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The imani i2Plus Breast Pump is a powered breast pump to be used by lactating women to express and collect milk from their breast. The imani i2Plus Breast Pump is a single user device.

The imani i2Plus Breast Pump is an electrically powered wearable single breast pump consisting of the following key components: a funnel, insert, milk collector, valve, protector, charging cable, adaptor, cap, and iBox accessory. It is designed to work in the user's bra and has a rechargeable battery so it can be used hands-free. The main body includes a press-button user interface, pump body, and LCD display. Pumping can be performed on one breast (single pumping) or two breasts (double pumping) when configured with the iBox accessory. The user interface allows the user to switch from massage to pumping mode and control the vacuum levels within those modes. Massage and pumping modes consist of 5 vacuum levels and fixed cycle speeds when used standalone. Massage mode consists of 5 vacuum levels and 1 cycle speed and pumping mode consists of 9 vacuum levels and 3 cycle speeds for each level. The i2Plus in standalone configuration is capable of providing vacuum levels from 50-150 mmHg at a fixed cycling rate of 65 cycles per minute in massage mode and vacuum levels from 80-270 mmHg with cycling rates from 24-55 cycles per minute in pumping mode. The i2Plus with the iBox accessory is capable of providing vacuum levels from 150-200 mmHg at a fixed cycling rate of 60 cycles per minute in massage mode and vacuum levels from 150-270 mmHg with cycling rates from 24-55 cycles per minute in pumping mode. The imani i2Plus is charged with a 5 V DC USB type C adaptor and powered by a 3.7 V, 1400mAh internal rechargeable lithium-ion battery. The motor unit operates on embedded software updates by endusers are not supported. The subject device is for repeated use by a single user in a home environment. The device is provided non-sterile. The breast pump expresses breast milk by creating a seal around the nipple using a flange and applying and releasing suction to the milk is collected in a milk collection container, which can be used for storage. To prevent milk from flowing into the vacuum system, a backflow protection membrane physically separates the milk-contacting pathway from the vacuum system. All other components (i.e., motor unit) of the subject device are not in contact with the breast. The i2Plus operates on a rechargeable battery when standalone and does not function when charging. When configured with iBox, the pump is only operable when connected with the AC adapter. The rechargeable battery can be charged using the external USB adapter if the motor unit is not in operation. All milk contacting components are compliant with 21 CFR 174-179.

This document is a 510(k) premarket notification for a breast pump, not a clinical study or effectiveness study for a medical device that uses AI. Therefore, it does not contain information about acceptance criteria or studies that prove an AI device meets acceptance criteria.

The document discusses the substantial equivalence of the imani i2Plus Breast Pump to a predicate device (imani i2) based on non-clinical performance testing.

Here's a breakdown of the information that is available, and why the requested AI-specific information is not present:

Information available in the document (and why it's not AI-specific):

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

   • The document provides a "Comparator Table for Subject and Predicate Devices" (Table 1) which compares technological characteristics like suction levels, cycles per minute, power supply, etc.
   • This table highlights differences and states that these differences "do not raise different questions of safety and effectiveness." This implicitly serves as a form of acceptance criteria (i.e., the differences are acceptable because they don't compromise safety or effectiveness compared to the predicate).
   • Performance data reported: Ranges for suction levels (e.g., 50-150 mmHg for massage, 80-270 mmHg for pumping) and cycles per minute (e.g., 65 CPM for stimulation, 24-55 CPM for pumping) are detailed for both the subject device (i2Plus, with and without iBox) and the predicate (i2).
   • Why it's not AI-specific: This is a comparison of physical and functional specifications of a "powered breast pump," not an AI-powered diagnostic or therapeutic device.

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

   • The document describes "Performance Testing" which included "Vacuum level verification testing," "Backflow protection testing," "Use life testing," "Battery performance testing," and "Battery status indicator testing."
   • It also mentions "Biocompatibility studies" and "Electrical Safety" and "Electromagnetic Compatibility" testing.
   • No specific sample sizes for these tests are provided. The document generally states that "testing was conducted."
   • Why it's not AI-specific: These are engineering and safety tests for a physical device, not a performance evaluation of an AI algorithm on a medical dataset.

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

   • Not applicable. The "ground truth" for a breast pump's performance involves mechanical measurements (vacuum, cycles per minute), material safety, electrical safety, and battery life, not expert interpretation of medical images or data.
   • Why it's not AI-specific: There is no medical data interpretation involved in evaluating the breast pump's function in this context.

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

   • Not applicable. This refers to methods for resolving discrepancies in expert interpretations, which is not relevant for the type of non-clinical tests described for a breast pump.
   • Why it's not AI-specific: Not relevant for this type of device submission.

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. This document describes a 510(k) submission for a breast pump. MRMC studies are typically for diagnostic imaging devices where human readers (e.g., radiologists) interpret images, sometimes with AI assistance.
   • Why it's not AI-specific: Not relevant to a breast pump.

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

   • No. There is no AI algorithm in this device that would have a "standalone performance."
   • Why it's not AI-specific: Not relevant to a breast pump.

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

   • The "ground truth" for this device's performance is based on engineering specifications and recognized safety standards. For example, vacuum levels are measured against specified mmHg ranges, biocompatibility is evaluated against ISO standards, and electrical safety against IEC standards.
   • Why it's not AI-specific: This is a fundamental difference in the nature of "ground truth" for a mechanical/electrical device versus an AI algorithm.

8. The sample size for the training set:

   • Not applicable. This device does not use machine learning or AI, and therefore has no "training set."
   • Why it's not AI-specific: No AI, no training set.

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

   • Not applicable. As there is no training set for an AI algorithm, there is no ground truth established for one.
   • Why it's not AI-specific: No AI, no training set, no ground truth for a training set.

In summary, this document pertains to the regulatory clearance of a standard powered breast pump and not an AI-powered medical device. Therefore, the information requested regarding AI-specific acceptance criteria and study details is not present.

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