Search Results

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).

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 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.

Ask a specific question about this device

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.

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 Lacevo Wearable Breast Pump (Model S70) 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 Lacevo Wearable Breast Pump (Model S70) 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, Expression mode, Massage mode, Auto mode and Stimulation mode. There is an LED status display for the S70, and the working mode and battery indicator are shown on the pump body. The user interface includes an on/off switch, mode selection/long press, and vacuum adjustment.

S70 is operated as a single or double pumping system, one on each breast. The pump is provided non-sterile and is reusable by a single user. The device is powered by rechargeable Li-ion battery (3.7V, 1200mAh). S70 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.

The provided FDA 510(k) clearance letter for the Lacevo Wearable Breast Pump (Model S70) describes the device, its intended use, and a comparison to a predicate device, along with a summary of non-clinical performance testing. However, it does not detail acceptance criteria for studies related to AI/ML performance validation, nor does it describe an AI/ML model performance study. This is expected, as a breast pump, while it may contain embedded software, is not a device typically cleared based on complex AI/ML algorithms requiring a comprehensive AI/ML performance study as described in your prompt.

Therefore, I cannot provide the requested information regarding AI/ML acceptance criteria, study details, sample sizes for test/training sets, expert qualifications, ground truth establishment, or MRMC studies, because this information is not present in the provided document.

The document focuses on the mechanical, electrical, and biocompatibility safety and efficacy of a medical device (a breast pump), rather than the performance of an AI/ML algorithm.

However, I can extract information regarding the device's general performance testing acceptance criteria and validation, which are relevant to its substantial equivalence.

Device: Lacevo Wearable Breast Pump (Model S70)

Based on the provided document, here's a description of the acceptance criteria and the studies that prove the device meets these criteria. Please note, as mentioned, this is not an AI/ML performance study.

1. A table of acceptance criteria and the reported device performance (Non-AI/ML specific)

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

• Sample Size for Testing: The document does not specify the number of units or samples used for the performance, biocompatibility, electrical safety, or software testing. It generally states that "Bench performance testing was conducted" and "Electrical safety and EMC testing were conducted on the Wearable Breast Pump device, consisting of all the modules and accessories in the system."
• Data Provenance: Not specified, but generally, these tests would be conducted internally by the manufacturer (Shenzhen TPH Technology Co., Ltd. in CHINA) or by accredited third-party laboratories.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

• This is not applicable as the studies described are device performance tests and not AI/ML algorithm validation requiring expert-derived ground truth. The "ground truth" for these tests are objective measurements against engineering specifications and international standards.

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

• Not applicable, as this refers to adjudication for expert consensus on ground truth in studies often involving image interpretation or complex clinical assessments, which is not the nature of the tests described in this document.

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 done. This type of study is relevant for AI-assisted diagnostic or interpretative devices, which this breast pump is not.

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

• Not applicable as this is a physical device, not an AI/ML algorithm. The embedded software controls the device's functions, but it's not a standalone AI model being evaluated.

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

• The "ground truth" for these performance tests are the pre-defined engineering specifications for vacuum pressure, cycle speed, battery life, etc., and the requirements of the relevant international standards (e.g., ISO 10993 for biocompatibility, IEC 60601 series for electrical safety). The device performance is measured and compared directly against these objective, established criteria.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device that requires a training set for model development. The software mentioned is embedded control software, not a learned AI model.

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

• Not applicable, as there is no AI/ML training set mentioned or implied by the device's description.

Ask a specific question about this device

The eufy Wearable Breast Pump S1 (T8D02); eufy Wearable Breast Pump E10 (T8D03); eufy Wearable Breast Pump S1 Pro (T8D04); eufy Wearable Breast Pump E20 (T6060) are intended to express milk from lactating women in order to collect milk from their breasts. These devices are intended for a single user.

The eufy Wearable Breast Pump S1 (T8D02); eufy Wearable Breast Pump E10 (T8D03); eufy Wearable Breast Pump S1 Pro (T8D04); eufy Wearable Breast Pump E20 (T6060) is intended to express milk from lactating women in order to collect milk from their breasts. It is an electrically powered, software-controlled, digital single user pump. The device consists of the following key components: flange, pump motor, silicone diaphragm, USB cable, milk collector, bra adjustment buckle, and valve. 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.

There device has two modes of operation - Expression mode and Stimulation mode, with multiple suction levels for each mode. Both modes consist of nine vacuum levels. Expression mode consists of pressures ranging from 120-245 mmHg and cycle speeds of 20-66 cycles/min and stimulation mode consists of ranges from 40-120 mmHg and cycle speeds of 69-92 cycles/min. There is an LED status display shown on the pump body, which displays the working mode and battery indicator.

The subject device may be operated as a single or double pumping system. For a user to pump both breasts simultaneously, they would need to use two devices at the same time one on each breast. The pump is provided in 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.

The provided FDA clearance letter and its associated 510(k) summary pertain to the eufy Wearable Breast Pumps (models S1, E10, S1 Pro, E20). However, the document does not describe any specific acceptance criteria or an original study to prove that the device meets acceptance criteria.

Instead, the submission leverages data and testing from a predicate device (Wearable Breast Pump Model S18, K223886) to demonstrate substantial equivalence. The core argument for clearance is that the subject devices are identical or sufficiently similar to the predicate device in terms of design, materials, components, and intended use, such that the predicate's performance and safety data can be applied to the new devices.

