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The Duo Hands-free breast pump is a powered breast pump to be used by lactating women to express and collect milk from their breasts.

The Duo Hands-free breast pump is intended for a single user.

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

The Duo Hands-Free breast pump is an electrically powered breast pump to be used in a home environment by a single user. The device is provided non-sterile and can be used on one breast (single pumping) or on both breasts at the same time (double pumping).

The device consists of the pump unit, two Hands-free Collection Cups (breast shields, membranes, outer shells), and tubing. The breast pump provides wireless connectivity via a Bluetooth Low Energy (BLE) 4.2 compliant protocol and is compatible with the Medela Family mobile application. The BLE component does not offer control of the breast pump and is only meant to store the information sent from the breast pump (such as session length, phases and vacuum intensity levels) and log additional information related to their pumping session. The device has four buttons allowing the user to power the device on/off, select between two pumping modes (expression, and stimulation), and control vacuum strength within each mode (9 levels of vacuum strength in each mode). The pump is powered by an internal, non-replaceable, rechargeable lithium-ion battery which is charged using the included AC power supply and cable. The subject device can be operated while plugged into AC power.

The Duo Hands-free breast pump utilizes a microcontroller executing embedded software to interpret user inputs and modulate the voltage applied to a DC motor and a solenoid to produce a negative vacuum pressure applied to the user. The vacuum is generated by turning on the motor, incrementally drawing air out of the pump set on each rotation and expelling it into the atmosphere. When the cycle is complete, the solenoid valve is opened, relieving the vacuum. Vacuum generated by the breast pump unit is applied to the membrane in the Hands-free Collection Cup pump set causing it to displace away from the breast and to apply vacum to the breast. Vacuum applied to the breast will cause milk to be expressed and to accumulate on the milk valve. Once the vacuum is relieved by the solenoid valve, milk will fall through the milk valve into the outer shells, and the cycle is repeated.

All milk contacting components are compliant with 21 CFR 174-179.

The Duo Hands-Free Breast Pump, described in the provided 510(k) summary, is a Class II medical device, and the information provided does not directly detail a clinical study involving human patients or complex AI algorithms requiring extensive acceptance criteria beyond basic device functionality and safety. The document focuses on bench testing and regulatory compliance.

However, based on the non-clinical performance testing conducted, we can infer some "acceptance criteria" related to the device's functionality and safety, and the "study" that proves it.

Here's the breakdown of the available information:

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

Since specific numerical acceptance criteria (e.g., "vacuum level must be within +/- 5 mmHg") are not explicitly stated in the summary, we will infer the performance criteria from the types of tests conducted and their stated purpose. The "reported device performance" is essentially that the device "meets its design requirements and performs as intended."

2. Sample size used for the test set and the data provenance

The document does not provide details on the specific sample sizes for the non-clinical tests (e.g., how many units were tested for vacuum level, how many cycles for use-life, etc.). These are typically bench tests conducted on a sufficient number of manufactured units as determined by the manufacturer's internal quality assurance procedures and risk management. The data provenance is internal manufacturer testing (Medela LLC). These are prospective tests conducted on the manufactured device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This section is not applicable in the context of this device and its testing. The "ground truth" for non-clinical performance and safety tests is established by recognized international standards (e.g., IEC, ISO) and the device's design specifications. The experts involved would be the engineers and quality assurance personnel at Medela LLC, qualified in electrical engineering, mechanical engineering, software development, and quality systems, who designed, built, and tested the device against these standards and specifications. No external expert panel was used to establish a "ground truth" in the way it might be for an AI-powered diagnostic device.

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

This is not applicable. Adjudication methods like 2+1 or 3+1 are used for clinical studies involving interpretation of medical images or data by multiple readers to establish a consensus "ground truth." The tests described are objective, non-clinical performance tests against pre-defined specifications and standards.

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 is not applicable. The device is a breast pump, not an AI-assisted diagnostic tool. No MRMC study was performed.

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

This is not applicable. The device is a breast pump, not an AI algorithm. While it contains embedded software to control its operation, there's no "standalone algorithm" performance assessed in the context of diagnostic accuracy.

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

For the non-clinical performance tests, the "ground truth" is defined by:

• International Standards: e.g., IEC 60601 series for electrical safety and EMC, ISO 10993-1 for biocompatibility.
• Device Design Specifications: Internal specifications set by Medela LLC for vacuum levels, cycle rates, battery life, and durability.
• Regulatory Requirements: 21 CFR 174-179 for milk-contacting materials.

8. The sample size for the training set

This is not applicable. This device does not use machine learning or AI that requires a "training set" of data.

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

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

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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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Pump In Style® is a powered breast pump to be used by lactating women to express and collect milk from their breasts. This powered breast pump is intended for a single user and is intended to be used in a home environment.

The Pump In Style® breast pump is used to express and collect milk from the breast of a lactating woman. The device is intended for daily use in a home environment to supplement breastleeding by a single user. Pumping can be performed on one breast (single pumping) or both breasts at the same time (double pumping).

The Pump In Style® breast pump is comprised of the breast pump unit, connector (including membranes, connector body and cap), breast shields, tubing, collection bottles, and power adaptor. In addition, optional accessories such as carry bag, bottle stand, battery pack, cooler bag, cooling element, vehicle power adaptor and additional milk collection containers may be included in the packaging as part of the product offering.

