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The Solo™ / Swing Maxi™ breast pumps are powered breast pumps to be used by lactating women to express and collect milk from their breasts.

The Solo™ / Swing Maxi™ breast pumps are intended for a single user.

The breast pumps are intended to be used in a home environment.

Solo™ and Swing Maxi™ are breast pump systems intended to be used in a home environment (or similar such as an office). Solo™ and Swing Maxi™ comprise a pump unit, power adapter, and one (Solo™) or two (Swing Maxi™) PersonalFit Flex™ connectors that include the connector body, membrane (diaphragm), and connector back cap. The breast pump systems also include breast shields (21, 24, 27, and 30 mm), bottle lid, bottle stand, and tubing. The device is provided non-sterile.

The breast pumps can be used on one breast (single pumping; Solo™ and Swing Maxi™)) or on both breasts (double pumping) at the same time (Swing Maxi 101).

The Solo"M and Swing Maxi™ breast pumps feature 2-Phase Expression® technology, which runs pumping in two phases (Stimulation and Expression) by applying a cyclic negative pressure to mimic a baby's natural nursing rhythm. A DC motor is used to drive a membrane aggregate. This membrane aggregate creates the negative pressure (suction) required to extract the breast milk. The pump unit includes the following features:

• user-adjustable controls: "On/Pause/Off" for powering on/off or pausing the device, "Letdown" for switching between pumping modes, and "Increase vacuum"/ "Decrease vacuum" for controlling vacuum intensity levels;
• a port for connection of the tubing that channels the vacuum for breast pumping;
• a port for connection of the power supply;
• a central LED light as status indicator; and
• a textile lanyard as an interface to the user's clothes/body.

The Solo™ and Swing Maxi™ breast pump systems allow the user to adjust the vacuum levels in both phases (stimulation and expression). The powered breast pumps are preprogrammed with variable vacuum levels and cvcle rates. The powered breast pumps are capable of providing vacuum levels from -45 to -140 mmHg with cycle speeds up to 111 cycles per minute for stimulation and from -45 to -245 mmHg with cycle speeds from 75 to 45 cycles per minute for expression.

Two different product configurations are available for the Swing Maxi™ breast pump: without and with Bluetooth®. These two product configurations share the same mechanical and electrical design components; however, the Swing Maxi111 breast pump with Bluetooth® additionally features always-on enabled Bluetooth® connectivity. This allows monodirectional wireless data transmission from the breast pump to a Bluetooth®-enabled personal mobile device, such as a smartphone or tablet computer. When the Medela FamilyTM smart application is installed on a compatible mobile device and the device is paired via Bluetooth® with the breast pump unit, the user can: automatically record pumping data (session length, phases, and vacuum intensity levels), manually input the amount of milk expressed, and get notified when the battery is low as indicated in provided instructional material and in-app information.

The provided document is a 510(k) premarket notification for the Medela Solo™ / Swing Maxi™ breast pumps. It describes the device, its intended use, and compares it to a predicate device. However, it does not contain information regarding acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of an AI/ML medical device.

The document states that the breast pumps comply with voluntary standards for electrical safety, electromagnetic compatibility, use in the home healthcare environment, and usability. It also lists performance data provided to support the substantial equivalence determination. These performance data are:

• Electrical Safety testing: In accordance with ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012, and IEC 60601-11:2015.
• Risk analysis: In accordance with ISO 14971:2007.
• Electromagnetic compatibility testing: In accordance with IEC 60601-1-2:2014.
• Biocompatibility evaluation: Completed according to FDA guidance "Use of International Standard ISO 10993-1," concluding no new testing was required as patient-contacting materials are identical to the predicate device.
• Software validation: In accordance with FDA Guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (May 11, 2005). The software was considered a "Moderate" level of concern.
• Bench testing: Conducted to determine minimum and maximum vacuum levels and cycle rates compared to specifications.
• Battery and pump use life testing: Conducted to demonstrate device maintenance of specifications throughout its use life.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving those criteria are met for an AI/ML device because the provided text is for a traditional medical device (breast pump) and does not describe an AI/ML component or associated performance studies against specific AI/ML metrics.

If you have a document related to an AI/ML medical device, please provide that, and I will do my best to extract the information you need.

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The Freestyle Flex™ breast pump is a powered breast pump to be used by lactating women to express and collect milk from their breasts.

The Freestyle Flex™ breast pump is intended for a single user.

The breast pump is intended to be used in a home environment.

The Medela Freestyle Flex™ breast pump system is comprised of the Freestyle Flex™ pump (motor unit), the PersonalFit Flex connector (including membranes and connector bodies), PersonalFit Flex breast shields (21, 24, 27, 30 mm), tubing, bottles, carry bag, cooler with cooling element, and Power Adapter.

The Medela Freestyle Flex™ breast pump system is used to express and collect milk from the breast of a lactating woman. The system is intended for daily use in a home (or similar environment such as an office) to supplement breastfeeding by a single user. Pumping with the Freestyle Flex 110 breast pump can be performed on one breast (single pumping) or on both breasts at the same time (double pumping).

The Freestyle Flex™ breast pump allows the user to adjust the vacuum levels. Two suction patterns are pre-programmed with variable vacuum levels and cycle rates (pump speed). The powered breast pump is capable of providing vacuum levels from -45 to -245 mmHg with cycle rates up to 111 cycles per minute. The device is AC/DC powered and incorporates a DC motor with membrane aggregate in its pump motor unit. The device is provided non-sterile.

