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The Electric Breast Pump (Model LD-208L, LD-3010L, LD-3010, LD-2010) 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 (LD-208L, LD-3010L, LD-3010, LD-3010, LD-2010) is an electrically powered breast pump to be used in a home environment by a single user. The device is provided non-sterile and can be used on one breast (single pumping) or on both breasts at the same time (double pumping).

The subject devices are capable of expression, stimulation, and the hybrid 'bionio' and 'variable frequency' modes. Stimulation mode is associated with six suction levels, and expression, bionic, and variable frequency modes are associated with nine suction levels. The subject devices feature various combinations of on/off buttons, level up/down buttons, mode selection buttons, suction level/time indicators, battery visual indicator display, and mode displays. The LD-208L, LD-3010L, and LD-2010L pumps are powered by internal, nonreplaceable, rechargeable lithium-ion batteries which are charged using the included AC power supply and cable. The LD-2010 and LD-3010 are powered by alkaline batteries or AC power.

The breast pumps use cyclic negative pressure (suction) to mimic the suckling patterns of a feeding infant. A DC motor drives a membrane vacuum pump to generate the suction required to stimulate and express breast milk. The timing of this pattern is dependent upon the suction/speed settings selected by the user and is pre-programmed in the devices. The devices are capable of producing peak suction levels between -40 and -290 mmHg at speeds between 20 and 120 cycles per minute. The subject device ensures backflow protection between the breast shield and the electronic components via a physical barrier (silicone diaphragm) mechanism.

All other components (i.e., motor unit) of the subject device are not in contact with the breast. All milk contacting components are compliant with 21 CFR 177.

The provided document is a 510(k) summary for an Electric Breast Pump (LD-208L, LD-3010L, LD-2010L, LD-3010, LD-2010). This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving independent effectiveness or advanced performance metrics typically associated with AI/ML devices. Therefore, much of the information requested in your prompt (e.g., sample size for test sets, expert ground truth, MRMC studies, standalone performance with effect sizes) is not applicable or generally required for a 510(k) clearance of a mechanical device like a breast pump.

Here's the information that can be extracted or inferred from the provided text:

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

For a breast pump, the "acceptance criteria" and "device performance" are primarily based on meeting safety standards, functional specifications, and demonstrating equivalence to a predicate. The document highlights various tests performed to ensure this.

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

The document does not specify sample sizes for the performance tests (e.g., how many units were tested for vacuum levels, how many use-life cycles). Data provenance details (country of origin, retrospective/prospective) are not provided as these are primarily engineering performance tests rather than clinical studies on patient data.

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 these performance tests is based on engineering specifications and adherence to international standards, not expert clinical consensus.

4. Adjudication method for the test set

Not applicable. This is not a study requiring adjudication of clinical findings.

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 device is an electric breast pump, a mechanical medical device, and does not involve AI or human readers for diagnostic interpretation.

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

Not applicable. This device does not use algorithms for diagnostic or interpretive performance separate from its mechanical function.

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

The ground truth for the performance testing is based on:

• Engineering specifications: Pre-defined ranges for suction levels, cycles per minute, and other functional parameters.
• International standards: Compliance with standards like ISO 10993 for biocompatibility, IEC 60601 for electrical safety, and IEC 60601-1-2 for EMC.
• Design requirements verification: Ensuring the device meets its intended design functions (e.g., backflow protection, battery function).

8. The sample size for the training set

Not applicable. There is no "training set" in the context of this 510(k) submission for a non-AI/ML device.

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

Not applicable. (See #8)

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