(16 days)
The Symphony breast pump is a powered breast pump to be used by lactating women to express and collect milk from their breast.
The Symphony Powered Breast Pump is intended to express the mother's milk of a lactating woman. The pumping can be performed on one breast or on both breasts at the same time. A DC motor is employed to drive both diaphragm pumps, one for each breast. The diaphragm pumps create the negative pressure (suction), required to extract the breast milk. Because the motor is controlled by a programmable microcontroller, the mother can potentially select from a number of pumping (suction) programs. The pumping programs are stored on separate pumping cards, which are inserted into the Breast Pump, prior to operating the device. The card is similar in size to a credit card.
The Symphony Powered Breast Pump employs a control knob, for the user to adjust the applied vacuum. The breast pump is capable of providing vacuum levels from 0 to 200 mmHg, constant or variable; 7 to 110 cycles per minute. Configured with a specific pumping card, the breast pump will provide a "Stimulation" mode of fast cycles along with an "Expression" mode of slower cycles.
All materials with milk contact or components with human breast contact are manufactured from materials that meet the appropriate FDA and international regulations concerning food contact and/or biocompatibility.
The provided text is a 510(k) submission for the Medela® Symphony® Breastpump, which is a regulatory document seeking clearance for a medical device. This type of document focuses on demonstrating substantial equivalence to existing devices rather than presenting detailed studies with acceptance criteria, sample sizes, and expert adjudications in the way an academic clinical trial report would.
Therefore, the requested information, specifically acceptance criteria for device performance, details of a study proving the device meets those criteria, sample sizes, expert qualifications, and ground truth establishment, is largely not present in this regulatory submission.
However, I can extract what is available and explain why other details are missing.
Here's an attempt to answer your questions based only on the provided text:
1. A table of acceptance criteria and the reported device performance
This document describes the device's technical characteristics and intended use, but does not specify quantifiable acceptance criteria such as performance metrics (e.g., milk expression rate, vacuum stability, noise level) or present a table of reported device performance against such criteria. The submission aims to show substantial equivalence to predicate devices, implying that its performance is comparable, but not necessarily measured against a rigid set of acceptance criteria within this document.
The document mentions:
- "The breast pump is capable of providing vacuum levels from 0 to 200 mmHg."
- "Configured with a two-phase pumping, the breast pump will provide a "Stimulation" mode of fast cycles along with an "Expression" mode of slower cycles."
These are descriptive features, not acceptance criteria with measured performance data.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not available. The document does not describe a test set or clinical study with sample sizes. It is a technical submission for regulatory clearance based on substantial equivalence.
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/Not available. There is no mention of a test set requiring expert ground truth establishment for performance evaluation in this document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable/Not available. As no test set for performance evaluation is described, no adjudication method is mentioned.
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 device is a breast pump, not an AI-assisted diagnostic or imaging device used by human "readers." Therefore, an MRMC comparative effectiveness study is not relevant to this product.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a powered breast pump that assists a human user, a lactating woman, in expressing milk. It does not operate as an algorithm-only standalone system in the way a diagnostic AI would. Its performance is inherent in its mechanical operation and interaction with the user.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable/Not available. For a breast pump, "ground truth" would typically relate to its ability to express milk effectively and safely. This document asserts the device's intended use is to "express and collect the mother's milk," and that based on its characteristics, it is "safe and effective for the intended use, and is substantially equivalent to the predicate devices." No specific "ground truth" methodology is detailed in this regulatory filing.
8. The sample size for the training set
Not applicable/Not available. The document does not mention any "training set" as it would be understood for an AI/machine learning device. The design and engineering would have involved typical product development and testing, but not in the format of a training set for an algorithm.
9. How the ground truth for the training set was established
Not applicable/Not available. As no training set is mentioned, this information is not provided.
Summary of what is available: Substantial Equivalence Basis
The core of this 510(k) submission is to demonstrate substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical trial.
- Predicate Devices:
- Conclusion: "Based upon the information presented above, it is concluded that the proposed Medela Symphony® breast pump is safe and effective for the intended use, and is substantially equivalent to the predicate devices."
- Technological Characteristics: "The technology of the Symphony® powered breast pump is identical to the predicate devices and the minor differences in technology do not raise new aspects regarding safety and effectiveness." (Note: The provided text has a typo, saying "perceive areast particle" instead of "powered breast pump" in this section, but the intent is clear from context).
- Intended Use: "The Symphony Powered Breast Pump is intended to express and collect the mother's milk from the breasts of a lactating woman, thus identical to the predicate devices."
The regulatory clearance (K020518 letter) confirms that the FDA reviewed the submission and found the device "substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices." This substantial equivalence finding allows the device to be marketed without requiring a Pre-Market Approval (PMA), which would typically involve more extensive clinical trials and explicit acceptance criteria demonstration.
§ 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).