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The Electric Breast Pump is intended to be used by lactating women to express and collect milk from their breasts, to alleviate engorgement of the breasts, maintain the ability of lactation, and provide mother's milk for future feedings when separation of mother and baby occurs. This electric breast pump is intended for multiple users in a hospital setting. It is also intended for home use by a single user.

The Electric Breast Pump is a multi-user electric breast pump designed for lactating women to express and collect milk from the breast. It is intended for use in the hospital and home environments and can also be used by a single user. The device is an electrically powered pump consisting of the following key components: a flange, breast shield body, silicone diaphragm, tubing/tubing connector, pump motor, AC/DC adapter, and milk collector. The Electric Breast Pump contains two models, SMG and GEA. Both models can be operated in single and double pumping modes while connected to AC power and have an onboard rechargeable lithium-ion battery.

The SMG model has an LCD display, and the user can select between stimulation or expression mode. Stimulation mode has 5 vacuum levels and expression mode has 16 vacuum levels. For every vacuum level, the user can independently select among 9 cycle speed levels (for stimulation) and 16 cycle speeds (for expression up to vacuum level 11; higher vacuum levels have less available cycle speeds). The SMG model is wirelessly operable via Bluetooth connection to a smart device.

The GEA model also has an LCD display, and the user can select stimulation or expression mode. Stimulation mode and expression mode have 10 levels. Stimulation speed is set to 70 cycles per minute, whereas expression mode allows for cycling speed between 3 levels.

Both devices operate via an electric negative pressure module that runs discontinuously to generate periodic negative pressure suction and are controlled by a magnetic valve for negative pressure adjustment. Each vacuum pump operates with a DC motor and corresponding DC power supply. Both devices have a 40 min stimulation and expression duration. To prevent milk from flowing into the vacuum, a backflow protection mechanism physically separates the milk-contacting pathway from the vacuum system.

The provided text is an FDA 510(k) summary for an Electric Breast Pump (K212564). It details the device, its intended use, comparison to a predicate device, and non-clinical performance testing.

However, the document does not describe an AI/ML medical device, nor does it contain information about acceptance criteria, a study proving the device meets acceptance criteria, sample sizes, ground truth establishment, expert adjudication, or MRMC studies for an AI/ML algorithm.

Therefore, I cannot extract the requested information regarding acceptance criteria and studies for an AI/ML device from this document. The document describes the testing performed for a standard medical device (an electric breast pump), primarily focusing on biocompatibility, electrical safety, electromagnetic compatibility, software evaluation (for embedded device software, not AI), and general performance tests like vacuum level verification and battery performance.

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The Electric Breast Pump is intended to be used by lactating women to express and collect milk from their breast, to alleviate engorgement of the breast, maintain the ability of lactation, and provide mother's milk for future feedings when separation of mother and baby occurs. It is intended for a single user in a home or hospital environment.

The Electric Breast Pump is intended to express and collect milk from the mother's breast, to alleviate engorgement of the breast, maintain the ability of lactation, and provide mother's milk for future feedings when separation of mother and baby occurs. This Electric Breast Pump is intended for a single user in a home or hospital environment. The Electric Breast Pump has two models: XN/MS-2224A and XN/MS-2224B. Both models are capable of single and double pumping and have two modes: stimulation and expression mode. Both models can be operated using AC power, a built-in rechargeable li-ion polymer battery, or AA batteries.

This document is a 510(k) Premarket Notification Summary for an Electric Breast Pump, not a study describing the acceptance criteria and performance of an AI/ML medical device. Therefore, a table of acceptance criteria and reported device performance related to AI/ML, sample size for test sets, data provenance, number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for AI/ML models are not applicable to the content provided.

The document focuses on the substantial equivalence of the new Electric Breast Pump to a legally marketed predicate device (Spectra S3 Plus Breast Pump) based on non-clinical performance testing, electrical safety, electromagnetic compatibility, biocompatibility, and software verification.

