(208 days)
The MINUET LCD and MINUET LCD eco are multiple-user, powered breast pumps intended to express and collect milk from the breasts of lactating women.
The MINUET LCD and MINUET LCD eco are portable, multiple-user, powered breast pumps to be used in home or health care settings. These devices are the same, except the MINUET LCD has a rechargeable battery whereas the MINUET LCD eco does not. The devices have two major components: control unit (pump) and breast shield kit (breast shield, diaphragm, tubing, silicone massager, and bottle components). Users have the option of single or double pumping. The devices have two operating modes: massage and expression. The massage mode has seven suction levels whereas the expression mode offers nine suction levels. The vacuum strength range is 50-280 mmHq.
The provided text is a 510(k) summary for the MINUET LCD and MINUET LCD eco powered breast pumps. It describes device information, comparison to a predicate device, and non-clinical performance testing. However, it does not include specific acceptance criteria for the device's performance (such as milk expression rates, user comfort metrics, or quantitative measures of vacuum strength under various conditions beyond its range). It also does not describe a study that details how the device meets such criteria in terms of the output performance of the device.
Therefore, I cannot populate the table or answer most of the questions as the information is not present in the provided document. The document focuses on showing substantial equivalence to a predicate device through conformity to general medical device standards and qualitative comparisons of features, rather than quantitative performance against specific acceptance criteria.
Here's what I can extract based on the limitations:
1. A table of acceptance criteria and the reported device performance
No explicit acceptance criteria with quantitative performance metrics for the device's primary function (milk expression) are provided in the document. The document states "Bench tests using internal test protocols to demonstrate device performance, including vacuum level settings, speed settings, backflow/cross-contamination protection, battery operation, and use-life," but does not give the specific criteria or the results of these tests.
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 does not specify sample sizes for any performance testing related to "device performance" (e.g., milk expression), nor does it mention the data provenance (country of origin, retrospective/prospective). The studies mentioned are primarily engineering and safety tests (biocompatibility, electrical safety, EMC, battery safety, software V&V).
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. This device is not an AI/imaging device requiring expert ground truth establishment in the way a diagnostic tool would. The studies conducted are primarily focused on hardware, software, and material safety and functionality.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessments, which are not described here for performance evaluation.
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 algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests mentioned, the "ground truth" would be established by validated test methods and reference standards (e.g., ISO for biocompatibility, IEC for electrical safety). For example, for biocompatibility, the ground truth is the pass/fail criteria defined within the ISO standards. The document does not describe specific performance ground truth for milk expression efficacy.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/machine learning device.
§ 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).