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The ISIS iQ UNO Handheld Electronic Breast Pump is intended to express and collect milk from the breasts of a lactating woman.

The ISIS iQ UNO Handheld Electronic Breast Pump is a safe and effective powered breast pump used for expressing and collecting breast milk from the breasts of a lactating woman. The diaphragm within the pump is activated by a 6V DC electric motor controlled by a microprocessor. The device is comprised of a vacuum pump, 6V DC power supply, hand controller, Avent ISIS standard manual breast pump parts, and feeding bottles. The hand controller is designed to replicate the handle of the Avent standard manual ISIS Breast Pump, and is used to control the frequency and level of vacuum. A sealed AC/DC transformer or a battery pack powers the ISIS iQ UNO Breast Pump.

The ISIS iQ UNO Handheld Electronic Breast Pump operates in two modes. In the manual mode, the user controls the frequency and level of vacuum by varying the stroke/cycle of the control handle lever. After a comfortable manual pumping cycle has been established, the user engages the automatic pumping mode by depressing the control button on the hand controller. In the automatic mode, the pumping cycle is stored and controlled by the microprocessor. The user can switch between the automatic mode and manual mode at any time by repeatedly depressing the control button.

All milk-contacting and human tissue-contacting components are manufactured from materials that meet the appropriate regulations regarding food contact and/or biocompatibility.

The provided text describes the ISIS iQ UNO Handheld Electronic Breast Pump and its 510(k) submission, not a study involving a device that meets acceptance criteria with reported performance metrics like sensitivity or specificity. This document is a regulatory submission demonstrating substantial equivalence to predicate devices, rather than a performance study.

Therefore, many of the requested sections (Table of acceptance criteria, sample sizes, number of experts, adjudication methods, MRMC study, standalone performance, ground truth types for test and training sets) cannot be fulfilled from the provided text, as they pertain to performance studies that were not conducted for this device.

Here's an analysis based on the information available:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. The submission focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and compliance with electrical, mechanical, environmental, food-contact, and biocompatibility standards, rather than defining and meeting specific performance acceptance criteria like accuracy, sensitivity, or specificity.

2. Sample Size Used for the Test Set and Data Provenance

No test set for performance was used as no clinical studies were performed (as stated in Section 8.9).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable as no clinical studies were performed and therefore no ground truth establishment was needed for device performance evaluation.

4. Adjudication Method for the Test Set

Not applicable as no clinical studies were performed.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study was done. The document explicitly states, "No clinical studies were performed."

6. Standalone (Algorithm Only) Performance Study

No standalone performance study was done. The device is a physical breast pump, not an algorithm. The document explicitly states, "No clinical studies were performed."

7. Type of Ground Truth Used

Not applicable as no clinical studies were performed.

8. Sample Size for the Training Set

Not applicable as no clinical studies were performed and this is a physical device, not an AI/ML algorithm.

9. How the Ground Truth for the Training Set Was Established

Not applicable as no clinical studies were performed.

Summary of Non-Clinical Performance Data (as provided in Section 8.8):

While not framed as "acceptance criteria" for a performance study, the device met the following standards, which serve as its non-clinical acceptance criteria for regulatory clearance:

The study that "proves the device meets the acceptance criteria" in this context is the non-clinical testing that demonstrated compliance with these listed electrical, mechanical, environmental, and material standards. This testing was conducted by the manufacturer, Avent America, Inc., and the results were submitted as part of their 510(k) premarket notification (K052047). The FDA reviewed these non-clinical performance data and the technological characteristics, concluding that the device is safe and effective and substantially equivalent to predicate devices, thus allowing it to be marketed. No specific details about the methodology or sample sizes for this non-clinical testing are provided in the summary.

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