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The Pump in Style® Advanced Breastpump is a powered breastpump to be used by lactating women to express and collect milk from their breasts.

The Medela® Pump in Style® Advanced Breastpump is intended to express the mother's milk of a lactating woman. The pumping can be performed on one breast or on both breasts at the same time. The Pump In Style® Advanced Breastpump employs a diaphragm-type vacuum pump, powered by a DC motor supervised by a microcontroller. The microcontroller drives the "H" bridge, providing speed and directional control over the DC motor. The Pump In Style® Advanced Breastpump can be powered by external batteries or a wall plug transformer or by a 12 VDC vehicle lighter adapter.

The control program resides in a microcontroller, inside the Pump In Style® Advanced Breastpump and provides the necessary a) time and b) vacuum parameters. By adjusting the knob, the microcontroller changes the vacuum and time parameters of the suction. The breast pump is capable of providing vacuum levels from 0 to 250mm Hg, with cycling rates up to 120 cycles per minute. The program residing on the microcontroller is designed to deliver two pumpina curves.

All materials with milk contact or components with human breast contact are manufactured from materials that meet the appropriate FDA and international regulations concerning food contact and/or biocompatibility.

This 510(k) premarket notification for the Medela® Pump in Style® Advanced Breastpump does not contain information typically associated with studies proving device performance against acceptance criteria in the context of an AI/ML medical device. Instead, it demonstrates Substantial Equivalence to legally marketed predicate devices.

Therefore, many of the requested fields (e.g., sample sizes, ground truth establishment, MRMC studies, effect sizes) are not applicable to this type of submission.

Here's a breakdown based on the provided document:

Acceptance Criteria and Reported Device Performance

The concept of "acceptance criteria" and "reported device performance" in this 510(k) focuses on demonstrating that the new device shares fundamental technological characteristics and intended use with previously cleared predicate devices, rather than a specific numerical performance metric benchmarked against a clinical study.

Table of Acceptance Criteria and Reported Device Performance (as inferred from the 510(k) submission):

Study Information (Based on 510(k) Context):

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • N/A. This 510(k) relies on demonstrating substantial equivalence to predicate devices, not on a clinical performance study with a specific test set of data. The "test" is a comparison of the device's design and intended use to existing, cleared devices.

2. 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):

   • N/A. Ground truth establishment by experts for a test set is not described in this type of submission for a breast pump. The "ground truth" for substantial equivalence is the regulatory status and established safety/effectiveness of the predicate devices.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • N/A. No adjudication method for a test set is discussed in this 510(k) submission.

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:

   • N/A. This device (a breast pump) is not an AI/ML diagnostic tool, and therefore, an MRMC comparative effectiveness study where human readers improve with AI assistance is entirely irrelevant and not performed.

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

   • N/A. This is a mechanical/electronic breast pump, not an algorithm. Standalone algorithm performance is not applicable.

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

   • N/A (in the typical sense of a clinical study). For a 510(k) using substantial equivalence, the "ground truth" is the established regulatory clearance and safety/effectiveness of the predicate devices based on their prior review by the FDA. The new device is compared to these established benchmarks.

7. The sample size for the training set:

   • N/A. There is no "training set" as this is not an AI/ML device.

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

   • N/A. Not applicable, as there is no training set for an AI/ML model for this device.

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