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The Hygeia Express Powered Breast Pump is a powered breast pump intended to express and collect milk from the breasts of a lactating woman. It is intended for a single user only.

The Hygeia Express Powered Breast Pump 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 device consists of a pump, Personal Accessory Set (PAS) pumping kit, and an AC adapter. The pump is also configurable with a wearable PAS kit which allows milk to flow into a cup pressed against the breast during use. It does not incorporate off-the-shelf (OTS) software or wireless technology/mobile app software functionality. The Hygeia Express Powered Breast Pump has a backlit LCD display, which shows pumping mode, suction level, timer, and battery level. The device also has four buttons allowing the user to power the device on/off, select between three pumping modes (massage, expression, and stimulation), and control vacuum strength within each mode (9 levels of vacuum strength in each mode). The pump is powered by an internal, non-replaceable, rechargeable lithium-ion battery which is charged using the included AC power supply and cable. The subject device can be operated while plugged into AC power. The breast pump uses cyclic negative pressure (suction) to mimic the suckling patterns of a feeding infant. A DC motor drives a membrane vacuum pump to generate the suction required to stimulate and express breast milk. The timing of this pattern is dependent upon the suction/speed settings selected by the user and is preprogrammed in the device. The device is capable of producing peak suction levels between -50 and -250 ± 25 mmHg in at speeds between 20 and 150 ± 5 cycles per minute. There are 3 available pumping modes with 9 distinct levels of vacuum and cycle speed. When connected to the pump, the PAS 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. All other components (i.e., motor unit) of the subject device are not in contact with the breast. All milk contacting components are compliant with 21 CFR 174-179.

The provided text is a 510(k) summary for the Hygeia Express Powered Breast Pump, which is a medical device. This document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than providing a detailed study that proves the device meets specific acceptance criteria in the context of diagnostic or AI-powered devices.

Therefore, the requested information elements (acceptance criteria, study details, sample size, expert ground truth, MRMC study, standalone performance, training set details) are not applicable to this type of regulatory submission as they relate to the evaluation of a diagnostic or AI device's performance against clinical endpoints.

Instead, the document details non-clinical performance testing to ensure the device meets safety and functional requirements. Here's a breakdown of the relevant information provided:

1. A table of acceptance criteria and the reported device performance: This document does not present a table of specific acceptance criteria in the format usually seen for diagnostic performance (e.g., sensitivity, specificity, AUC). Instead, it describes general compliance with standards and successful completion of various engineering and safety tests.

   Reported Device Performance (Functional/Safety Aspects):

   • Vacuum Levels (Massage): 50-170 ± 25 mmHg
   • Vacuum Levels (Expression): 70-250 ± 25 mmHg
   • Vacuum Levels (Stimulation): 70-250 ± 25 mmHg
   • Cycles per minute (Massage): 70-150 ± 5 cpm
   • Cycles per minute (Expression): 36-136 ± 5 cpm
   • Cycles per minute (Stimulation): 20-33 ± 5 cpm
   • Overall Peak Suction: -50 to -250 ± 25 mmHg
   • Overall Speed: 20 to 150 ± 5 cycles per minute
   • Biocompatibility: Compliant with ISO 10993-1
   • Electrical Safety: Compliant with ANSI/AAMI ES60601-1:2005/A2:2010, IEC 62133-2:2017, and IEC 60601-1-11:2015
   • Electromagnetic Compatibility: Compliant with IEC 60601-1-2:2014
   • Software Evaluation: Evaluated at the Basic Documentation level per FDA guidance.
   • Vacuum level verification testing: Demonstrated that the devices meet mode/cycle specifications.
   • Backflow protection testing: Verified liquid does not backflow into the tubing.
   • Use life testing: Demonstrated that the device maintains its specifications throughout its proposed use life.
   • Battery performance testing: Demonstrated that the battery remains functional during its stated battery use-life.
   • Battery status indicator testing: Demonstrated that the battery status indicator remains functional during its stated battery life.

2. Sample size used for the test set and the data provenance: Not applicable. This document refers to non-clinical engineering and safety testing, not a test set of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth from experts is not established for an electrical breast pump's functional and safety testing.

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 a breast pump, not an AI-assisted diagnostic 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 evaluation is primarily based on industry standards (e.g., electrical safety, biocompatibility, EMC) and the device's design specifications for vacuum levels and cycles. No clinical ground truth from patient outcomes or pathology is mentioned as this is a functional device, not a diagnostic one.

8. The sample size for the training set: Not applicable. This device does not use machine learning that requires a training set of data.

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

Summary of the Study that Proves the Device Meets the Acceptance Criteria:

The "study" described is a series of non-clinical performance tests conducted in accordance with recognized industry standards and FDA guidance documents. These tests evaluate the device's physical and electrical characteristics, its ability to function as intended, and its safety. The document states that "The results of the performance testing described above demonstrate that the Hygeia Express Powered Breast Pump is as safe and effective as the predicate device and supports a determination of substantial equivalence."

