(72 days)
The Unimom Allegro is intended to express breast milk from the breast of a lactating woman.
The Unimom Allegro electric breast pump is intended to express the mother's milk of a lactating woman. The pumping can be only on one breast at the time. The Unimom Allegro electric breast pump can operate off common batteries or off a DC POWER supply. The Unimom Allegro electric breast pump's drive unit employs a diaphragmtype vacuum pump, powered by a DC-motor, supervised by a microcontroller. Passing through an air tubing to breastshield, the vacuum is used to comfortably draw out the breast milk. This device is designed with 7 vacuum levels by pressing button.
This document is a 510(k) summary for the Unimom Allegro powered breast pump. It primarily focuses on demonstrating substantial equivalence to predicate devices based on intended use and technical characteristics. As such, it does not contain information about specific acceptance criteria, performance studies with detailed metrics, sample sizes for test/training sets, expert ground truth establishment, or comparative effectiveness studies typically found in submissions for diagnostic or AI-driven devices.
Therefore, many of the requested fields cannot be answered from the provided text.
Here is what can be inferred or explicitly stated from the document:
1. A table of acceptance criteria and the reported device performance
The document does not specify formal acceptance criteria or present a table of device performance against such criteria. The submission focuses on demonstrating substantial equivalence to predicate devices, implying that its performance is considered acceptable if it is comparable to the legally marketed predicates.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This device is a powered breast pump, not a diagnostic device that uses a "test set" of data in the manner typically described for AI/algorithm-driven products. The submission relies on a comparison of technical features and intended use.
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)
Not applicable. Ground truth establishment with experts is not relevant for this type of device and submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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-driven or 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-driven or diagnostic device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable.
8. The sample size for the training set
Not applicable. This is not an AI/algorithm-driven device.
9. How the ground truth for the training set was established
Not applicable.
Summary of what the document does provide:
- Device Name: Unimom Allegro
- Intended Use: To express breast milk from the breast of a lactating woman.
- Predicate Devices:
- Basis for Equivalence: Same intended use and similar technological characteristics as the predicate devices. The device employs a diaphragm-type vacuum pump, powered by a DC-motor, supervised by a microcontroller, with 7 vacuum levels.
§ 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).