The Freestyle Flex ™ breast pump provides the following user features:

• . Five buttons for user adjustment of on/off, let-down, increase vacuum, decrease vacuum, start/pause.
• 2-Phase Expression® Technology designed to mimic a baby's natural nursing rhythm: ●
  • o Stimulation Phase (phase 1): Suction pattern with fast cycles and low vacuum to start milk flowing.
• o Expression Phase (phase 2): Suction pattern with slower cycles and higher vacuum to express more milk gently and efficiently.
• "Let-down" control to change between stimulation phase and expression phase. .
• Option of either single or double breast pumping. .

This document is a 510(k) Summary for the Medela Freestyle Flex™ breast pump and focuses on demonstrating substantial equivalence to a predicate device (Medela Freestyle® Breast Pump K150499) rather than presenting a study to prove performance against specific acceptance criteria in the traditional sense of clinical performance measures (e.g., sensitivity, specificity, accuracy for diagnostic devices).

Therefore, some of the requested information regarding acceptance criteria and study design (especially related to expert ground truth, adjudication, MRMC, and standalone performance metrics) is not applicable or cannot be directly extracted from this type of regulatory submission for a powered breast pump. This submission is primarily concerned with safety and effectiveness through technological comparison and conformance to standards.

However, I can extract information related to the technical specifications and non-clinical testing performed to support the substantial equivalence claim.

Here's the closest representation of the requested information based on the provided text:

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

For a breast pump, "acceptance criteria" primarily revolve around meeting technical specifications for functionality, safety standards, and equivalence to a predicate device. The "reported device performance" refers to the device adhering to these specifications during testing.

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

This submission does not specify a "test set" in the context of clinical data. The performance claims are based on non-clinical bench testing. Therefore, sample sizes for human subjects or data provenance (country/retrospective/prospective) are not applicable or provided here. The tests are laboratory-based.

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 from experts is not a concept used in this type of non-clinical bench testing for a breast pump. Performance is measured against predefined engineering specifications and international standards.

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

Not applicable, as there is no clinical test set requiring expert 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 is not an AI-assisted diagnostic device, and no MRMC study was performed or is relevant for a breast pump's regulatory submission.

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

Not applicable. This is not an algorithm-based device requiring standalone performance evaluation in the context of diagnostic accuracy. The "standalone" performance here refers to bench testing of the pump's physical and electrical specifications.

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

The "ground truth" for the non-clinical tests are the engineering specifications and established international safety and performance standards for powered breast pumps and electrical medical equipment. For example, a vacuum level output of -245 mmHg is measured directly against a known standard.

8. The sample size for the training set

Not applicable. This device does not use machine learning algorithms that require a "training set."

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

Not applicable, as there is no training set for this device.

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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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The Pump in Style® Advanced Breastpump is a powered breastpump to be used by lactating women to express and collect milk from their breasts.

The Medela® Pump in Style® Advanced Breastpump is intended to express the mother's milk of a lactating woman. The pumping can be performed on one breast or on both breasts at the same time. The Pump In Style® Advanced Breastpump employs a diaphragm-type vacuum pump, powered by a DC motor supervised by a microcontroller. The microcontroller drives the "H" bridge, providing speed and directional control over the DC motor. The Pump In Style® Advanced Breastpump can be powered by external batteries or a wall plug transformer or by a 12 VDC vehicle lighter adapter.

The control program resides in a microcontroller, inside the Pump In Style® Advanced Breastpump and provides the necessary a) time and b) vacuum parameters. By adjusting the knob, the microcontroller changes the vacuum and time parameters of the suction. The breast pump is capable of providing vacuum levels from 0 to 250mm Hg, with cycling rates up to 120 cycles per minute. The program residing on the microcontroller is designed to deliver two pumpina curves.

All materials with milk contact or components with human breast contact are manufactured from materials that meet the appropriate FDA and international regulations concerning food contact and/or biocompatibility.

This 510(k) premarket notification for the Medela® Pump in Style® Advanced Breastpump does not contain information typically associated with studies proving device performance against acceptance criteria in the context of an AI/ML medical device. Instead, it demonstrates Substantial Equivalence to legally marketed predicate devices.

Therefore, many of the requested fields (e.g., sample sizes, ground truth establishment, MRMC studies, effect sizes) are not applicable to this type of submission.

Here's a breakdown based on the provided document:

Acceptance Criteria and Reported Device Performance

The concept of "acceptance criteria" and "reported device performance" in this 510(k) focuses on demonstrating that the new device shares fundamental technological characteristics and intended use with previously cleared predicate devices, rather than a specific numerical performance metric benchmarked against a clinical study.

Table of Acceptance Criteria and Reported Device Performance (as inferred from the 510(k) submission):

Study Information (Based on 510(k) Context):

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

   • N/A. This 510(k) relies on demonstrating substantial equivalence to predicate devices, not on a clinical performance study with a specific test set of data. The "test" is a comparison of the device's design and intended use to existing, cleared devices.

2. 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):

   • N/A. Ground truth establishment by experts for a test set is not described in this type of submission for a breast pump. The "ground truth" for substantial equivalence is the regulatory status and established safety/effectiveness of the predicate devices.

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

   • N/A. No adjudication method for a test set is discussed in this 510(k) submission.

4. 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:

   • N/A. This device (a breast pump) is not an AI/ML diagnostic tool, and therefore, an MRMC comparative effectiveness study where human readers improve with AI assistance is entirely irrelevant and not performed.

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

   • N/A. This is a mechanical/electronic breast pump, not an algorithm. Standalone algorithm performance is not applicable.

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

   • N/A (in the typical sense of a clinical study). For a 510(k) using substantial equivalence, the "ground truth" is the established regulatory clearance and safety/effectiveness of the predicate devices based on their prior review by the FDA. The new device is compared to these established benchmarks.

7. The sample size for the training set:

   • N/A. There is no "training set" as this is not an AI/ML device.

8. How the ground truth for the training set was established:

   • N/A. Not applicable, as there is no training set for an AI/ML model for this device.

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