Search Results

The Wearable Breast Pump (Model S33) 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 S33) is a wearable powered breast pump designed for lactating woman to express and collect milk from the breast.

It is an electrically powered, software-controlled, digital pump. It is powered by a rechargeable lithium ion battery (3.7 V, 1000mAh) that can be charged using the USB cable provided with the device. The device is designed not to be used during charging. The device utilizes an embedded control program to manage all product functions and does not incorporate any off-the-shelf (OTS) software. The main components of this pump include pump motor, valve, flange, silicone diaphragm, USB charging cable, bra extension strap and milk collector. The pump is provided non-sterile and reusable by a single user in home environment.

There are four (4) operating modes available for the device – Stimulation mode, Expression mode, Massage mode, and Auto mode. The device includes nine (9) suction levels within each mode. Wearable Breast Pump (Model S33) is capable of providing vacuum levels from 40-160 mmHg with cycling rates from 91 -121 cycles per minute in Stimulation mode, vacuum levels from 120-245 mmHg with cycling rates from 27-88 cycles per minute in Expression mode, vacuum levels from 40-120 mmHg with cycling rates from 92-130 cycles per minute in Massage mode and vacuum levels from 40-245 mmHg with cycling rates from 27-121 cycles per minute in auto mode. The device is equipped with an LED status display that displays information regarding working mode, operating time, and battery status. The user interface includes on/off switch that also acts as mode selection switch (through long press), pause button and vacuum level adjustment buttons.

Wearable breast pump (Model S33) is designed to be used as a single pumping system that can be converted to double pumping by using two devices, one on each breast. To prevent milk from flowing into the vacuum system, the device uses a silicone diaphragm that physically separates the milk contacting pathway from the vacuum system. All milk contacting components of the device are compliant with 21 CFR 177.

N/A

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 <= 42 degrees Celsius. The Wearable Breast Pump (Model W6) 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.

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

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).

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

The Wearable Breast Pump (Model S12A) 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 S12A) is an electrically powered, software-controlled, single user pump designed for lactating women to express and collect milk from the breast.

The device has three modes of operation - Expression mode, Stimulation mode, and Auto mode, with multiple suction levels for each mode. Stimulation mode consists of pressures ranging from 30/160-120/160 mmHg and cycle speeds of 74-134 cycles/min, expression mode consists of pressure ranges from 120-245 mmHg and cycle speeds of 29-92 cycles/min, and auto mode consists of pressure ranges from 30-245 mmHg and cycle speeds of 29-128 cycles per minute. There is an LED status display for S12A, and the working mode and battery indicator are shown on the pump body.

S12A may be operated as a single or double pumping system. For a user to pump both breasts simultaneously, they would need to use two S12A devices at the same time, one on each breast. The pump is provided non-sterile and can be re-used by a single user. The device is powered by a Li-ion battery and charged using a 5V DC adaptor. The device is designed not to be used during charging.

The breast pump does not incorporate any off-the-shelf (OTS) software, and it incorporates embedded software which controls all the features of the product. All milk contacting components of the device are compliant with 21 CFR 177.

This document is a 510(k) clearance letter for a Wearable Breast Pump. It does not contain details about acceptance criteria for an AI/ML device or a study proving an AI/ML device meets acceptance criteria.

The document discusses the regulatory clearance of a medical device (a breast pump) and its comparison to a predicate device, focusing on:

• Device Description: A powered breast pump with different modes, suction levels, and an LED display.
• Indications for Use: For lactating women to express and collect milk.
• Technological Characteristics: Comparison of classification, regulation, product code, intended use, single/double pump capability, user interface, materials, power source, control mechanism, maximum vacuum, vacuum range, cycle speed range, and backflow/overflow protection between the subject device (Wearable Breast Pump Model S12A) and the predicate device (Lucy Breast Pump).
• Performance Testing:
  • Biocompatibility testing: Cytotoxicity, skin irritation, and skin sensitization for patient-contacting components.
  • Electrical safety and electromagnetic compatibility (EMC) testing: Adherence to IEC standards.
  • Software Verification and Validation Testing: Evaluated at a basic documentation level.
  • Performance and Use Life Verification: Vacuum level verification, backflow protection, use life testing (device maintaining specifications), battery performance, and battery status indicator testing.

The document concludes that the Wearable Breast Pump (Model S12A) is as safe and effective as the predicate device, supporting a determination of substantial equivalence.

Therefore, I cannot provide the requested information about AI/ML device acceptance criteria or studies from this document, as it pertains to a mechanical/electronic medical device without AI/ML components.

