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The Rumble Tuff Electric Breast Pump is intended to express and collect milk from the breasts of lactating women. The Rumble Tuff Electric Breast Pump is intended for multiple users in a hospital setting. It is also intended for home use by a single user.

The Rumble Tuff electrically powered breast pumps (models PA219DM and PA210DM) are intended for multi-user use to extract milk from lactating breasts. The PA209DM model is powered by a 9V AC/DC Power Adaptor and/or built-in 7.4V Li-lon battery. The PA210DM model is powered by a 12V AC/DC Power Adaptor and does not have a batter powered option. Pumping can be performed on one breast (single pumping) or on both breasts (double pumping). The pumping system consists of a diaphragm-type vacuum pump which is driven by a microcontrolled DC electric motor. The controlling program consists of 3 phases of speed control (Reflex, Swift, and Natural) and various suction settings. The subject devices utilize an LCD screen as a user interface. All patient-contacting and breast milk-contacting materials are identical to the predicate device.

This document is a 510(k) Premarket Notification for a Rumble Tuff Electric Breast Pump (models PA209DM and PA210DM). It aims to demonstrate that this new device is substantially equivalent to a legally marketed predicate device (Rumble Tuff Electric Breast Pump K113315).

Let's break down the information to address your specific points about acceptance criteria and the study proving the device meets them.

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific quantitative acceptance criteria for a novel AI/software medical device. Therefore, many of your requested points regarding AI/algorithm performance, ground truth establishment, and MRMC studies are not directly applicable or explicitly detailed in this type of submission for a breast pump.

Instead, the "acceptance criteria" here are implicitly related to demonstrating that the new device is as safe and effective as the predicate, and that any technological differences do not raise new questions of safety or effectiveness. The "study" proving this largely relies on non-clinical tests comparing the new devices to the predicate and compliance with relevant voluntary standards.

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence submission for a physical device (breast pump), the "acceptance criteria" are primarily related to meeting performance specifications similar to the predicate and complying with relevant safety and performance standards. There isn't a table of specific AI algorithm acceptance criteria and reported AI performance as one might expect for a software-as-a-medical-device (SaMD) submission.

However, we can infer some comparative performance points:

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

• Sample Size: The document does not specify a "sample size" in the context of a clinical test set with human subjects for performance evaluation like an AI model would have. For physical devices, "testing" usually refers to bench testing, engineering validation, and compliance verification. The tests listed are non-clinical (e.g., electrical safety, vacuum performance, use life).
• Data Provenance: Not applicable in the context of clinical data for an AI/algorithm system. The "data" here would be test results from physical device measurements. No explicit mention of country of origin or retrospective/prospective for these non-clinical tests.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not applicable. This submission does not involve AI model performance evaluation requiring expert-established ground truth from medical images or clinical data. The tests are for the physical and functional aspects of a breast pump.

4. Adjudication Method for the Test Set

• Not applicable. There is no adjudication process described as it's not a clinical study involving human interpretation or subjective assessments.

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

• No. An MRMC study is relevant for evaluating the impact of AI on human reader performance, typically in diagnostic imaging. This is a breast pump, not an AI 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 breast pump. While it has a "microcontrolled DC electric motor" and a "controlling program," the submission focuses on its overall functional safety and equivalence, not on the standalone performance of its internal software/algorithm in the way one would evaluate a diagnostic AI.

7. The Type of Ground Truth Used

• Not applicable / Engineering and Regulatory Standards. The "ground truth" for this device's performance would be defined by engineering specifications, validated test methods, and compliance with the limits set by voluntary standards (e.g., IEC 60601-1 for electrical safety, ISO 14971 for risk management). For comparison to the predicate, the predicate's established performance serves as a reference.

8. The Sample Size for the Training Set

• Not applicable. This refers to machine learning models. This document describes a physical medical device.

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

• Not applicable. This refers to machine learning models.

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

The "study" in this context is a series of non-clinical tests and demonstrations of compliance with voluntary standards that support the claim of substantial equivalence.

