(80 days)
The design and construction of this device is such that it presents a mobility unit allowing users to be transported by an attendent or to be self propelled. This device is intended to provide mobility to invalids who are otherwise incapable of ambulation with patient ambulatory assist devices.
The design and construction of this device is such that it presents a mobility unit allowing users to be transported by an attendent or to be self propelled. This device is intended to provide mobility to invalids who are otherwise incapable of ambulation with patient ambulatory assist devices. The models to be offered are of different sizes allowing for user preferance because of physical needs. Options for users include removeable armrests & detachable footrests to accomodate user requirements.
This document is a 510(k) premarket notification for a mechanical folding wheelchair, submitted to the FDA in 1997. It is not a study report that describes acceptance criteria and device performance in the way a medical device efficacy study would.
Therefore, I cannot extract the information required in your request from the provided text for the following reasons:
- No Acceptance Criteria or Performance Data: The document states the device is "substantially equivalent" to existing products, but it does not define specific acceptance criteria (e.g., in terms of accuracy, sensitivity, specificity, or technical benchmarks) or report performance metrics (e.g., a study showing how well the device performs against these criteria). The provided tables are for dimensions and weights of various models, not performance data against specific criteria.
- No Study Conducted (in this context): A 510(k) notification primarily argues for substantial equivalence to a predicate device. It typically doesn't involve new clinical trials or rigorous performance studies to establish "acceptance criteria" and "prove the device meets them" in the way a novel medical diagnostic or therapeutic device would. The core of a 510(k) is demonstrating that the new device is as safe and effective as a legally marketed predicate device.
- No Details on Specific Study Design: Since no specific performance study against defined acceptance criteria is presented, there is no information about sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details.
In summary, the provided text is a regulatory submission for a medical device (a wheelchair), arguing for its substantial equivalence to already marketed devices. It does not contain the kind of performance study data and acceptance criteria you would find for a diagnostic or AI-driven device.
§ 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).