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The X-Change wheelchair family is designed mostly for adults who require assistance in the use of a device to assist them with their mobility needs.

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I am sorry, but the provided text does not contain the information needed to describe the acceptance criteria and the study that proves the device meets those criteria. The document is a 510(k) clearance letter for a mechanical wheelchair, the X-Change, and it primarily focuses on the regulatory approval process based on substantial equivalence to a predicate device.

Specifically, the document does not include:

• A table of acceptance criteria or reported device performance.
• Details about a study conducted to prove the device meets specific performance criteria.
• Information about sample sizes, data provenance, expert-established ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or how ground truth for training sets was established.

The document states that the FDA reviewed the premarket notification and determined that the device is "substantially equivalent" to legally marketed predicate devices. This typically means the device has the same intended use and the same technological characteristics as the predicate device, or if it has different characteristics, the new characteristics do not raise different questions of safety and effectiveness and are demonstrated to be as safe and effective as the predicate device. However, it does not provide the specifics of any performance studies that would typically be associated with acceptance criteria.

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The BRIX wheelchair is designed for children who have physical impairments that require the use of a device to assist them with their mobility needs. This device is intended solely for pediatric use.

BRIX wheelchair

The provided text is a 510(k) Premarket Notification from the FDA to Meyra, Inc. regarding their BRIX mechanical wheelchair.

This document is a regulatory clearance notice, confirming that the FDA has found the BRIX wheelchair to be substantially equivalent to legally marketed predicate devices. It does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert reviews as typically found in a study report for a medical device.

Therefore, I cannot fulfill your request for the detailed information you've asked for, as it is not present in the provided text. This document is a legal and regulatory clearance for market entry, not a technical study report.

If you have a different document that details the performance study for the BRIX wheelchair, I would be happy to analyze it for the information you've requested.

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The EUROCHAIR wheelchair family is designed mainly for adults with physical impairments that require the use of a device to assist them with their mobility needs.

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The provided text is a 510(k) premarket notification letter from the FDA for a mechanical wheelchair called "Eurochair." This document does not contain information about acceptance criteria or a study proving the device meets said criteria.

The letter confirms that the FDA has reviewed the 510(k) submission and determined the device to be "substantially equivalent" to legally marketed predicate devices. This means that the device is deemed as safe and effective as a device already on the market, but it does not detail specific performance criteria or the results of a study to demonstrate that.

Therefore, I cannot provide the requested information based on the provided text. The document is primarily an administrative letter granting market clearance based on substantial equivalence.

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