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Ask a specific question about this device

The Wearable Breast Pump (Model W6), is a powered breast pump intended to be used by lactating women to express and collect milk from their breasts. It is intended for a single user.

The Wearable Breast Pump (Model W6) is a powered breast pump intended to be used by lactating women to express and collect milk from their breasts; they are intended for a single user. Wearable Breast Pump (Model W6) is a breast pump powered by lithium battery, utilizing an embedded control program to manage all device functions. The main components of this pump includes: Pump, valve, control board, and milk collector. The user interface allows the user to switch from stimulation, expression, auto, and hot compress modes and control the vacuum levels within those modes.

The Wearable Breast Pump (Model W6) is capable of providing 12 vacuum levels from 40-120 mmHg with cycling rates from 90-143 cycles per minute in stimulation mode, vacuum levels from 105-245 mmHg with cycling rates from 30-105 cycles per minute in expression mode, vacuum levels from 40-150 mmHg with cycling rates from 87-128 cycles per minute in massage mode, and vacuum levels from 40-245 mmHg with cycling rates from 30-143 cycles per minute in auto mode. The Wearable Breast Pump (Model W6) has a hot compress mode with one heating level

This FDA 510(k) clearance letter pertains to a Wearable Breast Pump (Model W6), not an AI/software device that requires acceptance criteria for algorithm performance. The acceptance criteria and study detailed in the provided text are focused on the hardware performance, safety, and functionality of a physical medical device (a breast pump), not the diagnostic or analytical performance of an AI model.

Therefore, many of the requested items related to AI model evaluation (like sample size for test/training sets, data provenance, expert ground truth, MRMC studies, standalone performance, etc.) are not applicable to this document.

However, I can extract the acceptance criteria and the studies performed to prove the device meets these criteria as described in the 510(k) summary, reframing them to fit the provided sections where possible.

Acceptance Criteria and Device Performance for Wearable Breast Pump (Model W6)

Given that this document describes a physical medical device (a breast pump) and not an AI/software for diagnosis or analysis, the acceptance criteria and performance studies are focused on the device's functional safety and efficacy.

1. Table of Acceptance Criteria and Reported Device Performance

• Stimulation: 40-120 mmHg
• Expression: 105-245 mmHg
• Massage: 40-150 mmHg
• Auto: 40-245 mmHg | Demonstrated that the devices meet mode/cycle specifications. Implies successful verification that actual vacuum levels fall within the stated ranges. |
  | Cycle Speed Verification | Devices meet specified cycling rates (±2 cycles/minute) for each mode.
• Stimulation: 90-143 cycles/min
• Expression: 30-105 cycles/min
• Massage: 87-128 cycles/min
• Auto: 30-143 cycles/min | Demonstrated that the devices meet mode/cycle specifications. Implies successful verification that actual cycle speeds fall within the stated ranges. |
  | Backflow Protection | Liquid does not backflow into the tubing. | Testing verified liquid does not backflow into the tubing. Implies successful backflow protection. |
  | Use Life Consistency | Devices maintain specifications throughout their proposed use life. | Testing conducted to demonstrate devices maintain specifications. Implies successful use life performance. |
  | Battery Performance | Battery remains functional during its stated battery use-life. | Testing conducted to demonstrate battery remains functional. Implies successful battery performance. |
  | Battery Status Indicator Functionality | Battery status indicator remains functional during its stated battery life. | Testing conducted to demonstrate indicator remains functional. Implies successful battery status indicator performance. |
  | Hot Compress Temperature | Hot compress function remains functional during stated use-life and provides a heating level ≤ 42 ºC. | Testing conducted to demonstrate hot compress function remains functional. Implies successful temperature control (≤ 42 ºC) and functionality throughout use-life. |

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document does not specify exact sample sizes for each performance test (e.g., number of units tested for vacuum, cycle speed, use-life, etc.). It only states that "testing was conducted."
• Data Provenance: Not specified in terms of country of origin or whether the underlying studies were retrospective or prospective. These are typically laboratory performance tests, not clinical data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

• Not applicable. This relates to evaluation of AI/diagnostic algorithms. For a physical device like a breast pump, "ground truth" is established by direct measurement against engineering specifications and industry standards, not by expert human graders of images or clinical data.

