(82 days)
The AST Model MA012 and MS019 Rehab Wheelchairs are to provide mobility to persons limited to a sitting position.
The AST Model MA012 and MS019 Rehab Wheelchair are manual wheelchairs. They have adjustable armrests, and multiple axle position. The casters are 6"/7"/8" PU wheels with height adjustable forks and the rear wheels are 20"/22"/24″*1-3/8″ polyurethane(MA012 and MS019). The wheelchair also has a shear reduction system: by carefully aligning the pivot points of the user, to minimize the sliding down of the user and also minimize the shear force and pressure against the back. The armrest height can be adjusted from 8" to 12" and it is detachable. The wheel for MA012 is quick release rear wheel. The AST MS019 Rehab Wheelchair has NO quick release rear wheel; The upholstery of the device complies with ISO 7176-16:2012 Resistance to ignition of postural support devices. The device can be operated indoors, or outdoors on dry, level surfaces composed of concrete, blacktop, or asphalt under normal driving conditions.
The provided document is a 510(k) summary for a medical device (AST Model MA012 and MS019 Rehab Wheelchair). It describes the process of demonstrating substantial equivalence to a predicate device, not the development and validation of an AI/ML powered device. As such, most of the requested information regarding acceptance criteria, study design for AI, expert involvement, and ground truth establishment is not applicable to this document.
However, I can provide information based on what is available in the document regarding the device's performance against non-clinical test standards, which serves as a form of acceptance criteria for this type of medical device submission.
Here's the breakdown of the information provided in the document:
1. A table of acceptance criteria and the reported device performance
For a traditional medical device like a manual wheelchair, "acceptance criteria" are tied to compliance with recognized consensus standards. The performance is reported as meeting these standards.
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| ISO 7176-1:2014: Determination of Static Stability | Meets specifications |
| ISO 7176-3:2012: Determination of effectiveness of brakes | Meets specifications |
| ISO 7176-5:2008: Determination of overall dimensions, mass and maneuvering space | Meets specifications |
| ISO 7176-7:1998: Method of Measurement of Seating and Wheel Dimensions | Meets specifications |
| ISO 7176-8:2014: Requirements and test methods for static, impact and fatigue strengths | Meets specifications |
| ISO 7176-11:2012: Test dummies | Meets specifications (refers to test methodology) |
| ISO 7176-13:1989: Determination of coefficient of friction of test surfaces | Meets specifications (refers to test methodology) |
| ISO 7176-15:1996: Requirements for Information Disclosure, Documentation and Labeling | Meets specifications |
| ISO 7176-16:2012: Resistance to ignition of postural support devices | Meets specifications |
| ISO 14971:2007: Medical devices -- Application of risk management to medical devices | Meets specifications |
| ISO 10993-5:2009: Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity | Meets specifications |
| ISO 10993-10:2010: Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization | Meets specifications |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document describes compliance with international standards for wheelchair testing, which implies internal testing by the manufacturer. The country of origin of the manufacturer is China (Sichuan AST Medical Equipment Co., Ltd., Luzhou City, Sichuan, China). The type of testing (e.g., retrospective or prospective) is not applicable in the context of these device performance tests; they are typically conducted on manufactured units.
3. 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)
This is not applicable to a non-AI/ML device submission like this. The "ground truth" for a mechanical wheelchair's performance is determined by established engineering and medical device standards and test methods, not by expert consensus in a clinical diagnostic sense. The experts involved would be engineers and technical specialists responsible for conducting the ISO standard tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are relevant for clinical studies or expert review processes, which are not described here. Device performance is determined by passing predefined test criteria in the ISO standards.
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-powered device, and no MRMC comparative effectiveness study was performed or is relevant for this type of device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI-powered device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this medical device, the "ground truth" is defined by the objective performance criteria specified within the referenced ISO standards (e.g., static stability limits, brake effectiveness, dimensions within tolerance, strength requirements). Compliance with these standards confirms the device's fundamental safety and performance characteristics.
8. The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML 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).