Search Results
Found 2 results
510(k) Data Aggregation
(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.
Ask a specific question about this device
(58 days)
The FR-L05 (Luggie Super) provides transportation for an elderly or disabled person. It can be used in a variety of indoor and outdoor settings.
The FR-L05 (Luggie Super) is a battery-powered, three-wheeled scooter intended to provide mobility for elderly or disabled individuals in a variety of indoor and outdoor settings. The FR-L05 (Luggie Super) is meant to be used by a single rider weighing up to 360 pounds. The scooter is rear-wheel drive and has electric, regenerative electromechanical brakes. It has an adjustable seat that has several height adjustments. The steering and user controls are provided on the steering tiller/handlebars for ease of use by the rider. Steering is controlled simply by turning the handlebars in the desired direction. There are two thumb levers, and speed knobs on the tiller console to control movement speed of the scooter. The FR-L05 (Luggie Super) has a controller and 1 lithium battery. There is also an off-board battery charger.
This document is a 510(k) summary for the Freerider Corporation's Luggie Super, a motorized three-wheeled vehicle. It describes the device, its intended use, and its substantial equivalence to a predicate device.
Based on the provided text, there is no information about acceptance criteria or a study proving the device meets those criteria in the context of device performance related to a diagnostic or therapeutic function. This document is for a mobility device (electric scooter). The "testing" mentioned refers to non-clinical bench testing to ensure the device meets safety standards for motorized vehicles and electrical components, not performance criteria for a medical diagnostic or therapeutic function.
Therefore, I cannot provide the requested information in the format of the table and study details, as they are not applicable to the content of this document.
Here's why the requested information cannot be found:
- Type of Device: The Luggie Super is a motorized three-wheeled vehicle (electric scooter) for transportation. It is not a diagnostic device (e.g., AI for image analysis) or a therapeutic device with specific performance metrics like sensitivity, specificity, accuracy, etc.
- "Acceptance Criteria" in this context: For a device like an electric scooter, "acceptance criteria" primarily relate to safety standards (e.g., electromagnetic compatibility, stability, braking performance) and operational specifications (e.g., weight capacity, speed). These are typically met through engineering design and bench testing against established industry standards.
- "Study that proves the device meets the acceptance criteria": The document states "Non-clinical Testing" was conducted, referencing various ISO and IEC standards (e.g., ISO 7176, IEC 60601-1, electromagnetic interference testing). This testing is the "study" that proves it meets the relevant safety and performance standards for a motorized mobility device. The conclusion states: "The safety and effectiveness of the FR-L05 (Luggie Super) was demonstrated by the testing in compliance with national and international standards."
- Lack of Clinical Testing: The document explicitly states, "No clinical testing is included in this submission." This further confirms that its "performance" is not measured in a clinical context that would require ground truth, experts, and statistical metrics like those used for diagnostic AI.
- Lack of AI/Algorithm: This document does not pertain to an AI-powered device or algorithm. Therefore, questions regarding standalone performance, human-in-the-loop, training sets, adjudication, or ground truth for diagnostic purposes are irrelevant.
In summary, the provided text describes a regulatory submission for a simple mobility device. The "acceptance criteria" are compliance with safety and engineering standards, and the "study" consists of non-clinical bench testing against those standards.
Ask a specific question about this device
Page 1 of 1