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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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To offer to the consuming public, an electric 4-wheel scooter, that is reliable, safe and affordable.

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I am sorry, but the provided text does not contain the information requested in the prompt. The text is a letter from the FDA to American Dream International Corporation regarding the 510(k) clearance of their "Stealth," "Prowler," and "Intruder" devices, which are described as a 4-wheel electric scooter.

The letter discusses regulatory classifications and general controls, but it does not include any details about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications. Therefore, I cannot generate the table or answer the specific questions about the device's performance study.

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The intended use of this product is to provide freedom and mobility to persons who have difficulty walking. Hour electric ----scooter will provide freedom of movement at an affordable price.

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I am sorry, but the provided text does not contain the necessary information to describe the acceptance criteria and the study that proves the device meets those criteria. The document is a 510(k) clearance letter from the FDA, which confirms that certain devices (Stealth K972036, Prowler K972037, Intruder K972038) are substantially equivalent to previously marketed devices.

While it mentions the "intended use" for the Stealth scooter (K972036), it does not detail:

• Specific acceptance criteria (e.g., performance metrics, thresholds).
• Any details about a study conducted to demonstrate performance against such criteria.
• Information related to sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

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

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To offer to the consuming public, an electric 3-wheel scooter, that is reliable, safe and affordable.

ADI 3-wheel scooter

I am sorry, but based on the provided document, I cannot fulfill your request. The document is a 510(k) clearance letter from the FDA for a 3-wheel scooter. It does not contain any information about acceptance criteria, device performance, study details, expert qualifications, or ground truth related to a medical device or AI system.

The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined these devices are substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act)."

The indication for use is: "To offer to the consuming public, an electric 3-wheel scooter, that is reliable, safe and affordable."

Therefore, this document does not contain the type of information needed to answer your questions about acceptance criteria and a study proving device performance as it pertains to a diagnostic or AI-driven medical device.

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