(377 days)
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.
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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.
| Performance Characteristic | Acceptance Criteria (New Device: Rumble Tuff Electric Breast Pump) |
|---|---|
| Pumping Suction (Single Pumping Models) | 115 - 250 mmHg (PA201S, PA203S) |
| 125 - 250 mmHg (PA200S) | |
| Pumping Suction (Double Pumping Models) | 85 - 250 mmHg (PA201D, PA203D) |
| Suction Settings (Stimulation) | 8 Levels (PA201S, PA201D, PA203S, PA203D) |
| Suction Settings (Expression) | 8 Levels (PA201S, PA201D, PA203S, PA203D) |
| Adjustable Suction Level | Yes (All models) |
| Back Flow Protection | Yes (All models) |
| Let Down Function | Yes (All models) |
| Pumping Cycles (PA200S) | up to 1.67/sec |
| Pumping Cycles (PA201S) | Up to 1.83/sec |
| Pumping Cycles (PA203S) | Up to 1.11/sec |
| Pumping Cycles (PA201D, PA203D) | Up to 1.23/sec |
| Material Biocompatibility | Meets ISO 10993 standards (e.g., ISO 10993-5, ISO 10993-10) for direct and indirect patient contact. |
| Electrical Safety | Meets IEC 60601-1:2005 |
| Electromagnetic Compatibility (EMC) | Meets IEC 60601-1-2:2007 |
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.
§ 884.5160 Powered breast pump.
(a)
Identification. A powered breast pump in an electrically powered suction device used to express milk from the breast.(b)
Classification. Class II (performance standards).