(37 days)
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
The TEH LIN Powered Wheelchair, MDG-601 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.
This document describes the TeH LIN Powered Wheelchair, MDG-601, and its 510(k) submission for substantial equivalence to a predicate device. The information provided heavily focuses on regulatory approval and substantial equivalence, rather than detailed performance study reports with specific acceptance criteria and detailed device performance data.
Therefore, many of the requested elements for a detailed performance study description cannot be fully extracted from the provided text.
Here's what can be inferred and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria (Inferred/Missing) | Reported Device Performance (Inferred/Missing) |
|---|---|---|
| EMC Compliance | ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995 | "EMC Report" indicates compliance was tested, but specific pass/fail or measured values are not provided. |
| Safety and Functional Performance | Requirements from ANSI / RESNA WC/Vol.2-1998 for electrically powered wheelchairs, controllers, and chargers (e.g., stability, braking, speed, maneuverability, durability). | "Performance Testing" states these standards were applied, implying the device met the requirements. However, specific performance metrics are not given. |
| Intended Use | Ability to provide mobility to persons restricted to a seated position safely and effectively. | The device is intended and asserted to meet this use. No specific metrics are provided. |
| Substantial Equivalence | The device has the same intended use, technological aspects, and only minor dimensions and material differences exist compared to the predicate device (TEH LIN POWERED WHEELCHAIR MDG-201). | This was the primary "acceptance criterion" of the 510(k) submission and was** met**, leading to FDA clearance. |
2. Sample size used for the test set and the data provenance:
- The document describes "Performance Testing" against standards like ANSI / RESNA WC/Vol.2-1998. However, it does not specify a sample size for tested devices. Typically, such testing involves a limited number of production or pre-production units.
- Data Provenance: The testing was conducted by or on behalf of TEH LIN Prosthetic & Orthopaedic Inc. in Taiwan. The data would therefore be prospective in relation to the submission, but the location of the testing is not explicitly stated beyond the company's origin.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable in the context of this 510(k) summary. The "ground truth" for the performance testing is adherence to engineering and safety standards (e.g., ANSI / RESNA). This is determined by standardized test procedures and measurements, not by expert consensus on clinical findings.
- There are no "experts" in the sense of clinical reviewers establishing a ground truth for a diagnostic algorithm.
4. Adjudication method for the test set:
- Not applicable. Performance against engineering standards does not typically involve an adjudication method in the way a clinical study with human readers would. Results are objectively measured against defined criteria.
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 was not done. The device is a powered wheelchair, not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical product (a powered wheelchair), not an algorithm. Its performance is inherent to its design and manufacturing, not an AI algorithm operating independently.
7. The type of ground truth used:
- The "ground truth" for this device's performance is compliance with established international and national engineering and safety standards (e.g., ANSI / RESNA WC/Vol.2-1998, CISPR 11, EN61000-3-2, IEC61000-3-3). These standards define objective test methods and acceptable performance limits.
8. The sample size for the training set:
- Not applicable. This device is not an AI/ML product that requires a "training set." It's a manufactured medical device.
9. How the ground truth for the training set was established:
- Not applicable. As above, there is no training set for this type of device.
§ 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).