Here's an analysis of the provided document in the context of device acceptance criteria, but note it's for a physical medical device (breast pump), not an AI/ML algorithm.

Analysis of Acceptance Criteria and Study for the Electric Breast Pump (from the provided document)

Since the document describes a physical medical device (Electric Breast Pump) and not an AI/ML device, the questions regarding AI/ML-specific acceptance criteria, test sets, expert ground truth, MRMC studies, and training data are not directly applicable. However, I can extract the closest parallels and relevant information:

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

The document doesn't present a formal table of acceptance criteria with corresponding performance results in the typical machine learning sense. Instead, it describes various performance tests that were conducted and implied acceptance through successful completion.

Implied Acceptance Criteria and Reported Performance (from Section 7: SUMMARY OF NON-CLINICAL PERFORMANCE TESTING):

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

• Sample Size: The document does not specify the sample size for each performance test (e.g., how many units were tested for electrical safety, how many materials samples for biocompatibility). The testing appears to be primarily laboratory-based engineering and material testing rather than a clinical trial with human subjects for performance evaluation.
• Data Provenance: Not explicitly stated, but the testing would have been conducted by or on behalf of the manufacturer, Guangdong Horigen Mother & Baby Products Co., Ltd., likely in China where the company is based. The data would be retrospective in the sense that it was generated prior to the 510(k) submission.

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

• This question is not applicable as there is no "ground truth" in the context of an AI/ML model being established by human experts for this physical device. The "ground truth" for these tests are objective measurements based on engineering standards and physical laws. For instance, the ground truth for electrical safety is whether the device adheres to predefined safety limits as measured by calibrated equipment.

4. Adjudication method for the test set:

• Not applicable for a physical device's non-clinical performance testing. Adjudication methods (like 2+1 or 3+1) are common in clinical studies or for establishing ground truth in AI/ML tasks where human interpretation is involved. Here, results are determined by instrumentation and adherence to standards.

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 pertains to AI/ML algorithm evaluation in clinical decision-making. The Electric Breast Pump is a direct-use medical device, not an AI assistance tool.

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

• Not applicable. This question refers to AI/ML algorithm performance. The "performance testing" described in the document (vacuum pressure, backflow, etc.) is the device's inherent function, which could be considered "standalone" in a very broad sense but not in the context of an AI algorithm.

7. The type of ground truth used:

• For this device, "ground truth" is established through:
  • Engineering Standards and Specifications: Metrics like suction strength (mmHg), cycle speed (cycles/min), electrical safety parameters (e.g., leakage current limits), and material properties (cytotoxicity, sensitization).
  • Objective Measurement: Performance values are measured using calibrated equipment against defined thresholds or ranges from relevant international standards (e.g., IEC, ISO).
  • Functional Demonstrations: For tests like backflow prevention, the "ground truth" is simply the observable fact that liquid does not backflow.

8. The sample size for the training set:

• Not applicable. This concept belongs to AI/ML model development. For a physical device, there isn't a "training set" in the computational sense. Development involves design, prototyping, and iterative testing.

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

• Not applicable. As above, there's no "training set" for an AI/ML model here. The design and validation of the breast pump are based on established engineering principles, material science, and safety standards.

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Single-use medical face mask is intended for use by healthcare workers during procedures to protect both patients and healthcare workers against transfer of microorganisms, bodily fluids, and particulate materials. This device is single-use and provided non-sterile.

The proposed device is single-use medical face mask. It is non-sterile and for single use. The single-use medical face mask is manufactured with three-layers, the inner and outer layers are made of spun-bond polyethylene, and the middle layer is made of melt blown Polyethylene. The elastic ear loop of proposed device is made of spandex and polyester, not natural rubber latex. The nose piece contained in the proposed device allows the user to fit the face mask around their nose, which is made from zinc strip. It is a self-inhalation filter mask, which works by filtering the air through the filter material of the mask before being inhaled or exhaled.

