(43 days)
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
The HEARTWAY Power Mobility Scooter, S12 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 document is a 510(k) premarket notification for a medical device: the HEARTWAY Power Mobility Scooter, S12. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific acceptance criteria through a clinical study in the way typically associated with AI/ML-based medical devices or novel therapies.
Therefore, many of the requested categories (e.g., sample size for test sets, number of experts for ground truth, MRMC study, training set details) are not applicable to this document as it pertains to a mechanical mobility device and its comparison to an existing scooter.
Here's the breakdown based on the provided text:
Acceptance Criteria and Device Performance
The document doesn't explicitly list "acceptance criteria" in a quantitative table format with corresponding performance results. Instead, it describes performance testing and then justifies "substantial equivalence" based on various device characteristics and safety standards. The "performance" in this context relates to meeting safety and functional standards, rather than clinical efficacy metrics.
| Acceptance Criteria Category (Derived from document) | Reported Device Performance / Justification |
|---|---|
| Intended Use | Met: "The intended use between the two devices is the same." (Predicate: HEARTWAY Power Mobility Scooter, PT7) |
| Mainframe Materials | Met: "Mainframes materials of the two devices are fixed, and all meet the strength and fatigue tests and they use the same material aspects." |
| Weight Capabilities | Met: "The weight capabilities... for the two devices are all the same." |
| Maximum Speed | Met: "The maximum speed... for the two devices are all the same." |
| Suspension (Cross Brace) | Met: "The suspension of cross brace,... for the two devices are all the same." |
| Footplates, Armrest Type | Met: "Footplates, armrest type... for the two devices are all the same." |
| Back Upholstery Material | Met: "The back upholstery material is also the same fabric and passed the resistance ignition test." |
| Electronic Systems (Suppliers, Certifications) | Met: "The electronic systems between two devices are the same suppliers, and all passed by the UL certificated, for instance the electronic controller, batteries, recharger, and the competent switches and switching power supplies. Thus the same safety level for the two devices is assured." |
| Incline Capability | Met (with user guidance): Predicate: 10°. New device: up to 12° slope. "We provide the relevant specifications for ground clearance in the User's Manual. Thus, the user is not allowed to operate the device on the incline angle higher than the specified angle. The safety levels of the two devices are the same when operating the devices on the different inclines. They are substantially equivalent." |
| Cruising Range per Charge | Met (with practical consideration): New device: 25 miles; Predicate: 32 miles. "Certainly the real range depends on the practical environments, i.e., weight, surface, incline, and temperature. For the real life use, the two devices are substantially equivalent." (Note: This is a recognized difference but deemed equivalent in practical use). |
| Performance Testing Standards | Met: "EMC Report ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995 (Electrically powered wheelchairs, scooters, and their chargers - requirements and test methods)" (Implied that the device passed these tests, although specific results are not provided in this summary). |
The study proving the device meets the acceptance criteria is detailed in the "Performance Testing" and "Summary for substantial equivalence comparison" sections. The key aspects are:
- Nature of the "Study": This is not a clinical study but rather an engineering and regulatory comparison against a predicate device and relevant industry standards.
- Comparison to Predicate Device: The HEARTWAY Power Mobility Scooter, S12 (new device) was compared to the HEARTWAY Power Mobility Scooter, PT7 (K073044) (predicate device).
Specific Information Requests:
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- N/A. This is a physical device, and the "testing" refers to meeting engineering standards and direct comparison of specifications and components between the new device and the predicate device. There is no "test set" of clinical data. Data provenance would refer to the location of manufacturing and testing, which is Taichung, Taiwan, ROC.
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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):
- N/A. "Ground truth" in the context of clinical expert consensus is not relevant here. The "ground truth" is established by adherence to recognized engineering standards (e.g., ANSI/RESNA, CISPR, EN, IEC) and the specifications of the predicate device. Expertise would be in engineering and regulatory compliance.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. No adjudication method for clinical data is described or applicable. The "adjudication" is essentially the manufacturer demonstrating compliance to FDA regulators.
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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:
- N/A. This device is a power mobility scooter, not an AI/ML diagnostic or assistive device for human readers.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- N/A. This is a mechanical device, not an algorithm. Considerations of human-in-the-loop performance are related to the user operating the scooter safely and effectively, which is addressed by design and user manual instructions, not algorithmic performance.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Engineering Standards and Predicate Device Specifications: The "ground truth" used for demonstrating safety and effectiveness relies on established engineering and safety standards (e.g., EMC, strength, fatigue, ignition resistance, UL certifications) and the proven safety and performance characteristics of the legally marketed predicate device (HEARTWAY Power Mobility Scooter, PT7).
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The sample size for the training set:
- N/A. This is not an AI/ML device with a training set. The "training" for the device would be its design and manufacturing process, optimized through engineering iterations, but not in the sense of an algorithmic training set.
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How the ground truth for the training set was established:
- N/A. As above, no algorithmic training set is involved.
§ 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).