(251 days)
Wearable Breast Pump is a powered breast pump to be used by lactating women to express and collect milk from their breasts. The device is intended for a single user.
The Wearable Breast Pump is an electrically powered, software controlled, digital, single user, wearable breast pump for lactating women to express and collect milk from the breast. The subject device is capable of expression and stimulation modes, with nine associated suction levels for each. The vacuum pressure ranges from 80-200 mmHg for stimulation mode and 90-240 mmHg for expression mode. The device is powered by a rechargeable battery or a power adapter. The device has an LED display, which shows the power button, pumping mode, suction level, timer, and battery charge level. Surrounding the front panel display are soft-touch buttons allowing the user to power the device on/off, switch between stimulation and expression modes, and control the vacuum strength. The breast pump expresses by creating a seal around the nipple using the flange and applying and releasing suction to the breast. 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 provided text is an FDA 510(k) summary for a medical device (Wearable Breast Pump). It describes the device, its intended use, comparison to a predicate device, and the non-clinical testing performed to demonstrate substantial equivalence.
However, the document does NOT contain information about any study that involved human subjects, expert adjudication, AI/algorithm performance, or multi-reader multi-case (MRMC) comparative effectiveness studies. These types of studies are typically associated with complex diagnostic or AI-powered devices where the "acceptance criteria" relate to diagnostic accuracy, sensitivity, specificity, or reader improvement.
In the context of this 510(k) summary for a Mechanical Breast Pump, the "acceptance criteria" are related to engineering performance specifications and safety standards rather than a study proving clinical diagnostic performance. The "device performance" reported is the successful completion of these non-clinical tests.
Therefore, I cannot fulfill the request as specified, because the provided text does not contain the information required for points 2 through 9 for a study proving the device meets acceptance criteria related to a diagnostic or AI-powered device.
I can, however, extract the information related to the acceptance criteria and the "study" (non-clinical testing) as described in the document for this specific type of device.
Here's the closest interpretation of "acceptance criteria" and "device performance" based on the provided text, focusing on the non-clinical testing:
Acceptance Criteria and Device Performance (Based on Non-Clinical Testing for a Wearable Breast Pump)
For this device (Wearable Breast Pump), the "acceptance criteria" are primarily established by compliance with recognized electrical safety, electromagnetic compatibility, biocompatibility, and functional performance standards. The "study" proving the device meets these criteria refers to the non-clinical testing performed.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicitly: Compliance with Standard/Specification) | Reported Device Performance (Implicitly: Met Standard/Specification) |
|---|---|---|
| Electrical Safety | IEC 60601-1:2005+AMD 1:2012+AMD2:2020 | Verified (Device met all design specifications) |
| IEC 60601-1-11:2015+AMD1:2020 (Home Healthcare) | Verified (Device met all design specifications) | |
| Electromagnetic Compatibility | IEC 60601-1-2:2014+AMD1:2020 | Verified (Device met all design specifications) |
| Biocompatibility | Cytotoxicity (ISO 10993-5:2009) | Performed & Met (on material contacting human body) |
| Skin irritation (ISO 10993-23:2021) | Performed & Met (on material contacting human body) | |
| Skin Sensitization (ISO 10993-10:2021) | Performed & Met (on material contacting human body) | |
| Software | Compliance with FDA "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (2005) | Evaluated (as recommended in guidance) |
| Functional Performance | Vacuum level verification: Meet mode/cycle specifications | Demonstrated that devices meet mode/cycle specifications |
| Backflow protection: Prevent liquid backflow into tubing | Conducted to verify liquid does not backflow | |
| Use life: Maintain specifications throughout proposed use life | Conducted to demonstrate device maintains specifications | |
| Battery performance: Remain functional during stated use-life | Conducted to demonstrate battery remains functional | |
| Battery status indicator: Remain functional | Conducted to demonstrate indicator remains functional |
2. Sample size used for the test set and the data provenance:
This document describes non-clinical testing of the device itself (e.g., electrical, mechanical, materials testing), not a clinical study with a human "test set" in the traditional sense of medical images or patient data. The "sample size" would refer to the number of devices or components tested. This information is not detailed in the provided 510(k) summary. The data provenance is internal testing performed by the manufacturer.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This is not a diagnostic device requiring expert interpretation for ground truth establishment.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. This is not a diagnostic device requiring adjudication.
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 not a diagnostic device (and does not involve AI for diagnostic purposes).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device does not have a standalone algorithm that provides a diagnostic output in the way an AI medical device would. Its software controls the pump's mechanical functions.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For this device, "ground truth" for the non-clinical tests is established by:
- Engineering specifications and standards: e.g., the specified voltage range for electrical safety, the defined vacuum pressure range for performance.
- Laboratory measurements and validated test methods: e.g., using calibrated equipment to measure vacuum, confirming no liquid backflow based on physical observation.
8. The sample size for the training set:
Not applicable. This document refers to a physical breast pump, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established:
Not applicable. As above, there is no training set.
In summary, the provided document outlines the non-clinical, engineering, and safety testing undertaken to demonstrate the substantial equivalence of a breast pump. It does not describe a clinical study involving human subjects or AI performance metrics as typically seen for diagnostic devices.
§ 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).