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The Electric Breast Pump is a powered breast pump to be used by lactating women to express and collect milk from their breasts. The Electric Breast Pump is intended for a single user.

The Electric Breast Pump is a personal use electric breast pump capable of single pumping. The device is electrically powered from either internal batteries or an external AC powered supply and is provided non-sterile.
The Electric Breast Pump consists of the motor, breast shields, tubing, bottle and valve. The materials used are silicone (breast shield) and polypropylene (Pump body and bottle).
The electric breast pump's drive unit employs a diaphragm-type vacuum pump, powered by a DC-motor, supervised by a microcontroller. The microcontroller provides control over motor speed (vacuum creation) and solenoid (vacuum release).
The device has two modes of operation:

• Stimulation mode: Suction patterns with fast cycles and low vacuum to start milk flowing
• Expression mode: Suction patterns with slow cycles and high vacuum to express more milk gently and efficiently.

The provided document details the 510(k) summary for the Joytech Healthcare Co., Ltd. Electric Breast Pump (Models LD-202 and LD-213). It focuses on demonstrating substantial equivalence to a predicate device, the Medela Swing Breast Pump (K053052).

While the document describes performance tests conducted, it does not provide a table of specific acceptance criteria and detailed reported device performance for functional aspects (like vacuum pressure, battery life, or backflow leakage) that would be expected to demonstrate clinical effectiveness. Instead, it refers generally to "all requirements of the applicable standards" and lists the types of tests performed.

Therefore, for the information requested regarding acceptance criteria and detailed performance, I can only extract general statements and the types of tests, not specific numerical criteria or results.

Here's a summary of the information available, addressing your points as much as possible:

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

The document mentions that "Performance testing was conducted to validate and verify that the Electric Breast Pump met all requirements of the applicable standards." However, it does not provide a table with specific numerical acceptance criteria for functional performance (e.g., a specific vacuum range and the measured performance) nor the detailed reported device performance directly. It only lists the types of tests performed.

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

The document does not specify a sample size for any of the performance tests. The tests appear to be bench testing (laboratory-based) rather than clinical studies involving human subjects for performance evaluation, as indicated by the "Bench Performance Testing" section. Therefore, there is no mention of data provenance in terms of country of origin or retrospective/prospective nature for these tests.

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

Not applicable. The performance testing described is bench testing against established engineering and biocompatibility standards, not evaluation by clinical experts establishing ground truth for a diagnostic output.

4. Adjudication method for the test set

Not applicable. This is not a study involving human reader interpretation or adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done

No, an MRMC comparative effectiveness study was not done. The document focuses on demonstrating substantial equivalence through technical and safety performance, not on comparing reader performance with or without AI assistance.

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

This device is an electric breast pump, a mechanical and electrical device, not an AI algorithm. Therefore, "standalone (algorithm only)" performance is not applicable in this context. The performance tests are for the device's physical and electrical functions.

7. The type of ground truth used

For the safety and performance tests, the "ground truth" would be established by the specifications and requirements outlined in the referenced international standards (e.g., AAMI / ANSI ES60601-1, IEC 60601-1-11, IEC 60601-1-2, ISO 10993 series) and the internal design specifications for the vacuum pressure, cycling, and battery life. There's no clinical "ground truth" like pathology or outcomes data needed for this type of device submission.

8. The sample size for the training set

Not applicable. This device does not involve a "training set" as it is not an AI/machine learning device. The performance data comes from testing the physical device.

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

Not applicable, as there is no training set for this device.

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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 device is intended for a single user, not for hospital use.

The electric breast pump is designed and manufactured by the Shantou Xinghe Electrical Apparatuses Co., Ltd. It is intended to express and collect milk from breast 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 device is intended for a single user, not for hospital use. Model XN-2201M1, XN-2201M3, XN-2206M2, XN-2207M1, XN-2209M1, XN-2210M2 are included in this submission. The electric breast pump imitates a baby's sucking action to express milk with help of Single-Chip Microcomputer. It has multiple stimulation levels for breast massage, and multiple milk quantity of a baby's suction. The keyboard of the device control panel is soft. The screen is an LCD, and allows for process viewing.

The document provided is a 510(k) premarket notification for an Electric Breast Pump (K143585). It details the device's substantial equivalence to a predicate device, rather than presenting a study proving performance against acceptance criteria in the typical sense of a clinical or algorithm validation study.

Therefore, the requested information elements related to clinical studies, algorithmic performance (standalone, MRMC), ground truth establishment, expert adjudication, and sample sizes for test and training sets are not applicable (N/A) in this context, as this submission did not involve such studies.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here are based on demonstrating that the proposed device's specifications (technology, performance parameters, etc.) are substantially equivalent to the predicate device and meet general safety and performance standards through bench testing.

Footnotes for Table:

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

• Test Set Sample Size: N/A (No clinical test set was required or presented for substantial equivalence).
• Data Provenance: N/A. The non-clinical tests were bench tests performed by the sponsor (Shantou Xinghe Electrical Apparatuses Co., Ltd.) 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)

• N/A (No ground truth established by experts for a test set in this context).

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

• N/A.

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

• N/A. This is a physical medical device, not an AI/software as a medical device (SaMD) requiring MRMC studies.

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

• N/A. This is not an AI/SaMD.

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

• The "ground truth" for this submission largely relies on established engineering standards for performance, electrical safety, EMC, and biocompatibility, as well as the specifications and performance of the legally marketed predicate device (K122474). Therefore, the ground truth is derived from regulatory standards, predicate device characteristics, and internal bench test results demonstrating compliance with specifications.

8. The sample size for the training set

• N/A (No training set for an AI/ML algorithm was involved).

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

• N/A.

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