Search Results

The Electric Breast Pump (Models HL-3058, F5112) is intended to express milk from lactating women and collect milk from their breast. The device is intended for single user.

The Electric Breast Pump (Models HL-3058, F5112) is an over-the-counter, non-sterile, single-user, powered breast pump intended to be used by lactating women to express and collect milk from their breasts. The device is intended for daily use in a home environment. The device uses a diaphragm-type vacuum pump driven by software embedded in the device to generate suction required to stimulate and express breast milk. The software provides control over vacuum pressure and cycle speed.
Electric Breast Pump (Models HL-3058, F5112) also has a hot function which provides hear to the users neck for warmth. It does not affect the intended use of the product.

N/A

Ask a specific question about this device

The Electric Breast Pump (Models HL-3060, F5113) is intended to express milk from lactating women and collect milk from their breast. The device is intended for single user.

The Electric Breast Pump (Models HL-3060, F5113) is an over-the-counter, non-sterile, single-user, powered breast pump intended to be used by lactating women to express and collect milk from their breasts. The device is intended for daily use in a home environment. The device uses a diaphragm-type vacuum pump driven by software embedded in the device to generate suction required to stimulate and express breast milk. The software provides control over vacuum pressure and cycle speed.

N/A

Ask a specific question about this device

The electric breast pump (models FZ-P8, YH-P8, YH-P8X) is a wearable electric breast pump intended to express milk from lactating women in order to collect milk from their breasts. The device is intended for a single user.

The electric breast pump (models FZ-P8, YH-P8, YH-P8X) is an electrical wearable breast pump powered by a rechargeable Li-ion battery. It consists of a Pump, Diaphragm, Cup, Valve, Silicone breast shield (flange) and dust cap:

The pump is the core component of the electric breast pump. It generates a cyclic negative pressure (vacuum) to simulate a baby's sucking motion, drawing milk from the breast into the collection system. The pump is electrically driven and controlled via a motor and control unit, typically offering adjustable suction levels and mode. The diaphragm separates the milk collection system from the pump mechanism, preventing breast milk from entering the pump motor and tubing. The cup is the container that collects and stores the expressed breast milk. The valve controls the one-way flow of breast milk. It opens and closes in sync with the suction cycles to allow milk to flow into the cup while preventing backflow. The silicone breast shield, also known as the flange, is the part that comes into direct contact with the breast. It creates a seal around the nipple and areola to enable effective suction. The dust cap covers the opening of the breast shield or milk collection port when the electric breast pump is not in use. It prevents dust, dirt, and other contaminants from entering the breast pump

The electric breast pump has 2 (Primary mode and secondary mode) x 3 modes (Massage Mode, Expression Mode, and Mixed Mode), each mode has 10 adjustable levels:

• Massage Mode provides a vacuum range of 40–190 mmHg and a frequency of 52–110 cycles per minute;
• Expression Mode provides a vacuum range of 80-280 mmHg and a frequency of 19–75 cycles per minute;
• Mixed Mode provides a vacuum range of 80-280 mmHg and a frequency of 6–63 cycles per minute.

N/A

Ask a specific question about this device

The Electric Breast Pump (Model LD-208L, LD-3010L, LD-3010, LD-2010) is a powered breast pump to be used by lactating women to express and collect milk from their breasts. The Electric Breast Pump is intended for a single user.

The Electric Breast Pump (LD-208L, LD-3010L, LD-3010, LD-3010, LD-2010) 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 the hybrid 'bionio' and 'variable frequency' modes. Stimulation mode is associated with six suction levels, and expression, bionic, and variable frequency modes are associated with nine suction levels. The subject devices feature various combinations of on/off buttons, level up/down buttons, mode selection buttons, suction level/time indicators, battery visual indicator display, and mode displays. The LD-208L, LD-3010L, and LD-2010L pumps are powered by internal, nonreplaceable, rechargeable lithium-ion batteries which are charged using the included AC power supply and cable. The LD-2010 and LD-3010 are powered by alkaline batteries or 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 pre-programmed in the devices. The devices are capable of producing peak suction levels between -40 and -290 mmHg at speeds between 20 and 120 cycles per minute. 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 177.

