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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.

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The Electric breast pump (model: M5) is intended to express milk from lactating women in order to collect milk from their breasts. The device is intended for a single user.

Electric breast pump (model: M5)

I am sorry, but this document is an FDA clearance letter for an electric breast pump. It does not contain information about acceptance criteria, device performance tables, sample sizes for test or training sets, details about ground truth establishment, or information about specific studies like MRMC or standalone algorithm performance.

Therefore, I cannot fulfill your request for that specific information based on the provided text.

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The Wearable Breast Pump (Model S10) 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 (Model S10), is an electrically powered wearable single breast pump consisting of the following key components: a flange, linker, silicone diaphragm, pump motor, type-C USB cable, valve, and milk collector. It is designed to work in the user's bra and has a rechargeable battery so it can be used handsfree without any external power cords. The motor unit includes a press-button user interface, pump body, and LED display. Pumping can be performed on one breast (single pumping). The user interface allows the user to switch from stimulation to expression mode and control the vacuum levels within those modes. Both stimulation and expression mode consist of 9 vacuum levels. The S10 model is capable of providing vacuum levels from 45-112 mmHg with cycling rates from 49-100 cycles per minute in stimulation mode and vacuum levels from 133-225 mmHg with cycling rates from 20-57 cycles per minute in expression mode. The Wearable Breast Pump (Model S10) is charged with a 5 V DC adaptor and powered by an internal rechargeable lithium-ion polymer battery. The motor unit operates on embedded software updates by end-users are not supported. The subject device is for repeated use by a single user in a home environment. The device is provided not sterile.

The breast pump expresses by creating a seal around the nipple using the flange and applying and releasing suction to the nipple. The milk is collected in a milk collection container. To prevent milk from flowing into the vacuum system, a backflow protection membrane physically separates the milk-contacting pathway from the vacuum system.

The motor unit operates on a rechargeable battery and does not function when charging. The rechargeable battery can be charged from the external USB adapter.

The subject device components are made of the following materials:

• Motor unit: acrylonitrile-butadiene-styrene (ABS) plastic
• · Flange, tube, valve, diaphragm: Silicone
• · Linker, milk collection container: Polypropylene

All milk contacting components are compliant with 21 CFR 174-179.

This document describes the FDA clearance for the Wearable Breast Pump (Model S10) and not a study proving the device meets specific acceptance criteria in the context of an AI/ML-driven medical device. The document primarily focuses on demonstrating substantial equivalence to a predicate device, as required for a 510(k) submission.

Therefore, the requested information regarding acceptance criteria, study data, sample sizes, expert involvement, and ground truth establishment, which are typical for studies validating AI/ML performance, is not present in this regulatory submission.

The document does include:

• Indications for Use: The Wearable Breast Pump (Model S10) is intended to express milk from lactating women in order to collect milk from their breasts. The device is intended for a single user.
• Performance Testing (Non-Clinical):
  • Vacuum level verification testing.
  • Backflow protection testing.
  • Use-life testing.
  • Battery performance testing.
  • Battery status indicator testing.
  • Battery charging testing.

However, the specific acceptance criteria values for these performance tests are not explicitly outlined, nor are the detailed results presented in a table format that quantifies "reported device performance" against those criteria. The document states that testing demonstrated that the devices meet mode/cycle specifications, but doesn't provide the raw data or the specific numerical thresholds for "meeting specifications."

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them with the level of detail regarding AI/ML validation metrics, as this document pertains to a traditional medical device clearance and not an AI/ML-driven device validation study.

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