(17 days)
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
The HEARTWAY Power Mobility Scooter, PF6 is an indoor / outdoor electric scooter that is battery operated. It has a base with four-wheeled with a seat, armrests, and a front basket. The movement of the scooter 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 510(k) premarket notification for the HEARTWAY Power Mobility Scooter, PF6. The primary purpose of this submission is to demonstrate substantial equivalence to a legally marketed predicate device, rather than to establish acceptance criteria for a novel device through performance studies that generate numerical metrics like sensitivity or specificity.
Therefore, the requested information about acceptance criteria, detailed performance tables, sample sizes for test and training sets, expert qualifications, and adjudication methods is not directly applicable to this type of regulatory submission. This submission focuses on comparing design, materials, and safety standards to an existing device.
However, I can extract the relevant information from the document to address the spirit of your request:
1. Table of Acceptance Criteria and Reported Device Performance
Instead of traditional performance criteria for a medical diagnostic device, the "acceptance criteria" here relate to demonstrating substantial equivalence based on design, materials, and compliance with recognized standards.
| Acceptance Criteria Category | Specific Criteria / Standard | Reported Device Performance (HEARTWAY Power Mobility Scooter, PF6) |
|---|---|---|
| Intended Use | Same as predicate device (mobility for persons restricted to a seated position). | Same as predicate device. |
| Mainframe Materials | Fixed, meet strength and fatigue tests; same material aspects. | Fixed, meet strength and fatigue tests; same material aspects. |
| Cruising Range per Charge | Same as predicate device. | Same as predicate device. |
| Other Features | Suspension of cross brace, footplates, incline degree 10°, armrest type, warranty. | Same as predicate device. |
| Back Upholstery Material | Same fabric, passed resistance ignition test. | Same fabric, passed resistance ignition test. |
| Electronic Systems | Same suppliers as predicate, UL certificated (electronic controller, batteries, competent switches, switching power supplies). | Same suppliers, UL certificated. |
| Safety Level | Same as predicate device. | Same as predicate device. |
| Electromagnetic Compatibility (EMC) | Compliance with standards: ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995. | EMC Report indicates compliance with these standards. |
| Differences from Predicate | Overall appearance, weight capabilities, maximum speed, weight are different but do not affect safety. | Differences acknowledged; considered not to impact safety. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable. This is not a study involving a test set of data like images or patient records. The "test" refers to performance criteria validated through engineering tests and comparison to a predicate device.
- Data Provenance: Not applicable in the context of clinical or image data. The provenance relates to engineering test results and design specifications. The company is based in Taichung, Taiwan, R.O.C. The performance testing (EMC, ANSI/RESNA) would have been conducted according to international and US standards. All testing appears to be prospective in the sense that the device was evaluated against the specified 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 as typically defined for diagnostic AI (e.g., expert consensus on medical images or pathology) is not part of this type of submission. The "ground truth" for this product type is adherence to engineering standards and safety requirements for powered mobility scooters.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. There is no "test set" in the context of clinical data requiring expert 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-enabled diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device (mobility scooter), not an algorithm or software.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for this submission is established by adherence to recognized engineering standards (e.g., ANSI/RESNA WC/Vol.2-1998, CISPR 11, EN61000), safety certifications (UL certificated for electronics), and direct comparison of design specifications and materials to a legally marketed predicate device.
8. The sample size for the training set
- Not applicable. There is no "training set" as this is not a machine learning model.
9. How the ground truth for the training set was established
- Not applicable.
§ 890.3800 Motorized three-wheeled vehicle.
(a)
Identification. A motorized three-wheeled vehicle is a gasoline-fueled or battery-powered device intended for medical purposes that is used for outside transportation by disabled persons.(b)
Classification. Class II (performance standards).