(79 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 Model Arrow Front Wheel Drive (FWD) Power Wheelchair is a battery powered, motor driven device with the intended function and use of providing mobility to those persons limited to a sitting position that have the capability of operating a power wheelchair. It is a rigid or " non- folding" type power wheelchair, with front wheel drive capability.
Front wheel drive means that the drive motors are connected directly to the front wheels of the wheelchair, as opposed to a rear wheel drive chair which connects the drive motors to the rear wheels. Mounting the drive wheels on the front of the wheelchair, results in a chair that is easier to maneuver than the traditional rear wheel drive wheelchair. Because the center line of the pivoting casters is now behind the user, the user experiences a more natural feel when turning the wheelchair.
This is a premarket notification for a power wheelchair, not an AI/ML powered medical device. Therefore, the requested information regarding acceptance criteria and study details for an AI/ML device is not applicable. The document describes a traditional medical device (power wheelchair) and its substantial equivalence to previously marketed devices.
However, I can extract the information provided about the device's performance testing:
Device: Invacare Model Arrow Front Wheel Drive Power Wheelchair
Acceptance Criteria/Performance Testing:
| Criterion | Reported Device Performance |
|---|---|
| Electromagnetic Compatibility (EMC) | Met the required performance criteria of ISO EMC Draft Standard 7176-14 (Titled "Draft ISO EMC Group Proposal: Electromagnetic Compatibility Addition" And Dated April 3, 1995) |
| Functionality | Functioned as intended. |
Study Details (of the performance testing described):
- Sample size used for the test set and the data provenance: Not explicitly stated, but implies the Invacare Arrow Front Wheel Drive Power Wheelchair itself, likely a representative production model.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Performance criteria for mechanical and electrical devices like wheelchairs are typically established through standardized tests, not expert consensus on ground truth in the context of diagnostic AI.
- 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. This is not an AI/ML device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.
- The type of ground truth used: International Standard (ISO EMC Draft Standard 7176-14) for Electromagnetic Compatibility and "functioned as intended" based on mechanical and electrical operation.
- The sample size for the training set: Not applicable. This is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.
Additional Information from the document:
- Intended Use: To provide mobility to persons limited to a sitting position, that have the capability of operating a powered wheelchair.
- Predicate Devices: Invacare Corporations' Action Storm Ranger II and Action Storm Power 9000 Front Wheel Drive Power Wheelchairs (K982064, October 5, 1998) and Permobil's Chairman Front Wheel Drive Power Wheelchair (K960951, April 4, 1997).
- Regulatory Class: II
- Product Code: ITI
§ 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).