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The Philips Avent double electric breast pump Advanced is intended to express and collect milk from the breast of a lactating woman, and to alleviate engorgement of the breast. The device is intended for a single user.

The Philips Avent Double electric breast pump Advanced is intended to express and collect milk from the breast of a lactating woman. The device is intended for a single user. The subject devices are for repeated use by a single user and are for use in home and professional healthcare environments. The devices are not sterile. The subject devices are electrically powered double (Double Advanced) breast pumps consisting of the following key components: a motor unit with a press-button user interface, two expression kits with two milk collection containers connected with the motor unit via silicone tubes. The motor unit operates on embedded software. Software updates by end-users are not supported. The breast pump extracts milk from the breasts by creating a seal around the nipple and applying and releasing suction to the nipple. The milk is collection container, which can be used for storage. To prevent milk from flowing into the vacuum system, the expression kit includes a silicone diaphragm that physically separates the milk-contacting pathway from the vacuum system. The motor unit operates on a rechargeable battery or on an external mains adapter that is provided with the system via a micro-USB type connection. The rechargeable battery can be charged from the external mains adapter if the motor unit is not in operation. The breast pump is provided with the same accessories as the predicate device (K201381), with the addition of a breast pump belt. The breast pump belt intended to carry the electrical breast pump while the device is used to express and collect milk. The belt is intended to be worn over clothes. The expression kit is provided in two types: cushion-type (SCF394/61) and flange-type (SCF394/62). The cushion-type expression kit has a silicone cushion which is mounted on the expression kit pump body. The cushion comes into contact with the breast for the duration of the expression session. In the flange-type expression kit, the silicone cushion is integrated in a rigid frame. This integrated part (flange) can be attached to the pump body with a screw connection. The silicone part comes into contact with the breast for the duration of the expression. The rigid frame is not in contact with the breast. All other components of the subject devices are not in contact with the breast.

The provided document is a 510(k) summary for the Philips Avent Double electric breast pump Advanced. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that the device meets specific acceptance criteria through a clinical study with performance metrics in the way one might expect for a novel diagnostic or therapeutic device.

Therefore, the requested information regarding acceptance criteria, reported device performance, sample sizes, expert involvement, multi-reader studies, standalone performance, and ground truth establishment is not directly available or applicable in the context of this 510(k) summary.

The summary focuses on:

1. Comparison to a Predicate Device: The core of the 510(k) is to show that the new device (Philips Avent Double electric breast pump Advanced SCF394/61 and SCF394/62) is substantially equivalent to a previously cleared predicate device (Philips Avent Double electric breast pump Advanced K201381). This means demonstrating that it has the same intended use and similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness.
2. Non-Clinical Performance Testing: The provided "performance testing" is limited to biocompatibility testing, which is a common requirement for devices that come into contact with the body.

Here's how the requested information maps to the provided document:

1. Table of acceptance criteria and the reported device performance

• Acceptance Criteria for Device Performance (Clinical/Effectiveness): Not explicitly defined in terms of specific clinical efficacy metrics (e.g., milk volume expressed, comfort levels, duration of engorgement relief). The "acceptance criteria" here is primarily substantial equivalence to the predicate device.
• Reported Device Performance (Clinical/Effectiveness): No clinical performance data (e.g., how much milk is expressed, how effectively it alleviates engorgement in users) is reported in this summary. The summary states that the devices have "similar technological features, including design, user interface, vacuum pressure range, cycle speeds, and power source" and that any differences "do not raise different types of safety and effectiveness questions."

The only specific performance data mentioned are related to the biocompatibility studies:

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

• Clinical Test Set: Not applicable. No clinical test set for efficacy or effectiveness is described.
• Biocompatibility Test Set: The sample sizes for the in vitro and in vivo biocompatibility tests are not specified in the document. Data provenance (e.g., country of origin, retrospective/prospective) is also not specified for these tests.

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)

• Clinical/Effectiveness Ground Truth: Not applicable. No clinical ground truth was established by experts for efficacy or effectiveness. The device's performance is assumed to be substantially equivalent to the predicate.
• Biocompatibility Ground Truth: Not applicable in the sense of expert consensus for a "ground truth." Biocompatibility testing follows established protocols and standards (ISO 10993) where results are interpreted against predefined pass/fail criteria.

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

• Not applicable. There was no clinical test set requiring adjudication.

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 device is a breast pump, not an AI-powered diagnostic or decision support tool. Therefore, MRMC studies and AI assistance comparisons are not relevant.

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

• Not applicable. This device is a mechanical/electrical breast pump, not an algorithm.

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

• For demonstrating substantial equivalence: The "ground truth" is the performance and safety profile of the legally marketed predicate device (K201381). The comparison is based on technical specifications and adherence to recognized standards.
• For biocompatibility: The ground truth is established by standardized testing protocols (ISO 10993) which define acceptable biological responses.

8. The sample size for the training set

• Not applicable. This device does not use machine learning or AI models that require a training set.

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

• Not applicable. As there is no training set mentioned, there is no ground truth establishment for it.

In summary: The provided 510(k) premarket notification is for a powered breast pump, which is typically cleared based on substantial equivalence to an existing product and adherence to general controls and performance standards, rather than complex clinical trial data demonstrating specific performance metrics against a defined acceptance criterion. The "study" referenced is primarily a comparison of technological characteristics to a predicate device and non-clinical biocompatibility testing.

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