Therefore, many of the requested details about acceptance criteria, specific study design, sample sizes, expert involvement, and ground truth establishment for the subject device are not present in this document because they refer to the original studies performed for the predicate device, not new studies for the eufy Wearable Breast Pumps.

Here's a breakdown based on the information provided and the absence of specific details for the subject device's new studies:

Acceptance Criteria and Device Performance (Leveraged from Predicate Device)

Since the subject device leverages performance data from the predicate device (K223886), the acceptance criteria and reported performance for the eufy Wearable Breast Pumps are assumed to be met if they match or are within the validated ranges of the predicate device. The document explicitly states that the subject device has "identical functions and mode of operations" as the predicate device.

Study Details for eufy Wearable Breast Pumps (K250152)

Because this clearance relies heavily on leveraging data from a predicate device (K223886) rather than conducting wholly new, independent studies for all aspects, many of the specific study details you requested for this submission are not applicable or not provided. The document repeatedly states that testing was "leveraged from the predicate device."

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

   • No specific sample size for new test sets is provided for the eufy Wearable Breast Pumps in this document. The performance testing was "leveraged from the predicate device (K223886)."
   • Therefore, the provenance of the original data would refer to the studies conducted for the predicate device, which are not detailed here.

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

   • Not applicable as new "ground truth" establishment for clinical performance is not described for the subject device in this document. Performance data was leveraged from the predicate's testing.

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

   • Not applicable, as no new test set requiring expert adjudication for a clinical endpoint is described in this document.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • Not applicable. This device is a powered breast pump, not an AI-assisted diagnostic or imaging device used by human readers. Therefore, an MRMC study is not relevant to its clearance.

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

   • The device incorporates embedded software which controls its features. The document states, "software documentation, including verification & validation, was leveraged from the predicate device to support the validity of the subject device software-controlled functions." This implies that standalone software performance was assessed during the predicate device's evaluation, and that assessment is accepted for the subject device due to identical software.

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

   • For the technical performance aspects (vacuum, cycle speed, backflow, electrical safety, battery life), the "ground truth" is defined by engineering specifications and objective measurements against those specifications. For example, a vacuum gauge and timer would provide the "ground truth" for vacuum level and cycle speed.
   • For biocompatibility, the ground truth is compliance with regulatory standards (e.g., 21 CFR 177) and material testing results.
   • For software, the "ground truth" is its adherence to functional and performance requirements established through verification and validation.

7. The sample size for the training set:

   • Not applicable. This device involves hardware and embedded software; it does not utilize machine learning or AI models that require a "training set" in the typical sense. The software is deterministic and based on design specifications.

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

   • Not applicable, as no machine learning training set is involved.

Ask a specific question about this device

The Ameda GLO Wearable Breast Pump ( Model W8S ) 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 Ameda GLO Wearable Breast Pump (Model W8S) is a wearable powered breast pump designed for lactating woman to express and collect milk from the breast. The device is an electrically powered, software-controlled, digital single user pump.

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 W8S, 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.

Ameda GLO Wearable Breast Pump (Model W8S) can be 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 th subject device.

The provided document is a 510(k) summary for the Ameda GLO Wearable Breast Pump (Model W8S). It outlines the device's characteristics and compares it to a predicate device (Wearable Breast Pump, Model W8, cleared under K242850) to demonstrate substantial equivalence, rather than detailing a study that proves the device meets specific acceptance criteria for a novel functionality.

The document primarily states that performance data and testing were leveraged from the predicate device (K242850), indicating that a new, independent study for specific acceptance criteria for this particular device (Model W8S) was not conducted or detailed in this submission. Instead, confidence in the new device's performance is derived from the predicate device's established performance and the similarity in technological characteristics.

Therefore, many of the requested details such as sample size for test set, data provenance, number of experts, adjudication method, MRMC study effect size, and standalone algorithm performance are not applicable or not provided in this type of submission for this particular device, as the performance evaluation relies on the predicate device.

However, based on the provided information, I can extract the following:

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

The document does not explicitly list "acceptance criteria" in a typical quantitative sense for this device. Instead, it refers to the "Device specifications were met for all tests conducted" for performance and use life verification tests, implying the acceptance criteria are the device's specifications. These specifications are compared to the predicate device.

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

• Sample Size for Test Set: Not specified. The document states "Bench performance testing was conducted and leveraged from K242850." This implies the original testing for Model W8 (K242850) had a test set, but its details are not provided here for Model W8S.
• Data Provenance: Not specified for the leveraged data. The company is based in Shenzhen, China.

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)

• Not applicable as this is a breast pump, and the criteria primarily involve engineering and material safety standards, not diagnostic interpretation requiring expert consensus.

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

• Not applicable for the types of tests described (e.g., vacuum pressure, cycle speed, material biocompatibility). These are objective measurements against defined specifications.

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 breast pump, not an AI-assisted diagnostic tool.

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

• Not applicable. This device is a physical medical device (breast pump) with embedded software for control, not an AI algorithm.

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

• The "ground truth" for performance is based on the device's technical specifications and compliance with recognized international standards (e.g., IEC 60601 series for electrical safety, ISO 10993 for biocompatibility) outlined by regulatory bodies. For biocompatibility, the ground truth is the biological response to materials, determined through standardized assays (cytotoxicity, sensitization, irritation).

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning device that would typically have a "training set." The software is embedded control software, verified and validated against functional requirements.

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

• Not applicable, as there is no "training set" in the context of this device. Software verification and validation are typically established through testing against functional requirements, design specifications, and relevant software development lifecycle documentation rather than a "ground truth" derived from data.

Ask a specific question about this device