4. Adjudication Method for the Test Set

• Not applicable. This relates to resolving discrepancies in expert labeling for AI/diagnostic algorithms. For device performance testing, adjudication is generally a process of reviewing test results against predefined engineering limits and specifications, not expert consensus on qualitative data.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

• No, not specified and not applicable. An MRMC study is relevant for evaluating the impact of AI assistance on human performance in diagnostic tasks. This document describes the performance of a physical breast pump.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

• Not applicable for the overall device performance in the context of typical AI review. While the breast pump does have "embedded software," the performance described (vacuum, cycle speed, battery, etc.) is the device's standalone performance, not an algorithm's diagnostic or analytical performance. The document states "Software was evaluated at the Basic Documentation level," which refers to standard software validation processes for medical devices, not an "algorithm-only" performance study in the AI sense.

7. The Type of Ground Truth Used

• Engineering Specifications and Standardized Test Methods: The "ground truth" for this device's performance is derived from established international standards (IEC 60601 series, ISO 10993-1) and the device's own design specifications (e.g., specific vacuum ranges, cycle speeds, temperature limits). These are objective, measurable criteria. For example, a vacuum gauge provides the "ground truth" for vacuum level, and a timer/counter for cycle speed.

8. The Sample Size for the Training Set

• Not applicable. This device does not use a "training set" in the context of machine learning. Its internal software is "embedded" and controls device functions based on pre-programmed logic, not learned from data.

9. How the Ground Truth for the Training Set was Established

• Not applicable. (See point 8).

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Wearable Breast Pump is a powered breast pump to be used by lactating women to express and collect milk from their breasts. The device is intended for a single user

Wearable Breast Pump is a powered breast pump to be used by lactating women to express and collect milk from their breasts. The device is intended for a single user

I apologize, but the provided FDA 510(k) clearance letter for the "Wearable Breast Pump" does not contain any information about acceptance criteria or a study that proves the device meets those criteria.

The letter is a standard clearance notification that states the device is substantially equivalent to legally marketed predicate devices. It covers:

• The device name and model numbers.
• The regulation number and name.
• The regulatory class and product code.
• Dates of submission and clearance.
• General controls provisions of the Act that apply to the device.
• Links to FDA guidance documents and regulations (e.g., QS regulation, UDI rule, MDR).
• Contact information for FDA resources.
• The Indications for Use statement for the device.

There is no mention of performance studies, clinical trials, specific acceptance criteria, or data related to the device's functional performance (e.g., milk expression efficiency, comfort, battery life, etc.). The FDA's substantial equivalence determination for this type of device typically relies on demonstrating that the new device has the same intended use and similar technological characteristics to a predicate device, and does not raise different questions of safety and effectiveness. This often involves engineering bench tests and comparisons of specifications rather than detailed clinical performance studies, especially for well-established device types like breast pumps.

Therefore, I cannot fulfill your request for the specific points about acceptance criteria and study details because that information is not present in the provided document.

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The eufy Wearable Breast Pump S1 is a powered breast pump intended to be used by lactating women to express and collect milk from their breasts. It is intended for a single user.

The eufy Wearable Breast Pump E10 is a powered breast pump intended to be used by lactating women to express and collect milk from their breasts. It is intended for a single user.

The eufy Wearable Breast Pump is an electrically powered wearable single breast pump. There are two models, eufy Wearable Breast Pump S1 (T8DO2) and eufy Wearable Breast Pump E10 (T8DO3). S1 consists of a Pump Hub, Diaphragm, Milk Container, Pouring Spout, Heating Pins, Flange, Duckbill Valve and charging pins. E10 consists of Pump Hub, Diaphragm, Milk Container, Pouring Spout, Flange and Duckbill Valve.

The differences between S1 and E10 are as follows:

1. E10 has no heating function (S1 has a heating function);
2. The charging method is different (S1 for magnetic charging, E10 for Type-C charging).

The eufy Wearable Breast Pump is powered by an internal rechargeable lithium-ion polymer battery (3.7V 1460mAh). The eufy Wearable Breast Pump cannot be operated while it is being charged.

The eufy Wearable Breast Pump operates on embedded software, and software updates by end-users are supported. The subject device is intended for use in a home healthcare environment. An optional smartphone app may be used with the Breast Pump. The app may be used to control the operation of The Breast Pump (select mode and vacuum level, start and stop pumping), save pumping session history and display the quantity (in ml) of milk in the bottle on the user's smartphone. Use of the app is not mandatory to operate the Breast Pump.

The eufy Wearable Breast Pump is a closed-system breast pump with an anti-backflow diaphragm which physically separates the air-pumping system from the milk-flow system.

