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The Wearable Breast Pump is intended to express milk from lactating women in order to collect milk from their breasts. The device is intended for a single user.

The Wearable Breast Pump is an over-the-counter, non-sterile, single-user, 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. The device uses a diaphragm-type vacuum pump driven by software embedded in the device. The software provides control over vacuum pressure and cycle speed.

The Wearable Breast Pump series includes ten models: YD-1195, YD-1196,YD-1198,YD-1199:YD-1193S, YD-1195S, YD-1196S, YD-1198S, YD-1199S. All model have a single pumping configuration only and operate in three modes - stimulation, expression, and mixed modes. The Wearable Breast Pump is capable of providing vacuum levels up to 290 mmHg. All modes include 9 vacuum user-selected levels.

Models YD-1195, YD-1198, YD-1199, YD-1193S, YD-1196S, YD-1198S and YD-1199S are identical to model YD-1196 except for enclosure color and model name. YD-1196 and YD-1193 have the same suction modes, maximum vacuum, overvoltage protection functions, backflow protection functions, and material composition, but are different in user interface, schematic circuit, appearance and construction. YD-1193, YD-1195, YD-1196,YD-1198,YD-1199 are retailed with one unit per package. YD-1193S,YD-1195S,YD-1196S,YD-1198S,YD-1199S are retailed with two units per package.

The Wearable Breast Pumps are designed to work under the user's bra and has a rechargeable 3.7V, 1100mAh lithium ion battery so it can be used hands-free without any external power cords. The subject device is charged from an external USB adapter and does not function when charging. The subject device consists of the following key components: the pump unit, connector body, silicone shield, dust cap, top cover, diaphragm, valve, airway tube, bottle, nipple, bottle cap set, bottle stand, and USB cable. The pump unit includes a press-button user interface, pump body, and LED display. The user interface includes user-adjustable controls for turning the device on/off, switching between massage mode and expression mode and mixed mode, and controlling vacuum level within each of the modes. The subject device expresses mills by creating a seal around the nipple using the flange and applying and releasing suction to the nipple. The milk collection container. To prevent milk from flowing into the vacuum system, a backflow protection diaphragm physically separates the milk-contacting pathway from the vacuum system.

The provided text describes the performance data for a medical device, a Wearable Breast Pump, in the context of an FDA 510(k) premarket notification. However, it does not pertain to an AI/ML medical device and therefore does not include information typically sought for AI/ML device acceptance criteria and study design, such as:

• A table of acceptance criteria and reported device performance for AI/ML metrics (e.g., sensitivity, specificity, AUC).
• Sample size and data provenance for an AI test set.
• Number and qualifications of experts for AI ground truth establishment.
• Adjudication methods for AI test sets.
• MRMC comparative effectiveness study results for human readers with/without AI assistance.
• Standalone AI algorithm performance.
• Type of ground truth used for AI (e.g., pathology, outcomes).
• Sample size and ground truth establishment for an AI training set.

The document primarily focuses on the engineering and safety performance of a physical medical device (breast pump), detailing:

• Biocompatibility testing: Cytotoxicity, sensitization, irritation.
• Electrical safety and electromagnetic compatibility: Compliance with standards like ANSI AAMI ES60601-1, IEC 60601-1-2, ANSI AAMI HA60601-1-11, IEC 62133-2.
• Software verification and validation: Categorized as "Moderate" level of concern per FDA guidance.
• Sterilization, Cleaning, and Shelf-Life: Reusable, non-sterile, cleaning instructions provided, shelf-life not applicable due to low degradation likelihood but expected use-life of 1500 pumping sessions.
• Performance Testing (Bench Testing):
  • Vacuum performance, cycle performance, and backflow protection at min/max settings.
  • Use life testing for maintaining performance specifications.
  • Battery performance and battery status indicator testing.

Since the request asks for information specific to an AI/ML medical device study, and the provided text describes a non-AI/ML physical device, it's not possible to extract the requested AI-specific acceptance criteria and study details.

The provided document is about a physical breast pump, not an AI/ML device. Therefore, the requested information pertaining to AI/ML device acceptance criteria and study design (like specific AI/ML performance metrics, AI test/training set details, expert qualifications for AI ground truth, MRMC studies, etc.) is not present in the text.

The document confirms that the device passed all its engineering and safety performance tests, demonstrating it is "as safe and effective as the predicate device" for its intended use (expressing milk from lactating women).

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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.

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.

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