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

The ISIS iQ DUO Twin Electronic Breast Pump is a safe and effective powered breast pump for expressing and collecting breast milk from the breasts of a lactating woman. The pumping can be performed on one breast or two breasts simultaneously, from independent diaphragms. The diaphragms within the pump are activated by a 12V DC electric motor controlled by a microprocessor. The device is comprised of a vacuum pump, 12V DC power supply, twin tubing with data cable, 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 powers the ISIS iQ DUO Breast Pump.

The ISIS iQ DUO Twin Electronic Breast Pump operates in two modes. In the manual mode, the user controls the frequency and level of vacuum by varying the strokelcycle 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 DUO Twin Electronic Breast Pump and its 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. This type of regulatory submission often relies on non-clinical performance data and limited clinical data to show safety and effectiveness, rather than extensive comparative effectiveness studies typical for novel medical devices or AI-powered diagnostics.

Given the nature of this submission, direct acceptance criteria in a quantitative, prescriptive manner (e.g., "sensitivity must be >90%") are not explicitly stated for individual device performance metrics in the way one might expect for a diagnostic or AI device. Instead, the "acceptance criteria" are implied by the demonstration of conformance to applicable safety and performance standards and the overall conclusion of substantial equivalence to a pre-existing legally marketed device (the Medela Pump in Style Advanced Breast Pump).

Here's an analysis based on the provided text, structured to address your specific points where information is available:

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

2. Sample size used for the test set and the data provenance

• Sample Size: 72 study subjects. This was split into:
  • 48 study subjects (24 English-speaking and 24 Spanish-speaking) for the Human Factors/Labeling Study.
  • 24 study subjects for the Home Use Study.
• Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be prospective, as they involve actively recruiting and observing subjects using the device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the text. Given that the studies assess usability and safe/effective use for a breast pump, "ground truth" in the traditional sense of a diagnostic outcome is less applicable. The "ground truth" here is more about user experience, comprehension, and the device's ability to perform its function without adverse events, which would have been assessed by study personnel rather than clinical experts establishing a medical "ground truth."

4. Adjudication method for the test set

This information is not provided in the text. For human factors and home use studies, adjudication methods (like 2+1 review) are not typically used in the same way they would be for diagnostic accuracy studies. Assessment would likely be based on reported user feedback, observation, and analysis of safety events.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices where human readers (e.g., radiologists) interpret images with and without AI assistance. The ISIS iQ DUO Twin Electronic Breast Pump is a mechanical medical device, not an AI diagnostic, therefore, this type of study is not applicable and was not performed.

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

Not Applicable. The device is a mechanical breast pump. There is no "algorithm only" performance to evaluate in the context of an AI device. Its performance relies on its mechanical and electrical function, as well as user interaction. The "microprocessor" controls the pumping cycle based on user input, not autonomously interpreting medical data.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The concept of "ground truth" as typically defined for diagnostic devices (e.g., pathology for cancer detection) is not directly applicable here. For this breast pump, the "truth" or primary endpoints assessed in the studies relate to:

• User Safety and Effectiveness: Whether users could safely and effectively operate the device and express milk. This would be observed and reported.
• Usability/Human Factors: The clarity and appropriateness of the User Guide and the device's physical design. This would be assessed through user feedback and observation.
• Conformance to Standards: Verification that the device meets defined electrical, mechanical, and biocompatibility standards.

8. The sample size for the training set

Not Applicable. This is a hardware medical device, not an AI model that requires a training set.

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

Not Applicable. As there is no AI model or training set, the concept of establishing ground truth for it is irrelevant in this context.

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