The eufy Wearable Breast Pump allows the user to power the breast pump on and off, and to operate the breast pump in two modes (stimulation, expression) and to control the vacuum settings within these modes. Each mode consists of 7 vacuum levels, capable of providing suction from -75 to -292.5mmHg, with cycle speeds ranging from 71 to 110 cycles/minute in stimulation mode and 39 to 60 cycles/minute in expression mode.

The provided FDA 510(k) clearance letter and summary for the eufy Wearable Breast Pumps (S1 and E10) do not contain information about a clinical study involving human subjects or AI components that would require acceptance criteria related to accuracy, sensitivity, or specificity.

The document describes non-clinical performance testing for the device, which primarily focuses on:

• Electrical Safety, Electromagnetic Compatibility: Compliance with standards like ANSI AAMI ES60601-1, IEC 60601-1-2, HA60601-1-11, and IEC 62133-2.
• Performance testing: Verification of vacuum suction pressure & cycle speed, backflow protection, battery capacity, operating time/charging time, and use life testing. "Device specifications were met for all tests conducted." This statement indicates internal acceptance criteria were met, but the specific numerical criteria are not detailed in this summary.
• Packaging simulation testing: Compliance with ISTA 3A: 2018.
• Biocompatibility: Compliance with ISO 10993-1, 10993-5, 10993-10, and 10993-23. "The user-contacting materials were shown to be non-cytotoxic, non-irritating, and non-sensitizing." These are the acceptance criteria.
• Software: Evaluation based on FDA guidance documents for device software functions.
• Cybersecurity: Evaluation based on FDA guidance for cybersecurity in medical devices.

Therefore, I cannot provide a table of acceptance criteria and reported device performance in the way you've requested (e.g., accuracy, sensitivity, specificity), nor can I answer questions about sample size for a test set, data provenance, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment for clinical data, as this information is not present in the provided text.

The provided document indicates that the device has "embedded software" and an "optional smartphone app," but there's no mention of these software components being AI-driven in a way that would necessitate performance metrics like those typically seen for AI/ML devices (e.g., for diagnosis, prediction, or image analysis). The app primarily controls the pump and displays basic information like milk quantity.

Based on the provided text, the device is a powered breast pump, and its clearance is based on demonstrating substantial equivalence to a predicate device through non-clinical performance and safety testing.

To summarize what can be inferred from the provided text regarding acceptance and testing:

Acceptance Criteria and Study for eufy Wearable Breast Pump

The acceptance criteria and study detailed in the provided 510(k) summary are focused on the safety and performance of the electromechanical device as a powered breast pump, rather than on diagnostic or AI-powered functions requiring clinical accuracy metrics.

1. Table of Acceptance Criteria and Reported Device Performance

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

• The document describes non-clinical performance testing on the device itself (e.g., how many units were tested for vacuum, battery life, etc.). The sample sizes for these engineering or lab tests (e.g., number of breast pumps tested) and their provenance (e.g., manufactured in China, tested in specific lab environments) are not detailed in this 510(k) summary. There is no mention of a clinical test set involving human subjects for performance evaluation.

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

• Not applicable. This information pertains to studies where expert interpretation (e.g., for medical images) forms the ground truth. The acceptance criteria here relate to physical device performance and safety standards, which are evaluated by engineers and lab technicians against predefined specifications.

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

• Not applicable. Adjudication methods are typically used in clinical studies involving multiple human readers or interpretations.

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. An MRMC study was not conducted as this device is a breast pump, not an AI-driven diagnostic or interpretative tool for which human readers would interact.

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

• Not applicable. This applies to AI/ML algorithms, not the core function of a breast pump.

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

• For the performance testing, the "ground truth" or reference was engineering specifications and recognized international consensus standards (e.g., specified vacuum ranges, cycle speeds, battery capacities, biocompatibility definitions by ISO standards).

8. The sample size for the training set:

• Not applicable. This device is not described as involving machine learning from a training set for its core function. The embedded software and app are for control and display, not for learning or prediction based on large datasets.

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

• Not applicable. (See point 8).

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The Wearable Breast Pump (Model FS12A); Wearable Breast Pump (Model FS12B) are powered breast pumps intended to be used by lactating women to express and collect milk from their breasts. They are intended for a single user only.