This document is a 510(k) summary for a Single-use medical face mask. It focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the exact sample sizes for each performance test. It only mentions that "Performance testing was conducted on the single-use medical face mask." The data provenance is North America (as per ASTM standards), but the manufacturing country is China. The study is a non-clinical, retrospective study based on laboratory testing of the device.

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 this device's performance is established through standardized laboratory testing (e.g., ASTM standards) rather than expert consensus on images or clinical cases. The "experts" would be the certified laboratories performing these specific biomechanical/material tests, adhering to the outlined standards. Their qualifications are inherent in their accreditation to perform such tests.

4. Adjudication method for the test set

Not applicable. The tests are objective measurements against defined standards, not subjective assessments requiring adjudication.

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 a medical face mask, not an AI-powered diagnostic device. No human reader or AI comparative effectiveness study was performed or is relevant.

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

Not applicable. This is a physical medical device (face mask), not an algorithm.

7. The type of ground truth used

The ground truth used is based on standardized test methods and predefined quantitative acceptance criteria from regulatory and industry standards such as ASTM F2100-19, ASTM F1862, ASTM F2299, ASTM F2101-19, 16 CFR Part 1610, EN 14683:2019+AC:2019(E) Annex C, and ISO 10993 for biocompatibility.

8. The sample size for the training set

Not applicable. This is a physical medical device, not a machine learning model requiring a training set.

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

Not applicable, as there is no training set for a physical medical device.

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The Electric Breast Pump (model KP033 01), Electric Double Breast Pump (model KP053 01) are intended to express and collect milk from the mother's breast, to alleviate engorgement of the breast, maintain the ability of lactation, and provide mother's milk for future feedings when separation of mother and baby occurs. The Electric Breast Pump (model KP033 01), Electric Double Breast Pump (model KP053 01) are intended for a single user.

The Electric Breast Pump (model KP033_01), Electric Double Breast Pump (model KP053_01) are electric breast pumps that are intended for lactating women to express and collect breast milk. The Electric Breast Pump and Electric Double Breast Pump are intended for a single user and are to be used in the home environment. The Electric Breast Pump (model KP033 01), Electric Double Breast Pump (model KP053_01) are Li-ion-battery powered breast pumps that include following main components: the expressed milk collection kit, the pump unit, and tubing. The expressed milk collection kit includes a funnel cover, silicone cushion, funnel adapter, membrane, valve body, valve membrane cap, and milk bottle. The pump unit contains a chip that controls the work of the vacuum pump and solenoid valve to draw air inside of the funnel adapter to form negative pressure. The tubing has two connectors on the two ends. The user attaches the connector to the air vent of the membrane cap and the connector to the pump unit separately to ensure a tight fit.

This document is a 510(k) summary for the Electric Breast Pump (model KP033_01) and Electric Double Breast Pump (model KP053_01). It outlines the device's characteristics and the studies conducted to demonstrate its substantial equivalence to a predicate device.

Here's the information extracted and organized as requested:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the exact sample sizes (number of devices or tests) for the performance, biocompatibility, electrical safety, or EMC testing. However, it indicates that "Performance testing was conducted on the subject device," implying physical testing of the device itself.

The data provenance is not explicitly stated as country of origin, but the submitting company is "Guangdong Horigen Mother & Baby Products Co., Ltd." in China. The study appears to be prospective testing of the manufactured devices.

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

This information is not provided. The testing appears to be objective, engineering, and laboratory-based, rather than requiring expert adjudication of results.

4. Adjudication method for the test set

This information is not applicable and not provided. The testing is based on objective measurements against predefined criteria.

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

This is not applicable. The device is an electric breast pump, not an AI-assisted diagnostic or imaging device used by human 'readers'.

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

This is not applicable. The device is a physical product (breast pump), not an algorithm. The software component mentioned is for control of the device, not for independent diagnostic or analytical performance.

