(70 days)
Elvie Stride 2 is a powered breast pump to be used by lactating women to express and collect milk from their breasts. Elvie Stride 2 is intended for a single user.
The Elvie Stride 2 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 and stimulation modes with ten associated suction levels for each. The subject device features on/off buttons, level up/down buttons, mode selection buttons, suction level/time LED indicators/battery visual indicator displays. The pumps are powered by internal, non-replaceable, rechargeable lithium-ion batteries which are charged using the included cable. The subject device cannot 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. Elvie Stride 2 includes the Elvie Stride hub, including the existing firmware and mobile application functionality. The device is capable of producing peak suction levels between -35 and -260 mmHg when double pumping. -55 and -300 mmHg when single pumping, and operating at speeds between 52 to 103 cycles per minute for stimulation mode and 28 to 76 cycles per minute for expression mode. There are two available pumping modes with 10 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 (diaphragm) mechanism. The subject device includes a 28mm breast shield and 5 separate silicone insert sizes (24, 21, 19, 17 and 15 mm). The breast shield may be used with or without the addition of a nipple insert. The cup assembly includes components which are in contact with breastmilk. All food contacting components are composed of food grade material and have been tested to 21 CFR 174-177.
The provided text is a 510(k) Summary for the Elvie Stride 2 powered breast pump. It primarily focuses on demonstrating substantial equivalence to a predicate device, the Elvie Stride. The document details the device's characteristics, indications for use, and non-clinical performance testing.
However, it does not contain information about acceptance criteria or a study that specifically proves the device meets such criteria in the context of typical AI/ML device evaluations (e.g., performance metrics like sensitivity, specificity, accuracy, etc., often seen in diagnostic or screening AI).
Instead, the "performance testing" described in Section 9 focuses on engineering and functional verification, such as:
- Vacuum level verification: ensuring the pump meets mode/cycle specifications.
- Backflow protection testing: verifying liquid does not backflow into the tubing.
- Use life testing: demonstrating the device maintains specifications throughout its proposed use life.
- Battery performance testing: demonstrating battery functionality during stated use-life.
- Battery status indicator testing: demonstrating indicator functionality during stated battery life.
These are typical validation steps for a hardware medical device like a breast pump, ensuring it functions as intended and safely. The document does not describe a scenario where AI/ML diagnostic or predictive algorithms are being evaluated against ground truth established by experts. Therefore, many of the requested fields are not applicable to the information provided.
Based on the provided text, here's what can be extracted:
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A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria alongside reported performance in the manner typically seen for AI/ML device evaluations (e.g., sensitivity, specificity thresholds). Instead, the "performance testing" section describes verification activities. The reported performance is that the tests "demonstrated that the devices meet mode/cycle specifications" or "remains functional."
Acceptance Criteria (Implied from testing goals) Reported Device Performance (Implied from testing results) Device meets mode/cycle vacuum level specifications Devices meet mode/cycle specifications. Device prevents backflow into tubing Liquid does not backflow into the tubing. Device maintains specifications throughout use life Device maintains specifications throughout its proposed use life. Battery remains functional during stated use-life Battery remains functional during its stated battery use-life. Battery status indicator remains functional during stated battery life Battery status indicator remains functional during its stated battery life. -
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The "performance testing" described is for a physical device (breast pump), not an AI/ML algorithm evaluated on a test set of data. The document does not mention data subjects or patients, only the device itself and its components.
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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. No "test set" or "ground truth" establishment by experts is described for an AI/ML context. The verification of pump functions (vacuum levels, backflow, etc.) would be performed by engineering and quality control personnel against established internal specifications, rather than clinical experts establishing ground truth for data.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No adjudication method described as this is not an AI/ML data evaluation study.
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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 screening tool. No MRMC study was performed or is relevant to this submission.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical product, a breast pump. It relies on its mechanical and electronic functions, not on a standalone AI algorithm. While it has software, its evaluation is about functional safety and performance as a pump, not algorithmic accuracy.
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The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable in the context of AI/ML performance evaluation. The "ground truth" for the device's functional performance are its design specifications and relevant industry standards (e.g., IEC standards for electrical safety and EMC).
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The sample size for the training set
Not applicable. The document describes a physical medical device, not an AI/ML model that undergoes training on a dataset.
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How the ground truth for the training set was established
Not applicable. No AI/ML training set is described.
§ 884.5160 Powered breast pump.
(a)
Identification. A powered breast pump in an electrically powered suction device used to express milk from the breast.(b)
Classification. Class II (performance standards).