(64 days)
Its intended use is to provide mobility to persons limited to a sitting position, that have the capability of operating a powered wheelchair.
The Invacare Storm Series, Invacare Power 9000 Series, Power Tiger power wheelchairs with gyroscope control are battery powered, motorized mobility vehicles. Their intended function and use is to provide mobility and transportation to physically challenged persons that may be restricted to a seated position. The various models differ somewhat in design, drive mechanisms, styling, aesthetics and mechanical components. The primary difference between the Power 9000 Series and the Storm Series wheelchairs is in the wheelchair frame style. Where the Power 9000 is a cross brace type folding frame wheelchair, the Storm is a rigid frame non-folding type wheelchair. Additionally, the Power 9000 Series wheelchairs are a basic, economical, more traditional type wheelchair whereas the Storm Series wheelchairs, are designed to have a more sporty, aesthetic appeal. The gyroscope control feature is an angular rate sensor that measures power wheelchair speed and turning (rotational velocity), and compensates by changing wheel speed to correct for differences. The intended function of this feature is provide a more accurate response to wheelchair joystick user commands, thereby providing a more consistent response of the wheelchair drive wheels.
The provided text describes a 510(k) premarket notification for Invacare power wheelchairs with gyroscope control. However, it does not contain the detailed information requested regarding acceptance criteria and a study proving the device meets those criteria in the context of an AI/ML-driven medical device.
The document is a regulatory submission for a physical medical device (power wheelchairs) and focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than an AI/ML system's performance metrics.
Therefore, for aspects related to AI/ML device performance, such as sample sizes for test/training sets, data provenance, expert qualifications for ground truth, adjudication methods, MRMC studies, standalone performance, and how ground truth was established, the information is not available in the provided text.
The document does mention performance data in the context of adhering to industry standards for power wheelchairs.
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Applicability of RESNA Standard ANSI/RESNA WC/14 (1991) | "The Invacare Models Storm, Power 9000 and Power Tiger with Gyroscope Control meet the applicable requirements specified in the Rehabilitation Engineering Society of North America (RESNA) Standard ANSI/RESNA WC/14 (1991)" |
| Applicability of ISO Standard ISO 7176: 1993 (E) "ISO Standard, Wheelchairs - Requirements and Test Methods for the Power and Control Systems of Electric Wheelchairs" | "and ISO Standard ISO 7176: 1993 (E) 'ISO Standard, Wheelchairs - Requirements and Test Methods for the Power and Control Systems of Electric Wheelchairs'" |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided. The document states the device meets the standards but does not detail the specific testing methodologies (like sample size, test set characteristics, or data provenance) used to demonstrate compliance.
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)
- Not applicable/Not provided. This is relevant for AI/ML ground truth establishment. For a physical device demonstrating compliance with engineering standards, "ground truth" in this sense isn't derived from expert consensus on medical images or outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided. Similar to point 3, this is an AI/ML specific concept for resolving disagreements in ground truth labeling.
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/Not provided. This type of study is specifically for evaluating the impact of AI assistance on human performance, which is not relevant for this physical device submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/Not provided. This refers to the performance of an algorithm without human intervention, which is not applicable to a power wheelchair with gyroscope control in this context.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable/Not provided in the AI/ML sense. The "ground truth" here is compliance with established engineering and performance standards for wheelchairs (RESNA and ISO).
8. The sample size for the training set
- Not applicable/Not provided. This is relevant for AI/ML model training.
9. How the ground truth for the training set was established
- Not applicable/Not provided. This is relevant for AI/ML model training.
§ 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).