The provided document is a 510(k) summary for an Electric Breast Pump (LD-208L, LD-3010L, LD-2010L, LD-3010, LD-2010). This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving independent effectiveness or advanced performance metrics typically associated with AI/ML devices. Therefore, much of the information requested in your prompt (e.g., sample size for test sets, expert ground truth, MRMC studies, standalone performance with effect sizes) is not applicable or generally required for a 510(k) clearance of a mechanical device like a breast pump.

Here's the information that can be extracted or inferred from the provided text:

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

For a breast pump, the "acceptance criteria" and "device performance" are primarily based on meeting safety standards, functional specifications, and demonstrating equivalence to a predicate. The document highlights various tests performed to ensure this.

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

The document does not specify sample sizes for the performance tests (e.g., how many units were tested for vacuum levels, how many use-life cycles). Data provenance details (country of origin, retrospective/prospective) are not provided as these are primarily engineering performance tests rather than clinical studies on patient data.

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

Not applicable. The ground truth for these performance tests is based on engineering specifications and adherence to international standards, not expert clinical consensus.

4. Adjudication method for the test set

Not applicable. This is not a study requiring adjudication of clinical findings.

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 an electric breast pump, a mechanical medical device, and does not involve AI or human readers for diagnostic interpretation.

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

Not applicable. This device does not use algorithms for diagnostic or interpretive performance separate from its mechanical function.

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

The ground truth for the performance testing is based on:

• Engineering specifications: Pre-defined ranges for suction levels, cycles per minute, and other functional parameters.
• International standards: Compliance with standards like ISO 10993 for biocompatibility, IEC 60601 for electrical safety, and IEC 60601-1-2 for EMC.
• Design requirements verification: Ensuring the device meets its intended design functions (e.g., backflow protection, battery function).

8. The sample size for the training set

Not applicable. There is no "training set" in the context of this 510(k) submission for a non-AI/ML device.

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

Not applicable. (See #8)

Ask a specific question about this device

The Electric Breast Pump (F5055) is intended to express milk from lactating women and collect milk from their breast. The device is intended for single user.

The Electric Breast Pump (F5055) is a powered breast pump to be used by lactating women to express and collect milk from their breast. The Electric Breast Pump (F5055) is intended for a single user. The proposed device is electrically powered and software-controlled. The device operates via a microprocessor-driven air pump, which generates suction on the breast to extract milk. The proposed device is available in one model, F5055. The provided non-sterile and is not to be sterilized by the user prior to use. The device includes a breast shield assembly, bottles, pump unit, tubing, an adapter, and pump unit. The breast shield assembly includes a silicone breast shield and polypropylene breast shield body that contacts the user's breast.

The provided text is a 510(k) Summary for an Electric Breast Pump (F5055). This document details the manufacturer's claim of substantial equivalence to a predicate device, as required for FDA premarket notification.

However, the provided text does not contain information related to an AI/ML powered medical device, nor does it discuss acceptance criteria and a study proving the device meets those criteria in the context of AI/ML performance. The device described is an "Electric Breast Pump," a hardware device with software controls, but it does not appear to involve AI or machine learning for diagnostic or assistive functions that would require the typical performance study details asked in the prompt.

Therefore, I cannot fulfill the request for information on acceptance criteria and a study proving an AI/ML device's performance based on the provided text, as the text describes a non-AI/ML medical device.

To directly answer your prompt based on the provided text, focusing on the type of acceptance criteria and performance testing presented for this specific device (an electric breast pump):

The acceptance criteria for this medical device are primarily focused on safety and effectiveness as demonstrated through non-clinical performance testing, and comparison of technological characteristics and indications for use with a legally marketed predicate device.

