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The Freemie® Independence and Freemie® Liberty are powered breast pumps to be used by lactating women to express and collect milk from their breast. The Freemie® Independence and Freemie® Liberty pumps are intended for use by a single user.

The Freemie® Independence and Freemie® Liberty powered breast pumps utilizes the supplied previously cleared device (K130349) Freemie® Breast Pump Collection System to express and collect milk from the breast of a lactating woman. Pumping can be performed on one breast (single pumping) or both breasts (double pumping) at the same time. The system is designed for mobile pumping (home, office, etc.) as the device is light weight, compact in size and can be attached to the user's clothing with a clip. Ten (10) suction levels, eleven (11) cycle speeds and three (3) memory settings (suction and cycle levels) are user adjustable via tactile switches (referred to as buttons). The pumps are powered by a rechargeable lithium-ion polymer battery which can be charged with a USB to micro USB provided cable (laptop, car, etc.) and alternatively with a supplied wall charge adapter with a USB port for charging the battery with mains power. The sole function of the Micro USB port on the pump is for charging the pump. The power to the pump is always supplied by the battery, even when charging. Firmware controls a low voltage DC swash plate vacuum pump and solenoid that is capable of providing vacuum levels from -10 to -280 mmHq with cycle speeds from 18 to 150 cycles per minute. A physical barrier on the collection side prevents backflow of milk into the pump. The Freemie® Independence Pump has a series of LED lights to indicate the pump's current use settings to the user and has a pre-programmed auto shut-off timer that turns the pump off after 40 minutes. The Freemie® Liberty Breast Pump has an LCD screen to indicate the pump's current use settings to the user and has an auto shut-off timer that is user adjustable in five minute increments from 5 to 40 minutes.

The provided text describes the 510(k) summary for the Freemie® Independence and Freemie® Liberty Breast Pump. This document is for a medical device that aims to demonstrate substantial equivalence to a predicate device, not for an AI/ML powered device. As such, many of the typical acceptance criteria and study details for AI/ML devices (like sample size for test/training sets, data provenance, number of experts for ground truth, MRMC studies, or standalone performance metrics like AUC, sensitivity, specificity) are not applicable or not provided in this document.

However, I can extract the acceptance criteria related to the device's technical specifications and the non-clinical tests performed to demonstrate its performance and safety, which serve as the "study" proving it meets these criteria.

Here's the information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly derived from the comparison to the predicate device and compliance with voluntary standards. The device performance is detailed through its specifications and test results ensuring compliance with these standards and similar functionality to the predicate.

The "study" that proves the device meets these acceptance criteria is the Summary of Non-Clinical Tests section of the 510(k) submission (starting on page 5/6). This section explicitly lists the various tests and standards to which the device was subjected and found compliant.

Regarding AI/ML specific information, this document does not contain the following as it's not an AI/ML device submission:

2. Sample size used for the test set and the data provenance: Not applicable. Performance is validated through engineering tests and adherence to standards, not through a "test set" of data in the AI/ML sense. Data provenance is therefore not relevant.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/ML device usually refers to expert labels on data. For this breast pump, 'ground truth' is objective measurements against engineering specifications and safety standards.

4. Adjudication method (e.g. 2+1, 3+1, none) 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 device is a mechanical/electronic pump, not an AI diagnostic/interpretative tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. The device's performance is inherently "standalone" in its mechanical function, but this term typically applies to AI algorithms.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" here is adherence to established engineering specifications, safety standards (e.g., IEC 60601-1), and functional equivalence demonstrated through direct comparison measurements against the predicate device.

8. The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established: Not applicable.

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The Freemie breast pump collection system is intended to be used in conjunction with an approved powered breast pump for the purpose of expressing human milk.

The device is to be used by connection to an approved breast pump, and will be used in place of the pump's original breast milk collection equipment. The device has a funnel-shaped breast funnel, internal valve assembly and enclosing reservoir shaped like a bowl. Additional accessories, associated with the device to replicate the functional and performance characteristics necessary for use with some pump brands, will be sold separately but in conjunction with the sale of the Freemie when those specific brands are identified by the user. The Freemie device is designed to be supported within a woman's ordinary or nursing brassiere, and held in place there while the lactating woman is pumping. When the pump extracts milk, the milk flows out through the end of the funnel and enclosing valve system, where it gathers and is collected in the cup. When the lactating woman is done pumping, she turns off the pump, removes the Freemie from her brassiere and transfers the milk to a storage container for later use.
The Freemie device is available with two cup variations. The first (identified as "Round" or "Standard") is similar in shape to the predicate Freemie (K111411). The second (referred to as "Shaped" or "Natural" or "Formed") is a shaped cup that is intended to approximate a shape that, for aesthetic purposes, more resembles the natural shape of a breast supported by an ordinary brassiere. Both variants are made from the same materials, function identically and use the same valve and funnel assembly and will be chosen by the user based on individual preference. The interfaces where the cup and cone variants attach to each other are identical.
The Freemie will also be available in 3 funnel variants, a 25mm (similar to the predicate Freemie), identified by DAO Health as FG008 (Standard) and FG011 (Form Shape), and larger 28mm (FG009 for the Standard and FG012 for the Form Shape) and 32mm (FG010 for Standard and FG013 for the Form Shape) funnels. All funnel sizes are made from the same material, fit with either of the cup variants and use the same universal valve assembly.

The Freemie® Breast Pump Collection System, as described in the provided 510(k) summary, demonstrates its acceptance through various performance tests, primarily focusing on demonstrating equivalence to predicate devices and ensuring safety and effectiveness.