The Wearable Breast Pump (Model FS12A); Wearable Breast Pump (Model FS12B) are powered breast pumps intended to be used by lactating women to express and collect milk from their breasts; they are intended for a single user. Both Wearable Breast Pump (Model FS12A) and Wearable Breast Pump (Model FS12B) are breast pumps powered by lithium battery, utilizing an embedded control program to manage all device functions. The main components of these pumps include: Pump, valve, control board, and milk collector. The user interface allows the user to switch from stimulation, expression, and auto modes and control the vacuum levels within those modes. All available modes consist of 12 vacuum levels. The Wearable Breast Pump (Model FS12A); Wearable Breast Pump (Model FS12B) are capable of providing vacuum levels from 40-160 mmHg with cycling rates from 75-133 cycles per minute in stimulation mode, vacuum levels from 120-245 mmHg with cycling rates from 21-98 cycles per minute in expression mode, and vacuum levels from 40-245 mmHg with cycling rates from 21-150 cycles per minute in auto mode. The Wearable Breast Pump (Model FS12A); Wearable Breast Pump (Model FS12B) is charged with a 5 V DC adaptor and powered by an internal rechargeable lithium-ion polymer battery. The motor unit operates on embedded software. Software updates by end-users are not supported. The subject devices are for repeated use by a single user in a home environment. The devices are provided non-sterile. The motor unit operates on a rechargeable battery and does not function when charging. The rechargeable battery can be charged from the external USB adapter if the motor unit is not in operation. The breast pump expresses milk by creating a seal around the nipple using the flange 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, a backflow protection membrane physically separates the milk-contacting pathway from the vacuum system. All other components (i.e., motor unit/housing) of the subject devices are not in contact with the breast. All milk contacting components are compliant with 21 CFR 174-179.

I am sorry, but the provided text is a 510(k) Clearance Letter for a wearable breast pump. It describes the device, its intended use, comparison to a predicate device, and summaries of non-clinical performance testing (biocompatibility, electrical safety, EMC, software, and general performance testing like vacuum level verification, backflow protection, use life, and battery performance).

However, this document does not contain any information about acceptance criteria or a study design that would prove a device meets acceptance criteria specific to an AI/ML powered device, especially concerning diagnostic performance metrics like sensitivity, specificity, or reader studies. The device described is a physical breast pump, not an AI/ML software device.

Therefore, I cannot extract the information required by your prompts, such as:

1. A table of acceptance criteria and the reported device performance (for an AI/ML model)
2. Sample size used for the test set and the data provenance (for an AI/ML model)
3. Number of experts used to establish the ground truth (for an AI/ML model)
4. Adjudication method (for an AI/ML model)
5. MRMC comparative effectiveness study results (for an AI/ML model)
6. Standalone performance (for an AI/ML model)
7. Type of ground truth used (for an AI/ML model)
8. Sample size for the training set (for an AI/ML model)
9. How the ground truth for the training set was established (for an AI/ML model)

The document focuses on the mechanical, electrical, and material safety and performance of a physical pump. If you have a different document related to an AI/ML powered medical device, I would be happy to analyze it for the requested information.

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The Thrive 2-in-1 Breast Pump, Model P3 is a powered breast pump intended to be used by lactating women to express and collect milk from their breasts. It is intended for a single user.

Thrive 2-in-1 Breast Pump (Model P3) is a wearable powered breast pump intended to be used by lactating women to express and collect milk from the breast. It is an electrically powered, software-controlled, digital pump. It is powered by a lithium ion battery (3.7 V, 2000 mAh) and utilizes an embedded control program to manage all product functions. The device is designed not to be used during charging.

The main components of this pump include pump, valve, flange and flange body, silicone diaphragm, USB charging cable, tubing with y-connector, bra extension strap and collection cups. The pump is provided non-sterile and reusable by a single user.

There are two (2) operating modes available for the device - Expression mode and Massage mode, with two frequency options – "High" and "Low" within each operating mode. The subject device includes nine (9) suction levels within each mode of operation. The Expression mode has a suction pressure range of 60 -245 mmHg and cycle frequency in the range 17-50 (High)/15-36 (Low) cycles per minute while Massage mode has a suction pressure range of 60-130 mmHg and cycle frequency range of 38-52 (High)/28-36 (Low) cycles per minute. The subject device has an LED status display, which displays working mode and battery indicator. The user interface includes power on/off/pause switch, mode/frequency switch, vacuum level adjustment buttons (up and down). The subject device is intended only for double pumping, with one collection cup intended for each breast.

The breast pump does not incorporate any off-the-shelf (OTS) software. All milk contacting components of the device are compliant with 21 CFR 177.