Ask a specific question about this device

The Wearable Breast Pump (Model W8) 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 W8) is a wearable powered breast pump designed for lactating woman to express and collect milk from the breast. There are 4 modes available for the device which are Expression mode, Massage mode, Auto mode and Stimulation mode. There is a LED status display for W8, including working mode, and battery indicator can be shown on the pump body. The user interface includes on/off switch, mode selection/long press, and vacuum adjustment. W8 operated as a single or double pumping system, one on each breast. The pump is provided non-sterile and reusable by a single user. The device is powered by rechargeable Li-ion battery (3.7V, 1200mAh). W8 is designed not to be used during charging. The breast pump does not incorporate any off-the-shelf (OTS) software. The device incorporates embedded software which controls all the features of the product. All milk contacting components of the device are compliant with 21 CFR 177 which is applicable for the subject device.

Here's a breakdown of the acceptance criteria and study information based on the provided FDA 510(k) summary for the Wearable Breast Pump (Model W8).

It's important to note that the provided document is an FDA 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It primarily details non-clinical performance testing rather than clinical efficacy studies often associated with AI/ML devices or studies directly proving therapeutic effect. Therefore, many of the requested points related to AI, human readers, ground truth establishment for patient outcomes, and clinical study designs will not be present. The "device" in this context is a physical breast pump, not an AI algorithm.

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

For a breast pump, "acceptance criteria" primarily relate to engineering specifications and safety standards rather than diagnostic performance metrics like sensitivity/specificity. The document states that the device was tested against its own specifications, and "Device specifications were met for all tests conducted."

The subsequent points (2-9) are typically relevant for studies involving AI/ML devices, clinical performance, or diagnostic effectiveness based on expert interpretation. As this 510(k) is for a physical medical device (a breast pump) and not an AI/ML diagnostic tool, a direct equivalent for many of these points is not applicable or explicitly mentioned in the provided summary. The summary focuses on engineering, safety, and compatibility testing.

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

• Not Applicable / Not Explicitly Stated for Clinical Outcomes: The summary describes bench performance testing on the device itself and biocompatibility testing of materials, not a clinical study on human subjects with a "test set" of patient data. For bench testing, the "sample size" would refer to the number of devices or components tested, which is not detailed but assumed to be sufficient for engineering verification.

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

• Not Applicable: This relates to human interpretation of data for ground truth establishment in diagnostic studies. For a breast pump, "ground truth" is established by engineering specifications and objective measurements (e.g., pressure gauges, timers, chemical analysis).

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

• Not Applicable: Again, this pertains to expert review and consensus for diagnostic ground truth, which is not relevant for the type of testing described here.

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-assisted diagnostic workflows. No human reader interaction or AI assistance is mentioned or relevant for a breast pump.

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

• Not Applicable: This refers to standalone AI algorithm performance. This device is a physical breast pump, not an algorithm. While it has embedded software, its performance is evaluated as an integrated system, not a standalone algorithm.

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

• The "ground truth" for this device's performance is driven by:
  • Engineering Specifications: Defined ranges for vacuum pressure, cycle speed, battery life, etc.
  • International Standards: Compliance with ISO (e.g., ISO 10993 for biocompatibility) and IEC (e.g., IEC 60601 for electrical safety and EMC) standards.
  • Regulatory Requirements: Compliance with 21 CFR regulations (e.g., 21 CFR 177 for milk-contacting materials).
  • Functional Verification: Demonstrating features like backflow protection and proper software operation.

8. The sample size for the training set

• Not Applicable: This applies to AI/ML models. This device is not an AI/ML system trained on data.

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

• Not Applicable: This applies to AI/ML models.

Ask a specific question about this device

Wearable Breast Pump (ABP-1508PRO, ABP-1306, ABP-1306, ABP-1306 PRO, M1, M3, M8, M5, M6, K1, K2, K3, K5, ABP-1306PLUS, ABP-1308, M2) 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.

The Wearable Breast Pump (ABP-1508PRO, ABP-1506, ABP-1306 PRO, M1, M3, M8, M5, M6, K1, K2, K3, K5, ABP-1306PLUS, ABP-1308, M2) 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 subject devices are capable of expression, stimulation, and auto modes with nine associated suction levels for each. The subject devices feature various combinations of on/off buttons, level up/down buttons, mode selection buttons, suction level/time indicators, battery visual indicator displays. The pumps are powered by internal, non-replaceable, rechargeable lithium-ion batteries which are charged using the included AC power supply and cable. The subject device can be operated while plugged into AC power. The breast pumps use cyclic negative pressure (suction) to mimic the suckling patterns of a feeding infant. A DC motor drives a membrane vacuum pump to generate the suction required to stimulate and express breast milk. The timing of this pattern is dependent upon the suction/speed settings selected by the user and is preprogrammed in the devices. The devices are capable of producing peak suction levels between -60 and -240 mmHg at speeds between 26 and 108 cycles per minute. There available pumping modes with 9 distinct levels of vacuum and cycle speed. The subject device ensures backflow protection between the breast shield and the electronic components via a physical barrier (silicone diaphragm) mechanism. All other components (i.e., motor unit) of the subject device are not in contact with the breast. All milk contacting components are compliant with 21 CFR 174-179.

