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510(k) Data Aggregation
(257 days)
The Freemie milk collection system is intended to be used in conjunction with an approved electric breast pump for the purpose of expressing human milk.
The device is to be used by connection to an approved breast pump, and will be used in place of the pump's original breast milk collection equipment. The device has a funnel-shaped breast adapter, internal valve assembly and enclosing reservoir shaped like a bowl. Variations of the device incorporate minor differences to replicate the functional and performance characteristics necessary for use with additional pump brands. Additionally, smaller and larger breast adapter and milk collection sizes will be available, as is the practice with predicate devices. The Freemie device is designed to be supported within a woman's ordinary or nursing brassiere, and held in place there while the lactating woman is pumping. When the pump extracts milk, the milk flows out through the end of the funnel and enclosing valve system, where it gathers and is collected in the cup. When the lactating woman is done pumping, she turns off the pump, removes the Freemie from her brassiere and transfers the milk to a storage container for later use.
The provided document describes the Freemie® Breast Pump Collection System and its 510(k) submission (K111411) for market clearance. The study aimed to demonstrate substantial equivalence to predicate devices.
1. Acceptance Criteria and Reported Device Performance
The submission does not explicitly state numerical acceptance criteria in the format of sensitivity, specificity, AUC, or similar AI-specific metrics, as it predates the widespread use of AI in medical devices and focuses on mechanical performance and safety. Instead, the acceptance criteria are based on demonstrating equivalence in key functional and safety attributes to predicate devices. The study proves the device meets these criteria through comparative performance testing and biocompatibility assessments.
| Acceptance Criteria Category | Reported Device Performance (Summary) |
|---|---|
| Biocompatibility | Passed all biocompatibility testing. This suggests adherence to recognized standards for materials in contact with human tissue and milk. |
| Performance - Breast Adapter Design | Testing was conducted to demonstrate the design features. The report mentions "variations of the device incorporate minor differences to replicate the functional and performance characteristics necessary for use with additional pump brands." This implies successful adaptation. |
| Performance - Compatible Pumps | Testing was conducted to demonstrate compatibility. The device is intended to be used by connection to an "approved breast pump" and in place of "the pump's original breast milk collection equipment," implying successful integration and function with various pumps. |
| Performance - Vacuum Performance | Testing was conducted to demonstrate vacuum performance. This is crucial for effective milk expression and implies performance comparable to existing collection systems. |
| Performance - Capacity | Testing was conducted to demonstrate capacity. The report mentions "smaller and larger breast adapter and milk collection sizes will be available, as is the practice with predicate devices." This suggests a range of capacities similar to market standards. |
| Materials and Design Equivalence | Constructed of similar materials, has a similar design, and the same indications as predicate devices and other currently marketed accessories. Bench testing demonstrated equivalence. |
| Safety and Effectiveness | Bench and biocompatibility testing demonstrated the safety and effectiveness of the device. |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in the context of an AI/ML algorithm with data provenance like country of origin or retrospective/prospective data. The performance testing described (Breast Adapter Design, Compatible Pumps, Vacuum Performance, and Capacity) appears to be bench testing (laboratory-based evaluations) rather than clinical studies with human subjects. Therefore, the "sample size" would likely refer to the number of units or configurations tested in the lab, which is not detailed in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a mechanical breast milk collection system, and its evaluation does not involve establishing ground truth from expert interpretation of medical images or clinical outcomes in the way an AI diagnostic tool would. The "ground truth" for its performance is determined by physical measurements and functional testing against engineering specifications and predicate device performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for the same reasons as point 3.
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 not an AI-assisted diagnostic device, so MRMC studies and the concept of human reader improvement with AI assistance are irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance would be the direct measurements from the bench testing (e.g., vacuum pressure readings, milk volume collected, compatibility with various pump models) and adherence to material safety standards (biocompatibility testing results). It is based on engineering specifications and direct experimental measurements rather than clinical or pathological ground truth.
8. The sample size for the training set
Not applicable. This device does not involve an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This device does not involve an AI/ML algorithm.
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(36 days)
An electrically powered breast pump with adjustable vacuum and massage settings and 2 funnels for expressing milk from the breasts of a lactating woman.
The Gerber Double Electric Breast Pump is a simple and effective system for expressing milk from a lactating women's breast(s). The device includes the following components: a pump base, flexible tubing, a funnel assembly, a carrying bag, and accessories (e.g. bottles, nipples, and disposable nursing pads). The device is powered by a variable speed power supply that drives a diaphragm pump creates the negative pressure required to extract breast milk. The breast pump is capable of providing a variable vacuum and massage like motion. A maximum vacuum of 240 mm Hg can be applied to one or both breasts.
The provided document is a 510(k) premarket notification for the Gerber Double Electric Breast Pump, seeking substantial equivalence to existing predicate devices. It does not contain information about the acceptance criteria and a study proving device performance in the context of an AI/ML medical device.
The document discusses "non-clinical tests" as "Bench testing of the device has demonstrated that the Gerber Double Electric Breast pump meets established requirements when used in the manner and environment specified in product labeling." It explicitly states, "No clinical tests have been conducted on this device."
Therefore, I cannot provide the requested information as it pertains to a medical device that is not an AI/ML product and does not involve the types of studies described in your request. The device is a traditional medical device (breast pump), and its clearance is based on substantial equivalence to predicate devices rather than complex performance studies against specific acceptance criteria for an AI/ML algorithm.
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