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The Freestyle® is a powered breastpump to be used by lactating women to express and collect milk from their breasts. The Freestyle® is intended for a single user.

The Medela Freestyle® double electric breastpump system is comprised of the Freestyle® pump (motor unit), the Freestyle® media separation pump kit including tubing, the rechargeable battery, the AC/DC power supply and soft good accessories (tote bag, cooler bag with ice pack). The Medela Freestyle® pump is a double electric breastpump for pumping breastmilk from a single breast or simultaneously from both breasts of a lactating woman by applying a cyclic negative pressure.

The Freestyle® double electric breastpump is a mobile, personal, medical device that includes Medela's 2-Phase Expression technology and is intended to be used by a single user in a closed space as for example a home or office environment.

The Medela Freestyle® double electric breastpump is AC/DC powered and incorporates a DCmotor with membrane aggregate in its pump motor unit. A user friendly display offers information as for example duration of pump session or set vacuum level. The Freestyle® double electric breastpump is mobile and can be operated by connecting to the power supply and / or by rechargeable battery. The connection port for the power supply is located at the bottom side of the pump unit. The battery compartment is at the back of the pump motor unit and is covered by a battery door. The runtime of the removable lithium-ion battery is influenced by the number and duration of pumping sessions and lasts usually for one day. When the Freestyle® pump motor unit is connected to the power supply, the battery is recharged automatically.

A variety of accessories are available for use with the Freestyle® or are intended to be marketed with these pumps.

This document is a 510(k) premarket notification for the Medela Freestyle® double electric breast pump, seeking to demonstrate substantial equivalence to a predicate device. As such, it does not contain a study proving the device meets acceptance criteria in the way this request typically implies (i.e., performance thresholds for AI/ML algorithms).

Instead, the document details a comparison of the Freestyle® breast pump to a predicate device (Lansinoh powered electric breast pump, K122474) and references non-clinical tests to establish substantial equivalence.

Here's an analysis based on the provided text, addressing your points where applicable, and noting where the information is not present due to the nature of the document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not specify "acceptance criteria" in the sense of performance metrics for an AI/ML algorithm. Instead, it presents a comparison table of technical specifications and performance characteristics between the Medela Freestyle® and its predicate device to demonstrate substantial equivalence. The "Discussion" column in this table serves as the "reported device performance" against the implicitly accepted standards of the predicate device.

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

This information is not applicable and not provided. This document describes a medical device (breast pump), not an AI/ML algorithm requiring a test set of data. The "testing" involved non-clinical performance and safety evaluations of the physical device.

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

Not applicable. This is not an AI/ML algorithm submission.

4. Adjudication method 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 physical medical device.

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

Not applicable. This is a physical medical device.

7. The type of ground truth used

Not applicable. For a physical device, performance is evaluated against engineering specifications, safety standards, and equivalence to a predicate device's established performance, rather than "ground truth" labels. The "truth" here relates to meeting established physical and electrical safety standards and functional equivalence.

The document mentions several non-clinical tests that form the basis of proving compliance and equivalence:

• Risk Analysis
• Cleaning Validation
• Biocompatibility Evaluation
• Software Validation
• Electrical safety and electromagnetic compatibility testing per IEC 60601-1 and IEC 60601-1-2
• Safety testing for use in the home per IEC 60601-1-11
• Usability evaluation and validation
• Performance testing demonstrating compliance with EN ISO 10079-1: 2009 (Particular requirements for the safety of electrically powered suction equipment)
• Performance Testing to determine vacuum performance (minimum and maximum vacuum levels, vacuum stability, overflow performance, durability, pump temperatures during operation) compared to the predicate device.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/ML algorithm.

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

Not applicable.

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