The provided text describes a 510(k) premarket notification for a Wearable Breast Pump and does not include information about a study that proves the device meets specific acceptance criteria for AI/ML performance. The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing.

Therefore, I cannot provide the requested information regarding:

• A table of acceptance criteria and reported device performance for AI/ML.
• Sample size and data provenance for a test set.
• Number and qualifications of experts for ground truth establishment.
• Adjudication method for a test set.
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size.
• Whether a standalone (algorithm only) performance study was done.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
• The sample size for the training set.
• How the ground truth for the training set was established.

The document mentions "Software" and states it was "evaluated at the Basic Documentation level as recommended in the 2023 FDA guidance document 'Content of Premarket Submissions for Device Software Functions.'" This level of documentation suggests that the software in question is likely not an AI/ML algorithm that requires rigorous clinical validation with ground truth for diagnostic or prognostic purposes, but rather controls basic device functions (e.g., suction settings, modes, battery indicators).

The performance testing listed in Section 9 ("Summary of Non-Clinical Performance Testing") includes:

• Vacuum level verification testing
• Backflow protection testing
• Use life testing
• Battery performance testing
• Battery status indicator testing

These are standard engineering and safety tests for a powered breast pump, not the type of studies typically conducted to evaluate AI/ML performance against acceptance criteria for a diagnostic or decision-support system.

In summary, the provided FDA 510(k) clearance letter and summary do not contain information related to AI/ML device performance or the study details requested in your prompt.

Ask a specific question about this device

The Wearable Breast Pump (Model S32) is intended to express milk from lactating women in order to collect milk from their breasts. The device is intended for a single user.

The Wearable Breast Pump (Model S32), is an electrically powered wearable single breast pump consisting of the following key components: a flange, pump motor, silicone diaphragm, milk collector, bra adjustment buckle, valve, and USB charging cable. It is designed to work in the user's bra and has a rechargeable battery so it can be used hands-free without any external power cords. The motor unit includes a press-button user interface, pump body, and LED display. Pumping can be performed on one breast (single pumping). The user interface allows the user to switch from stimulation, expression, massage, and auto modes and control the vacuum levels within those modes. All available modes consist of 9 vacuum levels. The S32 model is capable of providing vacuum levels from 40-120 mmHg with cycling rates from 86-110 cycles per minute in stimulation mode, vacuum levels from 120-245 mmHg with cycling rates from 33-109 cycles per minute in expression mode, vacuum levels from 40-120 mmHg with cycling rates from 90-120 cycles per minute in massage mode, and vacuum levels from 40-245 mmHg with cvcling rates from 33-120 cvcles per minute in auto mode. The model S32 Wearable 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 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 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 text is a 510(k) Summary for a Wearable Breast Pump (Model S32). It outlines the device's characteristics, comparison to a predicate device, and a summary of non-clinical performance testing. However, it does not include the specific details typically found in a study proving a device meets acceptance criteria, especially for a medical device involving AI, image analysis, or complex diagnostics.

The document states: "Other performance testing was conducted to show that the device meets its design requirements and performs as intended. The performance tests include:

• Vacuum level verification testing at each mode/cycle demonstrated that the devices meet mode/cycle specifications.
• Backflow protection testing was conducted to verify liquid does not backflow into the tubing.
• Use life testing was conducted to demonstrate that the device maintains its specifications ● throughout its proposed use life.
• Battery performance testing was conducted to demonstrate that the battery remains functional during its stated battery use-life.
• Battery status indicator testing was conducted to demonstrate that the battery status indicator ● remains functional during its stated battery life."

Based on the provided text, here's an attempt to answer your questions, highlighting what is present and what is absent:

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

The document broadly outlines performance tests conducted, but it does not provide explicit acceptance criteria values or the specific reported device performance results in a table format. It states that "Vacuum level verification testing at each mode/cycle demonstrated that the devices meet mode/cycle specifications." This implies that the measured vacuum levels and cycle speeds met predefined targets, but those targets (acceptance criteria) and the actual measured values (reported performance) are not detailed.

Table Placeholder (Information NOT PROVIDED in the text):

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 does not specify the sample sizes for any of the performance tests (e.g., number of units tested for vacuum levels, backflow, use life, or battery performance). It also does not mention data provenance, as this is a mechanical/electrical device, not one that processes patient data. The testing is likely lab-based internal validation rather than clinical data collection.