Here's a breakdown of the "acceptance criteria" (implicitly, the aspects where the device must perform acceptably) and the study/testing performed, as per the document, rather than a typical AI/ML study:

Acceptance Criteria and Reported Device Performance (as inferred for an Electric Breast Pump):

Regarding the specific questions posed, adapted to the context of this non-AI/ML device:

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

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

   • The document does not specify sample sizes for the non-clinical performance tests (e.g., how many units were tested for electrical safety, or how many cycles for pump performance).
   • Data provenance is not explicitly stated in terms of country of origin for the testing itself, nor is it described as retrospective or prospective data collection from human subjects. The tests are non-clinical, so they are likely laboratory-based.

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

   • This question is largely not applicable to this type of device and testing. There is no "ground truth" establishment by experts in the sense of image interpretation or diagnostic accuracy.
   • The "ground truth" for non-clinical performance testing typically refers to the established engineering specifications and international standards (e.g., IEC, ISO) that the device must meet. The "experts" involved would be qualified test engineers and quality assurance personnel performing and verifying these tests. Their qualifications are not detailed in this summary.

4. Adjudication method for the test set:

   • This is not applicable as there is no subjective interpretation or consensus process like in clinical image review. Performance criteria are objective and quantitative (e.g., measured suction strength within a range, successful completion of electrical safety tests).

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:

   • Definitely not applicable. This is not an AI/ML diagnostic or assistive device. No human reader studies (MRMC) are mentioned or necessary for this type of product.

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

   • Not applicable in the context of AI/ML algorithm performance. The "standalone" performance here refers to the device itself meeting its engineering specifications rather than an algorithm's diagnostic accuracy. The non-clinical tests (suction strength, cycle speed, etc.) represent the standalone performance of the device.

7. The type of ground truth used:

   • For this device, the "ground truth" is defined by engineering specifications, international safety standards (IEC, ISO), and functional requirements. For example, a certain suction strength is a specified operating range, and the test verifies the device achieves this.

8. The sample size for the training set:

   • Not applicable. This device does not use a "training set" in the sense of machine learning. The design and development process for such a hardware device involves prototyping, testing, and refinement, but not machine learning training on a dataset.

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

   • Not applicable, as there is no training set for an AI/ML model for this device. Ground truth for the device's functionality is established by engineering and regulatory standards.

Ask a specific question about this device

Ask a specific question about this device

The Electric Breast Pump (Models AOV6821, AOV6826, AOV6830, and AOV6852) is a powered breast pump to be used by lactating women to express and collect milk from their breast Pump is intended for a single user.

The subject devices, Electric Breast Pump (Models AOV6821, AOV6826, AOV6830, AOV6852), are powered breast pumps to be used by lactating women to express and collect milk from their breast. The proposed devices are battery powered, software-controlled, and intended for a single user. The devices are intended for home use. The subject devices have the following modes: Massage mode, Expression mode, Bionic mode, Frequency Conversion mode A, Frequency Conversion mode B, Continuous suck mode and Mixed mode; each mode has multiple levels. Massage mode is for stimulating breast milk secretion. Expression mode is for pumping breast milk. Bionic mode cycles between massaging for 2 cycles and expressing for 2 cycles. Frequency Conversion mode A cycles between massaging for 3 cycles and expressing for 1 cycle. Frequency Conversion mode B cycles between massaging for 3 cycles and expressing for 2 cycles. Continuous suck mode applies a lower suction followed by a hold and then a second increase in suction before release as a cycle. Finally, Mixed mode cycles between massaging for 3 cycles and expressing for 1 cycle at levels 1-6, then cycles between massaging for 3 cycles and expressing for 2 cycles at levels 7-9. The subject devices can be used in a single or double pumping configuration and have anti-backflow protection. The subject devices have a USB connecting cable and matching power adapter to supply power to the device. The subject devices are provided non-sterile and are not to be sterilized by the user prior to use. Each device includes a breast shield assembly, collection bottles, tubing set, feeding accessories, power adapter (for charging), and pump unit. The breast shield assembly includes a silicone breast shield and polypropylene breast shield body, which contacts the user's breast.

This is a 510(k) premarket notification for an Electric Breast Pump (Models AOV6818, AOV6821, AOV6826, AOV6830, AOV6852) and not a study detailing the development and validation of an AI/ML powered device. As such, the information requested in your prompt (acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, and training set information) is not applicable or available within this document.

