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The Nuby™ Natural Touch Rhythm™ Dual Action Electric Breast Pump is a BPA-free breast pump designed with an electronic memory that allows the lactating mother to save and control personal pump settings or use one of the two settings that are already pre-programmed. The "soft flex" funnel protects and actuates in and out, replicating baby's suckling action and stimulating a fast, natural let-down. In addition to mains power, this single electronic pump can also operate using battery power or as a manual pump.

AI/ML Overview

This document is a 510(k) summary for the Nuby™ Natural Touch Rhythm™ Dual Action Electric Breast Pump, focusing on its substantial equivalence to a predicate device. It describes performance testing but does not detail a study with specific acceptance criteria that would typically be associated with a clinical trial or a performance study designed to achieve quantitative metrics like sensitivity, specificity, or improvement over a baseline in a medical imaging or diagnostic context.

Therefore, many of the requested sections about acceptance criteria, study details, expert involvement, and statistical analyses (like MRMC studies) are not applicable to this type of regulatory submission. The submission focuses on demonstrating substantial equivalence through component-level testing and general performance comparisons.

Summary of Device Performance and Acceptance Criteria (Based on Provided Document):

The document describes several forms of testing to demonstrate the device's safety and effectiveness, primarily through comparison with a predicate device and compliance with established standards.

Acceptance Criteria Category	Specific Criteria / Test	Reported Device Performance
Material Integrity	Cleaning/sanitization procedures should not significantly alter material/geometry of pump components nor negatively impact efficiency/operation.	Components were evaluated and found to meet this criterion.
Durability / Life Cycle	Device life cycle.	Estimated life cycle of approximately 1.6 years.
General Performance Characteristics (Comparison with Predicate)	Substantial equivalence in suction, speeds, and flow rates compared to the ISIS iQ UNO Handheld Electronic Breast Pump.	Both devices performed substantially equivalently in terms of suction, speeds, and flow rate (i.e., rate of fluid/milk extraction).
Biocompatibility	Softflex™ Funnel (patient-contacting component) must pass biocompatibility testing per ISO 10993 (cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity).	The Softflex™ Funnel was tested and passed all required biocompatibility testing.
Food Contact Compliance	Milk-contacting components must comply with 21 CFR 174 and 177.	Milk-contacting components comply with 21CFR 174 and 177.
Electrical Safety	Compliance with IEC/UL 60601-1 for electrical safety.	The device complies with IEC/UL 60601-1.
Electromagnetic Compatibility	Compliance with IEC 60601-1-2 for electromagnetic compatibility.	The device complies with IEC 60601-1-2.

Study Details Provided in the Document:

2. Sample size used for the test set and the data provenance:

Test Set: Not explicitly stated for the "general performance characteristics" comparison. The comparison states "testing was conducted on the Nuby™ Natural Touch Rhythm™ Dual Action Electric Breast Pump and the ISIS iQ UNO Handheld Electronic Breast Pump." This implies a comparative bench test rather than a clinical study with human subjects.
Data Provenance: The document does not specify the country of origin for the data or if it was retrospective or prospective. Given the nature of the testing described (material integrity, life cycle, pump performance), it primarily refers to laboratory testing and bench testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. The "ground truth" for this device's performance evaluation is based on engineering specifications, regulatory standards, and objective measurements of physical characteristics (e.g., suction, flow rate) using laboratory equipment, not expert human interpretation.

4. Adjudication method for the test set:

Not applicable. Adjudication methods (like 2+1, 3+1) are typically used in studies where expert human review is required to establish ground truth from subjective data (e.g., image interpretation). This document describes objective engineering and material testing.

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-assisted diagnostic device, nor does it involve human readers interpreting data. It is a powered breast pump.

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

Not applicable. This is not an algorithm-based device. The performance cited refers to the mechanical and electrical functioning of the breast pump itself.

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

The "ground truth" for the performance evaluation primarily consists of:
- Objective engineering measurements: for suction, speeds, flow rates, and electrical parameters.
- Standardized laboratory tests: for material integrity, life cycle estimation, and biocompatibility (e.g., ISO 10993 cytotoxicity, sensitization).
- Regulatory compliance standards: for electrical safety (IEC 60601-1, IEC 60601-1-2) and food contact materials (21 CFR 174 and 177).

8. The sample size for the training set:

Not applicable. This device does not use machine learning or AI that would require a "training set."

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

Not applicable. As there is no training set for an AI/ML algorithm.

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