The provided FDA 510(k) Clearance Letter for the Thrive 2-in-1 Breast Pump (Model P3) primarily details the regulatory pathway for a medical device and its equivalence to a predicate device. While it lists various performance tests conducted (biocompatibility, electrical safety, EMC, software V&V, and performance/use life verification), it does not provide specific acceptance criteria or the study details proving the device meets those specific acceptance criteria for its core function (expressing and collecting milk with specified pressure/frequency ranges).

The document states that "Vacuum level and cycle frequency verification testing at each mode/level demonstrated that the device meets the mode/level specifications." However, it does not present the actual data or the thresholds for "meeting specifications."

Therefore, based solely on the provided text, much of the requested information regarding detailed acceptance criteria and the specifics of the study proving these are met cannot be fully extracted or inferred. The response below will highlight what is available and explicitly state what is not.

Acceptance Criteria and Device Performance Study Details

The provided 510(k) summary for the Thrive 2-in-1 Breast Pump (Model P3) focuses on establishing substantial equivalence to a predicate device (Lucy Breast Pump, K213311) through various engineering and safety tests. While performance tests are mentioned, the document does not explicitly list quantitative acceptance criteria for many aspects of its primary function (milk expression efficiency or user effectiveness) beyond general statements about meeting specifications.

1. Table of Acceptance Criteria and Reported Device Performance

Given the provided text, specific quantitative acceptance criteria are not detailed for the performance of milk expression, nor are the precise resultant performance values reported in a comparative table format. The closest information is about the device's specifications for vacuum and cycle frequency.

2. Sample Size for the Test Set and Data Provenance

The document does not specify sample sizes for any of the performance tests (e.g., how many units were tested for vacuum/cycle frequency verification, how many cycles for use life, how many battery charge/discharge cycles).

The data provenance is implied to be from Shenzhen TPH Technology Co., Ltd. in China, as they are the submitter and manufacturer, conducting the tests internally or through contracted labs. The document does not specify if the data is retrospective or prospective for any of the performance studies. These are engineering performance tests, not clinical studies with patients.

3. Number of Experts and Qualifications for Ground Truth

This information is not applicable or not provided for this device's type of testing. The tests described are engineering performance tests and safety/EMC compliance, not diagnostic AI performance studies involving expert interpretation of medical images or data from human subjects. Ground truth would be established by calibrated measurement equipment for physical parameters (vacuum, frequency) or standard laboratory assays for biocompatibility.

4. Adjudication Method for the Test Set

Not applicable or not provided. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies where multiple human readers interpret data to establish a ground truth. The tests described are objective engineering measurements.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was mentioned or implied. This type of study is relevant for diagnostic AI devices where human performance with and without AI assistance is evaluated. The Thrive 2-in-1 Breast Pump is a mechanical device for milk expression, not a diagnostic tool.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)

Not applicable. The device is a "powered breast pump," a physical mechanism, not an AI algorithm. Its "software" controls the pump's mechanical functions (modes, vacuum levels, timing), not interpretable data for diagnosis.

7. Type of Ground Truth Used

For the performance tests mentioned, the "ground truth" would be established by:

• Calibrated Measurement Equipment: For vacuum level and cycle frequency, the ground truth is derived from readings by precision instruments.
• Standardized Laboratory Procedures: For biocompatibility, the ground truth is established by the results of validated assays (cytotoxicity, sensitization, irritation) according to ISO standards.
• Defined Specifications/Standards: For electrical safety, EMC, and software V&V, the ground truth is compliance with the requirements of the cited international and FDA standards/guidances.

8. Sample Size for the Training Set

Not applicable. This device is a mechanical/electrical product, not an AI/machine learning model that requires a training set of data. Its "embedded control program" is likely rule-based or firmware-driven, not a learned algorithm.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set for an AI/ML model, there is no ground truth to establish for such a set. The "control program" functions are based on engineering design and specifications.

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The Youha electric breast pumps (The INs, The INs Gen2, The INs NEXT, and P3) and BEBEBAO electric breast pump (P1s) are powered breast pumps intended to be used by lactating women to express and collect milk from their breasts. They are intended for a single user.

