Search Results

Wearable Breast Pump (ABP-1508PRO, ABP-1306, ABP-1306, ABP-1306 PRO, M1, M3, M8, M5, M6, K1, K2, K3, K5, ABP-1306PLUS, ABP-1308, M2) is a powered breast pump to be used by lactating women to express and collect milk from their breasts. The device is intended for a single user.

The Wearable Breast Pump (ABP-1508PRO, ABP-1506, ABP-1306 PRO, M1, M3, M8, M5, M6, K1, K2, K3, K5, ABP-1306PLUS, ABP-1308, M2) 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 auto modes with nine associated suction levels for each. The subject devices feature various combinations of on/off buttons, level up/down buttons, mode selection buttons, suction level/time indicators, battery visual indicator displays. The pumps are powered by internal, non-replaceable, rechargeable lithium-ion batteries which are charged using the included AC power supply and cable. The subject device can be operated while plugged into 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 preprogrammed in the devices. The devices are capable of producing peak suction levels between -60 and -240 mmHg at speeds between 26 and 108 cycles per minute. There available pumping modes with 9 distinct levels of vacuum and cycle speed. 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 174-179.

The provided text describes a 510(k) premarket notification for a Wearable Breast Pump and does not include information about a study that proves the device meets specific acceptance criteria for AI/ML performance. The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing.

Therefore, I cannot provide the requested information regarding:

• A table of acceptance criteria and reported device performance for AI/ML.
• Sample size and data provenance for a test set.
• Number and qualifications of experts for ground truth establishment.
• Adjudication method for a test set.
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size.
• Whether a standalone (algorithm only) performance study was done.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
• The sample size for the training set.
• How the ground truth for the training set was established.

The document mentions "Software" and states it was "evaluated at the Basic Documentation level as recommended in the 2023 FDA guidance document 'Content of Premarket Submissions for Device Software Functions.'" This level of documentation suggests that the software in question is likely not an AI/ML algorithm that requires rigorous clinical validation with ground truth for diagnostic or prognostic purposes, but rather controls basic device functions (e.g., suction settings, modes, battery indicators).

The performance testing listed in Section 9 ("Summary of Non-Clinical Performance Testing") includes:

• Vacuum level verification testing
• Backflow protection testing
• Use life testing
• Battery performance testing
• Battery status indicator testing

These are standard engineering and safety tests for a powered breast pump, not the type of studies typically conducted to evaluate AI/ML performance against acceptance criteria for a diagnostic or decision-support system.

In summary, the provided FDA 510(k) clearance letter and summary do not contain information related to AI/ML device performance or the study details requested in your prompt.

Ask a specific question about this device