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Intended use is attendant guided transportation for hospital patients. Amigo Mobility International's intent is to supply the above named device to hospital equipment distributors. The device can be operated indoors on carpeting, linoleum, and other floors, and on sidewalks.

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I am sorry, but the provided text from the FDA 510(k) letter for the Amigo Escort 7.5 powered wheelchair does not contain the information requested in your prompt.

The document is a substantial equivalence determination letter, which confirms that the FDA has reviewed the premarket notification for the device and determined it is substantially equivalent to a legally marketed predicate device. It specifies general controls, regulatory class, and lists the indications for use.

However, it does not include details about:

• Acceptance criteria and reported device performance in a table format.
• Sample sizes, data provenance, or details about the test set.
• Number or qualifications of experts for ground truth establishment.
• Adjudication methods.
• Results of a multi-reader multi-case (MRMC) comparative effectiveness study.
• Standalone algorithm performance studies.
• Type of ground truth used (expert consensus, pathology, outcome data).
• Training set sample size or how its ground truth was established.

This type of information, particularly regarding detailed performance studies, would typically be found in the 510(k) submission itself, which is a much more extensive document than the FDA's decision letter.

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Ask a specific question about this device

The subject device and the predicate device intended use The subject device and the produced individuals.

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The provided text is a 510(k) premarket notification approval letter from the FDA for a medical device called "Amigo Model 680000 Excite F350".

This document does not contain any information regarding acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert qualifications for AI/ML device evaluation. It is a regulatory approval for a physical mobility device (presumably a powered wheelchair or scooter). Therefore, I cannot fulfill your request for information related to AI/ML device studies based on this document.

The information sought in your prompt (e.g., sample sizes for test and training sets, data provenance, number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth) is typical for the evaluation of AI/ML-driven medical devices. However, this specific document predates the widespread use and regulatory frameworks for such devices and is for a different type of product entirely.

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The subject device and the predicate device intended use, e is personal transportation for walking impaired individuals.

AMIGO MODEL 590000 (Joystick)

The provided text is a 510(k) clearance letter from the FDA for a medical device (Amigo Model 590000, a joystick-controlled personal transportation device for walking-impaired individuals). It is not a study report or clinical trial document. Therefore, it does not contain information about acceptance criteria, device performance metrics, sample sizes, expert qualifications, ground truth establishment, or any details about a study proving the device meets acceptance criteria for an AI/ML product.

The letter explicitly states that the device is "substantially equivalent" to devices marketed prior to May 28, 1976. This means the clearance is based on a comparison to existing predicate devices, not on a new study demonstrating performance against specific acceptance criteria in the way you've outlined for an AI/ML product.

Therefore, I cannot extract the requested information from the provided text.

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Intended use is personal transportation for senior active and walking impaired individuals.

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The provided documents are a 510(k) clearance letter from the FDA for a device named "Amigo RT." This letter indicates that the device has been found substantially equivalent to a predicate device and can be marketed. However, the letters do not contain any information regarding acceptance criteria, study details, performance metrics, sample sizes, ground truth establishment, or expert qualifications for the device.

Therefore, I cannot provide the requested information based on the given input. The documents are purely administrative regarding regulatory clearance.

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