7. The type of ground truth used

For biocompatibility, electrical safety, EMC, software, and performance testing, the "ground truth" is defined by established international standards (ISO 10993-1, 10993-5, 10993-10; IEC 60601-1:2012; IEC 60601-1-2:2014) and predefined acceptance criteria based on those standards or engineering specifications. For comparison of certain parameters (e.g., maximum expression pressure), the predicate device's specifications served as a benchmark for substantial equivalence.

8. The sample size for the training set

This is not applicable. The device is not an AI/ML model that requires a "training set."

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

This is not applicable as there is no training set for this type of device.

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The Electric Breast Pump is intended to express and collect milk from the mother's breast, to alleviate engorgement of the breast, maintain the ability of lactation, and provide mother's milk for future feedings when separation of mother and baby occurs. The Electric Breast Pump is intended for a single user.

The Electric Breast Pump is designed, manufactured by the Guangdong Horigen Mother & Baby Products Co., Ltd. The device is intended for lactating women in a home setting for a single user. It comprises of a pump unit and the expression collection kit including tubing, and its raw materials include polypropylene, liquid and solid silicone, and thermoplastic elastomer. This electric breast pump has a negative pressure module that utilizes a single-chip microcomputer. It has multiple stimulation levels for breast massage, and multiple milk expression speed intensities. The keyboard of the control panel is soft. The screen is an LCD or LED screen, allowing for process viewing. The pump's electronic memory takes over, mimicking the rhythm. The electric breast pump is capable of providing vacuum levels from 30 to 247.5 mmHg with cycle rates up to 100 cycles per minute.

The provided document is a 510(k) K182413 FDA clearance letter and summary for an Electric Breast Pump. This type of document is for a physical medical device, not a software-based AI or diagnostic device that would involve a "test set" or "ground truth" established by experts or MRMC studies.

Therefore, many of the requested elements (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, type of ground truth, training set size and ground truth establishment for training set) are not applicable to this device and the information provided in this document.

However, I can extract the acceptance criteria and the performance testing performed to demonstrate the device meets those criteria.

Here's the information based on the provided document:

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

The document broadly states that "All of the tested parameters met the predefined acceptance criteria" in the Performance Testing section. While specific numerical acceptance criteria values are not explicitly stated in this public summary, the device's operational characteristics are described, which implies these fall within predefined acceptable ranges.

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

This information is typically not included in a 510(k) summary for a physical non-AI device. The testing described (biocompatibility, electrical safety, performance) uses established laboratory methods on physical units of the device. There isn't a "test set" of clinical data in the way you'd describe for an AI model.

• Sample Size: Not specified as a number of "cases" or "patients" but rather the physical units of the device tested in laboratory settings.
• Data Provenance: Not applicable in the context of clinical data. The tests were conducted by the manufacturer, Guangdong Horigen Mother & Baby Products Co., Ltd., which is located in 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. "Ground truth" in this context would refer to meeting engineering specifications or validated biological/electrical safety standards, not expert clinical interpretation.

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

Not applicable.

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

Not applicable. This is not an AI-assisted device.

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

Not applicable. This is a physical device, not an algorithm. Its "standalone" performance refers to its ability to meet the physical and electrical specifications independently.

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

The "ground truth" for this device's performance testing is defined by:

• International standards (ISO 10993, IEC 60601-1, IEC 60601-1-2) for biocompatibility, electrical safety, and EMC.
• FDA Guidance for software validation.
• Predefined engineering specifications (e.g., pressure ranges, cycle rates, noise levels) established by the manufacturer and accepted by the FDA as equivalent to the predicate device.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning model.

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

Not applicable.

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The Proture Double Electric Breast Pump to be used by lactating women in a home setting to express and collect milk from their breasts. This device is intended for a single user.

