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The Naya Breast Pump System is a powered breast pump to be used by lactating women in the hospital or home setting to express and collect milk from their breasts.

Device Description

The Naya Breast Pump System is a personal use electric breast pump capable of single or double pumping. The device is electrically powered from either an internal rechargeable battery or an external supply. The external supply also charges the battery. The device can also connect to an iPhone (iOS 8.0+) application (Mobile App) that replicates the front panel controls and indicators on the pump.

The Naya Breast Pump System may be used in the hospital or home setting. The Pump may be used by different users, but one person at a time. The Distal Breast Assembly (DBA) is intended as a single user component.

A reciprocating diaphragm vacuum pump, driven by a microprocessor, generates the suction to extract the milk at vacuum levels up to 260 mmHg. The Naya Breast Pump System is powered by a rechargeable battery or from mains.

The User Interface with the pump is:

Power Button
Mode Button
Touch Wheel

The Mobile App looks identical to the pump user interface in that the same three interface points are present.

The device has two modes of operation:

Stimulation Mode: Suction pattern with fast cycles and low vacuum to start milk flowing
Flow Mode: Suction pattern with slower cycles and higher vacuum to express more milk gently and efficiently.

AI/ML Overview

The provided document is a 510(k) premarket notification for the Naya Breast Pump System. It focuses on demonstrating substantial equivalence to a predicate device (Medela Symphony) rather than presenting a study proving that the device meets specific acceptance criteria related to an AI's performance, as the request implies. The device in question is a physical breast pump, not an AI-powered diagnostic or predictive tool.

Therefore, most of the information requested (AI acceptance criteria, test set sample size, expert ground truth, MRMC study, standalone AI performance, training set details) is not applicable to this document.

However, I can extract information related to the device's functional performance and equivalence to its predicate, as outlined in the document.

Here's a breakdown of what can be extracted and what cannot:

Information NOT APPLICABLE / NOT FOUND in the document:

1. A table of acceptance criteria and the reported device performance (for AI-specific metrics): This document does not describe AI-specific acceptance criteria or performance metrics. It describes the device's functional attributes and compares them to a predicate.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): No test set sample size or data provenance is mentioned in the context of an AI study. The document mentions "bench tests" and "non-clinical performance testing," which are engineering validations, not clinical studies with patient data for AI.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI algorithm is not established here.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

What can be inferred or extracted from the document regarding the device's performance and validation:

The document focuses on demonstrating substantial equivalence to an existing predicate device (Medela Symphony) based on similarities in:

Intended Use
Technology
Materials
Environment of Use
Patient Population
Non-Clinical Performance Testing

Table of Device Attributes vs. Predicate:

The document provides a "Comparison of the Proposed Device to the Predicate" (Table 1 on page 6). This isn't "acceptance criteria" in the AI sense, but rather a comparison of specifications to show equivalence.

Attribute	Proposed Naya Breast Pump System	Medela Symphony (Predicate) K151632	Note (Acceptance "Proxy")
Intended Use	A powered breast pump to be used by lactating women in the hospital or home setting to express and collect milk from their breasts.	A powered breast pump to be used by lactating women to express and collect milk from their breast.	Identical. This is a critical point for substantial equivalence. "Acceptance" is that it performs the same fundamental function.
Patient population	Lactating women	Lactating women	Identical.
Environment of use	Home and Hospital	Home and Hospital	Identical.
OTC	Yes	Yes	Identical.
Power Source	Input: 100-240 VAC, 50/60Hz, 2.1A; 1 x 14.8V / 3200 mAh Rechargeable Li-ion Battery	Input: 100-240 VAC, 50/60Hz, 0.3A; 2 x 6V / 1.2 Ah Rechargeable Pb batteries	Different specifications but similar function. The acceptance is that the proposed power source is safe and effective for its purpose, as validated by electrical safety tests (ES60601-1, IEC 60601-1-2, IEC 60601-1-11).
Pump Style	Reciprocating Pump	Diaphragm pump	Similar function, different mechanism. Both use a vacuum pump (the predicate is a diaphragm pump, the proposed is a reciprocating diaphragm vacuum pump). The acceptance is that the new mechanism achieves comparable performance.
Single/double Pumping	Both	Both	Identical.
Adjustable Suction Levels	10 levels	16 levels	Different number of levels, but both offer adjustability. The acceptance is that 10 levels are sufficient for the intended use and performance.
Cycle Speed	34 - 120	45 - 120	Overlapping range. The proposed device has a slightly wider range. The acceptance is that this range is safe and effective.
Overflow Protection	Yes (diaphragm)	Yes (diaphragm)	Identical. Critical safety feature.
Vacuum range - double (mmHg)	50-250	75-200	Overlapping ranges. Wider range for the proposed device, particularly on the lower end. Accepted if demonstrably safe and effective.
Vacuum range - single (mmHg)	50-260	75-270	Overlapping ranges. Wider range for the proposed device on the lower end, similar on the higher end. Accepted if demonstrably safe and effective.
Cycling/Suction Control Mechanism	Microprocessor	Microprocessor	Identical.
Accessories	Flange (Breast Shield Assembly), including tubing, check valve and puck diaphragm; Bottle (Collection Cup)	Flange / Soft Flange; Tubing; Check valve; Diaphragm; Bottle	Similar components. The acceptance is that these components work effectively and safely with the proposed pump.
Software	Yes (with Mobile App that replicates pump UI)	Yes	Similar functionality with added mobile app control. Acceptance is that the mobile app does not introduce new safety concerns and functions identically to the physical interface.
Cleaning method for Accessories	Soap and warm water	Soap and warm water; Boiling water	Similar cleaning methods. The predicate allows for boiling. Acceptance is that the stated cleaning method for the Naya system is adequate for hygiene and material integrity.
Materials in contact with user and expressed milk tested per ISO 10993-1	Cytotoxicity, Sensitization, Intracutaneous (No natural latex, certified for food-contact per 21 CFR 174-179)	(Not explicitly detailed for predicate in this table, but assumed to meet standards)	Compliance with ISO 10993-1. This indicates biological safety acceptance.
Electrical Safety	ES60601-1, IEC 60601-1-2, IEC 60601-1-11 home use	UL 1431	Compliance with recognized electrical safety standards. The acceptance is meeting these standards for safe operation.
Flange offered in multiple sizes	Yes	Yes	Identical.

Study Proving Device Meets "Acceptance Criteria" (Substantial Equivalence):

The "study" is a collection of Non-Clinical Performance Testing and a comparison ("Substantial Equivalence Discussion") to the predicate device.

Bench Tests/Non-Clinical Performance Testing Summary:
- Breast Shield Assembly (BSA) Concentrated Cleaning
- Biocompatibility Test (meets ISO 10993 requirements: Cytotoxicity, Intracutaneous reactivity, Sensitization for Surface contact, Intact skin, Limited duration (

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