(19 days)
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
The A&I Power Wheelchair, PC-401 is an indoor / outdoor Powered Wheelchair that is battery operated. It has a base with four-wheeled with a seat. The movement of the Wheelchair is controlled by the rider who uses hand controls located at the top of the steering column. The device can be disassembled for transport and is provided with an onboard battery charger.
The provided document describes the predicate device information, but does not sufficiently detail any studies to prove that the device meets the acceptance criteria. The document states that performance testing was conducted according to certain standards (ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995), but it does not provide any results from these tests or specific acceptance criteria. Instead, it relies on a comparison to a predicate device to establish substantial equivalence.
Therefore, the following information can be extracted, but many sections requested in the prompt cannot be fulfilled due to lack of detail in the source document.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical Performance | |
| Cruising Range | 20-30 km |
| Maximum Speed | 4.4 mph |
| Safety Climbing Ability | 12° |
| Weight Limit | Same as predicate device (not specified numerically) |
| Foldable Frame | Yes |
| Removable Arm Type | Yes |
| Back Upholstery Material | Passed resistance ignition test by SGS |
| Overall Dimensions | Different from predicate device |
| Size of Wheels | Different from predicate device |
| Seat Dimensions | Different from predicate device |
| Electrical Performance | |
| Battery Type | Same brand as predicate (UL certified U1 type) |
| Control System | Same brand (Dynamic types) |
| Recharger | HP8204A (UL certified) |
| Electronic Systems | All passed UL certification (safety level assured) |
| Safety Considerations | |
| Braking time and distance | Met relevant requirements (implied by similar speed) |
| Dynamic stability | Met relevant requirements (implied by similar speed) |
| User's climb not to exceed 12° | Owner's manual states this |
Note: The document emphasizes "substantial equivalence" to a predicate device (SINON Power Wheelchair, SN-W401, K040319) rather than predefined acceptance criteria for a new device. The "reported device performance" is primarily a comparison against the predicate.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a separate "test set" or its sample size. The performance testing refers to general compliance with standards, and the comparison is based on device specifications rather than a clinical trial or specific test set.
- Data Provenance: Not explicitly stated for specific tests, but the device is manufactured in Taiwan, R.O.C. (Republic of China). The testing standards are international.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. No ground truth establishment for a test set is mentioned. The assessment is based on engineering specifications and adherence to standards.
4. Adjudication Method for the Test Set
Not applicable. No test set requiring adjudication is mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is a medical device (power wheelchair), not an AI-powered diagnostic tool, so an MRMC study is not relevant.
6. Standalone (Algorithm Only) Performance
Not applicable. This is a physical medical device, not an algorithm.
7. Type of Ground Truth Used
Not applicable in the typical sense of a diagnostic algorithm. The "ground truth" for the device's performance would be the physical measurements and tests conducted according to the cited standards (ANSI / RESNA, CISPR, EN, IEC) to ensure functionality and safety.
8. Sample Size for the Training Set
Not applicable. This is a manufactured product, without a "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
§ 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).