(154 days)
The OPERA and OPERA eco are multiple-user, powered breast pumps intended to express and collect milk from the breasts of lactating women.
The OPERA & OPERA eco are multiple-user, powered breast pumps intended to express and collect milk from the breasts of lactating women. The OPERA eco are provided non-sterile. Two models are available; Opera and Opera eco.
- "OPERA" (pink color): powered by the adapter (AD/DC adapter, INPUT: AC 100 ~240V, . 50/60Hz, OUTPUT: DC14V, 2A) or by the internal battery (Rechargeable Lithium polymer battery, 11.1 V, 2200 mAh).
- . "OPERA eco" (blue color): powered by the adapter (AD/DC adapter, INPUT: AC 100 ~240V, 50/60Hz, OUTPUT: DC14V, 2A).
The OPERA & OPERA eco consists of a group of hardware and software components. The hardware component(s) consist of: - Opera or Opera eco pump body ●
- Breast Shield Set (Breast shield, K-POP Diaphragm, Bottle Disk, Bottle Cover, Bottle ● Cap, Bottle, Nipple, White Valve, Diaphragm Cap, Air Tube Connector, Silicone Massager)
- Adaptor
The OPERA & OPERA eco provide the following user features: -
- Two Modes
- Massage Mode: 5 Levels
- Expression Mode: 8 Levels
-
- Adjustment of vacuum level/cycles
-
- LCD Display, for user assistance/device status
Principle and Theory of Operation:
The Opera and Opera eco generate negative pressure on the breast and it moves diaphragm up and down to express and collect milk from the breasts of lactating women. To prevent backflow of breastmilk, Opera & Opera eco include a backflow protector on the top of breast shield. The inserted diaphragm blocks the upper side and bottom side of breast shield, which are the pathway of air and the breastmilk.
- LCD Display, for user assistance/device status
This document is a 510(k) Premarket Notification from the FDA for a powered breast pump. It primarily focuses on demonstrating substantial equivalence to a predicate device, rather than providing details on a study proving a device meets specific clinical acceptance criteria.
Therefore, many of the requested details about acceptance criteria, study design, expert involvement, and ground truth cannot be fully provided from this document.
However, based on the information available, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state clinical "acceptance criteria" in terms of performance metrics like accuracy, sensitivity, or specificity, as one might find for diagnostic devices. Instead, the acceptance criteria are demonstrated through compliance with established standards and performance tests confirming device functionality and safety.
| Acceptance Criteria Category | Reported Device Performance (Summary from studies) |
|---|---|
| Electrical Safety | Complies with IEC 60601-1:2005/AM1:2012 |
| Electromagnetic Compatibility (EMC) | Complies with IEC 60601-1-2:2014 |
| Home Healthcare Environment Safety | Complies with IEC 60601-1-11:2015 |
| Software Validation (Moderate Concern Level) | Designed and developed according to a software development process; verified and validated according to FDA guidance "The content of premarket submissions for software contained in medical devices, published on May 11, 2005". |
| Biocompatibility | Assessed per ISO 10993 |
| Device Performance (Bench Tests) | Demonstrated acceptable performance for: |
- Vacuum level settings
- Speed settings
- Backflow/cross-contamination protection
- Battery operation (for OPERA model)
- Use-life |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This document details bench testing and compliance with standards, not clinical studies involving human subjects or patient data. Therefore, the concept of a "sample size for the test set" (in a clinical sense) and "data provenance" (like country of origin of clinical data, retrospective/prospective) is not applicable here. The testing involves validating the physical device and its software's performance against specifications and standards.
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. The ground truth for this type of device (a powered breast pump) is established by engineering specifications, international safety and performance standards (like IEC and ISO), and the device's ability to consistently meet these predefined technical parameters. There is no mention of human experts establishing a clinical "ground truth" for the device's function in this context.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable, as this is not a clinical study involving human assessment of outcomes that would require an adjudication method.
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 medical device approval for a powered breast pump, not an AI-assisted diagnostic tool. No MRMC study or AI component is mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable, as this device does not involve an algorithm with "standalone" performance in the context of AI or diagnostic interpretation. The device's operation regarding vacuum and speed settings can be considered "standalone" in its mechanical function, but this is not an algorithm in the sense typically asked about for AI/ML devices.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance tests (bench tests) would be the established technical specifications and parameters for vacuum levels, cycle ranges, electrical safety, EMC, biocompatibility, and software functionality, as defined by relevant international standards (IEC, ISO) and the manufacturer's design requirements.
8. The sample size for the training set
Not applicable. This device does not use machine learning or AI that would require a "training set."
9. How the ground truth for the training set was established
Not applicable. No training set is used.
§ 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).