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The Swing™ breastpump is a powered breastpump to be used by lactating women to express and collect milk from their breasts.

The Medela® Swing™ Breastpump is intended to express the mother's milk of a lactating woman. The pumping can be only on one breast at the time. The Swing™ breastpump can operate off common batteries or off an AC/DC power supply. The Swing™ breastpump's drive unit employs a diaphragm-type vacuum pump, powered by a DC-motor, supervised by a microcontroller provides control over motor speed (vacuum creation) and solenoid (vacuum release). The control program resides in a microcontroller, inside the Swing™ breastpump and provides the necessary a) time and b) vacuum parameters. By depressing the vacuum-adjust buttons, the microcontroller changes the vacuum and time parameters of the breast pump is capable of providing vacuum levels from 0 to 250mmHg, with cycling rates up to 130cpm. The program residing on the microcontroller is designed to deliver two pumping curves. All materials with milk contact or components with human breast/skin contact are manufactured from' materials that meet the appropriate FDA and international requlations concerning food contact and/or biocompatibility.

The provided text describes a 510(k) summary for the Medela® Swing™ Breastpump. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study of the device's performance against specific acceptance criteria.

Therefore, many of the requested details about acceptance criteria, study methodologies, and performance metrics are not available in this document. The document states that the "technology of the Medela® Swing™ breastpump is identical to the predicate devices and there are no technical differences which would raise new aspects regarding safety and effectiveness." This implies that the acceptance criteria for this device are met by demonstrating its equivalence to predicate devices that have already met safety and effectiveness standards.

Here's a breakdown of the available information:

1. A table of acceptance criteria and the reported device performance

   Acceptance Criteria	Reported Device Performance
   Safety and Effectiveness for Intended Use: The device must be safe and effective for expressing and collecting milk from a lactating woman's breasts.	The submission concludes that the Medela® Swing™ breastpump is "safe and effective for the intended use, and is substantially equivalent to the predicate devices." Key technological characteristics include:

• Vacuum levels: 0 to 250mmHg
• Cycling rates: up to 130cpm
• Control: Microcontroller provides control over motor speed and solenoid for vacuum creation and release, delivering two pumping curves.
• Material Biocompatibility: All milk-contact or human breast/skin contact components are manufactured from materials meeting appropriate FDA and international regulations for food contact and/or biocompatibility. |
  | Substantial Equivalence to Predicate Devices: Technological characteristics, intended use, and performance must be substantially equivalent to legally marketed predicate devices, with no new safety or effectiveness concerns. | The document explicitly states: "The technology of the Medela® Swing™ breastpump is identical to the predicate devices and there are no technical differences which would raise new aspects regarding safety and effectiveness." The predicate devices are listed as:
• Medela® Symphony® Breastpump (K020518)
• Medela® Mini Electric® Breastpump (K901344)
  The intended use is also stated as identical to the predicate devices. |

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

   • This information is not provided in the 510(k) summary. The submission relies on claiming substantial equivalence to predicate devices rather than presenting a new clinical study with a test set.

3. 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)

   • This information is not provided. As no specific test set study is detailed, there's no mention of experts establishing ground truth.

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

   • This information is not provided.

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

   • This information is not applicable as the device is a breast pump, not an AI-assisted diagnostic tool involving human readers.

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

   • This information is not applicable as the device is a breast pump, not an algorithm. Its operation is standalone in the sense that it functions to express milk, but it doesn't perform diagnostic or analytical tasks that would typically involve "algorithm only" performance evaluation in the context of AI/software.

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

   • For this type of device, "ground truth" would likely relate to objective measurements of vacuum pressure, cycling rates, and material biocompatibility. The document states the device meets "appropriate FDA and international requlations concerning food contact and/or biocompatibility" and provides specific technical parameters (vacuum levels and cycling rates). This implies that engineering specifications and regulatory compliance serve as the "ground truth" for its performance and safety, validated through direct measurement and adherence to standards rather than expert consensus on a clinical outcome from a test set.

8. The sample size for the training set

   • This information is not applicable to a mechanical device like a breast pump in the context of AI/machine learning training sets.

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

   • This information is not applicable.

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