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 to the type of device and testing described. Ground truth establishment by experts (like radiologists for image analysis) is relevant for AI/ML-driven diagnostic devices. For a breast pump, performance is assessed through engineering measurements (e.g., vacuum pressure, cycle speed, battery life, physical backflow).

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

Not applicable. Adjudication methods are used in studies involving human interpretation (e.g., reading medical images) where there might be disagreement among experts. For mechanical/electrical performance testing, measurements are typically objective and repeatable.

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. An MRMC study is relevant for diagnostic devices (especially those involving AI assistance to human readers/interpreters). This document is for a medical device (breast pump) that does not involve AI assistance for human interpretation or diagnosis.

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

Not applicable. The device has "embedded software" but it's for controlling the pump's operation (modes, vacuum levels, timing), not for diagnostic or analytical purposes that would require standalone algorithm performance evaluation against a "ground truth" in the typical sense of AI/ML devices.

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

For this device, "ground truth" refers to the engineering specifications and expected performance, verified through direct physical measurements. For example:

• Vacuum levels: Verified against calibrated pressure sensors.
• Cycle speed: Verified against timing mechanisms.
• Backflow protection: Verified visually or with sensors to confirm no liquid passes.
• Use life/Battery performance: Verified by running the device for specified durations and checking if performance metrics remain within tolerance.

8. The sample size for the training set

Not applicable. This device's embedded software controls the pump's mechanical functions; it is not an AI/ML model trained on a dataset. Therefore, there is no "training set" in the context of machine learning.

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

Not applicable, as there is no training set for an AI/ML model. The "ground truth" for the device's design specifications would have been established through engineering design principles, regulatory standards (e.g., IEC standards for medical electrical equipment), and a thorough understanding of the physiological requirements for breast milk expression.

Ask a specific question about this device

The Wearable Breast Pump, Model S18 is intended to express milk from lactating women in order to collect milk from their breasts. The device is intended for a single user.

The Wearable Breast Pump, Model S18 is an electrically powered breast pump to be used in home environment by a single user. The device is provided non-sterile and can be re-used by a single user. The device is electrically powered by an internal rechargeable Li-ion battery. It can be charged using 5V DC adaptor and the device is designed to be not used during charging. The device consists of the pump motor, milk collection parts, adjustment buckle and charging cable. The device functionality is controlled using an embedded firmware. The subject device has three modes of operation - Expression mode, Stimulation mode and Massage mode, and each mode of operation allows for switching between nine suction levels. The device has three buttons, a power button to turn the device on/off or switch between the modes, a '+ plus' button to increase the suction level and a '- minus' to decrease the suction level within a mode. The device includes an LED status display for the device operating mode and battery status indicator on the pump body. The operating mode LED changes to specific color based on the mode of operation. The device is designed to automatically shut down after 30 minutes of continuous operation. The device operates on a suction(vacuum) cycle that consists of an inhale (letting in air to release vacuum) and an exhaust (removal of air to create vacuum) process. When the breast pump is powered on, the vacuum pump exhausts the air inside the cavity. Once the suction strength reaches the set value, the vacuum pump stops and the valve for the milk opens and expressed milk flows into the bottle due to a pressure difference. All milk contacting components of the device are compliant with 21 CFR 177.

The provided document is a 510(k) Pre-Market Notification for a wearable breast pump (K232774). This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving the safety and effectiveness of a novel device through extensive clinical studies, especially those with AI components.

Therefore, the document does not contain the information requested regarding acceptance criteria and the study that proves a device with an AI component meets those criteria. Such information would be found in a submission for a device incorporating AI/ML, which would require performance data against defined metrics, often involving ground truth established by experts.

The document discusses performance testing relevant to a traditional electromechanical device (breast pump), such as:

• Biocompatibility Testing: Evaluating tissue-contacting components for cytotoxicity, irritation, and sensitization.
• Electrical Safety and Electromagnetic Compatibility (EMC): Compliance with recognized standards like IEC 60601-1.
• Software Verification and Validation Testing: This is to ensure the embedded firmware functions correctly according to its specifications, not to assess AI performance. The documentation level is "Basic Documentation Level," which is typical for non-AI software in medical devices.
• Performance Testing and Use Life Verification: This includes testing vacuum level and cycle frequency, backflow, battery capacity, button performance, and automatic shutdown function over the device's 3-year use-life.

None of these tests involve AI-specific acceptance criteria, ground truth establishment by multiple experts, MRMC studies, or standalone algorithm performance.

In summary, the provided text does not contain the information necessary to answer the questions about AI device acceptance criteria and study methodology because the device in question (a breast pump) is not an AI/ML medical device.

Ask a specific question about this device