(39 days)
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
The HEARTWAY Power Mobility Scooter, PF7 is an indoor / outdoor electric scooter that is battery operated. It has a base with three-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 text describes a 510(k) submission for the HEARTWAY Power Mobility Scooter, PF7. This is a regulatory submission for a medical device and, as such, focuses on demonstrating substantial equivalence to a predicate device rather than presenting a clinical study with detailed acceptance criteria and performance metrics in the way a novel AI/software medical device would.
Therefore, many of the requested elements (sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) are not applicable to this type of device and submission. The document primarily details performance testing related to safety and engineering standards, and comparison to an existing device to establish equivalence.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
For medical devices like power mobility scooters, acceptance criteria are typically met through compliance with recognized standards for safety, performance, and electrical compatibility. The "reported device performance" is framed as meeting these standards and demonstrating equivalence to a predicate device in key functional areas.
| Acceptance Criteria Category | Specific Criteria / Standard | Reported Device Performance | Comments |
|---|---|---|---|
| Electromagnetic Compatibility (EMC) | ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995 | Passed | These standards govern electrical safety and electromagnetic interference for electrically powered wheelchairs and scooters. |
| Material Strength and Fatigue | Not explicitly stated (implied by "meet the strength and fatigue tests") | Mainframes materials are fixed and meet strength and fatigue tests. | The device's structural integrity meets defined standards. |
| Resistance Ignition Test | Not explicitly stated (implied for back upholstery) | Back upholstery material passed the resistance ignition test. | Ensures safety against flammability. |
| Electronic Systems Certification | UL certificated | Electronic controller, batteries, and competent switches and switching power supplies are UL certificated. | Verification of electrical component safety. |
| Cruising Range (Comparison Point) | 18 miles (predicate device) | 32 miles (new device) | The new device exceeds the predicate device's range, which is noted as a difference but not a failure criterion, as "the real range depends on the practical environments." |
| Overall Safety Level | Substantially equivalent to predicate device | Same safety level as the predicate device (HEARTWAY Power Mobility Scooter, PF6). | Established through comparison of components and testing. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable in the context of clinical or AI performance. The "test set" here refers to the physical device undergoing engineering and safety tests. It's typically one device or a representative sample for these types of compliance tests.
- Data Provenance: The testing was conducted by or for HEARTWAY Medical Products Co., Ltd. in Taiwan, R.O.C. The reports (e.g., EMC Report) would be generated from this physical testing. This is a design validation/verification process, not a clinical data collection.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. The "ground truth" for a power mobility scooter's performance is objective measurements against established engineering and safety standards, not expert consensus on medical images or clinical outcomes. Certification bodies (like UL, those associated with ISO/IEC/EN standards) provide the "ground truth" by defining the tests and acceptable limits.
4. Adjudication Method for the Test Set
- Not applicable. Performance against engineering standards is typically binary (pass/fail) based on objective measurements, not a consensus or adjudication process.
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 device is a power mobility scooter, not an AI or diagnostic imaging device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is electro-mechanical, not an algorithm.
7. The Type of Ground Truth Used
- Engineering and Safety Standards: The "ground truth" is defined by internationally recognized engineering and safety standards (e.g., ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995, UL certifications). Compliance with these standards serves as the ground truth for safety and basic performance.
8. The Sample Size for the Training Set
- Not applicable. This device does not involve a "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set was Established
- Not applicable. As there's no training set, there's no ground truth to be established for it.
§ 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).