(30 days)
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
The LERADO Power Wheelchair, PB 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 text is a 510(k) summary for the LERADO Power Wheelchair, PB. It does not describe an AI/ML powered medical device, but rather a traditional powered wheelchair seeking substantial equivalence to a predicate device. Therefore, much of the requested information regarding acceptance criteria for an AI/ML device and specific study details (like sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment) is not applicable or present in this document.
However, I can extract information related to the device's performance testing and comparison to the predicate device to infer some "acceptance criteria" through the lens of substantial equivalence.
Here's the closest interpretation of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from comparison to predicate and standards) | Reported Device Performance (LERADO Power Wheelchair, PB) |
|---|---|
| Safety and Performance Standards: | Passed EMC Report ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995. Electronic systems (motor, batteries, recharge) UL certified. |
| Intended Use: Mobility for persons restricted to a seated position. | Intended use is the same as the predicate device. |
| Strength and Fatigue Tests: Meet requirements. | Mainframes meet strength and fatigue tests. |
| Weight Capabilities: Equivalent to predicate. | Same as predicate. |
| Maximum Speed: Equivalent to predicate. | Same as predicate. |
| Suspension of Cross Brace: Equivalent to predicate. | Same as predicate. |
| Footplates: Equivalent to predicate. | Same as predicate. |
| Armrest: Equivalent to predicate. | Same as predicate. |
| Warranty: Equivalent to predicate. | Same as predicate. |
| Back Upholstery Material: Equivalent to predicate. | Same as predicate. |
| Electronic Controller Certification: UL certified. | Dynamic DA series controller is UL certified. |
| Incline Capability: Safe operation up to 10 degrees. | Can drive under 10 degrees. Owner's Manual specifies limit of 10 degrees. |
| Cruising Range per Charge: Discussed in comparison. | 22.5 miles. (Predicate: 15 miles) |
| Overall Dimensions: Discussed in comparison. | Similar to predicate, but with some differences. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable or not specified in the document. This is not an AI/ML device where a 'test set' of data would be used to evaluate an algorithm's performance. The "test set" here would refer to the physical device undergoing performance testing.
- Data Provenance: The device underwent performance testing according to international standards (listed above). The document doesn't specify if these tests involved human subjects or specific data sets in the way an AI/ML study would. It refers to the testing of the physical wheelchair.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This is a traditional device. The "ground truth" is established by the specifications and performance standards themselves, not by expert consensus on data interpretation.
4. Adjudication method for the test set
- Not applicable for the type of device and submission. Adjudication methods like 2+1 or 3+1 are typically used for expert review of medical images or other complex data where varying interpretations are possible to establish a consensus ground truth, which is not relevant here.
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. This is not an AI/ML device, and no MRMC study was performed or is relevant for this type of submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is not an AI/ML device.
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 (e.g., ANSI / RESNA WC/Vol.2-1998, CISPR 11, EN61000-3-2, IEC61000-3-3, UL certification) which the device is tested against. The claim of substantial equivalence is based on meeting these standards and having similar performance characteristics to a legally marketed predicate device.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device, so there is no "training set."
9. How the ground truth for the training set was established
- Not applicable. As there is no training set for an AI/ML model, there is no ground truth to be established for such a set.
§ 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).