The subject devices are wearable-style breast pumps designed for lactating women to express and collect milk from the breast. They are electrically powered, software controlled, digital pumps for a single user. The subject devices include The INs, The INs Gen 2, The INs NEXT, P1s, and P3 models, which are capable of expression, massage, and mixed modes with ten associated suction levels for each. All five models have a single pumping configuration and can be operated in 'normal' or 'quiet' modes.
Massage, expression, and mixed pumping modes consist of 10 vacuum levels. Each Youha and BEBEBAO electric breast pump model is capable of providing vacuum levels from 40-190 mmHg with cycling rates from 90-110 cycles per minute in massage mode, vacuum levels from 80-280 mmHg with cycling rates from 40-75 cycles per minute in expression mode, and vacuum levels from 80-280 mmHg with cycling rates from 6-46 cycles per minute in mixed mode. The Youha electric breast pump is charged with a 5 V DC adaptor and powered by an internal rechargeable lithium-ion polymer battery. The motor unit operates on embedded software. Software updates by end-users are not supported. The subject devices do not have wireless capability or other external functionality (i.e., no Bluetooth or mobile application). The subject device is for repeated use by a single user in a home environment. The device is provided not sterile.
The motor unit operates on a rechargeable battery and can function when charging.
The breast pump expresses milk by creating a seal around the nipple using the breast shield 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, a backflow protection membrane physically separates the milk-contacting pathway from the vacuum system.
All other components (i.e., motor unit/housing) of the subject device are not in contact with the breast. All milk contacting components are compliant with 21 CFR 174-179.

The provided FDA 510(k) summary for the Youha electric breast pumps (K242725) outlines the device's technical specifications and the non-clinical performance testing conducted to demonstrate substantial equivalence to a predicate device. However, this document does not detail acceptance criteria and a study proving that the device meets those acceptance criteria in the context of an AI/ML medical device, as it is a powered breast pump, not an AI/ML system.

The prompt's request for detailed information such as "sample size used for the test set," "number of experts used to establish ground truth," "MRMC comparative effectiveness study," and "standalone (algorithm only) performance" are typical requirements for the validation of AI/ML-driven medical devices, particularly those involving image analysis or diagnostic support.

Since the Youha electric breast pump is a physical device with a software component that controls its operation (massage, expression, mixed modes, vacuum levels, cycle speeds), and not an AI/ML diagnostic or therapeutic device, the requested information (acceptance criteria for AI performance, clinical study results comparing AI-assisted vs. non-AI scenarios, etc.) is not applicable to this type of submission.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria (as defined for an AI/ML device) using the provided document. The document focuses on performance testing relevant to a mechanical/electronic medical device, such as biocompatibility, electrical safety, electromagnetic compatibility, software validation (at a basic documentation level, not AI performance), vacuum level verification, backflow protection, use life, and battery performance.

To answer your specific questions based on the provided document and its scope:

1. A table of acceptance criteria and the reported device performance:
   The document describes various performance tests and implies their acceptance criteria are met (e.g., "Vacuum level verification testing at each mode/cycle demonstrated that the devices meet mode/cycle specifications."). However, it does not present these in a formal table of acceptance criteria vs. specific reported values in the way one would for an AI/ML device's diagnostic performance (e.g., sensitivity, specificity, AUC).

   • Examples of Implicit Acceptance Criteria and Performance (derived from "Performance Testing" section):

     Acceptance Criteria (Implied)	Reported Device Performance
     Device meets mode/cycle specifications for vacuum levels.	"Vacuum level verification testing at each mode/cycle demonstrated that the devices meet mode/cycle specifications."
     No liquid backflow into tubing.	"Backflow protection testing was conducted to verify liquid does not backflow into the tubing."
     Device maintains specifications throughout proposed use life.	"Use life testing was conducted to demonstrate that the device maintains its specifications throughout its proposed use life."
     Battery remains functional during stated battery use-life.	"Battery performance testing was conducted to demonstrate that the battery remains functional during its stated battery use-life."
     Battery status indicator remains functional during stated battery life.	"Battery status indicator testing was conducted to demonstrate that the battery status indicator remains functional during its stated battery life."

2. Sample sized used for the test set and the data provenance: Not applicable in the context of AI/ML test sets. The testing here refers to physical device units rather than data samples for an algorithm. The document does not specify the number of physical units tested for each non-clinical test.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for AI/ML (e.g., for disease detection or image interpretation) is not established for a breast pump's functional performance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This refers to consensus methods for establishing ground truth in AI/ML studies.

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 specific to AI/ML devices that assist human interpretation.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. The device's software controls its mechanical function; it's not a standalone diagnostic algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the AI/ML sense. The "ground truth" for this device's performance would be engineering specifications and validated physical measurements (e.g., actual vacuum levels vs. specified, absence of backflow).

8. The sample size for the training set: Not applicable. The "software" mentioned refers to embedded code controlling the hardware, not a machine learning model that requires a training set.