The document focuses on demonstrating substantial equivalence to a predicate device (Electric Breast Pump Models 918, HF918, K211024) through non-clinical testing. It highlights that the subject and predicate devices have the same indications for use and intended use. The non-clinical tests performed are related to the safety and performance of the physical device components, not AI/ML algorithm performance.

Here's a breakdown of the available information regarding device performance and acceptance criteria from the provided text, adapted to your table format where possible, and noting what information is not present:

1. Table of Acceptance Criteria and Reported Device Performance

Since this document is a 510(k) summary for a powered breast pump (a traditional medical device), and not an AI/ML device, the following points are not applicable or derivable from the provided text:

2. Sample sizes used for the test set and the data provenance: Not applicable for a physical device's non-clinical safety/performance testing. The "test set" would be the manufactured devices and their components.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device is established through engineering specifications and objective measurements against those specifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this is not an AI-powered device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device's performance would be objective measurements against engineering design specifications and relevant international standards (e.g., IEC standards for electrical safety, ISO 10993 for biocompatibility).
8. The sample size for the training set: Not applicable, as this is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device

The Electric Breast Pump Model: YM-8166 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 Electric Breast Pump Model: YM-8166 is an over-the-counter, non-sterile, single-user, powered breast pump intended to be used by lactating women to express and collect milk from their breasts. The device is intended for daily use in a home environment. The device uses a diaphragm-type vacuum pump driven by software embedded in the device to generate suction required to stimulate and express breast milk. The software provides control over vacuum pressure and cycle speed.

The provided text is a 510(k) summary for an Electric Breast Pump Model: YM-8166. This document focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical performance testing related to safety and effectiveness, rather than a clinical study evaluating the accuracy or performance of an AI/ML algorithm with human-in-the-loop.

Therefore, the specific information requested in the prompt, such as acceptance criteria for AI performance, sample sizes for test sets (in the context of AI models), expert ground truth, multi-reader multi-case studies, and training set information for AI, is not applicable to this device and the provided document.

The document describes the device's technical specifications and how they compare to a predicate device, along with the results of various engineering and biological safety tests.

Here's the relevant information that can be extracted from the provided text, framed in the context of device performance, rather than AI performance:

Acceptance Criteria and Device Performance (Non-AI/ML Device)

This device, an Electric Breast Pump, is a mechanical and electrical medical device. Its "performance" is assessed based on its ability to effectively and safely express milk, primarily through its engineering specifications and biological material compatibility, not through an AI algorithm's diagnostic or predictive accuracy.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated as a "test set" in the context of an AI algorithm. For non-clinical performance testing (e.g., biocompatibility samples, electrical safety tests, functional tests), the sample sizes are implicitly defined by the testing standards and protocols used. These are typically engineering samples of the device, not a "data set" of patient cases.
• Data Provenance: The testing was conducted by the manufacturer, Guangdong Youmeng Electrical Technology Co., Ltd., based in China. The nature of these tests (e.g., bench testing, material testing) means there's no patient data involved, hence no "retrospective or prospective" designation in the AI sense.

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

• Not applicable. This device does not use an AI/ML algorithm that requires expert annotation for ground truth. The "ground truth" for this device's performance is objective measurements (e.g., electrical readings, vacuum pressure, material properties) and laboratory test results as per established engineering and biocompatibility standards.

4. Adjudication Method for the Test Set

• Not applicable. No expert adjudication is described or required for the type of non-clinical, objective performance testing conducted for this device.

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

• No. This is not an AI-assisted diagnostic device, so an MRMC study comparing human readers with and without AI assistance is not relevant or performed.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Not applicable. There is no standalone AI algorithm for medical interpretation being evaluated. The device has embedded software for controlling the pump's functions (e.g., vacuum pressure, cycle speed), and its verification and validation are noted, but this is functional software, not an AI for diagnosis or treatment decision support.

