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The intended use of this product is to make available a safety device for people using lift chairs to get from their feet to a seated position. This will ensure that the unit will stop if any thing is under the chair.

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I am sorry, but the provided text does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets them. The document is a 510(k) clearance letter from the FDA for a device called "Prevent I II" by American Dream International Corporation.

This letter primarily states that the FDA has reviewed the 510(k) notification and found the device to be "substantially equivalent" to previously marketed devices. It outlines the regulatory framework and allows the company to market the device.

However, it does not include:

• A table of acceptance criteria and reported device performance.
• Details about sample sizes, data provenance, number of experts, adjudication methods for a test set.
• Information on MRMC comparative effectiveness studies or standalone algorithm performance.
• The type and method of establishing ground truth for either a test or training set.
• The sample size for a training set.

The only piece of relevant information provided is the intended use of the device: "to make available a safety device for people using lift chairs to get from their feet to a seated position. This will ensure that the unit will stop if any thing is under the chair." This statement describes the functionality of the device but not specific quantitative or qualitative acceptance criteria or the study data demonstrating its fulfillment.

Therefore, I cannot fulfill your request based on the provided text.

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