Here's an breakdown outlining the acceptance criteria and the study that proves the device meets them:

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

Since the provided text does not explicitly detail a "table of acceptance criteria" with numerical targets and direct comparisons, I will synthesize the information to create a table based on the various performance testing categories mentioned and the general conclusion of equivalence.

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

The document states that "Performance testing was conducted to demonstrate Safety and Effectiveness and for comparison to the predicate device."
The specific sample sizes for tests such as Breast Funnel Design, Compatible Pumps, Vacuum Performance, Capacity, Freedom from Leakage, and Ability to be Supported are not explicitly mentioned in the provided summary.
The data provenance is not stated, but the testing would typically be conducted by the manufacturer or contracted labs within the country of origin (USA, based on the submitter's address). The nature of the performance tests (bench testing) suggests that this was likely prospective testing designed specifically for this submission, rather than retrospective analysis of existing data.

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)

The provided information does not specify the number of experts or their qualifications used to establish ground truth. The tests described are primarily engineering/bench performance tests rather than clinical evaluations requiring expert interpretation. For biocompatibility, certified labs and toxicologists would establish "ground truth" through adherence to established standards (e.g., ISO 10993).

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

Given that the tests described are bench performance and biocompatibility evaluations, an "adjudication method" in the sense of clinical human-reader consensus (e.g., 2+1 for image interpretation) is not applicable or described. The results of bench tests are typically objective measurements against predefined specifications or comparison points.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of data, often with AI assistance. The Freemie Breast Pump Collection System is a mechanical device for milk expression, not a diagnostic tool, and involves no AI component or human readers in the context of an MRMC study.

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

Not applicable. The Freemie Breast Pump Collection System is a physical medical device, not a software algorithm. Therefore, "standalone algorithm performance" is not relevant to this submission.

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

For the performance tests mentioned (Breast Funnel Design, Compatible Pumps, Vacuum Performance, Capacity, Freedom from Leakage, Ability to be Supported), the 'ground truth' was based on:

• Predicate device performance: direct comparison to the established characteristics of the legally marketed predicate device (Freemie Breast Pump Collection System K111411 and Medela® Pump in Style Advanced® Breastpump K031614).
• Established engineering specifications/standards: adherence to functional and safety requirements for breast pumps, even if no formal performance standards are promulgated (as stated, "Performance standards have not been promulgated for powered breast pumps," but general engineering principles and safety considerations would apply).
• Biocompatibility standards: meeting established international standards for biological evaluation of medical devices (e.g., ISO 10993 series).

8. The sample size for the training set

Not applicable. This device is hardware and does not utilize a training set in the context of machine learning or AI models.

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

Not applicable for the same reason as point 8.

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The Freemie milk collection system is intended to be used in conjunction with an approved electric breast pump for the purpose of expressing human milk.

The device is to be used by connection to an approved breast pump, and will be used in place of the pump's original breast milk collection equipment. The device has a funnel-shaped breast adapter, internal valve assembly and enclosing reservoir shaped like a bowl. Variations of the device incorporate minor differences to replicate the functional and performance characteristics necessary for use with additional pump brands. Additionally, smaller and larger breast adapter and milk collection sizes will be available, as is the practice with predicate devices. The Freemie device is designed to be supported within a woman's ordinary or nursing brassiere, and held in place there while the lactating woman is pumping. When the pump extracts milk, the milk flows out through the end of the funnel and enclosing valve system, where it gathers and is collected in the cup. When the lactating woman is done pumping, she turns off the pump, removes the Freemie from her brassiere and transfers the milk to a storage container for later use.

The provided document describes the Freemie® Breast Pump Collection System and its 510(k) submission (K111411) for market clearance. The study aimed to demonstrate substantial equivalence to predicate devices.

1. Acceptance Criteria and Reported Device Performance

The submission does not explicitly state numerical acceptance criteria in the format of sensitivity, specificity, AUC, or similar AI-specific metrics, as it predates the widespread use of AI in medical devices and focuses on mechanical performance and safety. Instead, the acceptance criteria are based on demonstrating equivalence in key functional and safety attributes to predicate devices. The study proves the device meets these criteria through comparative performance testing and biocompatibility assessments.

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

The document does not specify a "test set" in the context of an AI/ML algorithm with data provenance like country of origin or retrospective/prospective data. The performance testing described (Breast Adapter Design, Compatible Pumps, Vacuum Performance, and Capacity) appears to be bench testing (laboratory-based evaluations) rather than clinical studies with human subjects. Therefore, the "sample size" would likely refer to the number of units or configurations tested in the lab, which is not detailed in this summary.

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

Not applicable. This device is a mechanical breast milk collection system, and its evaluation does not involve establishing ground truth from expert interpretation of medical images or clinical outcomes in the way an AI diagnostic tool would. The "ground truth" for its performance is determined by physical measurements and functional testing against engineering specifications and predicate device performance.

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

Not applicable for the same reasons 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

Not applicable. This is not an AI-assisted diagnostic device, so MRMC studies and the concept of human reader improvement with AI assistance are irrelevant to this submission.

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

Not applicable. This is not an algorithm.

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

The "ground truth" for this device's performance would be the direct measurements from the bench testing (e.g., vacuum pressure readings, milk volume collected, compatibility with various pump models) and adherence to material safety standards (biocompatibility testing results). It is based on engineering specifications and direct experimental measurements rather than clinical or pathological ground truth.

8. The sample size for the training set

Not applicable. This device does not involve an AI/ML algorithm that requires a training set.

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

Not applicable. This device does not involve an AI/ML algorithm.

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