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The Philips Avent Manual Breast Pump is intended to express and collect milk from the breasts of a lactating woman.

The Philips Avent Manual Breast Pump expresses and collects milk from the breast of a lactating woman. The device is designed to be reusable by a single user. The pump diaphragm is activated by a manual pivoting handle. The duckbill valve closes to prevent backflow and seal the device under negative pressure as the handle is depressed. The valve then relaxes to allow milk flow into the bottle between pump actuations. Pumping can only be performed on one breast at a time. The vacuum level can be adjusted to comfort by varying the speed and travel of the manual handle. The device is comprised of the manual breast pump parts and feeding bottle. The Philips Avent Manual Breast Pump operates in one mode - manual. In the manual mode, the user controls the frequency and level of vacuum by varying the stroke/cycle of the control handle lever. All milk-contacting and human tissue-contacting components are manufactured from materials that meet the appropriate regulations regarding food contact and/or biocompatibility.

This document is a 510(k) summary for the Philips Avent Manual Breast Pump, seeking to establish substantial equivalence to predicate devices. The study conducted is a performance test comparing the subject device to existing predicate devices, focusing on vacuum pressure levels.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size:
  • For vacuum pressure testing: Not explicitly stated as a number of devices tested, but it mentions "All devices were tested" for the subject device and the two predicate devices. This implies at least one of each device was tested, but more details like replicates are not provided.
  • For biocompatibility: Not specified in terms of sample size of materials or tests.
• Data Provenance: The document does not specify the country of origin for the data. The study appears to be a prospective performance test specifically conducted for this 510(k) submission, comparing the new device against existing ones under controlled conditions.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• This information is not applicable. This study is a technical performance test (measuring vacuum pressure and biocompatibility), not a study requiring expert interpretation of diagnostic images or clinical outcomes to establish ground truth. The "ground truth" here is the physical measurement of pressure and the results of standardized biocompatibility tests.

4. Adjudication Method for the Test Set

• This information is not applicable. As this is a technical performance test rather than a clinical trial requiring subjective assessments, there is no mention of an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

• No, an MRMC comparative effectiveness study was not done. This device is a manual breast pump, and the study focuses on its physical performance characteristics (vacuum pressure and biocompatibility) compared to predicate devices, not on human reader performance with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

• This information is not applicable. This device is a physical, non-electronic medical device (a manual breast pump) and does not involve an algorithm or AI.

7. The Type of Ground Truth Used

• Vacuum Pressure: The ground truth used was direct physical measurement of vacuum pressure (in mmHg) under specified operating conditions (recommended use and worse-case use).
• Biocompatibility: The ground truth was established by standardized laboratory tests for cytotoxicity, irritation, and dermal sensitization, which provide objective results based on established protocols (e.g., ISO10993).

8. The Sample Size for the Training Set

• This information is not applicable. This is not an AI/ML device, so there is no training set in the typical sense.

9. How the Ground Truth for the Training Set was Established

• This information is not applicable. As there is no training set, there is no ground truth established for one.

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The Philips AVENT Digital Thermometer Set is intended for determination of temperature. The set contains three items:

• A pacifier thermometer to detect baby's oral temperature.
• . An ordinary pacifier that can be used as a daily used regular pacifier.
• A digital flexible-tip thermometer that measures the oral, rectal, and axillary body temperature of humans.

The Philips AVENT Digital Thermometer Set contains three items:

• A pacifier thermometer to detect baby's oral temperature.
• . An ordinary pacifier that can be used as a daily used regular pacifier.
• A digital flexible-tip thermometer that measures the oral, rectal, and axillary body temperature of humans.

The provided text is related to a 510(k) premarket notification for a medical device: Philips Avent Digital Thermometer Set, Model SCH540. It is a clearance letter from the FDA, and as such, it does not contain the detailed study information or acceptance criteria specifications that would typically be found in a clinical study report or a more comprehensive regulatory submission.

The document primarily focuses on the FDA's determination of substantial equivalence to predicate devices and outlines general regulatory compliance requirements.

Therefore, I cannot fulfill all parts of your request based on the provided text. Specifically, the following information is not available in the given document:

• A table of acceptance criteria and the reported device performance: This document does not specify any performance metrics or acceptance criteria used in testing.
• Sample sized used for the test set and the data provenance: Not mentioned.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
• Adjudication method for the test set: Not mentioned.
• 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 device is a thermometer, not an AI-assisted diagnostic tool. Therefore, an MRMC study is not relevant, and no information about it is provided.
• If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not relevant for a thermometer.
• The type of ground truth used: For a thermometer, "ground truth" would typically refer to a reference temperature measurement method, but the details are not provided.
• The sample size for the training set: Not mentioned.
• How the ground truth for the training set was established: Not mentioned.

Based on the available text, here's what can be inferred or stated:

The document confirms that the Philips Avent Digital Thermometer Set, Model SCH540, has received 510(k) clearance from the FDA. This indicates that the manufacturer submitted data demonstrating that their device is substantially equivalent to legally marketed predicate devices. The "substantial equivalence" determination implies that the device performs as safely and effectively as a predicate device.

The intended uses of the device are explicitly stated in the "Indications for Use" section:

• Indications for Use: The Philips AVENT Digital Thermometer Set is intended for determination of temperature. The set contains three items:
  • A pacifier thermometer to detect baby's oral temperature.
  • An ordinary pacifier that can be used as a daily used regular pacifier.
  • A digital flexible-tip thermometer that measures the oral, rectal, and axillary body temperature of humans.

Without the full 510(k) submission (which includes performance data, test protocols, and acceptance criteria), it is impossible to provide the specific details requested in your prompt regarding the study and acceptance criteria.

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Ask a specific question about this device