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The ExploraMed NC7 Athena Breast Pump is intended to express milk from lactating women in order to collect milk from their breasts. The device is intended for a single user.

The ExploraMed NC7 Athena Breast Pump (Athena) is a small electric breast pump that is intended for lactating women to express and collect breast milk. The subject device is intended for multiple uses with a single user. Athena may be operated as a single or double pumping system. For a user to pump both breasts simultaneously, she would need to use two (2) Athena devices at the same time, one on each breast.

The provided document describes the FDA 510(k) summary for the Athena Breast Pump (K161266) and states that clinical testing was not required to demonstrate substantial equivalence. Therefore, the document does not contain information about acceptance criteria and a study proving the device meets those criteria, nor does it include details like sample sizes, ground truth establishment, or expert qualifications related to a clinical study.

The performance data listed pertains to bench testing, electrical safety, electromagnetic compatibility, biocompatibility, cleaning validation, and software validation. These tests are typically used to show that the device meets its design specifications and general safety standards, rather than clinical performance criteria.

Here's a breakdown of the requested information based only on the provided document:

1. A table of acceptance criteria and the reported device performance:
   The document does not provide a table of acceptance criteria for clinical performance or reported clinical device performance. It lists various engineering and safety tests with the implication that the device met the requirements of the listed standards/guidances, but specific acceptance criteria for each test and detailed results are not presented.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
   No clinical test set data is provided, as clinical testing was not required.

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, as no clinical test set or ground truth derived from expert consensus is mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   Not applicable, as no clinical test set requiring adjudication 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. The device is a breast pump, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   Not applicable. The device is a breast pump and does not involve an algorithm for standalone performance evaluation in this context.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
   Not applicable, as no clinical ground truth was established for a performance study.

8. The sample size for the training set:
   Not applicable, as no algorithm training set is mentioned for clinical performance.

9. How the ground truth for the training set was established:
   Not applicable, as no algorithm training set is mentioned.

In summary, the provided document clearly states: "Clinical testing was not required to demonstrate substantial equivalence of the Athena to its predicate device." Therefore, the detailed information requested about clinical testing, acceptance criteria, sample sizes, and ground truth is not available within this document. The provided "Performance Data" section solely focuses on non-clinical engineering and safety validations.

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