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510(k) Data Aggregation
(221 days)
The powered Electric Double Breast Pumps are intended to express and collect milk from the breast of a lactating woman. They are double pumps with a single pumping option and intended for single user.
The Electric Double Breast Pumps are designed and manufactured to express and collect milk from a lactating woman's breast. Both models, XB-8636 and XB-8703, are electrically powered, softwarecontrolled, digital single-user pumps.
When powered, the XB-8636 starts with stimulation mode for 120 seconds then automatically switches to expression mode for 30 minutes before automatic shutdown. This model has seven suction levels. When powered, the XB-8703 starts with stimulation mode for 180 seconds then automatically switches to expression mode for 30 minutes before automatic shutdown. This model has nine suction levels. Both models allow the user to adjust the suction levels when necessary.
This document is a 510(k) premarket notification for an Electric Double Breast Pump. It does not describe a study involving humans or AI for diagnostic purposes. Therefore, most of the requested information regarding acceptance criteria, study details, and AI performance will not be applicable.
However, I can extract the non-clinical acceptance criteria and the summary of non-clinical tests performed to meet those criteria.
1. A table of acceptance criteria and the reported device performance
Based on the document, the acceptance criteria are implicit in compliance with recognized standards and design specifications. The performance reported is that the device met these specifications and standards.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Safety and Essential Performance (Electrical) | Complies with IEC 60601-1: 2005 + CORR.1 (2006) + CORR.2 (2007) + AM1 (2012) |
| Home Healthcare Environment Compliance | Complies with IEC 60601-1-11: 2010 |
| Electromagnetic Compatibility (EMC) | Complies with IEC 60601-1-2: 2007 |
| Suction Curves | All test results complied with the design specifications of the proposed devices. |
| Backflow Prevention | No backflow occurred into the tubing or pump motor during testing, even if the bottle was over-filled. |
| Use-Life/Durability | No significant difference in suction strength or simulating milk suction flow rate between new-manufactured devices and devices after two-year use and 1000 cycles' disinfection. |
| Substantial Equivalence to Predicate Device | The differences in suction level, suction strength, cycle speed, and suction flow rate do not raise different questions of safety and effectiveness, and performance testing showed no adverse effects. |
2. Sample sized used for the test set and the data provenance
The document does not specify sample sizes for non-clinical tests (e.g., how many units were tested for use-life, backflow, or suction curves). The tests are entirely non-clinical/bench tests. Data provenance is implied to be from the manufacturer's internal testing in China (Wuxi Xinzhongrui Baby Supplies Co., Ltd).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a breast pump, and the evaluation involves engineering and safety standards, not medical diagnostic "ground truth" established by experts in the context of a clinical study or AI performance evaluation.
4. Adjudication method for the test set
Not applicable, as this is not a study involving human or AI interpretation of data requiring adjudication.
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. This document pertains to the regulatory clearance of a physical medical device (breast pump) and does not involve AI or human readers for diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This document does not describe the evaluation of an algorithm.
7. The type of ground truth used
For the non-clinical tests performed:
- Engineering specifications and recognized international standards: This serves as the "ground truth" or benchmark against which the device's performance was measured for safety and efficacy from an engineering perspective. For example, IEC standards define acceptable limits for electrical safety and EMC.
- Design Specifications: The manufacturer's own design specifications for parameters like suction curves, backflow prevention, and use-life were used.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning study.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/machine learning study.
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