(17 days)
The intended use of the Quantum Blast is to provide mobility to persons limited to a seated position that are capable of operating a powered wheelchair.
The Pride Quantum Blast model rear-wheeled drive powered wheelchairs are battery powered, motor driven devices. A P&G Remote Plus joystick and 100 amp controller is used to operate the Quantum Blast. The Quantum Blast is powered by two 12 VDC, Group 24 batteries and has a range of up to 25 miles on a full charge. The base of the chair is made of welded steel construction. The Quantum Blast comes standard with a Versa Seat. Optional seating material meets California 117 standards for fire retardancy.
This K011993 submission for the Quantum Blast powered wheelchair is for a medical device that does not involve AI/ML. The provided document details the substantial equivalence of the Quantum Blast to a predicate device (Jazzy SC-900) based on non-clinical performance standards and intended use. There are no acceptance criteria, device performance metrics, or studies involving AI/ML described in the document.
Therefore, I cannot provide the information requested in the prompt, as it pertains to AI/ML device performance and studies, which are not relevant to this submission.
Specific answers to the prompt questions, based on the provided document:
- A table of acceptance criteria and the reported device performance: Not applicable. This submission concerns a physical medical device, not an AI/ML system. The document lists ANSI/RESNA standards for stability, brakes, dimensions, obstacle climbing, and EMC, but doesn't provide specific quantitative acceptance criteria or reported performance values against those criteria within this summary. It states the non-clinical testing was performed.
- Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. No test set for an AI/ML model is mentioned. The testing refers to physical product testing according to ANSI/RESNA standards.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. No ground truth for an AI/ML system is mentioned.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
- The sample size for the training set: Not applicable. No training set for an AI/ML model is mentioned.
- How the ground truth for the training set was established: Not applicable.
§ 890.3860 Powered wheelchair.
(a)
Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class II (performance standards).