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The Wearable Breast Pump (Model S12A) is a powered breast pump intended to be used by lactating women to express and collect milk from their breasts. It is intended for a single user.

The Wearable Breast Pump (Model S12A) is an electrically powered, software-controlled, single user pump designed for lactating women to express and collect milk from the breast.

The device has three modes of operation - Expression mode, Stimulation mode, and Auto mode, with multiple suction levels for each mode. Stimulation mode consists of pressures ranging from 30/160-120/160 mmHg and cycle speeds of 74-134 cycles/min, expression mode consists of pressure ranges from 120-245 mmHg and cycle speeds of 29-92 cycles/min, and auto mode consists of pressure ranges from 30-245 mmHg and cycle speeds of 29-128 cycles per minute. There is an LED status display for S12A, and the working mode and battery indicator are shown on the pump body.

S12A may be operated as a single or double pumping system. For a user to pump both breasts simultaneously, they would need to use two S12A devices at the same time, one on each breast. The pump is provided non-sterile and can be re-used by a single user. The device is powered by a Li-ion battery and charged using a 5V DC adaptor. The device is designed not to be used during charging.

The breast pump does not incorporate any off-the-shelf (OTS) software, and it incorporates embedded software which controls all the features of the product. All milk contacting components of the device are compliant with 21 CFR 177.

This document is a 510(k) clearance letter for a Wearable Breast Pump. It does not contain details about acceptance criteria for an AI/ML device or a study proving an AI/ML device meets acceptance criteria.

The document discusses the regulatory clearance of a medical device (a breast pump) and its comparison to a predicate device, focusing on:

• Device Description: A powered breast pump with different modes, suction levels, and an LED display.
• Indications for Use: For lactating women to express and collect milk.
• Technological Characteristics: Comparison of classification, regulation, product code, intended use, single/double pump capability, user interface, materials, power source, control mechanism, maximum vacuum, vacuum range, cycle speed range, and backflow/overflow protection between the subject device (Wearable Breast Pump Model S12A) and the predicate device (Lucy Breast Pump).
• Performance Testing:
  • Biocompatibility testing: Cytotoxicity, skin irritation, and skin sensitization for patient-contacting components.
  • Electrical safety and electromagnetic compatibility (EMC) testing: Adherence to IEC standards.
  • Software Verification and Validation Testing: Evaluated at a basic documentation level.
  • Performance and Use Life Verification: Vacuum level verification, backflow protection, use life testing (device maintaining specifications), battery performance, and battery status indicator testing.

The document concludes that the Wearable Breast Pump (Model S12A) is as safe and effective as the predicate device, supporting a determination of substantial equivalence.

Therefore, I cannot provide the requested information about AI/ML device acceptance criteria or studies from this document, as it pertains to a mechanical/electronic medical device without AI/ML components.

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The Wearable Breast Pump (Model W8) is a powered breast pump intended to be used by lactating women to express and collect milk from their breasts. It is intended for a single user.

The Wearable Breast Pump (Model W8) is a wearable powered breast pump designed for lactating woman to express and collect milk from the breast. There are 4 modes available for the device which are Expression mode, Massage mode, Auto mode and Stimulation mode. There is a LED status display for W8, including working mode, and battery indicator can be shown on the pump body. The user interface includes on/off switch, mode selection/long press, and vacuum adjustment. W8 operated as a single or double pumping system, one on each breast. The pump is provided non-sterile and reusable by a single user. The device is powered by rechargeable Li-ion battery (3.7V, 1200mAh). W8 is designed not to be used during charging. The breast pump does not incorporate any off-the-shelf (OTS) software. The device incorporates embedded software which controls all the features of the product. All milk contacting components of the device are compliant with 21 CFR 177 which is applicable for the subject device.

Here's a breakdown of the acceptance criteria and study information based on the provided FDA 510(k) summary for the Wearable Breast Pump (Model W8).

It's important to note that the provided document is an FDA 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It primarily details non-clinical performance testing rather than clinical efficacy studies often associated with AI/ML devices or studies directly proving therapeutic effect. Therefore, many of the requested points related to AI, human readers, ground truth establishment for patient outcomes, and clinical study designs will not be present. The "device" in this context is a physical breast pump, not an AI algorithm.

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

For a breast pump, "acceptance criteria" primarily relate to engineering specifications and safety standards rather than diagnostic performance metrics like sensitivity/specificity. The document states that the device was tested against its own specifications, and "Device specifications were met for all tests conducted."

