(171 days)
The Merlexi Craft Bariatric series of manual wheelchairs are intended for use to empower physically challenged persons by providing a means of mobility. This includes temporary and permanent conditions for which manual wheelchairs are generally prescribed for use. In particular, the Merlexi Craft Bariatric wheelchairs are intended for users up to 425 pounds. They are not for MRI environment use.
Not Found
Due to the nature of the provided document, which is a letter from the FDA regarding a 510(k) premarket notification for a medical device (manual wheelchairs), the requested information about acceptance criteria and a study proving those criteria are met is not present in the document.
This document is primarily concerned with confirming that the Merlexi Craft Bariatric series of manual wheelchairs is substantially equivalent to legally marketed predicate devices, and it outlines regulatory requirements and general controls for marketing such a device.
Here's why the requested information is not found:
- Acceptance Criteria and Device Performance: The letter states the device is "substantially equivalent" to predicate devices. This means it has similar technological characteristics and is intended for the same use as a device already on the market. It does not provide specific performance metrics or acceptance criteria for the new device itself. Information like wheelchair weight capacity (up to 425 pounds) is an "indication for use" rather than a performance criterion for a study.
- Study Details: A 510(k) submission generally relies on comparisons to predicate devices or on non-clinical (bench) testing to demonstrate substantial equivalence, rather than a clinical study with human subjects, especially for a Class I device like a manual wheelchair. The letter itself does not describe any specific study, sample sizes, ground truth, or expert involvement as typically would be found for AI/software devices requiring detailed performance evaluation.
- AI/Software-Specific Information: Questions 5, 6, 8, and 9 are highly specific to AI/software performance studies (MRMC, standalone algorithm, training set size, etc.). The Merlexi Craft Bariatric series of manual wheelchairs is a mechanical device, and these types of studies are not applicable.
Therefore, I cannot populate the table or answer the specific questions based on the provided text. The document serves a different regulatory purpose than detailing performance study results.
§ 890.3850 Mechanical wheelchair.
(a)
Identification. A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class I (general controls).