-AI medical device.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a breast pump and not an AI/ML device, the "acceptance criteria" are related to performance specifications rather than diagnostic accuracy.

The document states that "The test results demonstrated that the proposed device complies with the following standards and guidance documents" and "The specifications were met for vacuum level, cycle rate, and backflow protection for the duration of a pumping session... These specifications were maintained under conditions of single and double pumping mode with varying power sources."

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

The document describes non-clinical performance testing of the device itself (hardware and software), rather than a clinical study with human subjects or a dataset derived from humans. Therefore, the concept of a "test set" and "data provenance" (country of origin, retrospective/prospective) as typically applied to AI/ML performance studies, does not directly apply here. The testing involved measuring the device's physical and electrical properties against its design specifications and recognized standards.

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

Not applicable. As this is a non-AI/ML medical device, no expert clinical review for ground truth establishment on a test set (e.g., image interpretation) was performed. The "ground truth" for the device's physical performance was its design specifications and compliance with international standards, which would be verified by qualified engineers and technicians.

4. Adjudication Method for the Test Set

Not applicable for a non-AI/ML medical device.

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 not an AI-assisted device.

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

Not applicable. This is not an AI/ML device.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by:

• Its design specifications (e.g., target vacuum levels, cycle rates).
• Compliance with international and national standards for medical device safety and performance (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, ISO 14971, IEC 62304, FDA biocompatibility guidance).

8. The Sample Size for the Training Set

Not applicable. This is a non-AI/ML medical device, so there is no "training set" in the context of machine learning.

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

Not applicable. This is a non-AI/ML medical device.

Ask a specific question about this device