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

In summary, the provided document details a 510(k) submission for an electric breast pump, which is a traditional medical device regulated under 21 CFR 884.5160 as a Class II powered breast pump. The testing described (biocompatibility, electrical safety, EMC, software validation at a basic level, and performance tests for vacuum, backflow, life, and battery) is appropriate for this type of device. The questions posed in the prompt are tailored for AI/ML device submissions, which are not relevant to this specific FDA clearance document.

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The Motif Aura Glow breast pump (Model Motif Aura Glow) is a powered breast pump intended to be used by lactating women to express and collect milk from their breasts. It is intended for a single user.

The Motif Aura Glow breast pump (Model Motif Aura Glow) is a powered breast pump intended to be used by lactating women to express and collect milk from their breasts, it is intended for a single user. The Motif Aura Glow breast pump (Model Motif Aura Glow) is powered by a lithium battery, utilizing an embedded control program to manage all device functions. The main components of this pump include: Pump, valve, control board, and milk collector. The user interface allows the user to switch from massage, expression, cluster feeding, and general pumping modes and control the vacuum levels within those modes.

Massage, expression, and general pumping modes consist of 9 vacuum levels. Cluster feeding mode consists of 5 vacuum levels. The Motif Aura Glow breast pump (Model Motif Aura Glow) is capable of providing vacuum levels from 40-160 mmHg with cycling rates from 75-120 cycles per minute in massage mode, vacuum levels from 120-245 mmHg with cycling rates from 30-85 cycles per minute in expression mode, vacuum levels from 40-200 mmHg with cycling rates from 45-120 cycles per minute in cluster feeding mode, and vacuum levels from 60-245 mmHg with cycling rates from 30-120 cycles per minute in general pumping mode. The Motif Aura Glow breast pump (Model Motif Aura Glow) is charged with a 5 V DC adaptor and powered by an internal rechargeable lithium-ion polymer battery. The motor unit operates on embedded software. Software updates by end-users are not supported. The subject device is for repeated use by a single user in a home environment. The device is provided not sterile.

The motor unit operates on a rechargeable battery and does not function when charging. The rechargeable battery can be charged from the external USB adapter if the motor unit is not in operation.

The breast pump expresses milk by creating a seal around the nipple using the flange 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, a backflow protection membrane physically separates the milk-contacting pathway from the vacuum system.

All other components (i.e., motor unit/housing) of the subject device are not in contact with the breast. All milk contacting components are compliant with 21 CFR 174-179.

Based on the provided FDA Clearance Letter for the Motif Aura Glow breast pump (Model Motif Aura Glow), here's an analysis of the acceptance criteria and the study that proves the device meets them:

Important Note: This document is an FDA Clearance Letter, which is a summary of the FDA's decision regarding substantial equivalence. It does not contain detailed study reports or raw data typically found in clinical trial results or full submission documents. Therefore, some of the requested information (especially quantitative effectiveness data for AI-assisted human reading, if this were an AI device) is not present here, as this is a breast pump, not an AI diagnostic device. I will address each point based on the information available and indicate where information is not applicable (N/A) or not provided in this specific document.

Device: Motif Aura Glow breast pump (Model Motif Aura Glow)

Device Type: Powered Breast Pump (Medical Device, not an AI/Software as a Medical Device for diagnostic purposes)
Product Code: HGX
Regulatory Class: Class II

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a breast pump and not a diagnostic AI device, the "acceptance criteria" revolve around functional performance, safety, and equivalence to a predicate device, rather than diagnostic metrics like sensitivity/specificity.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: The document does not specify the sample sizes for the individual performance, safety, or biocompatibility tests. It only states that "Testing was conducted" and "Performance testing was conducted." For a physical device like a breast pump, "test set" typically refers to the number of units tested. This information is not detailed in the summary letter.
• Data Provenance: The manufacturer is "Shenzhen TPH Technology Co., Ltd." in Shenzhen, Guangdong, China. The testing was conducted as part of their 510(k) submission to the US FDA. The document does not specify whether the tests themselves were conducted in China or elsewhere, nor whether they were retrospective or prospective studies (this concept mostly applies to clinical data collection, which is not detailed here for this device type).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Not Applicable (N/A): For a breast pump, there isn't a concept of "ground truth" established by experts in the same way as for a diagnostic AI device (e.g., radiologists interpreting images). The acceptance criteria are based on engineering specifications, safety standards, and functional performance. The "ground truth" is typically defined by the device's design specifications and industry standards, verified through objective measurements and validated test methods.

