(80 days)
The Momcozy Wearable Electric Breast Pump (Model: S9 Pro, S12 Pro) is a powered breast pump intended to express milk from lactating women in order to collect milk from their breasts. The device is intended for a single user.
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This document is an FDA 510(k) clearance letter for the Momcozy Wearable Electric Breast Pump. Unfortunately, it does not contain the detailed information required to answer your specific questions regarding acceptance criteria and the study that proves the device meets them.
The FDA 510(k) clearance process primarily focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than requiring extensive performance studies with detailed acceptance criteria as one might see for novel AI/ML medical devices or higher-risk devices.
Here's why the document doesn't have the information you're looking for, and generally, what a 510(k) submission for a non-AI/ML device typically entails:
- Acceptance Criteria and Device Performance Table: This type of table is not part of a standard 510(k) clearance letter for a powered breast pump. A 510(k) submission might include performance testing data (e.g., motor strength, suction levels, battery life, biocompatibility), but this data is usually summarized in the submission itself, not in the clearance letter. The FDA clears the device based on the sponsor demonstrating that these performance characteristics are substantially equivalent to the predicate device, not necessarily against pre-defined clinical acceptance criteria for an AI algorithm.
- Sample Size and Data Provenance for Test Set: Not applicable in the context of this 510(k) clearance letter. There isn't a "test set" in the sense of clinical image data for an AI algorithm. Performance testing for a breast pump would involve engineering tests (e.g., measuring suction, flow rate) rather than clinical studies with patient data.
- Number of Experts, Ground Truth, Adjudication, MRMC Study, Standalone Performance: These concepts are relevant to AI/ML device evaluations. A breast pump is a mechanical device, not an AI algorithm. Therefore, none of these aspects would be part of its 510(k) submission or clearance.
- Type of Ground Truth: For a breast pump, "ground truth" would relate to its physical performance metrics (e.g., milk expression efficiency, comfort), which are assessed through engineering tests and user feedback, not expert consensus on medical images or pathology.
- Sample Size for Training Set & Ground Truth for Training Set: These are concepts specific to AI/ML model development. A breast pump does not have a "training set" in this context.
In summary, the provided document is a regulatory clearance for a medical device (a breast pump) that is not an AI/ML device. Therefore, the detailed questions about acceptance criteria, study design, and ground truth for AI model validation do not apply to this specific document or the type of device it describes.
To find the kind of information you are asking for, you would need to look at FDA clearance documents and associated summaries for AI/ML-enabled medical devices. These documents, particularly the Decision Summary (or Summary of Safety and Effectiveness), often detail the clinical study information, validation methods, acceptance criteria, and performance results for the AI algorithm.
§ 884.5160 Powered breast pump.
(a)
Identification. A powered breast pump in an electrically powered suction device used to express milk from the breast.(b)
Classification. Class II (performance standards).