Search Results

The Electric Breast Pump, model PJ2012 is used to express and collect milk from the breast to alleviate engorgement of the breast, maintain the ability of lactation and provide mother's milk for future feeding when separation of mother and baby occurs. The device is intended for multiple uses.

The Electric Breast Pump, model PJ2012 is designed and manufactured by Limerick, Inc. It is intended to express and collect milk from a lactating woman's breast. This action helps to alleviate engorgement of the breast, maintain the woman's ability to lactate, and provide a mother's milk for future feedings when separation of the mater and baby occur.

The product uses a Single-Chip Microcontroller to imitate a baby's suckling action. The device is ergonomically designed to create comfortable milk stimulation, massage, and suction from the breast. There are 80 vacuum levels and 30 speeds available to imitate the rhythm and action of a baby's suckling. Selection of the vacuum and speed is made by adjusting the control knobs on the front panel of the pump. The control panel is soft and viewing is provided by a LCD screen. Once programmed, the pump's electronic memory stores the selected rhythm and intensity of the device.

The provided document is a 510(k) summary for the PJ's Serenity Electric Breast Pump, Model PJ2012. It details the device's characteristics and compares them to predicate devices, but it does not contain a clinical study with detailed acceptance criteria, sample sizes, expert ground truth, or MRMC studies for AI performance. This document primarily focuses on demonstrating substantial equivalence to legally marketed predicate devices through bench testing and compliance with recognized standards.

Therefore, many of the requested elements for describing a study proving the device meets acceptance criteria cannot be extracted from this document, as such a study (as described by your prompts) was not performed or reported in this 510(k) summary.

However, I can provide information based on the "bench testing" mentioned, which serves as the "study" demonstrating the device meets its specifications (acceptance criteria).

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document implicitly defines the "acceptance criteria" through the device specifications that are compared to predicate devices. The "reported device performance" is stated as performing "within specifications."

2. Sample size used for the test set and the data provenance:

• Sample Size: Not specified. The summary states "the sponsor has performed bench testing to demonstrate the electric breast pump performs within the specifications." This implies testing of the device itself, but the number of units tested is not stated.
• Data Provenance: Not specified, but generally, bench tests are performed by the manufacturer in their own facilities. It is inherently "prospective" in the sense that the testing is done to approve the specific device for market.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable/Not specified. This is a breast pump, not an AI diagnostic device. Bench testing typically relies on instrument measurements against engineering specifications, not expert interpretation or ground truth establishment in the clinical sense.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable. This concept is for diagnostic interpretation, not mechanical device performance.

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 an AI-powered diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

• Not applicable. This is not an AI-powered device. The device does have a microcontroller with embedded firmware, but its performance is measured against physical parameters (vacuum, cycle rate) rather than an algorithm's standalone diagnostic accuracy.

7. The type of ground truth used:

• Engineering Specifications / Recognized Standards: The "ground truth" for this device's performance is its adherence to predefined engineering specifications (e.g., specific vacuum range, cycle rates) and compliance with recognized safety and biocompatibility standards (e.g., IEC60601-1, ISO 10993 series).

8. The sample size for the training set:

• Not applicable. As this is not an AI/machine learning device, there is no "training set."

9. How the ground truth for the training set was established:

• Not applicable.

In summary: The provided document is a 510(k) summary for a powered breast pump. It describes the device and its compliance with established performance specifications and standards through bench testing. It does not involve AI or diagnostic interpretations that would require clinical studies with human readers, expert ground truth, or MRMC analyses.

Ask a specific question about this device