7. The Type of Ground Truth Used

• Objective Measurements and Standard Compliance: The "ground truth" for this device's performance is based on established engineering specifications, published international standards (e.g., IEC for electrical safety, ISO for biocompatibility), and bench test results (e.g., vacuum pressure readings, cycle speeds, observing no backflow). It is not expert consensus, pathology, or outcomes data in the sense of clinical decision-making.

8. The Sample Size for the Training Set

• Not applicable. This is not an AI/ML device that requires a training set of data for model development. The software is noted as having "Verification and Validation" but this refers to traditional software engineering processes, not machine learning training.

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

• Not applicable. As there is no AI training set, this question is not relevant. Software "ground truth" or correct functionality is established through design specifications, requirements, and traditional software testing methodologies.

In summary, the provided document is a regulatory submission for a standard medical device (an electric breast pump) that relies on non-clinical performance testing and substantial equivalence to a predicate device, not on AI/ML algorithm performance. Therefore, many of the questions related to AI evaluation criteria are not applicable.

Ask a specific question about this device

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

Not Found

The provided text is an FDA 510(k) clearance letter for an "Electric breast pump." This document details the regulatory clearance of a physical medical device, not a software-based AI/ML device.

Therefore, the information required to answer your query – acceptance criteria, study details (sample size, data provenance, expert adjudication, MRMC, standalone performance, ground truth establishment), and training set details – is not present in the provided text.

This document is a regulatory approval for a mechanical device and does not contain the kind of performance data and study design details typically found in submissions for AI/ML-driven diagnostic or assistive technologies.

Ask a specific question about this device

The Electric Breast Pumps are single-user, powered breast pumps intended to express and collect milk from the breasts of lactating women.

The subject devices are intended to be used by lactating women to express and collect milk from their breasts. The devices are intended for a single user in the home environment or hospital setting. When properly connected, the pumping kit transfers the vacuum generated by the powered pump to the breast, enabling expression and collection of milk. A diaphragm in the backflow protection assembly physically isolates pump and tubing from the space where milk is expressed and collected, protecting the breast milk from contamination.

The Electric Breast Pumps contain 4 models, YY-A203, YY-A204 and YY-TC201. The YY-A46 model operates in single pumping mode only; models YY-A203, YY-A204 and YY-TC201 can be operated in single or double pumping modes. Models YY-A203 and YY-A204 have an LED panel and model YY-TC201 has an LCD panel to display working mode, cycle, timer, battery level, and Bluetooth symbol to user. While YY-A46 has an LED indicator to indicate the working status of the device, models YY-A46, YY-A203, and YY-A204 can be wirelessly operated via Bluetooth connection to a smart device. Users can select the working mode, adjust the suction level and cycle speed, and start or pause the device from a smart device. Model YY-TC201 can only be operated on the pump unit itself. All models have massage and expression mode and have a maximum working time of 30 minutes.

The provided document is an FDA 510(k) clearance letter for Electric Breast Pumps. It details the device description, indications for use, comparison to a predicate device, and a summary of non-clinical performance testing.

However, the document does not contain information related to acceptance criteria or a study proving that the device meets those criteria, specifically concerning AI device performance. The sections discussed are typical for a breast pump's safety and performance (electrical safety, EMC, software validation, biocompatibility, vacuum/cycle performance, backflow protection, use life, battery performance) rather than AI-related metrics like accuracy, sensitivity, or specificity.

Therefore, I cannot answer the requested questions using the provided text as it does not describe an AI medical device or its performance criteria and study. The prompt asks for information pertaining to AI model validation, such as:

1. A table of acceptance criteria and reported device performance: Not present in the document for AI performance.
2. Sample size and data provenance for test set: Not present for AI device testing.
3. Number of experts and qualifications for ground truth: Not present.
4. Adjudication method: Not present.
5. MRMC comparative effectiveness study and effect size: Not present.
6. Standalone AI performance: Not present.
7. Type of ground truth used: Not present for AI evaluation.
8. Sample size for training set (AI): Not present.
9. How ground truth for training set was established (AI): Not present.

The document focuses on the hardware and basic functional performance of an electric breast pump, not an AI component.

Ask a specific question about this device