(260 days)
The Merits Yoga Power Scooter, S542, is to provide mobility to adult persons limited to a sitting position and capable to operate a few simple controls.
The Merits Yoga Power Scooter, S542, is battery powered, rear transaxle driven and is controlled by the PG S-Drive 45amp controller. The user interface is a wig-wag control lever and a speed knob on the control panel. S542 is powered by one 12 VDC 11.5Ah battery. The batteries are charged by 4.3A off-board charger connect with 3-pin Microphone Connector to charging socket on the rear shroud. The approximate driving range on fully charged batteries is up to 18km (11.3mi). The scooter frame is a welded aluminum construction and includes 2 rear wheels with drive units (including motor, gear box, and brake), a removable battery pack, a front wheel set which consists of 2 wheels for better stability and a tiller to control its turning direction. When the user activates the wig-wag control lever, the controller receives a signal to release the brakes. With the brakes released, the scooter is allowed to move forwards or backwards. When the user releases the control lever, the scooter slows to a stop and the brakes are automatically re-engaged. The solenoid electromechanical brakes allow the user stop by letting go of the control lever. The frame is designed to be foldable for easy storage and transportation.
For safety reason, this solenoid electromechanical brake is designed as normal close type. In case of the brake or electrical failure, the brake shoe will re-engage automatically to prevent the movement of the scooter. The upholstery of the device complies with ISO 7176-16:2012 Resistance to ignition of postural support devices.
The device can be operated on dry, level surfaces composed of concrete, blacktop, or asphalt under normal driving conditions.
This document is a 510(k) premarket notification for the Merits Yoga Power Scooter, S542. It focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria and an independent study for the S542. Therefore, much of the requested information about device performance against acceptance criteria for an AI/CAD-type device is not applicable or cannot be extracted from this document, as this is a physical medical device.
However, I can extract information related to the performance testing done to show substantial equivalence.
Here's the breakdown of what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't provide a typical "acceptance criteria" table in the sense of a statistical performance target for a diagnostic device (e.g., sensitivity, specificity). Instead, it relies on demonstrating compliance with a series of ISO standards for mobility devices and comparing key characteristics to a predicate device. The "reported device performance" is essentially that the device passed these ISO tests and its characteristics are within an acceptable range or are superior to the predicate device without raising new safety concerns.
| Characteristic / Test | Acceptance Criteria (Implied by ISO Standard Compliance & Predicate Comparison) | Reported Device Performance (Merits Yoga Power Scooter, S542) |
|---|---|---|
| Functional & Safety Standards | Compliance with relevant ISO 7176 series standards for wheelchairs and scooters, and ISO 14971 for risk management. | Passed: |
| - ISO 7176-1:1999 Determination of Static Stability | - Device passed. | |
| - ISO 7176-2:2001 Determination of Dynamic Stability of electric wheelchairs | - Device passed. Addressed differences in Turning Radius, Dimension, and Max. Speed by confirming no deleterious effect. | |
| - ISO 7176-3:2012 Determination of effectiveness of brakes | - Device passed. | |
| - ISO 7176-4:2008 Energy consumption... determination of theoretical distance range | - Device passed. Travel range of 11.25 miles (better than predicate's 10 miles). | |
| - ISO 7176-5:2008 Determination of overall dimensions, mass and maneuvering space | - Device passed. Differences in dimensions accepted due to stability tests. | |
| - ISO 7176-6:2001 Determination of maximum speed, acceleration and deceleration | - Device passed. Max. Speed 4 mph (vs predicate's 4.5 mph), confirmed no deleterious effect. | |
| - ISO 7176-7:1998 Method of Measurement of Seating and Wheel Dimensions | - Device passed. | |
| - ISO 7176-8:1998 Requirements and test methods for static, impact and fatigue strengths | - Device passed. Addressed differences in Max. Speed, Weight, and Battery by confirming no deleterious effect. | |
| - ISO 7176-9:2009 Climatic tests for wheelchairs | - Device passed. | |
| - ISO 7176-10:2008 Determination of obstacle-climbing ability | - Device passed. | |
| - ISO 7176-11:2012 Test dummies | - Device passed. | |
| - ISO 7176-13:1989 Determination of coefficient of friction of test surfaces | - Device passed. | |
