(149 days)
The Elvie Stride is a powered breast pump to be used by lactating women to express and collect milk from their breasts. The Elvie Stride is intended for a single user.
Elvie Stride is an electric breast pump that is intended for lactating women to express and collect breast milk. It is intended for a single user. It may be operated as a single or double pumping system. Elvie Stride has adopted the in-bra aesthetic. It is designed to work in the user's nursing bra and has a rechargeable battery so it can be used hands-free without any external power cords. The pump is located off the body and the milk collection bottle is located on the breast. It expresses milk by applying negative pressure to the nipple so that expressed milk may collect in the milk collection bottle. It can be controlled through the physical interface on the pump or through a mobile companion app. Elvie Stride consists of 15 components: Hub, Breast Shield, Cup Front, Diaphragm Seal, Valve, Stopper, Tubing, Tube Splitter, Hub Connector, Cover, Cup Seal, Cap, Cap Seal, Clip and USB Charging Cable. All components are reusable and may be manually cleaned or placed on the top shelf of a dish washer.
This document is a 510(k) premarket notification for the Elvie Stride, a powered breast pump. It primarily focuses on demonstrating substantial equivalence to a predicate device (Elvie Pump K181863), not on clinical performance studies that would typically involve acceptance criteria for an AI/software as a medical device (SaMD).
Therefore, the provided text does not contain the information required to answer the prompt regarding acceptance criteria and the study proving a device meets those criteria, specifically in the context of an AI/SaMD.
The document details:
- Device Type: Powered breast pump (hardware device, not an AI/SaMD).
- Approval Type: 510(k) Premarket Notification, which relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel clinical performance against pre-defined acceptance criteria for, say, diagnostic accuracy.
- Non-Clinical Testing: Biocompatibility, electrical safety, electromagnetic compatibility, wireless technology, software verification (for the breast pump's internal software, not an AI for diagnosis), and performance testing (e.g., vacuum pressure, cycle rate, backflow, battery life).
To illustrate, if this were an AI/SaMD for, for example, breast cancer detection, the information I would expect to find (but is absent here) would be:
- A table of acceptance criteria and the reported device performance: This would list metrics like sensitivity, specificity, AUC, or F1-score with defined thresholds and the actual values achieved in a clinical study.
- Sample size and data provenance: Details on the number of images/cases in the test set, their origin (e.g., US hospitals, European clinics), and whether the data was collected retrospectively or prospectively.
- Number of experts and qualifications for ground truth: How many radiologists or pathologists reviewed the data to establish the definitive diagnosis, and their experience levels.
- Adjudication method: How disagreements among experts were resolved (e.g., majority vote, senior expert review).
- MRMC study and effect size: If human performance with and without AI assistance was compared, and the quantitative improvement.
- Standalone performance: The AI's performance without human intervention.
- Type of ground truth: Whether it was expert consensus, biopsy-confirmed pathology, or long-term clinical outcomes.
- Training set sample size: How many cases were used to train the AI.
- Ground truth for training set: How the training data labels were established.
Since the provided document is for a physical breast pump and not an AI/SaMD, none of this detailed information about AI performance or clinical study design elements for AI validation is present. The "Testing" section refers to engineering and safety tests for the breast pump itself, not diagnostic performance of an AI.
§ 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).