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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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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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