The specific non-clinical tests cover:

• Biocompatibility: To ensure materials in contact with the body are safe.
• Electrical Safety: To ensure the device operates safely electrically.
• Electromagnetic Compatibility (EMC): To ensure the device doesn't interfere with or is interfered by other electronic devices.
• Software Evaluation: To ensure the integrated software functions correctly and safely (evaluated at a "Basic Documentation level" as recommended for this type of device).
• Performance Testing (Specific to Breast Pumps):
  • Verification of vacuum levels at each mode/cycle (Massage, Expression, Stimulation) against specifications.
  • Backflow protection testing to prevent milk contamination.
  • Use life testing to demonstrate durability over its expected lifetime.
  • Battery performance and status indicator testing to ensure reliable power.

The overall "acceptance criterion" is demonstrated substantial equivalence to a legally marketed predicate device (Electric Breast Pump, K211024) by showing that the subject device's differences in technological characteristics (mainly vacuum/cycle specifications) "do not raise different questions of safety and effectiveness" and that it passes the specified non-clinical performance tests.

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The FIT Pro Breast Pump is a single-user, powered breast pump intended to express and collect milk from the breasts of lactating women.

The FIT Pro Breast Pump is an electric breast pump powered by an external AC-DC power supply or by an internal rechargeable lithium-ion battery. The device is provided non-sterile. The device is intended to be used by lactating women to express and collect milk from their breasts. Pumping can be performed on either one breast (single pumping) or both breasts at the same time (double pumping). The FIT Pro Breast Pump utilizes a DC-powered motor driving a diaphragmtype vacuum pump and an electromechanical solenoid which are controlled electronically to provide a range of user-selectable vacuum (suction) levels at various pre-determined cycle frequencies. The FIT Pro Breast Pump has a backlit LCD display, which shows pumping mode, suction level, timer, and battery level. The device also has four softtouch buttons allowing the user to power the device on/off, switch between stimulation and expression pumping modes, and control vacuum strength within each mode (6 levels of vacuum strength in stimulation mode and 12 levels in expression mode). The FIT Pro Breast Pump is intended for a single user in the home environment. When properly connected, the Hygeia PAS 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 base model of the FIT Pro Breast Pump contains a pump, pumping kit, AC adapter with detachable USB-C cable, and a lanyard.

This document is a 510(k) summary for the FIT Pro Breast Pump, a medical device. It does not describe an AI medical device or software. Therefore, the requested information about acceptance criteria and study details for an AI/software device cannot be extracted from this document, as it does not pertain to such a device. This document focuses on the substantial equivalence of the breast pump to a predicate device, based on non-clinical performance testing.

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The Evolve breast pump is intended to be used by lactating women to express and collect milk from their breasts.

The Evolve Breast Pump, the subject device, is an electrically powered breast pump from an external AC-DC power supply or internal, rechargeable batteries; the device is provided non-sterile. The subject device is a cordless version of the predicate device.

The Evolve Breast Pump is intended to be used by lactating women to express and collect mills from their breasts. Pumping can be performed on one breast (single pumping) or on both breasts of a lactating woman at the same time (double pumping). The breast pump is designed as a multi-user breast pump and is available as a cordless model powered by an internal, rechargeable Lithium lon battery or an external AC-DC power supply.

The Evolve Breast Pump utilizes a DC-powered motor driving a reciprocating-type vacuum pump and an electromechanical solenoid which are controlled electronically to provide vacuum (suction) capability that extracts and collects milk from breasts of lactating women.

The Evolve Breast Pump has a backlit, LCD display. The subject device also has soft-touch buttons for the user to power the device on/off, switch between two different pumping modes - stimulation and expression – and to control vacuum speed and strength within each of the modes. Multiple vacuum speed and strength settings are available in both pumping modes.

The Evolve Breast Pump is intended for repeated use by multiple users in the home environment.

The Evolve Breast Pump requires Hygeia's Personal Accessory System for users to express and collect milk from their breasts.

The provided text is related to an FDA 510(k) premarket notification for a medical device: an Evolve Breast Pump. This document is a regulatory submission demonstrating substantial equivalence to a legally marketed predicate device, not a study proving device performance against acceptance criteria for an AI/ML powered device.

Therefore, the requested information about acceptance criteria, study design for AI, sample sizes, ground truth establishment, expert adjudication, MRMC studies, or standalone algorithm performance cannot be extracted from this document, as it pertains to a different type of medical device submission and evaluation.

