(34 days)
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
The HEARTWAY Power Mobility Scooter. S11 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.
The provided documents describe a 510(k) premarket notification for the HEARTWAY Power Mobility Scooter, S11. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing extensive clinical study data with specific acceptance criteria and performance metrics in the way a novel medical device might.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details for an AI-powered device is largely not applicable to this 510(k) submission.
However, I can extract the relevant performance testing and equivalence information that is present:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Standards Met) | Reported Device Performance |
|---|---|
| EMC Report ANSI / RESNA WC/Vol.2-1998 | Device meets this standard |
| CISPR 11: 1990 | Device meets this standard |
| EN61000-3-2: 1995 | Device meets this standard |
| IEC61000-3-3: 1995 | Device meets this standard |
| UL certified electronic systems | Electronic systems (controller, batteries, switches, power supplies) are UL certified. |
| Strength and Fatigue tests | Mainframes meet strength and fatigue tests. |
| Resistance Ignition test | Back upholstery material passed the resistance ignition test. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not explicitly stated in terms of a "test set" for performance evaluation of a new algorithm. The performance testing refers to compliance with established international standards for wheelchairs, scooters, and their chargers. These are typically engineering and safety tests performed on representative units of the device.
- Data Provenance: The manufacturing company is HEARTWAY Medical Products Co., Ltd. in Taichung, Taiwan, R.O.C. The certifications are to international standards (ANSI / RESNA, CISPR, EN, IEC, UL).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. This submission does not involve expert-established ground truth for a diagnostic or AI-driven device. Compliance with engineering and safety standards is assessed through physical testing methods, not expert review of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. See point 3.
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 a physical medical device (mobility scooter), not an AI-assisted diagnostic or therapeutic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. See point 5.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable in the typical sense of "ground truth" for clinical data. The "ground truth" for this device's performance is adherence to established engineering, safety, and electrical standards as measured through predefined test protocols (e.g., strength tests, electrical compatibility tests, flammability tests).
8. The sample size for the training set
- Not applicable. This submission does not involve machine learning or a "training set."
9. How the ground truth for the training set was established
- Not applicable. See point 8.
Summary of the Study (510(k) Submission for Substantial Equivalence):
The "study" described in these documents is essentially a demonstration of substantial equivalence for the HEARTWAY Power Mobility Scooter, S11, to a legally marketed predicate device, the HEARTWAY Power Mobility Scooter, PF6 (K072104).
The core of the submission focuses on demonstrating that all critical safety and performance aspects of the new device are either identical to the predicate device or meet relevant recognized consensus standards.
Key arguments for substantial equivalence include:
- Identical Intended Use: Both devices provide mobility to persons restricted to a seated position.
- Similar Materials: Mainframe materials are fixed and meet strength and fatigue tests; back upholstery uses the same fabric and passed ignition resistance.
- Similar Components/Design: Suspension, cross brace, footplates, incline degree, and armrest type are all the same.
- Identical & Certified Electronic Systems: The electronic systems (controller, batteries, switches, power supplies) are from the same suppliers and are UL certified, ensuring the same safety level.
- Compliance with Standards: The device underwent performance testing against EMC Report ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, and IEC61000-3-3: 1995.
The differences noted (overall appearance, weight capabilities, maximum speed, and total weight) are argued not to affect the safety and effectiveness, and thus the devices are considered substantially equivalent. The new device also has an additional "free-wheel" manual feature, which is presented as an advantage rather than a safety concern.
§ 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).