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The NUK Expressive Double Electric Breast Pump is intended to express milk from the breasts. It is intended for use by a single user.

The NUK Expressive Double Electric Breast Pump is intended to express milk from the breasts. It is intended for use by a single user. This is accomplished by an electrical pump system generating a suck and release vacuum pattern. The suction strength is adjustable. The cycles per minute are adjustable. The electrical pumping unit of the device is connected to the breast shields via silicone tubing. The breast shield and screw housing is equipped with a flap valve separating the breast shield from the NUK breast milk container. The system is assembled in an airtight way to ensure that the system can build up vacuum when the breast shield is connected to the breast. The milk will flow through the flap back flow valve into the bottle. A voltage adaptor is provided with the device.

Here's an analysis of the provided text, focusing on the acceptance criteria and the study that proves the device meets those criteria:

Device: NUK Expressive Double Electric Breast Pump

Intended Use: To express milk from the breasts, intended for use by a single user.

Acceptance Criteria and Reported Device Performance

The provided document describes a 510(k) submission, which focuses on demonstrating substantial equivalence to a predicate device rather than setting new, explicit acceptance criteria for performance beyond what is comparable to the predicate. The "acceptance criteria" can be inferred from the comparison points and the tests conducted to show equivalence.

Here's a table based on the comparison and performance sections:

Table: Acceptance Criteria (Inferred from Predicate Equivalence) and Reported Device Performance

Study Details

The document describes device verification testing to demonstrate conformance with specifications and equivalence to the predicate device. This is typical for a 510(k) submission.

1. Sample sizes used for the test set and data provenance:

   • Test Set Sample Size: Not explicitly stated in terms of number of devices or number of human participants. The document mentions "device verification testing" and tests for "suction pressure," "biocompatibility," and "electrical safety." These typically involve testing multiple units of the device and material samples, but specific numbers are not provided.
   • Data Provenance: The tests were conducted internally by MAPA GmbH ("the company's Design Control Process"). The country of origin for the data is Germany (MAPA GmbH is in Zeven, Germany). The nature of the studies (e.g., suction pressure testing, electrical safety testing) is an engineering and material compliance assessment, not a clinical trial in the traditional sense. It's an internal verification process.

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

   • Not applicable in the context of this device's verification. The "ground truth" for electrical safety is defined by IEC standards, for biocompatibility by ISO 10993, and for suction pressure by engineering specifications and comparison to the predicate device's measured parameters. These are objective engineering and regulatory standards, not subjective expert consensus on clinical findings.

3. Adjudication method for the test set:

   • Not applicable. The tests involve objective measurements against established specifications/standards, not subjective assessments requiring expert adjudication.

4. 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 device is a breast pump, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted.

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

   • Not applicable. This is a mechanical/electrical medical device, not an algorithm. The device performance (e.g., suction pressure) is inherent to its design and operation.

6. The type of ground truth used:

   • Objective Engineering Specifications and Standards:
     • Suction pressure: Measured values compared against the predicate device's established range and the device's own internal specifications.
     • Biocompatibility: Results of tests (e.g., cytotoxicity, sensitization, irritation) according to ISO 10993 standards.
     • Electrical Safety: Conformance with IEC 60601-1 and IEC 60601-1-2 standards.

7. The sample size for the training set:

   • Not applicable. This device does not use machine learning or AI, so there is no concept of a "training set."

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

   • Not applicable, as there is no training set.

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