(89 days)
The Pump In Style® Advanced breast pump is a powered breast pump to be used by lactating women to express and collect milk from their breast. The powered breast pump is intended for a single user.
The Pump In Style® Advanced breast pump and kit are used to express and collect milk from the breast of a lactating woman. The system is intended for daily use in a home (or similar environment such as an office) to supplement breastfeeding by a single user. Pumping with the Pump In Style® Advanced breast pump can be performed on one breast (single pumping) or on both breasts at the same time (double pumping).
The Pump In Style® Advanced breast pump employs a control knob (potentiometer) for the user to adjust the vacuum levels. Two suction rhythms are pre-programmed with variable vacuum levels and cycle rates (pump speed). The powered breast pump is capable of providing vacuum levels from -50 to -240 mmHg with cycle rates up to 120 cycles per minute.
The device employs a gear-driven diaphragm-type vacuum pump, powered by a DC motor supervised by a microcontroller. The microcontroller drives the "H" bridge providing speed and directional control over the DC motor. The device is electrically powered from external batteries (AA batteries) or from an external direct plug-in AC power supply or from a vehicle lighter adapter. The device is provided non-sterile.
The Pump In Style® Advanced breast pump provides the following user features:
- . Rotary knob for user adjustment of vacuum level/cycles and on/off
- 2-Phase Expression® Technology designed to mimic a baby's natural nursing rhythm: ●
- o Stimulation Phase (phase 1): Suction pattern with fast cycles and low vacuum to start milk flowing
- o Expression Phase (phase 2): Suction pattern with slower cycles and higher vacuum to express more milk gently and efficiently.
- . "Let-down" control to change between stimulation phase and expression phase.
- Option of either single or double breast pumping. .
The provided document is a 510(k) summary for the Medela Pump In Style® Advanced breast pump, which is a powered breast pump. This document outlines the device's characteristics, its comparison to a predicate device, and the non-clinical tests performed to demonstrate substantial equivalence. It does not describe an AI/ML powered medical device, nor does it contain a study proving the device meets AI-specific acceptance criteria.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving an AI device meets these criteria in the format specified, as the document does not pertain to an AI device.
Here's an analysis based on the information available, noting the absence of AI/ML specifics:
1. A table of acceptance criteria and the reported device performance
The document does not provide a formal table of general acceptance criteria with numerical performance targets for the entire device. However, it mentions that for "bench performance testing," "The specifications were met for vacuum levels, cycle rate and overflow protection."
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Vacuum Levels | "The specifications were met." |
| Cycle Rate | "The specifications were met." |
| Overflow Protection | "The specifications were met." |
| Battery Use Life | "maintains its specifications throughout its use life." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document refers to "bench performance testing" conducted with "internal test protocols." It does not specify sample sizes for these tests, nor does it provide information about data provenance (e.g., country of origin or retrospective/prospective nature). Given it's a physical device and bench testing, "data provenance" in the context of patient data is not applicable here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable as the tests described are non-clinical, bench performance tests of a physical device (a breast pump), not an AI/ML system requiring expert-adjudicated ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable for the same reason as point 3.
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
This is not applicable as the device is not an AI-powered system designed to assist human readers or clinicians.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable, as it's a physical breast pump, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the bench performance tests, the "ground truth" would be the engineering specifications and calibrated measurement equipment. No expert consensus, pathology, or outcomes data were used for these particular non-clinical tests.
8. The sample size for the training set
This is not applicable as there is no mention of a training set, as the device is not an AI/ML model.
9. How the ground truth for the training set was established
This is not applicable as there is no mention of a training set.
§ 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).