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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.

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The Kidro Digital Electric Breast Pump and Dr. Brown's Digital Electric Breast Pump are powered breast pumps to be used by lactating women to express and collect milk from their breasts. They are intended for a single user.

The Kidro Digital Electric Breast Pump and Dr. Brown's Digital Electric Breast Pump are single-user powered breast pumps capable of single pumping. The subject devices are powered by a rechargeable lithium ion battery or AC adapter. They are non-sterile. The powered breast pumps' drive unit employs a diaphragm-type vacuum pump, powered by a DC-motor, supervised by a microcontroller. The microcontroller provides control over vacuum pressure and cycle speed.

Models YY-A11, YY-A21 and YY-A41 are capable of single pumping and have two modes:

• Massage mode: Helps to relax the muscle around the breast and prepare for suction.
• Normal mode: Suction patterns are characterized by low vacuum to start milk flow.

In addition to the two modes described above, Models YY-A31, YY-A103, YY-A103, YY-A104, and BF103 are capable of single pumping and have an additional mode:

• Rapid mode: Suction patterns are characterized by high vacuum to express more milk.

Model BF100 is capable of single and double pumping and has two modes only:

• Letdown mode: Helps to relax the muscle around the breast and prepare for suction.
• Expression mode: Suction patterns are characterized by high vacuum to express more milk.

This document is a 510(k) summary for a powered breast pump (Kidro Digital Electric Breast Pump and Dr. Brown's Digital Electric Breast Pump). It describes testing conducted to demonstrate substantial equivalence to a predicate device, but it does not provide acceptance criteria or detailed study results in the format requested for an AI model evaluation.

Therefore, I cannot extract the specific information about acceptance criteria and study detailed performance as per your request because it is not present in the provided document. The document focuses on demonstrating substantial equivalence through non-clinical testing against industry standards, rather than reporting device performance against specific, quantifiable acceptance criteria with a documented study for an AI model.

Here's what I can tell you based on the document's content regarding the type of information you requested:

• Acceptance Criteria & Reported Device Performance: This information is not explicitly provided in a table or detailed study report format. The document states that "Non-clinical testing was conducted to verify that the subject devices met all design specifications, demonstrated safety based on current industry standards, and to demonstrate substantial equivalence to the predicate."
• Sample Size for Test Set and Data Provenance: Not applicable as this is a physical device, and the testing described is non-clinical bench testing.
• Number of Experts Used to Establish Ground Truth & Qualifications: Not applicable.
• Adjudication Method: Not applicable.
• Multi Reader Multi Case (MRMC) Comparative Effectiveness Study: Not applicable.
• Standalone Performance (Algorithm only): Not applicable, as this is a physical medical device, not an AI algorithm.
• Type of Ground Truth Used: Not applicable. The "ground truth" for this device would be its physical performance characteristics (e.g., vacuum, cycle speed) matching design specifications and industry standards.
• Sample Size for Training Set: Not applicable. This is not an AI/machine learning device.
• How Ground Truth for Training Set was Established: Not applicable.

Summary of Non-Clinical Testing Performed (as provided in the document):

The document lists the following categories of non-clinical testing performed:

• Electromagnetic Compatibility, Electrical Safety, and Battery Safety: Tested in compliance with ANSI/AAMI ES60601-1, IEC 60601-1-2, IEC 60601-1-11, and IEC 62133-2.
• Biocompatibility: Patient-contacting components were tested in compliance with ISO 10993-1, including cytotoxicity (ISO 10993-5), sensitization (ISO 10993-10), and irritation (ISO 10993-10).
• Software Verification: Software documentation was provided in accordance with FDA guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (May 11, 2005).
• Performance Testing (Bench testing): Conducted to demonstrate pump performance (vacuum performance, speed verification, milk collection in worst-case scenario), battery performance, backflow protection, and overflow protection using internal test protocols.

The conclusion states that these tests demonstrate the devices are "as safe and effective as the predicate device and supports a determination of substantial equivalence." However, specific numerical performance results or explicit acceptance criteria values for these tests are not detailed in this summary.

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