| - ISO 7176-14:2008 Power and control systems... | - Device passed. | |
| - ISO 7176-15:1996 Requirements for Information Disclosure, Documentation and Labeling | - Device passed. | |
| - ISO 7176-16:2012 Resistance to ignition of postural support devices | - Device passed. Upholstery complies. | |
| - ISO 7176-21:2009 Requirements and test methods for electromagnetic compatibility | - Device passed. | |
| - ISO 14971:2007 Medical devices -- Application of risk management | - Device passed. | |
| Key Device Characteristics (Comparison to Predicate: Merits Travel Ease Electric Scooter, Model Pioneer 5) | Substantially equivalent or demonstrably safe/effective despite differences. | |
| Max. Speed | No deleterious effect compared to predicate (4.5 mph). | 4 mph (Passed ISO 7176-2 & ISO 7176-8 tests demonstrating no deleterious effect despite lower speed). |
| Range up to | No less than predicate (10 miles). | 11.25 miles (Better than predicate). |
| Weight | No deleterious effect compared to predicate (92 lb total, 50 lb base). | 56.7 lb total, 53 lb base (lighter, passed ISO 7176-8 confirming no deleterious effect; beneficial for transport). |
| Battery | Safe and effective compared to predicate (24V/12Ah Lead Acid Battery). | 24V/11.5Ah Li-ion Battery (lighter, longer range; passed ISO 7176-8 and UN 38.3 Transportation Testing for safety, confirming no deleterious effect). |
| Turning Radius | No deleterious effect compared to predicate (33.8"). | 37.8" (Passed ISO 7176-2 tests confirming no deleterious effect). |
| Dimension (L, W, H) | No deleterious effect compared to predicate (L: 38.5", W: 19.7", H: 48"). | L: 39"/20.2", W: 17.2", H: 39.6"/24.2" (Passed ISO 7176-1 & ISO 7176-2 tests confirming no deleterious effect). |
| Suspension | No deleterious effect compared to predicate (No Suspension). | Front Wheel Leaf Spring (More comfortable; passed ISO 7176-2 & ISO 7176-8 tests confirming no deleterious effect). |
2. Sample size used for the test set and the data provenance
- Sample Size: The document does not specify a "sample size" in terms of number of devices tested or cases, but implies that one or more Merits Yoga Power Scooters, S542, were subjected to the specified ISO standard tests. For physical device testing against standards, typically a representative sample is used, but a specific number is not provided.
- Data Provenance: The tests were conducted to comply with international (ISO) standards. The manufacturer is Merits Health Products Co., Ltd. in Taiwan, which implies the testing likely occurred at accredited labs in Taiwan or through international certification bodies. The document does not explicitly state if the testing was retrospective or prospective, but standard compliance testing is typically performed prospectively as part of product development and validation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This is not applicable to a physical mobility device like a scooter. "Ground truth" established by experts is typically relevant for diagnostic AI/CAD devices where clinical opinions or pathology results define the correct answer. For this product, the "ground truth" is defined by compliance with engineering standards and performance specifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This is not applicable. Adjudication methods are specific to expert review or consensus building for diagnostic interpretations, not for physical device performance testing against objective standards.
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
- This is not applicable. MRMC studies are for evaluating diagnostic image interpretation by human readers, often with and without AI assistance. This document describes a physical mobility device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This is not applicable. "Standalone performance" refers to the performance of an algorithm without human interaction, relevant for AI/CAD devices. This is a physical scooter.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for this device is compliance with established international engineering and safety standards (ISO 7176 series, ISO 14971) and meeting stated performance specifications (e.g., speed, range, weight capacity). The benchmark for "substantial equivalence" is also the performance and characteristics of the identified predicate device (Merits Travel Ease Electric Scooter, Model Pioneer 5 – K013788).
8. The sample size for the training set
- This is not applicable. There is no "training set" in the context of a physical mobility device. Training sets are relevant for machine learning algorithms.
9. How the ground truth for the training set was established
- This is not applicable for the same reason as above.
§ 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).