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Non-powered Breast Pump to express milk from the breast.

Easy Comfort ™ Deluxe Manual Breast Pump

This document is a 510(k) premarket notification letter from the FDA for a nonpowered breast pump. It does not include information about acceptance criteria or a study proving device performance in the way described in your request (e.g., performance metrics, sample sizes, expert ground truth).

Therefore, I cannot extract the requested information from this document. The document primarily focuses on:

• Device Identification: Easy Comfort™ Deluxe Manual Breast Pump, Regulation Number 21 CFR 884.5150 (Nonpowered breast pump).
• Regulatory Determination: Substantially equivalent to legally marketed predicate devices, allowing it to proceed to market.
• General Controls: Reference to general controls provisions of the Act (registration, labeling, good manufacturing practice, etc.).
• FDA Contact Information: For questions regarding labeling, promotion, and general responsibilities.
• Indications for Use: "Non-powered Breast Pump to express milk from the breast."

There is no mention of "acceptance criteria" for performance, specific metrics like sensitivity or specificity, or details of any clinical or performance study conducted to establish these.

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Powered Breast Pump to express milk from the breast.

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This document is a 510(k) premarket notification letter from the FDA for a breast pump. It does not contain information about acceptance criteria or a study proving device performance as requested. The content focuses on the regulatory clearance for the device, including its classification and compliance requirements. Therefore, I cannot provide the requested information based on this document.

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Powered Breast Pump to express milk from the breast.

Natural Comfort ™ Battery / Electric Breast Pump

I am sorry, but based on the provided text, I cannot provide the requested information about acceptance criteria and a study proving device performance. The document is an FDA 510(k) clearance letter for a breast pump, which confirms that the device is substantially equivalent to a legally marketed predicate device. It does not contain details about specific acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth establishment.

The letter explicitly states:
"We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."

And later:
"This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market."

This indicates that the clearance is based on substantial equivalence to an already approved device, rather than a detailed performance study presented in this document.

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The powered Simplicity Breast Pump is designed to express milk from the breast.

The Simplicity Breast Pump uses a mechanical pumping system to generate suction. It is powered either by two (2) standard C batteries (not included with kit) or powered electrically by utilizing the AC adapter which is provided in the kit and can be plugged into any standard wall outlet. The powered motor activates movement of a rubber dlaphragm inside a pumping chamber which provides suction to express breast milk.

This document describes the premarket notification (510(k)) for the Simplicity Electric/Battery Breast Pump Kit. It seeks to demonstrate substantial equivalence to a predicate device, the Evenflo Sof-Touch Ultra Breast Pump.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" with numerical thresholds in the typical sense of a target performance metric. Instead, the acceptance criterion for the Simplicity Breast Pump was to demonstrate substantial equivalence to the Predicate device (Evenflo Sof-Touch Ultra Breast Pump) in terms of vacuum pressure as a function of time.

2. Sample Size Used for the Test Set and Data Provenance

The document states, "Laboratory bench testing was performed to assess the effects of the new characteristics of the proposed Simplicity Breast Pump. These tests compared the proposed Simplicity Breast Pump against the Predicate [Evenflo]."

• Sample Size for the test set: Not specified. The document only mentions "relatively simple experimental methods for determination of vacuum pressures as a function of time" and "laboratory bench testing." It does not provide the number of devices tested or the number of measurements taken.
• Data Provenance: The testing was "Laboratory bench testing," implying it was conducted in a controlled environment by the manufacturer or a designated facility. The country of origin is not explicitly stated for the testing, but the submitter, The First Years, Inc., is based in Avon, MA, USA. The data is prospective in the sense that it was generated specifically for this 510(k) submission to demonstrate equivalence.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. This was a bench test evaluating physical performance characteristics (vacuum pressure), not a human-interpreted diagnostic outcome. Therefore, there was no "ground truth" established by human experts in the medical sense. The "ground truth" or reference was the performance of the predicate device.

4. Adjudication Method for the Test Set

Not applicable. As this was a bench test comparing a physical property (vacuum pressure), there was no human adjudication of diagnostic outcomes. The comparison was based on objective measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study focused on the physical performance characteristics of a breast pump, not the diagnostic efficacy or interpretation by human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This is not applicable in the context of a breast pump. There is no "algorithm" in the sense of AI or a diagnostic tool that would have a standalone performance. The "device" itself is a mechanical and electrical system whose performance was evaluated in isolation (standalone) from a user, by measuring its physical output.

7. The Type of Ground Truth Used

The "ground truth" for the comparison was the performance of the predicate device (Evenflo Sof-Touch Ultra Breast Pump) in terms of vacuum pressure as a function of time. This is a form of empirical data from an established, legally marketed device used as a benchmark for substantial equivalence.

8. The Sample Size for the Training Set

Not applicable. This device is a mechanical breast pump, not an AI or machine learning algorithm that requires a "training set."

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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