(177 days)
The electric breast pump is intended to be used by lactating women to express and collect milk from their breast. It is intended for a single user.
The electric breast pump is an over-the-counter powered breast pump intended to be used by lactating women to express and collect milk from their breasts. The device is intended for daily use in a home environment by a single user. The electric breast pump includes three models: YD-1132S, and YD-1168. YD-1130S and YD-1132S has a double pumping from both breasts at the same time) configuration only. YD-1168 has both single pumping (pumping from one breast) and double pumping (pumping from both breasts at the same time) configurations. The electric breast pump is comprised of the pump unit, system parts (including connector body, silicone shield, dust cap, top cover, diaphragm, valve, airway tube, bottle, nipple, bottle cap set, bottle stand), and USB cable. The electric breast pump provides two suction modes: Massage mode and Expression mode, with adjustable vacuum levels and cycle speeds. The device is electrically powered from either an internal rechargeable battery or an external AC power adapter.
The provided text describes the 510(k) premarket notification for an Electric Breast Pump (K211755). This document focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical performance testing and compliance with recognized standards.
Crucially, the provided document DOES NOT contain information regarding a study involving AI assistance, multi-reader multi-case (MRMC) studies, expert ground truth establishment for AI, or training/test set data for an AI/algorithm-based device. The device in question is an "Electric Breast Pump," a physical medical device, not a software-driven diagnostic or image analysis tool that would typically involve the types of studies listed in the prompt.
Therefore, I cannot fulfill the request to describe acceptance criteria and associated studies for an AI/algorithm-based device based on the provided text. The questions in the prompt are specific to the evaluation of AI/Machine Learning-enabled medical devices, which is not applicable to the Electric Breast Pump.
The document details the following for the Electric Breast Pump:
1. Acceptance Criteria and Reported Device Performance (Non-AI Device):
The acceptance criteria are implicitly derived from standards compliance and performance testing to ensure the device functions as intended and is safe. The reported performance is primarily demonstrated through successful completion of these tests.
| Acceptance Criteria (Implicit) | Reported Device Performance Statement |
|---|---|
| Safety - Electrical Safety & EMC | Complied with ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, IEC 60601-1-2:2014, IEC 60601-1-11:2015. |
| Safety - Biocompatibility | (Patient-contacting components): Non-cytotoxic, non-sensitizing, and non-irritating per ISO 10993-5:2009 and ISO 10993-10:2010. |
| Performance - Vacuum Level | Met specifications for vacuum level at minimum and maximum settings under single and double pumping modes with varying power sources (AC adapter and battery). Capable of providing a vacuum pressure up to 280 mmHg (specific ranges vary by model and mode, see comparison table for details). |
| Performance - Cycle Rate | Met specifications for cycle rate at minimum and maximum settings under single and double pumping modes with varying power sources. Cycle speeds stated in the comparison table (e.g., Massage mode: 10-140 cycles/min; Expression mode: 21-83 cycles/min, depending on model/pumping option). |
| Performance - Backflow Protection | Met specifications for backflow protection. |
| Performance - Use Life | Maintained performance specifications throughout its proposed use-life. |
| Performance - Battery Functionality & Indicator | Battery remained functional during its stated use-life. Battery status indicator remained functional during its stated battery life. |
| Software Functionality (for embedded software, if applicable) | Software documentation provided in accordance with FDA guidance "Guidance for the Content of Premarket Submissions for Software in Medical Devices" issued May 11, 2005. (This indicates compliance with documentation standards for embedded software, not an AI/ML algorithm-specific performance study). |
2. Sample size used for the test set and the data provenance: Not applicable. These terms relate to AI/ML model evaluation with a dataset of cases (e.g., images, patient records). This submission describes performance testing on the physical breast pump device itself (e.g., electrical safety, vacuum performance, use-life).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth establishment with experts is relevant for diagnostic or AI interpretation devices, not a physical pump.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for a physical device's performance testing.
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 a physical device, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no standalone algorithm being evaluated; it's a physical medical device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc.): Not applicable. Ground truth in this context would refer to objective measurements of the physical pump's performance against its specifications (e.g., measured vacuum pressure matches specified range).
8. The sample size for the training set: Not applicable. There is no AI model or training set mentioned in the context of this device.
9. How the ground truth for the training set was established: Not applicable.
In summary: The provided document is a 510(k) submission for a physical Electric Breast Pump, demonstrating its safety and performance through standard engineering and medical device testing, and its substantial equivalence to a predicate device. It does not involve any AI/Machine Learning components or the types of studies (AI performance, ground truth, MRMC) outlined in your request.
§ 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).