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The device is indicated to provide mobility to persons limited to a sitting position.

The subject Küschall Advance Manual Wheelchair is available in a number of seat width, depth and height option. The subject device is a manual or attendant operated wheelchair that is indicated to provide mobility to persons limited to a sitting position with a weight capacity of 276 lbs. The standard components of the subject device include a complete rear wheels (hand rims and tires), front castors, tube style, footrest, carbon cloth guards, fold down and locking backrest, wheel locks and quick release axles. The carbon seat pan has a central Velcro band that is used for fixation. There is no prior submission for the subject device.

The provided text describes a 510(k) premarket notification for a manual wheelchair. This type of submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving a new device meets specific acceptance criteria based on performance metrics that would be typical for a software-based medical device (like an AI algorithm).

Therefore, the requested information about acceptance criteria, ground truth, expert adjudication, multi-reader multi-case studies, and training/test set sample sizes for an AI device does not apply to this document. The document describes a physical medical device (a manual wheelchair) and its substantial equivalence to another manual wheelchair.

Here's a breakdown of why each point of your request doesn't fit this document:

1. A table of acceptance criteria and the reported device performance: Not applicable. The "performance data" section (page 5) lists compliance with various RESNA and CAL standards for physical properties (stability, brakes, dimensions, strength, flammability, etc.) and biocompatibility testing, not performance metrics of an AI algorithm.
2. Sample sizes used for the test set and the data provenance: Not applicable. This is not an AI device with test sets. The "testing" refers to physical compliance testing, not a data-driven evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI algorithm is irrelevant to a wheelchair.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI device assisting human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

In summary: The provided document is a 510(k) submission for a mechanical wheelchair, demonstrating substantial equivalence through comparison of technological characteristics and compliance with established physical and biocompatibility standards. It is not an AI/software device, and thus the requested information regarding AI device evaluation criteria (acceptance criteria, ground truth, studies for AI performance, etc.) is not present in this text.

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