The Pump In Style® breast pump has user-adjustable controls for powering the device on/off, switching between two pumping modes, stimulation and expression, and controlling vacuum level within each of the modes. The Pump In Style® breast pump is capable of providing vacuum levels from -50 to -240 mmHg with cycle rates up to 140 cycles per minute. The tubing port is for connection of the tubing for pumping. The power supply port is for connection of the power supply or portable vehicle adaptor or battery pack.

The Pump In Style® breast pump provides the following user features:

• . 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.
• The option of either single or double breast pumping. ●

This document is a 510(k) premarket notification for a breast pump, which falls under medical device regulations. It is not an AI/ML device, and therefore the acceptance criteria and study information typically associated with AI/ML device approvals (like sensitivity, specificity, ROC curves, ground truth establishment with expert readers, etc.) are not applicable here.

The document discusses the regulatory review of a conventional medical device, a powered breast pump, and its substantial equivalence to a legally marketed predicate device. The "acceptance criteria" in this context refer to complying with relevant medical device regulations, standards, and demonstrating the device's technical specifications and safety.

However, I can extract the closest analogous information based on the request, reinterpreting "acceptance criteria" and "study" in the context of a traditional medical device submission.

Here's a breakdown of the available information:

1. Table of acceptance criteria and the reported device performance (Reinterpreted for a non-AI/ML device):

The acceptance criteria here are derived from the device's stated specifications and compliance with voluntary standards, especially in comparison to the predicate device. "Reported device performance" refers to the results of the bench testing and compliance reports.

2. Sample size used for the test set and the data provenance:

This information is not directly applicable in the terms of an AI/ML test set. The submission describes non-clinical bench testing. For such physical device testing, "samples" refer to the manufactured units of the device being tested. The document doesn't specify the exact number of units tested, but it implies standard engineering and regulatory testing practices. There's no "data provenance" in terms of patient data or geographical origin for this type of testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This is not applicable. "Ground truth" in the context of this breast pump refers to the physical and functional specifications of the device, established through engineering design, industry standards, and regulatory requirements, not expert interpretation of medical images or patient data.

4. Adjudication method for the test set:

Not applicable. There is no expert adjudication process described for the non-clinical bench testing of 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:

Not applicable. This is a conventional medical device; there is no AI assistance involved, and therefore no MRMC study.

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

Not applicable. This is a conventional medical device, not an algorithm.

7. The type of ground truth used:

The "ground truth" for this device's performance is its engineering specifications, design requirements, and compliance with recognized national and international electrical, safety, and performance standards (e.g., AAMI / ANSI ES60601-1, IEC 60601-1-11, ISO 14971, IEC 60601-1-2). These standards define acceptable ranges for vacuum, cycle rates, safety features, biocompatibility, and electrical characteristics.

8. The sample size for the training set:

Not applicable. This is a physical device, not an AI/ML model that undergoes training.

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

Not applicable. There is no training set for a physical breast pump.

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The Pump In Style® Advanced breast pump is a powered breast pump to be used by lactating women to express and collect milk from their breast. The powered breast pump is intended for a single user.

The Pump In Style® Advanced breast pump and kit are 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 Pump In Style® Advanced breast pump can be performed on one breast (single pumping) or on both breasts at the same time (double pumping).

The Pump In Style® Advanced breast pump employs a control knob (potentiometer) for the user to adjust the vacuum levels. Two suction rhythms are pre-programmed with variable vacuum levels and cycle rates (pump speed). The powered breast pump is capable of providing vacuum levels from -50 to -240 mmHg with cycle rates up to 120 cycles per minute.

The device employs a gear-driven 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 device is electrically powered from external batteries (AA batteries) or from an external direct plug-in AC power supply or from a vehicle lighter adapter. The device is provided non-sterile.

The Pump In Style® Advanced breast pump provides the following user features:

• . Rotary knob for user adjustment of vacuum level/cycles and on/off
• 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. .

The provided document is a 510(k) summary for the Medela Pump In Style® Advanced breast pump, which is a powered breast pump. This document outlines the device's characteristics, its comparison to a predicate device, and the non-clinical tests performed to demonstrate substantial equivalence. It does not describe an AI/ML powered medical device, nor does it contain a study proving the device meets AI-specific acceptance criteria.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving an AI device meets these criteria in the format specified, as the document does not pertain to an AI device.

Here's an analysis based on the information available, noting the absence of AI/ML specifics:

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

The document does not provide a formal table of general acceptance criteria with numerical performance targets for the entire device. However, it mentions that for "bench performance testing," "The specifications were met for vacuum levels, cycle rate and overflow protection."

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

The document refers to "bench performance testing" conducted with "internal test protocols." It does not specify sample sizes for these tests, nor does it provide information about data provenance (e.g., country of origin or retrospective/prospective nature). Given it's a physical device and bench testing, "data provenance" in the context of patient data is not applicable here.

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 is not applicable as the tests described are non-clinical, bench performance tests of a physical device (a breast pump), not an AI/ML system requiring expert-adjudicated ground truth.

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

This is not applicable for the same reason as point 3.

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 is not applicable as the device is not an AI-powered system designed to assist human readers or clinicians.

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

This is not applicable, as it's a physical breast pump, not an algorithm.

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

For the bench performance tests, the "ground truth" would be the engineering specifications and calibrated measurement equipment. No expert consensus, pathology, or outcomes data were used for these particular non-clinical tests.

8. The sample size for the training set

This is not applicable as there is no mention of a training set, as the device is not an AI/ML model.

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

This is not applicable as there is no mention of a training set.

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