(207 days)
The Electric Breast Pumps are single-user, powered breast pumps intended to express and collect milk from the breasts of lactating women.
The subject devices are intended to be used by lactating women to express and collect milk from their breasts. The devices are intended for a single user in the home environment or hospital setting. When properly connected, the pumping kit transfers the vacuum generated by the powered pump to the breast, enabling expression and collection of milk. A diaphragm in the backflow protection assembly physically isolates pump and tubing from the space where milk is expressed and collected, protecting the breast milk from contamination.
The Electric Breast Pumps contain 4 models, YY-A203, YY-A204 and YY-TC201. The YY-A46 model operates in single pumping mode only; models YY-A203, YY-A204 and YY-TC201 can be operated in single or double pumping modes. Models YY-A203 and YY-A204 have an LED panel and model YY-TC201 has an LCD panel to display working mode, cycle, timer, battery level, and Bluetooth symbol to user. While YY-A46 has an LED indicator to indicate the working status of the device, models YY-A46, YY-A203, and YY-A204 can be wirelessly operated via Bluetooth connection to a smart device. Users can select the working mode, adjust the suction level and cycle speed, and start or pause the device from a smart device. Model YY-TC201 can only be operated on the pump unit itself. All models have massage and expression mode and have a maximum working time of 30 minutes.
The provided document is an FDA 510(k) clearance letter for Electric Breast Pumps. It details the device description, indications for use, comparison to a predicate device, and a summary of non-clinical performance testing.
However, the document does not contain information related to acceptance criteria or a study proving that the device meets those criteria, specifically concerning AI device performance. The sections discussed are typical for a breast pump's safety and performance (electrical safety, EMC, software validation, biocompatibility, vacuum/cycle performance, backflow protection, use life, battery performance) rather than AI-related metrics like accuracy, sensitivity, or specificity.
Therefore, I cannot answer the requested questions using the provided text as it does not describe an AI medical device or its performance criteria and study. The prompt asks for information pertaining to AI model validation, such as:
- A table of acceptance criteria and reported device performance: Not present in the document for AI performance.
- Sample size and data provenance for test set: Not present for AI device testing.
- Number of experts and qualifications for ground truth: Not present.
- Adjudication method: Not present.
- MRMC comparative effectiveness study and effect size: Not present.
- Standalone AI performance: Not present.
- Type of ground truth used: Not present for AI evaluation.
- Sample size for training set (AI): Not present.
- How ground truth for training set was established (AI): Not present.
The document focuses on the hardware and basic functional performance of an electric breast pump, not an AI component.
§ 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).