(155 days)
The intended use of the Pride Mobility Products Corporation Quantum Bariatric 451 is to provide mobility to persons limited to a seated position that have the capability of operating a Powered Wheelchair.
The Quantum Bariatric 451 is a Powered Wheelchair having a digital controller, electrical system, motors, batteries, seating, and frame. The Quantum Bariatric 451 is equipped with electronic regenerative disc brakes, 8A off-board battery charger, removable 12 volt batteries, front anti-tip wheels, and rear caster wheels.
The Quantum Bariatric 451 is designed with ultimate safety, stability, and performance in mind. The Powered Wheelchair is designed for, but not limited to Pride Mobility Products Corporation, providers/retailers and their consumers.
This document primarily details the substantial equivalence of the Quantum Bariatric 451 powered wheelchair to a predicate device and its compliance with relevant testing standards, rather than presenting a study proving a device meets specific acceptance criteria based on performance metrics such as sensitivity, specificity, or accuracy.
Therefore, many of the requested elements for describing an acceptance criteria study, particularly those related to diagnostic performance or AI model validation, are not applicable or cannot be extracted from this document.
However, I can provide information based on the document's content:
1. A table of acceptance criteria and the reported device performance
Based on the document, the "acceptance criteria" are compliance with established testing standards and demonstrating substantial equivalence to a predicate device. The "device performance" in this context refers to successfully meeting these standards and exhibiting similar characteristics to the predicate device.
| Acceptance Criteria Category | Specific Acceptance Criteria (Standards / Equivalence) | Reported Device Performance |
|---|---|---|
| Safety & Performance Standards | RESNA WC Vol.1 2009 - Requirements and Test Methods for Wheelchairs | Compliance |
| RESNA WC Vol. 2 2009 - Additional Requirements for Wheelchairs with Electrical Systems | Compliance | |
| ANSI/RESNA WC Vol. 2-2008 Section 21 - Requirements and Test Methods for Electromagnetic Compatibility | Compliance | |
| CAL 117 - Flammability Testing | Compliance | |
| BS EN1021- Furniture - Assessment of the Ignitability of Upholstered Furniture, Part 2 | Compliance | |
| ISO 10993 - Biological evaluation of medical devices | Compliance | |
| Substantial Equivalence | Performance, maneuverability, stability, and structure compared to predicate (Pride Mobility Jazzy Frontie - K092961) | "Substantially equivalent" with similar performance characteristics and mechanisms for intended use and stability. Differences in weight capacity, drive wheels, and dimensions do not raise new safety/effectiveness questions. |
2. Sample size used for the test set and the data provenance
- Sample Size: The document does not specify a "sample size" in the context of a test set for performance metrics the way one would for an AI or diagnostic device. The testing refers to engineering and safety standards applied to the device itself.
- Data Provenance: Not applicable in the context of clinical or AI data. The "data" refers to the results of non-clinical engineering and safety tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The ground truth for this type of device (powered wheelchair) is established by adherence to recognized engineering, safety, and flammability standards, and comparison to existing legally marketed predicate devices, rather than expert interpretation of a test set.
4. Adjudication method for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies for discrepancies in expert opinion on ground truth. This document concerns engineering and safety compliance.
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 document is about a powered wheelchair, not an AI or diagnostic device that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not applicable to a powered wheelchair. The device itself is a "standalone" product in the sense that it operates, but not in the context of an algorithm's performance without human interaction.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" here is compliance with established international and national standards for medical devices and wheelchairs, along with the mechanical and functional characteristics of the predicate device (Jazzy Frontie K092961). It's essentially engineering standards compliance and predicate device comparison.
8. The sample size for the training set
Not applicable. This device does not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
Not applicable, as no training set (for AI) is involved.
§ 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).