Search Results

The Ameda Platinum Breast Pump is intended to express and collect milk from the mother's breast, to alleviate engorgement of the breast, maintain the ability of lactation, and provide mother's milk for future feedings when separation of mother and baby occurs.

The Ameda Platinum electric breast pump is a simple and effective system for expressing milk from a mother's lactating breast(s). The Ameda Platinum Breast Pump is electric or battery operated. The Ameda Platinum Breast Pump utilizes the separately supplied predicate device. the Ameda HygieniKit.

The provided text does NOT describe a study that uses acceptance criteria and reports device performance against them in the way typically seen for AI/ML-driven medical devices.

Instead, this document is a 510(k) Premarket Notification for a powered breast pump, the Ameda Platinum Breast Pump. The "acceptance criteria" table in the original text is actually a comparison of attributes of the Ameda Platinum with its predicate devices to establish substantial equivalence, not a performance study.

Therefore, most of the requested information (sample sizes, experts, adjudication, MRMC studies, standalone performance, ground truth types and establishment, training set size) is not applicable to this type of device and submission.

Here's why and what can be extracted:

1. A table of acceptance criteria and the reported device performance

The document does not present acceptance criteria in the context of a performance study with quantitative results. The provided table titled "Attribute" and "Ameda Platinum" is a comparison to predicate devices for demonstrating substantial equivalence. The "Performance Testing and Differences" section states: "We have performed bench tests to demonstrate the Ameda Platinum breast pump performs within its specifications, included vacuum and life cycling." However, no specific acceptance criteria or quantitative performance results from these bench tests are provided in this summary.

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 is a mechanical device, and the "bench tests" mentioned likely refer to engineering validation, not clinical studies with patient data.

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. No ground truth establishment by experts for a test set is mentioned.

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

Not applicable. No adjudication method is mentioned.

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 a breast pump, not an AI/ML diagnostic or assistive device.

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

Not applicable. This is a mechanical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. Mechanical device specifications and engineering tests would be verified against design requirements, not "ground truth" derived from clinical data in this context.

8. The sample size for the training set

Not applicable.

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

Not applicable.

Summary regarding the provided text:

The provided document is a 510(k) summary for a physical medical device (a breast pump) seeking substantial equivalence to existing predicate devices. It does not contain the type of AI/ML performance study information you are asking for, as those metrics are not relevant to this product. The "Performance Testing" mentioned refers to engineering bench tests (e.g., vacuum, life cycling) to ensure the device meets its own specifications, not diagnostic or predictive performance against a clinical ground truth.

Ask a specific question about this device