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510(k) Data Aggregation
(378 days)
The Tek RMD (Robotic Mobilization Device) is an electric lift and mobile stander and brings the user from a seated position to a passive standing position.
Tek RMD (TEK ROBOTIC MOBILIZATION DEVICE) Models: TEKRMD02, TEKRMD03, TEKRMD04, TEKRMD04, TEKRMD06, TEKRMD06, TEKRMD07, TEKRMD08
The provided text is a 510(k) premarket notification letter from the FDA regarding the Tek RMD (TEK ROBOTIC MOBILIZATION DEVICE). This document does not contain any information about acceptance criteria, device performance, clinical study design, or ground truth establishment relevant to an AI/ML medical device.
Therefore, I cannot provide the requested information. The document focuses on regulatory approval, product codes, and general controls, rather than a performance evaluation of the device based on specific criteria.
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(100 days)
The Tek RMD (Robotic Mobilization Device) is an electric lift and mobile stander and brings the user from a seated position to a passive standing position.
The Tek RMD (Robotic Mobilization Device) is an electric lift and mobile stander and brings the user from a seated position to a passive standing position.
This FDA 510(k) clearance letter for the Tek RMD (Robotic Mobilization Device) does not contain specific details about acceptance criteria, device performance results, or a detailed study description as typically found in an AI/ML device submission summary.
The document is a clearance letter from the FDA to Matia Robotics, indicating that their device has been found substantially equivalent to a legally marketed predicate device. This type of document confirms regulatory clearance but does not delve into the granular technical details of performance evaluation for AI/ML devices.
Therefore, the requested information cannot be extracted from the provided text. To answer your questions, one would need to access the actual 510(k) submission summary for K15058, which would contain the performance study details.
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