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The Electric Breast Pump is intended to express and collect milk from the mother's breast, to alleviate engorgement of the breast, maintain the ability of lactation, and provide mother's milk for future feedings when separation of mother and baby occurs. The Electric Breast Pump is intended for a single user.

The Electric Breast Pump is designed, manufactured by the Guangdong Horigen Mother & Baby Products Co., Ltd. The device is intended for lactating women in a home setting for a single user. It comprises of a pump unit and the expression collection kit including tubing, and its raw materials include polypropylene, liquid and solid silicone, and thermoplastic elastomer. This electric breast pump has a negative pressure module that utilizes a single-chip microcomputer. It has multiple stimulation levels for breast massage, and multiple milk expression speed intensities. The keyboard of the control panel is soft. The screen is an LCD or LED screen, allowing for process viewing. The pump's electronic memory takes over, mimicking the rhythm. The electric breast pump is capable of providing vacuum levels from 30 to 247.5 mmHg with cycle rates up to 100 cycles per minute.

The provided document is a 510(k) K182413 FDA clearance letter and summary for an Electric Breast Pump. This type of document is for a physical medical device, not a software-based AI or diagnostic device that would involve a "test set" or "ground truth" established by experts or MRMC studies.

Therefore, many of the requested elements (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, type of ground truth, training set size and ground truth establishment for training set) are not applicable to this device and the information provided in this document.

However, I can extract the acceptance criteria and the performance testing performed to demonstrate the device meets those criteria.

Here's the information based on the provided document:

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

The document broadly states that "All of the tested parameters met the predefined acceptance criteria" in the Performance Testing section. While specific numerical acceptance criteria values are not explicitly stated in this public summary, the device's operational characteristics are described, which implies these fall within predefined acceptable ranges.

The document also specifies the operational parameters:Vacuum levels: 30 to 247.5 mmHgCycle rates: up to 100 cycles per minuteStimulation Phase: Fast cycles (70100 Cycles/min), low vacuum (30 ~ 112.5 mmHg), 9 levels.Expression Phase: Cycles (2490 Cycles/min), higher vacuum (75 ~ 247.5 mmHg), 9 levels.Features: Closed system with anti-backflow, LCD or LED screen, single/double pumping, dual power source. (These implicitly met their respective criteria). |

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

This information is typically not included in a 510(k) summary for a physical non-AI device. The testing described (biocompatibility, electrical safety, performance) uses established laboratory methods on physical units of the device. There isn't a "test set" of clinical data in the way you'd describe for an AI model.

• Sample Size: Not specified as a number of "cases" or "patients" but rather the physical units of the device tested in laboratory settings.
• Data Provenance: Not applicable in the context of clinical data. The tests were conducted by the manufacturer, Guangdong Horigen Mother & Baby Products Co., Ltd., which is located in China.

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. "Ground truth" in this context would refer to meeting engineering specifications or validated biological/electrical safety standards, not expert clinical interpretation.

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

Not applicable.

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-assisted device.

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

Not applicable. This is a physical device, not an algorithm. Its "standalone" performance refers to its ability to meet the physical and electrical specifications independently.

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

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

• International standards (ISO 10993, IEC 60601-1, IEC 60601-1-2) for biocompatibility, electrical safety, and EMC.
• FDA Guidance for software validation.
• Predefined engineering specifications (e.g., pressure ranges, cycle rates, noise levels) established by the manufacturer and accepted by the FDA as equivalent to the predicate device.

8. The sample size for the training set

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

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

Not applicable.

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