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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:
• 1. Two Modes
  • Massage Mode: 5 Levels
  • Expression Mode: 8 Levels
• 2. Adjustment of vacuum level/cycles
• 3. 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.

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.

• 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.

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The MINUET LCD and MINUET LCD eco are multiple-user, powered breast pumps intended to express and collect milk from the breasts of lactating women.

The MINUET LCD and MINUET LCD eco are portable, multiple-user, powered breast pumps to be used in home or health care settings. These devices are the same, except the MINUET LCD has a rechargeable battery whereas the MINUET LCD eco does not. The devices have two major components: control unit (pump) and breast shield kit (breast shield, diaphragm, tubing, silicone massager, and bottle components). Users have the option of single or double pumping. The devices have two operating modes: massage and expression. The massage mode has seven suction levels whereas the expression mode offers nine suction levels. The vacuum strength range is 50-280 mmHq.

The provided text is a 510(k) summary for the MINUET LCD and MINUET LCD eco powered breast pumps. It describes device information, comparison to a predicate device, and non-clinical performance testing. However, it does not include specific acceptance criteria for the device's performance (such as milk expression rates, user comfort metrics, or quantitative measures of vacuum strength under various conditions beyond its range). It also does not describe a study that details how the device meets such criteria in terms of the output performance of the device.

Therefore, I cannot populate the table or answer most of the questions as the information is not present in the provided document. The document focuses on showing substantial equivalence to a predicate device through conformity to general medical device standards and qualitative comparisons of features, rather than quantitative performance against specific acceptance criteria.

Here's what I can extract based on the limitations:

1. A table of acceptance criteria and the reported device performance

No explicit acceptance criteria with quantitative performance metrics for the device's primary function (milk expression) are provided in the document. The document states "Bench tests using internal test protocols to demonstrate device performance, including vacuum level settings, speed settings, backflow/cross-contamination protection, battery operation, and use-life," but does not give the specific criteria or the results of these tests.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify sample sizes for any performance testing related to "device performance" (e.g., milk expression), nor does it mention the data provenance (country of origin, retrospective/prospective). The studies mentioned are primarily engineering and safety tests (biocompatibility, electrical safety, EMC, battery safety, software V&V).

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. This device is not an AI/imaging device requiring expert ground truth establishment in the way a diagnostic tool would. The studies conducted are primarily focused on hardware, software, and material safety and functionality.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessments, which are not described here for performance evaluation.

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 not an AI-powered diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI algorithm.

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 validated test methods and reference standards (e.g., ISO for biocompatibility, IEC for electrical safety). For example, for biocompatibility, the ground truth is the pass/fail criteria defined within the ISO standards. The document does not describe specific performance ground truth for milk expression efficacy.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set.

9. How the ground truth for the training set was established

Not applicable. This is not an AI/machine learning device.

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