(43 days)
The C.T.M. Power Chair HS-1000 is an indoor/outdoor powered wheelchair that provides transportation for a disabled or elderly person.
The C.T.M. Power Chair HS-1000 is an indoor/outdoor powered wheelchair that is battery operated. It has a base with four wheels, an adjustable padded seat with armrests, and a controller attached to one armrest which allows the rider to control the movement of the chair. It can be disassembled for transport and is provided with an on-board battery charger.
The provided document (K040020) is a 510(k) Pre-Market Notification for a powered wheelchair, the C.T.M. Power Chair HS-1000. For this type of device and submission, the acceptance criteria and study detailed are not typically in the format of an AI/software device evaluation. Instead, the submission focuses on demonstrating substantial equivalence to a predicate device through engineering performance testing. It does not involve AI, human readers, or medical image analysis.
However, I can extract information relevant to "performance" in the context of this device based on the available text:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria / Predicate Performance (HS-5600) | Reported Device Performance (HS-1000) |
|---|---|---|
| Use Parameters | Very similar to HS-5600 | Very similar to HS-5600, varying only in minor parameters (e.g., turning radius) |
| Braking System | Automatic and electric, default to "brakes on" if electrical system fails | Automatic and electric, default to "brakes on" if electrical system fails. Braking time: 1.0 seconds. Braking distance: about 10 feet. |
| Motors | Two motors, battery operated | Two motors, maximum 420W, battery operated |
| Batteries | Two 12-volt SLA (sealed lead acid) batteries, identical charging recommendations | Two 12-volt SLA (sealed lead acid) batteries, identical charging recommendations |
| On-board charger | Yes | 3A charger, plugs into 110V or 220V socket |
| Maximum Forward Speed | N/A (implied similar to predicate) | 4.5 mph |
| Maximum Reverse Speed | N/A (implied similar to predicate) | 2.1 mph |
| Minimum Turning Radius | N/A (implied similar to predicate) | 30.7 inches |
| Disassembly for transport | N/A (functional equivalence) | Yes, into 5 components (base, cover, seat with controller, 2 batteries) |
| Weight (assembled without batteries) | N/A | 120 lbs |
| Weight (assembled with batteries) | N/A | Approximately 175 lbs |
| Weight (base section) | N/A | 86 lbs |
| Controller | N/A (functional equivalence) | Shark Model Controller from Dynamic Controls, Ltd. |
| Self-diagnostic warnings | N/A (functional equivalence) | 11 specific fault codes indicated by flashing power reserve light |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The document does not specify a "sample size" in the context of individual units tested. The testing appears to have been performed on the C.T.M. Power Chair HS-1000 device itself, likely one or a few units, as part of engineering verification.
- Data Provenance: The document does not provide details on the country of origin of the data or whether it was retrospective or prospective. The testing was conducted by the submitter, C.T.M. Homecare Product, Inc. (located in Riverside, CA, USA).
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 to this 510(k) submission. "Ground truth" in the context of expert consensus is typically used for AI/diagnostic devices where human interpretation is being evaluated against an objective standard. For a powered wheelchair, the performance is assessed against technical specifications and safety standards as outlined in relevant guidance documents.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods are relevant for studies involving human reviewers or diagnostic decisions, not for the engineering performance testing of a mechanical device like a wheelchair.
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
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI or diagnostic imaging devices involving human readers. The submission explicitly states: "Comparative performance testing and clinical evaluations were not submitted as part of this 510(k)."
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
No, a standalone algorithm performance study was not done. This device is a powered wheelchair; it does not contain an algorithm that operates independently for diagnostic or interpretative tasks.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance is established by engineering and safety standards outlined in the "Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Mechanical and Powered Wheelchairs, and Motorized Three Wheeled Vehicles, July 1995." The device's performance parameters (e.g., braking time, speed, turning radius) are measured against criteria derived from these standards for safe and effective operation. In essence, meeting the criteria outlined in the guidance document serves as the "ground truth" for its safety and functional performance.
8. The sample size for the training set
This information is not applicable as there is no AI algorithm being developed or "trained" for this device.
9. How the ground truth for the training set was established
This information is not applicable as there is no AI algorithm and therefore no training set or its associated ground truth.
§ 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).