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The Willow Wearable Breast Pump 2.0 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 Willow Wearable Breast Pump 2.0 (Willow) is a small electric breast pump that is intended for lactating women to express and collect breast milk. Willow may be operated as a single or double pumping system. For a user to pump both breasts simultaneously, she would need to use two Willow devices at the same time, one on each breast. Willow is for use by a single user only.

Willow is a battery-powered electro-mechanical device that contains software. The device includes the following main components: Pump, milk collection component (milk bag or container), and a charger.

All milk contacting components of the device are compliant with 21 CFR 174-179.

This submission was for clearance of modifications made to the predicate device, including addition of a milk container for milk collection, updates to device firmware, inclusion of Bluetooth for connection to an optional mobile app, and a change in the flange attachment method.

The provided text is a 510(k) summary for the Willow Wearable Breast Pump 2.0. It describes the device, its intended use, and compares it to a predicate device to demonstrate substantial equivalence. However, it does not contain the specific information requested in your prompt regarding acceptance criteria, a study proving the device meets those criteria, or details about test set size, ground truth establishment, or training set size typically found in AI/ML device submissions.

The breast pump is a physical medical device, not an AI/ML-driven diagnostic or assistive device that would typically have the kind of performance metrics and study details you've asked for (e.g., effect size of human readers with AI assistance, standalone algorithm performance, expert consensus for ground truth). The document focuses on showing that the modifications to the device (e.g., addition of a milk container, firmware updates, Bluetooth connectivity) do not raise new questions of safety or effectiveness compared to the predicate device.

Here's a breakdown of why I cannot answer your specific questions with the provided text:

• Acceptance Criteria and Reported Device Performance (Table): The document lists various bench testing (vacuum profile, leakage, flow rate, mechanical stress), electrical safety, EMC, biocompatibility, software, and cybersecurity testing performed. While these tests have internal acceptance criteria (e.g., device operation maintained, within specified ranges for vacuum), the specific numerical acceptance criteria and reported performance values are not explicitly stated in this summary. It only states that these tests were performed to assess modifications and support substantial equivalence.

• Sample size for the test set and data provenance: Not applicable in the context of a breast pump's 510(k) submission as described. There isn't a "test set" in the sense of a dataset for an AI/ML algorithm. The performance data refers to physical device testing.

• Number of experts and qualifications for ground truth: Not applicable. Ground truth for a breast pump is functionality, safety, and performance as a physical device, based on engineering standards and regulatory requirements, not expert interpretation of outputs.

• Adjudication method: Not applicable.

• Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. This type of study is for evaluating observer performance with and without an AI/ML aid, which is not relevant for a breast pump.

• Standalone (algorithm only without human-in-the-loop performance): Not applicable. The device is a physical breast pump; it does not have a standalone algorithm in the sense of a diagnostic or assistive AI.

• Type of ground truth used: For the physical device, it's based on engineering specifications, physical measurements, and compliance with standards (e.g., IEC 60601 for electrical safety, ISO 10993 for biocompatibility), not expert consensus, pathology, or outcomes data in the context of disease diagnosis.

• Sample size for the training set: Not applicable. This refers to AI/ML model training data.

• How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a regulatory submission for a physical medical device (breast pump) and therefore does not contain the information requested about AI/ML algorithm performance, ground truth establishment for datasets, or comparative effectiveness studies involving human readers, which are typically found in submissions for AI/ML-driven software as a medical device (SaMD) or AI-assisted devices.

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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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