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The Moxxly Flow breast pump collection system is intended to be used in conjunction with a compatible powered breast pump for the purpose of expressing human milk

Moxxly, Inc. is the manufacturer of the Moxxly Flow, a device intended to be used in conjunction with a compatible breast pump for the purpose of expressing human milk.

The Moxxly Flow consists of two collection units designed to be compatible with select compatible electric breast pumps and provide a more comfortable design to aid collection of breast milk. The Moxxly Flow is provided non-sterile and is a single patient reusable device. The system should be cleaned by the user prior to use.

The device has a sloped flange (cup insert), flexible neck, internal valve assembly and low-profile bottle. Variations of the device incorporate minor differences to replicate the functional and performance characteristics necessary for use with additional pump brands.

The Moxxly device is designed to fit within a lactating woman's ordinary or nursing bra and held in place there while breast pumping. When the pump extracts milk, the milk flows out through the end of the flange, where it passes through the neck and valve system at the bottom of the bra and into the attached collection bottle. When the lactating woman is done pumping, she turns off the pump, removes the Moxxly device from under her clothes and transfers the milk to a storage container for later use.

The provided text is a 510(k) Summary for the Moxxly Flow breast pump collection system. It outlines the device's description, intended use, and comparison to a predicate device, as well as a summary of non-clinical performance tests.

However, the document does not describe a study that proves the device meets specific acceptance criteria related to AI/algorithm performance in medical imaging or diagnosis. The "acceptance criteria" and "study" described in the document pertain to the physical and functional aspects of a breast pump system, such as biocompatibility, vacuum performance, and usability, which are typical for mechanical medical devices.

Therefore, many of the specific points requested in your prompt regarding AI/algorithm performance (e.g., sample size for test/training sets, data provenance, number/qualifications of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth) are not applicable to the content provided.

Here's how to address the requested information based on the provided document:

Acceptance Criteria and Device Performance (Based on provided document for Physical Device)

The document primarily focuses on demonstrating the substantial equivalence of the Moxxly Flow breast pump system to a predicate device. The performance tests are geared towards ensuring the device functions safely and effectively as a breast pump, rather than providing diagnostic or AI-driven insights.

1. Table of Acceptance Criteria and Reported Device Performance

The document notes that "Test results established that the device meets its design requirements and intended use, that it is as safe, as effective, and performs as well as the predicate device." However, specific numerical performance metrics for each criterion (e.g., exact vacuum pressure range, specific leakage rates, quantitative usability scores) are not provided in this summary.

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided in the 510(k) summary. The document mentions "Verification and Validation" and "Testing," but does not specify sample sizes for any of the non-clinical performance tests (e.g., number of units tested for vacuum performance, number of individuals in usability study). The data provenance (country of origin, retrospective/prospective) is also not stated, as these tests are laboratory/simulated use tests, not clinical data collection.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This is not applicable as the device is a mechanical breast pump system, not an AI/diagnostic device. Ground truth, in the context of medical imaging interpretation or diagnosis, is not a concept applied to the testing described for this device. The testing primarily involves engineering and materials science validation.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods (e.g., 2+1, 3+1) are used in clinical studies, particularly for interpreting medical images or clinical outcomes, where human experts might disagree. The non-clinical tests described for this breast pump would have defined pass/fail criteria or quantitative measurements without a need for expert adjudication in this sense.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

This is not applicable. MRMC studies are specific to evaluating the diagnostic performance of human readers, often comparing performance with and without AI assistance, especially in medical imaging. The Moxxly Flow is a mechanical breast pump, not a diagnostic imaging device, and its evaluation does not involve human readers interpreting cases.

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

This is not applicable. There is no AI algorithm being evaluated for standalone performance within the context of this breast pump.

7. The Type of Ground Truth Used

This is not applicable in the context of AI/diagnostic device evaluation. For the physical breast pump, "ground truth" would be established by engineering specifications, validated test methods, and regulatory standards (e.g., ISO standards for biocompatibility).

8. The Sample Size for the Training Set

This is not applicable. The device is a physical product, not an AI model that requires a "training set" of data.

9. How the Ground Truth for the Training Set was Established

This is not applicable for the same reason as point 8.

Summary of what is present in the document relevant to device acceptance:

The 510(k) summary for the Moxxly Flow emphasizes substantial equivalence to a predicate device (DAO Health Freemie Breast Pump Collection System, K130349). Acceptance criteria for this type of device are primarily based on:

• Meeting design specifications (evidenced by vacuum performance, capacity, leakage, etc.).
• Compliance with relevant international standards (e.g., ISO 10993 for biocompatibility, IEC 62366 for usability).
• Demonstrating that any differences in technological characteristics (e.g., flange size, material) do not raise new questions of safety or effectiveness.

The study proving acceptance involves a series of non-clinical performance tests focused on the physical and functional attributes of the breast pump system. While the document asserts that "Test results established that the device meets its design requirements and intended use, that it is as safe, as effective, and performs as well as the predicate device," it does not provide detailed quantitative results or specific methodologies beyond the general categories of testing and the standards referenced.

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