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The Action Trackchair all-terrain power wheelchair provides mobility to individuals who need a power wheelchair and are capable of operating a powered wheelchair.

Action Trackchair Hawk

My apologies, but the provided text is a 510(k) clearance letter from the FDA for a medical device called "Action Trackchair Hawk." This document primarily addresses regulatory aspects, such as substantial equivalence to predicate devices, and outlines general controls and regulations.

It does not contain any information regarding:

• Acceptance criteria for device performance.
• Details of a study proving the device meets acceptance criteria.
• Sample sizes for test or training sets.
• Data provenance.
• Number or qualifications of experts for ground truth.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance.
• Type of ground truth used (e.g., pathology, outcomes data).
• How ground truth for the training set was established.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. This information would typically be found in a separate study report, clinical trial summary, or a more detailed device description submitted as part of the 510(k) application, which is not included here.

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The Action Trackchair all-terrain power wheelchair provides mobility to individuals who need a power wheelchair, that are capable of operating a powered wheelchair and are limited to a seated position. The Action Trackchair does not require a doctor's prescription.

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The provided document describes a 510(k) premarket notification for a powered wheelchair, the "Action Trackchair: Eagle 16, Eagle 20, Eagle 20, Eagle 24". It confirms that the device is substantially equivalent to legally marketed predicate devices for providing mobility to individuals who need a power wheelchair, can operate one, and are limited to a seated position. The document states that it does not require a doctor's prescription.

However, the provided text is a regulatory clearance letter and does not contain any information regarding acceptance criteria, device performance numbers, specific studies conducted, sample sizes, expert qualifications, or ground truth establishment relevant to the performance of a medical device's AI component or its clinical efficacy.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the provided input. This type of information would typically be found in a separate clinical study report or a detailed summary of safety and effectiveness, which are not present in this regulatory clearance letter.

Ask a specific question about this device