The Proture Double Electric Breast Pump is designed, manufactured by the Guangdong Horigen Mother & Baby Products Co., Ltd. The device is intended for lactating women in a home setting and is for a single user. It comprises a pump unit and the expression collection kit including tubing, and its raw materials include polypropylene, liquid and solid silicone, and thermoplastic elastomer.

This electric breast pump imitates baby's sucking rhythm with help of a single-chip microcomputer. It has multiple stimulation levels for breast massage, and multiple milk suction speed intensities to imitate rhythm of a baby's suction. The keyboard of the control panel is soft. The screen is an LCD, allowing for process viewing. The pump's electronic memory takes over, mimicking the rhythm. The electric breast pump is capable of providing vacuum levels from 15 to 247 mmHg with cycle rates up to 107 cycles per minute.

The Proture Double Electric Breast Pump provides the following user features:

• Closed system with anti-backflow
• LCD screen touch button operation
• 2-phase expression: Stimulation and Expression phases
• Stimulation Phase: Suction pattern with fast cycles (53-107 cycles/min) and low vacuum (15-120mmHg) to start milk flowing, 5 levels
• Expression Phase: Suction pattern with slower cycles (19~47T/min) and higher vacuum (82-247mmHg) to express milk, 9 levels
• Double-pumping ability: single or double pumping
• Dual power source: it can be operated by A/C adapter or batteries

All parts of the device that directly contact with breast and milk are to be sanitized by boiling in water for 5 minutes, followed by drying with a clean towel. After use, all parts that directly contact the breast and milk are to be cleaned in warm, soapy water.

This document provides a 510(k) summary for the Proture Double Electric Breast Pump. Let's extract the requested information based on the provided text.

Based on the provided document, the device in question is a Proture Double Electric Breast Pump. The studies conducted are primarily focused on safety and performance, comparing the device to a predicate device (Naya Breast Pump System). There is no mention of a study involving AI, human readers, or a ground truth established by medical experts for diagnostic purposes, as this is a breast pump, not a diagnostic imaging device.

Therefore, many of the requested categories (like sample size of test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth for test set, training set sample size, and how ground truth for training set was established) are not applicable to the type of device and study described here.

Here's a breakdown of the available information:

1. Table of acceptance criteria and the reported device performance:

The document mentions that "All of the tested parameters meet the predefined acceptance criteria" for performance testing, but it does not explicitly list these criteria in a table format alongside the reported device performance. It mainly discusses the types of tests conducted.

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: Not specified. The document states "Performance testing was conducted on the Proture Double Electric Breast Pump" but does not give a sample size (e.g., number of units tested).
• Data Provenance: Not specified. The manufacturer is Guangdong Horigen Mother & Baby Products Co., Ltd. in China, implying testing was likely done in China, but this is not explicitly stated. The studies are non-clinical (laboratory testing), not patient data.

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

• Not Applicable. This is a physical device (breast pump) and the "ground truth" is based on engineering and safety standards, not expert medical opinion on a diagnostic image or patient outcome.

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

• Not Applicable. As the "ground truth" is based on compliance with international standards (ISO, IEC) and engineering specifications, an adjudication method for expert consensus is not relevant.

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. This is a breast pump, not a diagnostic AI device. MRMC studies are not relevant here.

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

• Not Applicable. This is not an algorithm or AI device.

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

• For biocompatibility: Ground truth is defined by compliance with International Standards (ISO 10993-1, ISO 10993-5, ISO 10993-10) demonstrating non-cytotoxicity, non-sensitization, and non-irritation.
• For electrical safety and EMC: Ground truth is defined by compliance with International Standards (IEC 60601-1, IEC 60601-1-2).
• For performance testing: Ground truth is defined by predefined acceptance criteria based on technical parameters (working current, pressure, cycle rate, noise, vacuum level stability, use-life).
• For software: Ground truth is defined by software requirements specifications.

8. The sample size for the training set:

• Not Applicable. There is no mention of a training set as this is not an AI/machine learning device.

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

• Not Applicable. There is no mention of a training set.

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