(275 days)
As a motorized portable electric vehicle for indoor or outside use by persons with medical conditions requiring assistance.
Motorized portable electric vehicle for indoor or outside use by persons with medical conditions requiring assistance. It is available in multiple models with varying specifications for wheels, size, weight capacity, speed, and travel distance. It uses dynamic braking and electromagnetic brake systems and is powered by SLA or Lithium batteries with an off-board charger.
The provided text describes a submission for a 510(k) premarket notification for a motorized vehicle called "SupaScoota." This document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study design for a novel medical device AI/ML algorithm.
Therefore, many of the requested elements for describing acceptance criteria and the study that proves the device meets them (especially those related to AI/ML performance, ground truth, expert adjudication, and comparative effectiveness studies) are not applicable to this document. The document describes a traditional medical device submission for a physical product (a motorized vehicle).
However, I can extract information related to the device's performance and the testing conducted to ensure its safety and effectiveness based on the provided text.
Here's a breakdown of the relevant information:
Device: "SupaScoota" Motorized Vehicle
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a quantitative, measurable way for each performance metric in the same manner one might expect for an AI/ML algorithm. Instead, it relies on a comparison to predicate devices and compliance with international standards (ISO 7176 series). The performance metrics listed are descriptive specifications of the device.
| Performance Metric | Reported Device Performance (SupaScoota) | Implied Acceptance Criteria (based on comparison to predicates and ISO standards) |
|---|---|---|
| Physical Characteristics | ||
| Number of wheels | 3 wheels + 2 stabilizer wheels / 4 wheels (varies by model) | Comparable to predicate devices (FR168-3A3 and HEARTWAY S11 have 3 or 4 wheels) |
| Front wheel size | 200 x 65 mm (8"x2.5") / 200 x 50 mm (8"x2") | Comparable to predicate devices (e.g., HEARTWAY S11: 240 x 75 mm, FREERIDER FR168-3A3: 200 x 50 mm) |
| Rear wheel size | 200 x 65 mm (8"x2.5") / 260 x 85mm (10"x3") | Comparable to predicate devices (e.g., FREERIDER FR168-3A3: 200 x 50 mm) |
| Ground clearance | 60-65 mm (2.4-2.6") | Comparable to predicate devices (e.g., HEARTWAY S11: 70 mm, FREERIDER FR168-3A3: 86 mm) |
| Length | 945-1100 mm (37-43") | Comparable to predicate devices (e.g., HEARTWAY S11: 1070 mm, FREERIDER FR168-3A3: 945 mm) |
| Width | 550-600 mm (22-26") | Comparable to predicate devices (e.g., HEARTWAY S11: 580 mm, FREERIDER FR168-3A3: 508 mm) |
| Max Loading (weight capacity) | 80-125 kg (175-275 lbs) | Comparable to predicate devices (e.g., HEARTWAY S11: 120 kg, FREERIDER FR168-3A3: 110 kg) |
| Weight w/battery | 27.3-42.6 kg (60-94 lbs) | Comparable to predicate devices (e.g., HEARTWAY S11: 58 kg) |
| Turn Radius | 780-975 mm | Comparable to predicate devices (e.g., HEARTWAY S11: 1980 mm, FREERIDER FR168-3A3: 820 mm) |
| Functional Performance | ||
| Brakes | Dynamic braking and electromagnetic brake | Functional similar to predicate devices, and in compliance with ISO 7176-3 (Efficiency of brakes tests) |
| Motor Output | 1 x 180W / 2 x 150 W / 2 x 180 W | Comparable to predicate devices (e.g., HEARTWAY S11: 400 Watt), and in compliance with ISO 7176-14 (Power and control system) |
| Battery | SLA: 12V-20ah/ 24V-15ah; Lithium: 12V-20ah/ 24V-15ah | Comparable to predicate devices (e.g., HEARTWAY S11: 12V-22ah x 2, FREERIDER FR168-3A3: 24V 12ah) |
| Max Speed | 6.5 kph (4 mph) / 9.0 kph (5.6 mph) | Comparable to predicate devices (e.g., HEARTWAY S11: 8 kph, FREERIDER FR168-3A3: 6.5 kph), and in compliance with ISO 7176-6 (Maximum speed tests) |
| Travel Distance | SLA: 13-18 km (8-11 miles); Lithium: 16-22 km (10-13.6 miles) | Comparable to predicate devices (e.g., HEARTWAY S11: 20 km, FREERIDER FR168-3A3: 16 km), and in compliance with ISO 7176-4 (Theoretical distance) |
| Climbing angle | 8-12 Degrees | Comparable to predicate devices (e.g., HEARTWAY S11: 10 Degrees), and in compliance with ISO 7176-10 (Obstacle-climbing ability tests) |
| Safety and Other | Compliance with ISO 7176-1 (Static stability), ISO 7176-2 (Dynamic stability) | |
| Stability | ||
| EMC | Compliance with ISO 7176-21 (EMC test) and EN 12184 | |
| Fatigue Strengths | Compliance with ISO 7176-8 (Static, impact and fatigue strengths tests) |
2. Sample sized used for the test set and the data provenance
The document does not specify a "test set" in the context of an AI/ML algorithm or a clinical trial with human subjects. The testing described is non-clinical, primarily focusing on engineering and performance standards for the physical device. Therefore, the concept of sample size for a test set and data provenance (country of origin, retrospective/prospective) is not directly applicable in this context. The tests are conducted on the device models themselves.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth and expert adjudication are concepts typically associated with AI/ML algorithms, especially for diagnostic or prognostic tasks. For this physical device, "ground truth" is established by direct physical measurements, engineering principles, and adherence to international performance standards (ISO 7176 series).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as there's no diagnostic or interpretative task by human experts being evaluated.
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 not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML algorithm. The "standalone" performance refers to the device's physical capabilities as tested against ISO standards.
7. The type of ground truth used
For the safety and effectiveness testing of the "SupaScoota" Motorized Vehicle, the "ground truth" is established by:
- International Standards: Compliance with the ISO 7176 series standards (e.g., static stability, dynamic stability, brake efficiency, theoretical distance range, maximum speed, climbing angle, EMC). These standards define measurable performance requirements.
- Engineering Specifications and Measurements: Direct physical measurements and tests of the device's technical characteristics (e.g., wheel size, weight, dimensions, motor output, battery capacity).
- Comparison to Predicate Devices: The key argument for substantial equivalence relies on comparing the "SupaScoota"'s characteristics and performance to legally marketed predicate devices.
8. The sample size for the training set
Not applicable. This is not an AI/ML algorithm device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML algorithm device.
§ 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).