The document discusses the following:

• Device: Evolve Breast Pump (K200406)
• Predicate Device: Hygeia Evolve Breast Pump (K190465)
• Key Modification: Addition of an internal rechargeable Lithium Ion battery for cordless operation.
• Performance Data Summary:
  • Risk Analysis (ISO 14971:2007)
  • Electrical Safety (IEC 60601-1:2005 with AAMI/ANSI ES60601-1:2005/(R)2012 and A1:2012 deviations)
  • Electromagnetic Compatibility (IEC 60601-1-2: 2014)
  • Performance Testing: Measurement of vacuum and cycles for minimum and maximum settings in both single and double pumping modes, and for stimulation and expression modes. It also verified battery energy capacity and operation time.
• Conclusion: The performance testing demonstrates that the Evolve Breast Pump is substantially equivalent to the predicate device.

This submission focuses on engineering and safety performance rather than the diagnostic or predictive performance that would be associated with AI/ML devices. Therefore, the specific questions regarding AI/ML performance metrics, ground truth, and expert adjudication are not applicable to this document.

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The Evolve breast pump is intended to be used by lactating women to express and collect milk from their breasts.

The Evolve Breast Pump, is an electrically powered breast pump from an external AC-DC power supply; the device is provided non-sterile. The Evolve Breast Pump is intended to be used by lactating women to express and collect milk from their breasts. Pumping can be performed on one breast (single pumping) or on both breasts of a lactating woman at the same time (double pumping). The Evolve breast pump is designed as a multi-user breast pump and available in a corded model (external AC-DC power supply). The Evolve Breast Pump utilizes a DC-powered motor driving a reciprocating-type vacuum pump and an electromechanical solenoid which are controlled electronically to provide vacuum (suction) capability that extracts and collects milk from breasts of lactating women. The Evolve Breast Pump has a backlit, LCD display for user display. The subject device also has soft-touch buttons for the user to power the device on/off, switch between two different pumping modes - stimulation and expression - and to control vacuum speed and strength within each of the modes. Multiple vacuum speed and strength settings are available in both pumping modes. The Evolve Breast Pump is intended for repeated use by multiple users in home environment. The Evolve Breast Pump requires Hygeia's Personal Accessory System for users to express and collect milk from their breasts.

The provided text describes a 510(k) premarket notification for the Evolve Breast Pump (K190465), comparing it to a predicate device, the Hygeia EnDeare Breast Pump (K081932).

However, the document does not contain information about specific acceptance criteria or a study proving the device meets those criteria in the context of diagnostic performance (e.g., sensitivity, specificity, accuracy) which would typically be relevant for AI/ML devices. This is a breast pump, not a diagnostic device.

Instead, the "acceptance criteria" for a breast pump would relate to its functional performance, electrical safety, electromagnetic compatibility, and software/firmware robustness. The "study" proving it meets these criteria refers to the non-clinical performance data provided to the FDA.

Based on the provided text, here's an attempt to answer your questions, interpreting "acceptance criteria" and "study" in the context of a breast pump's regulatory submission:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly state "acceptance criteria" in a tabulated format with corresponding performance for each criterion. Instead, it describes general performance specifications that were met. Below is a reconstruction based on the information provided, focusing on the functionality of the breast pump.

The document states, "Specifications were met and within required, acceptable range for pump operation, cycle rate, and vacuum pressure."

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

The document does not specify a "test set" in the context of patient data or clinical imaging for AI/ML. For this medical device (a breast pump), the "testing" involves hardware and software performance.

• Sample Size: Not applicable in the traditional sense of patient data. Testing was performed on the device itself.
• Data Provenance: Not applicable. The testing was non-clinical, likely conducted by the manufacturer in a lab environment.

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

Not applicable. The ground truth for a breast pump's performance is objective measurement against engineering specifications (e.g., vacuum pressure, cycle rate, electrical safety standards). It does not involve expert interpretation of medical data.

4. Adjudication Method for the Test Set

Not applicable. This is not a diagnostic device requiring adjudication of expert interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a breast pump, not an AI-assisted diagnostic device. No human readers or AI assistance are involved in its primary function.

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

Not applicable. While the device contains firmware/software, the "standalone" performance concept typically applies to AI algorithms whose output is a diagnosis or risk assessment. Here, the "standalone" performance would be the pump's mechanical and electronic function, which was tested.

7. The Type of Ground Truth Used

The "ground truth" for the performance data in this submission is based on:

• Engineering Specifications and Measurements: Direct physical measurements of vacuum (mmHg) and cycle rates (CPM) against predefined ranges.
• Regulatory Standards: Compliance with international and national standards for electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), and risk management (ISO 14971).
• Software Verification & Validation Best Practices: Adherence to FDA guidance for software in medical devices.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a "training set" of data in the typical sense. The firmware/software development process would involve iterative testing and refinement, but not "training" on a dataset to learn patterns.

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

Not applicable, as there is no "training set" in the context of AI/ML. The firmware's functionality is designed and verified against established engineering principles and requirements, not learned from a dataset with pre-established ground truth labels.

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