(167 days)
The indication for use of the Ability Power Gurney is to provide mobility to persons limited to a prone position, that have the capability of operating a powered wheelchair.
The Ability Power Gurney is a battery powered, motor driven device consisting of a platform mounted on a wheeled frame that is designed to provide mobility and transportation to physically challenged persons that may be restricted to a horizontal position. The device may have patient securement straps and supports for fluid infusion equipment.
A Penny and Giles VSI controller joystick and a 70amp controller is used to operate the Ability Power Gurney, the same as the predicate device, the Invacare Storm Power Wheelchair. The Ability Power Gurney is powered by two 12VDC, Group U-1 Gel Batteries and has a range of up to 15 miles on a full charge. The base of the stretcher is made of welded steel construction.
The Ability Power Gurney and the predicate both have a caster mounted design with a variable height top surface. The top may be controlled by the client for pressure relief and access to different heights. Optional material meets California 117 standards for fire retardancy.
The provided text describes a 510(k) premarket notification for the "Ability Power Gurney," a powered wheeled stretcher. It focuses on establishing substantial equivalence to predicate devices, rather than an AI/ML medical device. As such, the specific metrics and study types requested in your prompt (e.g., acceptance criteria for algorithm performance, sample sizes for test/training sets, ground truth establishment, MRMC studies, standalone performance) are not applicable to this submission.
The document demonstrates compliance with recognized safety and performance standards for medical electrical equipment and wheelchairs, which serves as the "acceptance criteria" for this type of device.
Here's an attempt to answer your questions based on the provided text, while acknowledging its limitations regarding typical AI/ML device evaluations:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Voluntary Standards/Regulations) | Reported Device Performance |
|---|---|
| Safety & Performance for Power and Control Systems: | |
| ANSI/RESNA WC/14 (1991) | The motors and control mechanisms (same as Invacare Storm power wheelchair) meet the applicable requirements specified in this standard. |
| ISO 7176:1993 (E) | The motors and control mechanisms (same as Invacare Storm power wheelchair) meet the applicable requirements specified in this standard. |
| General Safety for Medical Electrical Equipment: | |
| IEC 601-1-1 | The Ability Power Gurney will comply with this standard. |
| IEC 601-1-2 | The Ability Power Gurney will comply with this standard. |
| UL 2601-1 | The Ability Power Gurney will comply with this standard. |
| CAN/CSA-C22.2 No. SD1.1-M90 | The Ability Power Gurney will comply with this standard. |
| Material Flammability (Optional): | |
| California 117 standards for fire retardancy | Optional material meets California 117 standards for fire retardancy. |
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 applicable and not provided in the document. The evaluation of this device is based on compliance with established engineering and safety standards for medical devices and wheelchairs, rather than a clinical trial with human subjects or a dataset for AI model evaluation.
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 information is not applicable and not provided. "Ground truth" in the context of AI/ML evaluation does not apply to this type of device submission. The "truth" is whether the device meets the physical and electrical safety standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided. Adjudication methods are relevant for resolving disagreements among multiple experts generating ground truth for AI model testing.
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
An MRMC study is not applicable and was not done. This type of study is used to evaluate the impact of AI assistance on human performance in diagnostic tasks. The Ability Power Gurney is a mobility device, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance assessment (in the context of an AI algorithm) is not applicable and was not done. The device itself is a standalone product, but not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's acceptance is its compliance with internationally recognized consensus standards for safety, performance, and electrical characteristics of powered wheelchairs and medical electrical equipment. This is a technical and engineering "ground truth," not a clinical one.
8. The sample size for the training set
This information is not applicable and not provided. There is no AI model being trained for this device.
9. How the ground truth for the training set was established
This information is not applicable and not provided. There is no AI model or training set involved. The "ground truth" for compliance with the standards is established by testing the physical device against the defined parameters and requirements within those standards.
§ 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).