(202 days)
The VIVACE is a powered breast pump intended to express and collect milk from the breasts of lactating women. The VIVACE is intended for single user and multiple users in home and healthcare environments.
The VIVACE is a powered breast pump intended to express and collect milk from the breasts of lactating women. The device is intended for daily use in a home or health care and by a single user and multiple users. VIVACE is both AC- powered battery-powered. The AC adapter uses a 100-240 VAC, 50/60Hz, 1.0A adapter, and the battery is a rechargeable Li-ion battery with specifications of 11.1V, 2200mAh, 24.4Wh. VIVACE is comprised of a flange, breast shield body, wide adapter, diaphragm cover, white valve, bottle cover, cap, disk, bottle, adapter, air tube, main body, nipple, and instruction manual. VIVACE supports a single pumping mode in which only one breast is expressed and a double pumping mode in which both breasts are expressed. The double pumping mode is divided into a synchronous mode that expresses at the same time and an alternative mode that expresses on both sides alternately. The vacuum provided covers a range of pressures from 50 mmHg, and cycle speeds (cycles/min) from 20 to 80 cycles/min. The device is provided non-sterile.
I am sorry, but the provided text is a 510(k) summary for a powered breast pump (VIVACE) and does not contain the specific information requested about acceptance criteria and a study proving a device meets them, especially in the context of AI/ML or diagnostic performance.
The document focuses on:
- Regulatory clearance (510(k) for a medical device).
- Comparison to a predicate device (OPERA) for substantial equivalence.
- Non-clinical performance testing: Biocompatibility, electrical safety, electromagnetic compatibility, software evaluation, and general performance tests (vacuum level, backflow protection, use life, battery performance, multi-user cross-contamination).
It does not include:
- A table of acceptance criteria and reported device performance for a diagnostic or AI-driven system.
- Details about sample sizes for test sets, data provenance, or ground truth establishment for AI/ML performance.
- Information about expert adjudication, MRMC studies, standalone AI performance, or training set details.
Therefore, I cannot fulfill your request for these specific details based on the provided text.
§ 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).