These include:

• Risk Analysis: Developed in accordance with EN ISO 14971:2012.
• Electrical Safety Testing: In accordance with IEC 60601-1:2005-1:2005+CORR.2.2007+AM1:2012.
• Electromagnetic Compatibility Testing (EMC): In accordance with IEC 60601-1-2:2014.
• Safety Testing for Home Setting Use: In accordance with IEC 60601-1-11:2015.
• Software Verification and Validation Testing: Adhering to FDA's guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." (May 11, 2005).
• Backflow Protection Testing
• Vacuum Performance Testing
• Use Life Testing

The conclusion (Section 8) explicitly states: "The performance testing described above demonstrate that the subject devices are as safe and effective as the predicate device and supports a determination of substantial equivalence." This statement is the qualitative proof that the device meets the implicit acceptance criteria for substantial equivalence to its predicate.

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The Rumble Tuff Electric Breast Pump is an electrically powered single-user device used to express and collect milk from the breasts of lactating women. The device is not intended for hospital use.

The Rumble Tuff Electric Breast Pump is a powered Breast Pump. With different models, the Pumping can be performed on one breast or on both breasts at the same time; the Rumble Tuff Electric Breast Pump can be powered by 4 AA batteries, one 7.4V Li batteries or an AC Adapter provided with the pump. The pumping system consists of a diaphragm-type vacuum pump which is driven by a microcontroller controlled DC electric motor. Rumble Tuff Electric Breast Pump has five models; PA200S, PA201S, PA201D, PA203S, and PA203D. The suffix "S" stands for the model with single collection kit, and "D" stands for the model with dual collection kits. The user interface of PA200S uses 4 LEDs for indicating pumping cycle and uses a roller type adjuster for pumping level adjustment and indicating pumping level. Models PA201S, PA201D, PA203S, and PA203D all use the same user interface, a LCD screen for showing the pumping information; it also uses a roller type adjuster for pumping level adjustment. For all models, the user is able to control the cycle speed and vacuum level.

Given the provided document, the "acceptance criteria" and "study proving the device meets the acceptance criteria" pertain to the performance specifications of the medical device (Rumble Tuff Electric Breast Pump) and the testing conducted to demonstrate its performance and safety, primarily for substantial equivalence to predicate devices under a 510(k) submission.

Here's an analysis based on the provided text, formatted to address your specific points:

Since this document is a 510(k) summary for a breast pump, the "acceptance criteria" are the performance specifications and safety standards it must meet to be considered substantially equivalent to a legally marketed predicate device. The "study that proves the device meets the acceptance criteria" refers to the testing performed and summarized in the application to demonstrate these aspects.

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

The document provides the performance specifications for the Rumble Tuff Electric Breast Pump models. These are the reported device performance and implicitly serve as the acceptance criteria because the device is being presented as meeting these specifications for substantial equivalence.

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

The document states, "Additionally, the tests of vacuum levels and cycle speeds conducted by Acute Ideas are provided to demonstrate the performance of Rumble Tuff Electric Breast Pump."

• Sample Size: The specific sample size for performance testing (e.g., number of units tested for vacuum levels and cycle speeds) is not specified in this document.
• Data Provenance: The tests were "conducted by Acute Ideas," which is based in Taipei, Taiwan. The document does not explicitly state whether the testing was prospective or retrospective, but typically, performance verification testing for a new device submission would be prospective.

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 document describes a medical device's performance validation (a breast pump), not an AI algorithm requiring expert ground truth for interpretation (like medical images). Therefore, this question is not applicable in the context of this device and submission. Performance is measured against physical specifications and international safety standards, not expert consensus on qualitative data.

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

Not applicable for device performance testing, which involves objective measurements against specifications rather than subjective interpretation 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 breast pump, not an AI-assisted diagnostic device where MRMC studies are 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, not an algorithm. Performance is inherent to the device's mechanical and electrical functions.

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

The "ground truth" for this device primarily relies on objective physical measurements (e.g., vacuum pressure, cycle speed) against established engineering and medical device standards (e.g., IEC 60601-1, ISO 10993) and comparison to the performance of predicate devices. There is no qualitative "ground truth" in the diagnostic sense.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

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

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