4. Adjudication Method for the Test Set

• N/A: As "ground truth" from human experts is not established for this device type, there is no adjudication method among experts. Performance is measured against predefined objective standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No: An MRMC comparative effectiveness study is typically conducted for diagnostic devices (especially AI-powered ones) to assess the impact of the device on human reader performance. This is a physical breast pump, not a diagnostic device, so such a study is not applicable.

6. If a Standalone Performance Study (Algorithm Only) was done

• Yes, in essence. The performance testing (e.g., vacuum level verification, cycle speed, backflow protection, battery life) are "standalone" tests of the device's inherent functional capabilities against its specifications. The software evaluation was also a standalone assessment of the embedded control program. There isn't an "algorithm-only" performance in the sense of an AI model's output being compared to ground truth, but the physical and software functionalities were tested independently of human interaction for their core performance.

7. The Type of Ground Truth Used

• Objective Engineering Specifications and International/National Standards: The "ground truth" for this device's performance acceptance is based on its own design specifications (e.g., stated vacuum ranges and cycle speeds), and adherence to recognized electrical safety (e.g., IEC 60601 series), EMC, and biocompatibility (e.g., ISO 10993-1) standards. For instance, a stated vacuum level of -160 mmHg is verified by direct measurement using calibrated equipment; the "ground truth" is the measurement itself, compared to the specification.

8. The Sample Size for the Training Set

• N/A: This is a physical breast pump with embedded control software, not a machine learning/AI model that requires a "training set" of data in the common sense (e.g., for image classification or prediction). The software is a "fixed function" embedded control program.

9. How the Ground Truth for the Training Set was Established

• N/A: As there is no "training set" in the context of machine learning, this question does not apply. The "ground truth" for the device's design and functionality is derived from engineering principles and regulatory requirements for powered breast pumps.

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The Wearable Breast Pump (Model S21) is a powered breast pump intended to be used by lactating women to express and collect milk from their breasts, it is intended for a single user.

The Wearable Breast Pump (Model S21) is a powered breast pump intended to be used by lactating women to express and collect milk from their breasts, it is intended for a single user. The Wearable Breast Pump (Model S21) is a breast pump powered by lithium battery, utilizing an embedded control program to manage all device functions. The main components of this pump include: Pump, valve, control board, and milk collector. The user interface allows the user to switch from stimulation, expression, and auto modes and control the vacuum levels within those modes.

All available modes consist of 12 vacuum levels. The Wearable Breast Pump (Model S21) is capable of providing vacuum levels from 40-120 mmHg with cycling rates from 62-104 cycles per minute in stimulation mode, vacuum levels from 120-245 mmHg with cycling rates from 22-86 cycles per minute in expression mode, and vacuum levels from 40-120 mmHg with cycling rates from 22-104 cycles per minute in auto mode.

The Wearable Breast Pump (Model S21) is charged with a 5 V DC adaptor and powered by an internal rechargeable lithium-ion polymer battery. The motor unit operates on embedded software. Software updates by end-users are not supported. The subject device is for repeated use by a single user in a home environment. The device is provided not sterile.

The motor unit operates on a rechargeable battery and does not function when charging. The rechargeable battery can be charged from the external USB adapter if the motor unit is not in operation.

The breast pump expresses milk by creating a seal around the nipple using the flange 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, a backflow protection membrane physically separates the milk-contacting pathway from the vacuum system.

All other components (i.e., motor unit/housing) of the subject device are not in contact with the breast. All milk contacting components are compliant with 21 CFR 174-179.

It appears there has been a misunderstanding in the request. The provided FDA 510(k) clearance letter for the "Wearable Breast Pump (Model S21)" does NOT contain information about an AI/Algorithm-driven device or an associated study that proves the device meets acceptance criteria related to AI performance.

The document outlines the regulatory clearance process for a physical medical device (a breast pump) and focuses on its electrical safety, biocompatibility, electromagnetic compatibility, and mechanical performance verification. It does not involve any artificial intelligence, machine learning, or software functions that would require a ground truth, expert adjudication, or MRMC studies for accuracy.

Therefore, I cannot provide the requested information regarding acceptance criteria for an AI/Algorithm, data provenance, expert qualifications, or MRMC studies, as these concepts are not applicable to the content of the provided document.

If you have a different document related to an AI/Algorithm-driven medical device, please provide it, and I will be happy to extract the relevant information.

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