(86 days)
The Lactaline Personal Powered Breast Pumps (Premier/Expresse) are intended to express and collect the mother's milk of a nursing woman for the purpose of feeding the collected milk to a baby.
The Expresse and Premier powered breast pumps are intended to express the mother's milk of a nursing woman. The pumping can be performed on one breast or both breasts at the same time. A control knob adjusts the suction strength (vacuum) to one of 8 settings between
The provided document is a 510(k) premarket notification for the Ameda Egnell Powered Breast Pumps (Expresse and Premier). This document focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving the device meets specific performance acceptance criteria through clinical trials or extensive standalone testing.
Therefore, much of the requested information (acceptance criteria, specific study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, specific ground truth methods for training/testing sets) is not explicitly available within the provided text.
However, based on the information provided, I can infer what constitutes "acceptance" for this regulatory submission and extract the performance characteristics presented for comparison.
Here's a breakdown of what can be inferred and what is not available:
1. Table of Acceptance Criteria and Reported Device Performance
For a 510(k), "acceptance criteria" are generally met when the proposed device demonstrates substantial equivalence to legally marketed predicate devices, particularly concerning intended use, technological characteristics, and safety/effectiveness. The table provided is a comparison of technological characteristics to establish this equivalence, rather than a list of "acceptance criteria" in the traditional sense of performance targets.
| Characteristic | Acceptance (Substantial Equivalence to Predicate) | Ameda Egnell Expresse/Premier Performance (Proposed Devices) |
|---|---|---|
| Intended Use | As described in 21 CFR 884.5160 | As described in 21 CFR 884.5160 |
| Suction Levels (Single) | Comparable to predicate devices (e.g., 0-360 mbar, 80-240 mmHg) |
§ 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).