(30 days)
The Annabella Double Breast Pump is a powered breast pump to be used by lactating women to express and collect milk from their breasts. The Annabella Double Breast Pump is intended for a single user.
The Annabella Double Breast Pump is a double, electric breast pump system intended to express and collect milk from the breasts of lactating women. Each pump is comprised of a vacuum unit including tubing (connected to a hybrid cable with a "Y" connector) and a massage unit (tongue mechanism) that mimics the baby's sucking motions. The Y hybrid cable delivers the vacuum from the vacuum unit through the Y splitter to both massage units. The user employs buttons on the vacuum unit to control the vacuum intensity levels, suction rate as well as the massage unit speed and location on the breast. The device is supplied with a reusable and adjustable breast shield, a bottle, bottle lids and a charger. The Annabella is a rechargeable Li-ion battery operated device that contains software. The device cannot be operated while connected to the mains AC Power core.
The battery compartment is at the bottom of the pump motor unit and is covered by a battery door. The runtime of the removable lithium-ion battery is influenced by the number and duration of pumping sessions and lasts usually for one day.
The device is to be used in the home.
The provided text describes the Annabella Double Breast Pump (K241506) and its comparison to a predicate device (Annabella Breast Pump K230672). It outlines performance data from non-clinical tests but does not specify acceptance criteria in a quantitative table or directly present reported device performance against such criteria. Instead, it lists the types of tests performed to demonstrate substantial equivalence to the predicate device.
Given the information, here's an attempt to answer your questions based on the provided text.
1. A table of acceptance criteria and the reported device performance
The document does not provide a specific table of acceptance criteria with quantitative values and corresponding reported device performance. It only states that "Non-clinical tests were conducted to verify that the subject device met all design specifications to be considered substantially equivalent to the predicate device."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The text describes only non-clinical performance testing, which typically involves testing of prototype devices or components rather than human subjects. Therefore, the concepts of "sample size used for the test set" and "data provenance (country of origin, retrospective/prospective)" as they relate to human subjects or clinical data are not applicable here. The tests mentioned include:
- Electrical Safety Testing
- Electromagnetic compatibility testing
- Software Verification
- Biocompatibility (leveraged from predicate device testing)
- Vacuum level/suction strength testing
- Battery performance testing
- Battery status indicator testing
- Device use life testing
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 question is not applicable as the study involves hardware and software performance testing of a medical device, not a diagnostic or AI-driven system requiring expert ground truth for interpretation of medical images or data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable for the same reasons as #3.
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
No MRMC study was conducted. The device is a breast pump and does not involve AI assistance for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not directly applicable in the context of a breast pump. However, the "Software Verification" was performed according to IEC 62304 and FDA guidance, indicating an assessment of the software's standalone performance and safety within the device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests mentioned, the "ground truth" would be established by:
- Industry standards and regulations: e.g., IEC 60601-1, IEC 60601-1-11, IEC 60601-1-2, IEC 62304.
- Design specifications: The device was tested to verify it met "all design specifications."
- Predicate device characteristics: The subject device's performance (e.g., suction levels, cycle speeds) was compared to that of the predicate device.
8. The sample size for the training set
This question is not applicable as this is not an AI/ML-driven diagnostic device that requires a training set. The software verification focuses on life cycle processes and compliance.
9. How the ground truth for the training set was established
This question is not applicable for the same reasons as #8.
§ 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).