(42 days)
The DEBP is 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 Double Electric Breast Pump (DEBP) is a powered breast pump. The pumping can be performed on one breast or on both breasts at the same time. The Lansinoh DEBP can be powered by 6 AA batteries or an AC adaptor provided with the pump. The pumping system consists of a diaphragm-type vacuum pump which is driven by a microcontroller controlled DC electric motor. The user interface consists of a front panel keypad and LCD display. The user is able to control cycle speed and vacuum level. The Lansinoh DEBP is capable of providing vacuum levels from 50 to 250 mmHg, with cycling rates up to 1.85 cycles per second.
The provided text describes a 510(k) premarket notification for a Double Electric Breast Pump (DEBP) and includes some performance testing information, but it does not contain a detailed study report with acceptance criteria and results in the format requested.
The document focuses on establishing substantial equivalence to predicate devices and adherence to general safety standards (IEC 60601-1, IEC 60601-1-2).
Here's a breakdown of what can be extracted and what information is missing from the input based on your prompt:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria / Performance Metric | DEBP Performance (Reported) |
|---|---|
| General Safety and Performance Standards | |
| IEC 60601-1, "Medical Electrical Equipment, General Requirements for Safety" | Will be tested to meet |
| IEC 60601-1-2:2007, "Electromagnetic Compatibility" | Will be tested to meet |
| Functional Performance (Comparison to Predicates) | |
| Pumping Suction (Expression Phase) | 50 - 250 mmHg |
| Suction Levels (Stimulation/Let Down Phase) | 50 – 150 mmHg |
| Cycles per Second (Stimulation/Let Down Phase) | 1.85 (fixed) |
| Cycles per Second (Expression Phase) | 0.51 - 1.0 |
| Suction Settings | 8 |
| Back Flow Protection | Yes |
| Let Down Function | Yes |
Missing Information: The document states the DEBP "will be tested to meet" IEC standards, but it does not provide the specific acceptance criteria for these standards within the document or the results proving it has met them. Similarly, the functional performance metrics are presented as device capabilities rather than explicit acceptance criteria from a study with corresponding reported results demonstrating compliance to those criteria specifically.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Missing Information: The document mentions "Performance Testing" including "Suction curves" and a "backflow test." However, it does not provide any details about the sample size (e.g., number of pumps tested), the methodology of these tests, or the data provenance (country of origin, retrospective/prospective). This section only states what will be tested or general capabilities.
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):
Missing Information: This information is not applicable as the device is a powered breast pump, not an imaging or diagnostic device requiring expert interpretation for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Missing Information: This is not applicable for the type of device and testing described.
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:
Missing Information: This is not applicable as the device is a powered breast pump, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Missing Information: This is not applicable as the device is a powered breast pump, not an algorithm. The "Microcontroller" is a control system, not an AI algorithm for standalone performance evaluation in the context of the prompt.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
Missing Information: For the performance tests mentioned (suction curves, backflow), the "ground truth" would likely be engineering specifications and physical measurements, but the specific validation method (e.g. against a calibrated standard) is not detailed.
8. The sample size for the training set:
Missing Information: This is not applicable as the device is a physical product, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established:
Missing Information: This is not applicable for the reason stated above.
In summary: The provided document is a 510(k) summary for regulatory submission, focusing on substantial equivalence and general safety standards. It outlines intended performance capabilities and states that the device "will be tested to meet" certain IEC standards. However, it does not present a detailed study report with specific acceptance criteria, comprehensive performance data from a defined test set, or information relevant to clinical studies, human readers, or AI algorithms, which many of your requested points pertain to.
§ 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).