The subsequent points (2-9) are typically relevant for studies involving AI/ML devices, clinical performance, or diagnostic effectiveness based on expert interpretation. As this 510(k) is for a physical medical device (a breast pump) and not an AI/ML diagnostic tool, a direct equivalent for many of these points is not applicable or explicitly mentioned in the provided summary. The summary focuses on engineering, safety, and compatibility testing.

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

• Not Applicable / Not Explicitly Stated for Clinical Outcomes: The summary describes bench performance testing on the device itself and biocompatibility testing of materials, not a clinical study on human subjects with a "test set" of patient data. For bench testing, the "sample size" would refer to the number of devices or components tested, which is not detailed but assumed to be sufficient for engineering verification.

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

• Not Applicable: This relates to human interpretation of data for ground truth establishment in diagnostic studies. For a breast pump, "ground truth" is established by engineering specifications and objective measurements (e.g., pressure gauges, timers, chemical analysis).

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

• Not Applicable: Again, this pertains to expert review and consensus for diagnostic ground truth, which is not relevant for the type of testing described here.

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 specific to AI-assisted diagnostic workflows. No human reader interaction or AI assistance is mentioned or relevant for a breast pump.

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

• Not Applicable: This refers to standalone AI algorithm performance. This device is a physical breast pump, not an algorithm. While it has embedded software, its performance is evaluated as an integrated system, not a standalone algorithm.

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

• The "ground truth" for this device's performance is driven by:
  • Engineering Specifications: Defined ranges for vacuum pressure, cycle speed, battery life, etc.
  • International Standards: Compliance with ISO (e.g., ISO 10993 for biocompatibility) and IEC (e.g., IEC 60601 for electrical safety and EMC) standards.
  • Regulatory Requirements: Compliance with 21 CFR regulations (e.g., 21 CFR 177 for milk-contacting materials).
  • Functional Verification: Demonstrating features like backflow protection and proper software operation.

8. The sample size for the training set

• Not Applicable: This applies to AI/ML models. This device is not an AI/ML system trained on data.

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

• Not Applicable: This applies to AI/ML models.

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

The Wearable Breast Pump (model: 1203) is an electric breast pump system comprised of a single or double portable unit that integrates the pump body and milk collection bottle. It consists of a pump (motor unit) and includes a breast shield, bottle, seal, valve, spout, and bra adjuster. All components (minus the pump) are reusable and may be manually cleaned. The Wearable Breast Pump includes rotary electric pump technology which generates negative pressure on the nipple to express milk, which is collected in the integrated milk collection bottle. It is designed to work in the user's nursing bra and has a rechargeable battery so it can be used hands-free without external power cords or milk collection tubes. The Wearable Breast Pump is a battery-powered electro-mechanical device that can be controlled through the physical interface on the device or through a mobile companion app, which also provides real-time milk monitoring, pump battery life, pumping time elapsed, and pumping history information. All milk contacting components are constructed out of food grade materials that are compliant with 21 CFR 174-179.

The Wearable Breast Pump has undergone non-clinical testing to demonstrate that it meets design specifications and is substantially equivalent to the predicate device (Elvie Pump, K181863).

Here's the breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not specify a separate "test set" in the context of clinical data for the Wearable Breast Pump. The testing appears to be primarily non-clinical, focusing on engineering, safety, and performance standards. Therefore, information regarding sample size and data provenance (e.g., country of origin, retrospective/prospective) for a clinical test set is not provided. The testing conducted falls more under product validation and verification based on regulatory standards.

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

This information is not applicable as the "ground truth" for the non-clinical tests described is based on established engineering and safety standards (e.g., IEC, ISO) and the device's own design specifications, rather than expert interpretation of clinical data.

4. Adjudication method for the test set:

Not applicable, as this refers to a clinical adjudication process. The non-clinical testing relies on objective measurements against predefined standards.

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 a powered breast pump, not an AI-assisted diagnostic or interpretative system that would involve human readers or MRMC studies.

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

Not applicable. This device is a mechanical-electronic device, not an algorithm, so standalone algorithm performance is not a relevant concept here.

7. The type of ground truth used:

The ground truth for the non-clinical testing is based on:

• International Standards: e.g., IEC 60601 series for electrical safety and EMC, ISO 10993 for biocompatibility.
• FDA Guidance Documents: e.g., for wireless technology and software validation.
• Device Specifications: Internal design requirements for vacuum pressure, cycle rate, backflow prevention, use life, and battery performance.

8. The sample size for the training set:

Not applicable. This device is not an AI/ML product that utilizes a training set for algorithm development.

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

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

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