(11 days)
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
The SINON Power Wheelchair, SN-W401 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 describes a 510(k) premarket notification for the SINON Power Wheelchair, SN-W401. This document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed performance study with acceptance criteria and their fulfillment in the way one might see for a diagnostic AI device.
Therefore, many of the requested elements (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set details) are not applicable or not present in this type of regulatory submission for a powered wheelchair. The submission relies on established engineering standards and comparison to a legally marketed equivalent device, not a performance study as typically understood for AI/diagnostic tools.
Here's a breakdown of the information available and what is not applicable:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| EMC Report: | |
| ANSI / RESNA WC/Vol.2-1998 | Passed |
| CISPR 11: 1990 | Passed |
| EN61000-3-2: 1995 | Passed |
| IEC61000-3-3: 1995 | Passed |
| Safety Certification: | |
| UL certificated for electronic systems (controller, batteries, recharge) | Passed |
The "acceptance criteria" here are defined by compliance with established Electromechanical Compatibility (EMC) standards and safety certifications for powered wheelchairs. The document states that the device "passed" these.
2. Sample size used for the test set and the data provenance
- Not applicable in the context of this device. This is not a data-driven diagnostic device. Performance is assessed through engineering tests on the device itself.
- The "test set" would be the single device or a small sample of devices manufactured for testing against the engineering standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. Ground truth for a powered wheelchair involves meeting specific engineering and safety standards, not expert interpretation of diagnostic data. The "experts" would be the certified testing bodies (e.g., those issuing UL certification and conducting EMC tests).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. Performance against engineering standards is typically binary (pass/fail) or quantitative measurement against a threshold, not subjective adjudication.
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
- Not applicable. This is not an AI or diagnostic device that involves human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a hardware device (powered wheelchair), not an algorithm. Its "standalone" performance refers to its operational capabilities as a wheelchair, which are validated through compliance with the listed engineering standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device is defined by established international and national engineering standards for powered wheelchairs (e.g., ANSI / RESNA WC/Vol.2-1998, CISPR 11, EN61000-3-2, IEC61000-3-3) and safety certifications (UL certification).
8. The sample size for the training set
- Not applicable. This is not a machine learning or data-driven device.
9. How the ground truth for the training set was established
- Not applicable.
Additional context from the document:
- Legally marketed device for substantial equivalence comparison: EPW Foldable Power Wheelchair EPW-03 (K033206)
- The basis for substantial equivalence is that the electronic systems (controller, batteries, recharge) are the "same and all passed by the UL certificated" as the predicate device, ensuring the "same safety level."
- Differences like battery type, overall dimensions, tire size, and weight are noted but deemed "not safety aspect" differences that would negate substantial equivalence.
§ 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).