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510(k) Data Aggregation
(10 days)
HEARTWAY LIGHTWEIGHT POWER MOBILITY SCOOTER, S33
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
The HEARTWAY Lightweight Power Mobility Scooter, S33 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.
This document is a 510(k) premarket notification for the HEARTWAY Lightweight Power Mobility Scooter, S33. It focuses on establishing substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and performance data for a new, standalone medical device.
Therefore, many of the requested categories (like specific numerical acceptance criteria, various types of studies, ground truth establishment, sample sizes for training/test sets for AI models, human-in-the-loop studies) are not applicable to this type of regulatory submission. This submission primarily relies on performance testing to established standards and comparison to a predicate device.
Here's an analysis based on the information provided, with "N/A" for categories that are not present or applicable to this document's scope:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Standard/Requirement | Reported Device Performance | Comments |
|---|---|---|---|
| Performance Testing | ANSI/RESNA WC/Vol.2-1998 | Conforms | Standard for electrically powered wheelchairs, scooters, and their chargers. |
| CISPR 11: 1990 | Conforms | Standard for industrial, scientific and medical (ISM) radio-frequency equipment - electromagnetic disturbance characteristics. | |
| EN61000-3-2: 1995 | Conforms | Standard for electromagnetic compatibility (EMC) - limits for harmonic current emissions. | |
| IEC61000-3-3: 1995 | Conforms | Standard for electromagnetic compatibility (EMC) - limitation of voltage changes, voltage fluctuations and flicker. | |
| Material Strength/Fatigue | N/A (Implied by comparison) | Mainframes fixed & meet strength/fatigue tests | Compared to predicate device. |
| Electrical Systems Safety | UL certificated | All electrical systems UL certificated | Same suppliers as predicate device; includes controller, batteries, switches. |
| Incline Capability | Driving angle up to 10° | Can drive under 10° slope | Improved over predicate device (8°), with user manual guidance. |
| Cruising Range | N/A (Comparison, not a specific pass/fail criteria) | 18 miles | Improved over predicate device (10 miles); noted that real range varies. |
| Resistance to Ignition | N/A (Implied by comparison) | Back upholstery passed resistance ignition test | Same fabric as predicate device. |
2. Sample size used for the test set and the data provenance
- Sample Size: N/A. This document describes performance testing against standards and comparison to a predicate device, not a test set of data points in the way an AI/ML model would be evaluated. The testing is on the physical device itself.
- Data Provenance: N/A for a "test set" of data. The performance testing was carried out on the device by HEARTWAY Medical Products Co., Ltd. (Taiwan, ROC) to international and national standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- N/A. The "ground truth" here is compliance with established engineering and safety standards (e.g., ANSI/RESNA, CISPR, EN, IEC, UL) and manufacturing specifications, rather than expert consensus on medical image interpretations or diagnoses. Compliance is typically verified through laboratory testing and engineering analysis.
4. Adjudication method for the test set
- N/A. This is not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among multiple human readers on ground truth labeling of data for AI/ML studies. Here, compliance is determined by test results against specifications.
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
- N/A. This is not an AI/ML device, nor is it a diagnostic device where human reader performance is a relevant metric. It is a power mobility scooter.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. This is not an algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Engineering and Safety Standards Compliance: The "ground truth" for this device's performance testing is its adherence to a series of recognized international and national standards for electric wheelchairs/scooters and electromagnetic compatibility (e.g., ANSI/RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995), and UL certification for electrical components. Substantial equivalence is also established by direct comparison to a legally marketed predicate device (WU'S 3-WHEELED NEO SCOOTER, WT-T3D).
8. The sample size for the training set
- N/A. This document does not describe the development or evaluation of an AI/ML model; therefore, there is no "training set."
9. How the ground truth for the training set was established
- N/A. As there is no training set for an AI/ML model, this question is not applicable.
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