(126 days)
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
The Home Health Power Wheelchair, HC-200 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 Home Health Power Wheelchair, HC-200. It focuses on establishing substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and performance data for the HC-200 itself.
Therefore, many of the requested details about acceptance criteria, study design, expert involvement, and ground truth are not present in this document. The document primarily discusses the comparison of design features and a general statement about meeting certain performance standards.
Here's a breakdown of what can and cannot be extracted from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
This information is not explicitly provided in the format requested. The document states that the device underwent "Performance Testing" according to certain standards, but it does not detail specific acceptance criteria values or the quantitative performance results (e.g., maximum speed, range, turning radius, battery life).
However, it does implicitly state that the device meets the functional requirements by citing adherence to these standards and by asserting substantial equivalence.
Implicit Acceptance of Performance Standards:
| Acceptance Criteria (Standard Adherence) | Reported Device Performance (Adherence Indicated) |
|---|---|
| Adherence to ANSI/RESNA WC/Vol.2-1998 | Meets ANSI/RESNA WC/Vol.2-1998 standards for Electrically Powered Wheelchairs |
| Adherence to CISPR 11: 1990 | Meets CISPR 11: 1990 standards for Electrically Powered Wheelchairs |
| Adherence to EN61000-3-2: 1995 | Meets EN61000-3-2: 1995 standards for Electrically Powered Wheelchairs |
| Adherence to IEC61000-3-3: 1995 | Meets IEC61000-3-3: 1995 standards for Electrically Powered Wheelchairs |
| Electronic systems passed UL certification | Electronic systems (controller, batteries, charger) are from UL-certified suppliers and passed UL certification. |
| Overall substantial equivalence to predicate device (SINON Power Wheelchair, SN-P401) | Determined to be substantially equivalent to K040320 based on design and safety aspects. |
2. Sample size used for the test set and the data provenance:
- Sample size for test set: Not specified. The document refers to "Performance Testing" but doesn't mention the number of units or specific test cases.
- Data provenance: The performance testing was done in relation to international and national standards (ANSI/RESNA, CISPR, EN, IEC). The location of the testing facility is not explicitly stated, but the company is based in Taiwan. It's likely prospective testing conducted by the manufacturer or a contracted lab to demonstrate compliance with these standards for the specific device model (HC-200). It's not a clinical study on a patient population.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of experts: Not applicable/not specified. The "ground truth" here is compliance with established engineering and safety standards, not a diagnostic or clinical outcome requiring expert consensus.
- Qualifications of experts: Not applicable. Compliance with standards is typically assessed by engineers and technicians.
4. Adjudication method for the test set:
- Adjudication method: Not applicable. This document describes performance testing against engineering standards, not a study where human judgment or adjudication of outcomes would be used. The testing would follow the methodologies outlined in the cited standards.
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:
- MRMC study: No, this is not an MRMC study. The device is a power wheelchair, not an AI-assisted diagnostic or therapeutic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone algorithm performance: Not applicable. The device is a physical product (power wheelchair), not an algorithm. The "performance testing" described refers to the functional and safety performance of the wheelchair itself.
7. The type of ground truth used:
- Ground truth type: The "ground truth" for this submission is adherence to recognized engineering and safety standards (ANSI/RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995) and the UL certification of its electronic components. The comparison to the predicate device (SINON Power Wheelchair, SN-P401) also serves as a "ground truth" for substantial equivalence.
8. The sample size for the training set:
- Sample size for training set: Not applicable. This document is not describing an AI/machine learning model, so there is no training set in that context.
9. How the ground truth for the training set was established:
- Ground truth for training set established: Not applicable, as there is no training set in this context.
§ 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).