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The Lansinoh® Smartpump 3.0 Double Electric Breast Pump is intended to express and collect the breastmilk of a nursing woman for the purpose of feeding collected breastmilk to a baby. The pump is intended for a single user.

Device Description

The Lansinoh Smartpump 3.0 Double Electric Breast Pump is a double electric breast pump intended to express the breast milk of a nursing woman. The pumping can be performed on one breast or on both breasts at the same time. The pumps can be powered by a rechargeable 7.4 V, 1,500 mAh lithium-ion battery or by an AC adapter that is provided with each pump. The pumping system consists of a diaphragm-type vacuum pump which is driven by a microprocessor-controlled DC electric motor. The user interface consists of a front panel keypad and LCD display. The user is able to adjust cycle mode and vacuum level based on personal comfort and preference.

AI/ML Overview

The provided text describes the acceptance criteria and the studies conducted for the Smartpump 3.0 Double Electric Breast Pump (K222726) to demonstrate its substantial equivalence to a predicate device (Lansinoh® Smartpump™ Double Electric Breast Pump (DEBP 2.2) [K182749]).

Here's a breakdown of the requested information based on the document:

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

The document doesn't explicitly present a table of "acceptance criteria" in the way one might expect for an AI diagnostic device (e.g., sensitivity, specificity thresholds). Instead, the performance studies are focused on demonstrating that the device meets its design specifications and relevant safety standards, and functions equivalently to the predicate. The "acceptance criteria" are implied by the standards and specifications the device passed.

Category of Testing	Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility	Patient-contacting components must be identical in formulation, processing, sterilization, and geometry to those cleared in K182749, and contain no new chemicals. Milk-contacting components must meet FDA's Food Additive criteria (21 CFR 175-179).	Patient-contacting components are identical to those in K182749; no additional biocompatibility testing was needed. All milk-contacting materials meet FDA's Food Additive criteria.
Electrical Safety (IEC 60601-1)	Device must satisfy general requirements for basic safety and essential performance, including US deviations.	The device passed all tests in accordance with IEC 60601-1:2005 (3rd ed) + CORR. 1:2006 + CORR.2:2007+A1:2012 (except Clause 11.7, biocompatibility, which was addressed separately).
EMC (IEC 60601-1-2)	Device must satisfy requirements for electromagnetic disturbances.	The device passed all tests in accordance with IEC 60601-1-2:2014+A1:2021.
Home Healthcare (IEC 60601-1-11)	Device must satisfy requirements for medical electrical equipment used in the home healthcare environment.	The device passed all tests in accordance with IEC 60601-1-11:2015.
Battery Safety (IEC 62133-2)	Secondary cells and batteries must meet safety requirements for portable sealed secondary cells.	The device's battery complied with all relevant sections of IEC 62133-2:2017.
Software V&V	Software should be verified and validated as recommended by FDA guidance and in accordance with IEC 62304:2016 for a Moderate level of concern. Cybersecurity documentation provided per FDA guidance.	Software verification and validation testing was conducted and documentation provided; the software was considered a Moderate level of concern. Cybersecurity documentation was also provided.
Shelf-Life / Use-Life	Expected use-life of 500 hours demonstrated to operate within specifications.	Devices demonstrated to operate within specifications for up to 500 hours of continuous operation at the maximum setting (Expression mode 3, Level 8).
Battery Life Testing	Battery life must be approximately 2 hours at highest level (Expression Mode 3, Level 8).	Testing supported that the battery life, as noted in the labeling, is approximately 2 hours at the highest level (Expression Mode 3, Level 8).
Suction Pressure Stability Testing	Device must meet its specifications and perform within the specified working ranges of pressure and cycle speed for each mode/level.	The suction curves for each cycle mode and suction level demonstrated that the device meets its specifications and performs within the specified working ranges of pressure and cycle speed for each mode/level.
Backflow Testing	The design must prevent breastmilk from flowing into the tubing or pump body, especially at maximum pressure/cycle settings and various orientations. No milk should be present in the tubing during or after testing. Leverage data from K182749 for backflow protection mechanism materials if identical.	The diaphragm was demonstrated to prevent backflow of milk into the tubing and pump. No milk was present in test devices' tubing during and following the test at maximum pressure/cycle settings (Expression Mode 3, Level 8) and various orientations. Backflow data from K182749 was leveraged.

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

Sample Size for Test Set: The document does not specify a numerical sample size for "test sets" in the context of human subjects or a dataset. The testing described (biocompatibility, electrical safety, software V&V, bench testing like battery life, suction pressure, backflow) appears to be primarily laboratory-based device testing, likely involving a limited number of device units.
Data Provenance: Not applicable in the context of this device's type of testing. The data originates from laboratory and bench testing of the device itself.

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)

This information is not applicable as the device is a breast pump, not an AI diagnostic device requiring expert interpretation of medical images or data to establish ground truth. The "ground truth" for this device's performance is objective measurements against engineering specifications and industry standards.

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

This information is not applicable. Adjudication methods are typically used in clinical studies or expert review processes for diagnostic devices, not for basic performance testing of a breast pump.

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

This information is not applicable. This is not an AI diagnostic device that assists human readers.

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

This information is not applicable. The Smartpump 3.0 is a physical medical device, not an AI algorithm. Its "standalone" performance refers to its functional operation as an electric breast pump, which is what the bench tests evaluate.

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

The "ground truth" for this device's performance is established by:

Compliance with recognized industry standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 62133-2, IEC 62304).
Demonstration of performance against engineering specifications for parameters like battery life, suction pressure range and stability, and backflow prevention.
Meeting FDA Food Additive criteria for milk-contacting materials (21 CFR 175-179).

8. The sample size for the training set

This information is not applicable. This is not an AI/ML device that requires a training set. The "software" mentioned has a "Moderate level of concern," indicating it's likely firmware or control software, not an AI model trained on data.

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

This information is not applicable as there is no training set for an AI/ML model for this device.

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