Search Results

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.

Ask a specific question about this device

The Philips Avent single/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 Single/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 single (Single Advanced) and double (Double Advanced) breast pumps consisting of the following key components: a motor unit with a press-button user interface, and expression kit with milk collection container (double pump: two kits and containers) connected with the motor unit via a silicone tube. 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 collected in a milk 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 an external mains adapter that is provided with the system via a micro-USB type connection. Models SCF392 and SCF394 include a rechargeable battery that can be used for device operation. The rechargeable battery can be charged from the external mains adapter if the motor unit is not in operation.

The expression kit is provided in two types: cushion-type and flange-type.

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 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 Single/Double electric breast pump Advanced. This type of document is a premarket notification to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device.

The questions you are asking typically relate to the performance of AI/ML-driven medical devices in diagnostic or screening applications, where metrics like sensitivity, specificity, and reader performance are critical.

This document, however, describes a powered breast pump, which is a physical device, not an AI/ML diagnostic tool. Therefore, many of your specific questions regarding acceptance criteria and studies (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, training set size, ground truth for training set) are not applicable to the information provided for this type of medical device.

I can, however, extract the information that is relevant to the document for a medical device such as a breast pump, which focuses on safety and performance in a different context.

Here's the relevant information based on the provided text:

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

The document doesn't provide a direct "acceptance criteria table" with numerical thresholds for clinical performance metrics (like accuracy for an AI device). Instead, it lists various engineering and safety standards that the device complies with, along with technical specifications that define its functional performance. The "reported device performance" is compliance with these standards and the specified operating ranges.

2. Sample sized 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 document. The document describes compliance with engineering and electrical standards through testing, not a clinical study with human subjects for performance evaluation in the way an AI diagnostic device would be tested. The tests are focused on the device's hardware and software functionality, and material safety.

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 applicable/not provided. Ground truth established by medical experts is paramount for diagnostic AI/ML devices. For a breast pump, "ground truth" relates to physical and electrical performance, and biocompatibility, which are assessed through engineering and materials science tests, not expert clinical consensus on interpretations.

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

This information is not applicable/not provided. Adjudication methods are used in studies involving subjective interpretation, typically by multiple human readers, which is not the case for device safety and performance testing for a breast pump.

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

An MRMC study is not applicable/not provided. This type of study is relevant for AI-assisted diagnostic tools. The breast pump is a therapeutic/supportive device, not a diagnostic one.

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

This is not applicable for this device in the context of typical AI/ML evaluation. While the device contains software, its "performance" is mechanical and electrical, not an AI algorithm making independent diagnostic decisions. The software verification and validation are for the embedded control software.

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

The "ground truth" for this device's performance relies on objective measurements and adherence to established engineering, electrical, and biocompatibility standards. For example:

• Electrical safety tests verify voltage, current, and insulation against specified limits.
• EMC tests verify emission and immunity levels against regulatory standards.
• Vacuum/cycle performance tests measure actual vacuum levels and cycles per minute against the device's specified operating ranges.
• Biocompatibility tests use standardized laboratory assays to detect cytotoxicity, sensitization, and irritation.

8. The sample size for the training set

This information is not applicable/not provided. There is no "training set" in the context of an AI/ML algorithm for this breast pump. The software is likely deterministic control logic, not a machine learning model that requires training data.

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

This information is not applicable/not provided due to the absence of a machine learning training set.

Ask a specific question about this device

The Philips Avent Comfort Single/Twin Electric Breast Pump 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 electrically powered single (Comfort Single) and double (Comfort Double) breast pumps consisting of a motor and pump body, press-button user interface, and collection kit. A vacuum pump creates a vacuum at the breast of the lactating woman. This vacuum is released after a short period of time. By repeating this behavior, a cyclic vacuum generation pattern is created which enables expressing of milk from the breast. The expressed milk will be collected in the container which can be used for storage. The breast pump supports different operating modes: stimulation, expression 1, expression 2 and expression 3. The stimulation mode is entered upon start of the device when suction is felt on the breast. Once the milk starts flowing an expression mode may be chosen that has the most comfort, e.g. the combination of rhythm and suction level.

The provided text describes the 510(k) summary for the Philips Avent Comfort Single/Twin Electric Breast Pump (K161532). It outlines performance testing, but it does not contain information about acceptance criteria or a study proving that a "device" (in the context of an AI/ML medical device) meets specific performance criteria like sensitivity, specificity, or accuracy. This document is for a traditional medical device (a breast pump), not an AI/ML algorithm. Therefore, many of the requested fields are not applicable.

However, I can provide information based on the performance testing that was conducted for this breast pump, mapping it to the closest relevant categories where possible.

Acceptance Criteria and Device Performance (Breast Pump)

Since this is a physical medical device and not an AI/ML algorithm, the "acceptance criteria" are related to safety, electrical performance, software validation, usability, biocompatibility, and vacuum performance, rather than diagnostic accuracy metrics.

1. Table of Acceptance Criteria and the Reported Device Performance

• Cycles per second (stimulation): within acceptable ranges and comparable to predicate (e.g., 1.42 - 2.0 compared to 1.7 - 1.93 for predicate).
• Suction levels (expression): within acceptable ranges and comparable to predicate (e.g., 168 – 250mmHg compared to 45 - 245mmHg for predicate).
• Cycles per second (expression): within acceptable ranges and comparable to predicate (e.g., 0.70 - 0.87 compared to 0.83 – 1.36 for predicate).
• Maximum Vacuum: comparable to predicate (e.g., 250mmHg compared to 270mmHg for predicate).
• Vacuum stability, durability, pump temperatures during operation. | - Suction levels (stimulation): 127mmHg +/- 15mmHg
• Cycles per second (stimulation): 1.42 - 2.0
• Suction levels (expression): 168 – 250mmHg
• Cycles per second (expression): 0.70 - 0.87
• Maximum Vacuum: 250mmHg
  The testing demonstrated the mechanical performance and performance specifications of the subject device and validated that the performance of the subject device is substantially equivalent to the predicate device. |

Regarding AI/ML specific questions:

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

• Not applicable. This device is a breast pump, not an AI/ML algorithm. Performance testing was conducted on hardware, software functionality, and physical characteristics.

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)

• Not applicable. Ground truth in the context of diagnostic accuracy for AI/ML does not apply here. Experts involved in testing would be engineers, usability specialists, and potentially clinicians for biocompatibility or usability assessments, but not to establish "ground truth" for diagnostic purposes.

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

• Not applicable. No adjudication method for diagnostic outcomes. Testing involved validation against standards and comparison to a predicate device.

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. No MRMC study was conducted as this is not an AI-assisted diagnostic device.

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

• Not applicable. This device is a physical breast pump; there is no standalone algorithm in the sense of an AI/ML diagnostic or assistive tool.

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

• Not applicable in the AI/ML diagnostic sense. For this device, "ground truth" equates to established engineering specifications, safety standards (e.g., electrical safety, EMC, biocompatibility), and the performance characteristics of the legally marketed predicate device.

8. The sample size for the training set

• Not applicable. There is no "training set" in the context of AI/ML for this device. Software verification and validation would use test cases, not a training set.

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

• Not applicable. See point 8.

Ask a specific question about this device