(207 days)
The C.T.M. Mobility Scooter HS-115 in an indoor/outdoor scooter that provides transportation for a disabled or elderly person.
The C.T.M. Mobility Scooter HS-115 is an indoor/outdoor scooter that is powered by two 12Ah lead-acid batteries, equipped with three wheels, capacity of 115 kilograms and a lightweight adjustable seat. It's a rear wheel drive scooter with theoretical driving ranges of 10 kilometer. 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 off-board battery charger. The maximum speed is 4 m.p.h.
The provided text describes a 510(k) premarket notification for a medical device, the C.T.M. Mobility Scooter, HS-115. This document focuses on demonstrating substantial equivalence to a predicate device, not on proving new clinical effectiveness or performance through the type of studies typically associated with AI-driven medical devices. Therefore, many of the requested categories (e.g., effect size of human readers with AI, adjudication methods for ground truth, sample size for training sets) are not applicable to this submission.
Here's an analysis of the available information:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria for this device are its compliance with various recognized consensus standards (ISO, IEC, EN, and FDA). The reported device performance is that it met the requirements of these standards.
| Category | Acceptance Criteria (Standards Met) | Reported Device Performance |
|---|---|---|
| Material Safety | - ISO 10993-5: Part 5: Test for in vitro cytotoxicity | Performed and met requirements. |
| - | - ISO 10993-10: Part 10: Tests for irritation and skin sensitization | Performed and met requirements. |
| Electrical Safety | - EN 60601-Part 1: General Requirements for basic safety and essential performance 1:2006 +A11:2011 + A1:2013 + A12:2014 | Performed and met requirements. |
| Electromagnetic Compatibility (EMC) | - IEC 60601-1-2: Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests | Performed and met requirements. |
| - | - ISO 7176-21: Wheelchairs - Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters, and battery chargers | Performed and met requirements. |
| Power & Control Systems | - ISO 7176-14: Wheelchairs - Part 14: Power and control systems for electrically powered wheelchairs and scooters - Requirements and test methods | Performed and met requirements. |
| Batteries & Chargers | - ISO 7176-25: Wheelchairs - Part 25: Batteries and chargers for powered wheelchairs | Performed and met requirements. |
| Performance - Static Stability | - ISO 7176-1: Wheelchairs Part 1: Determination of static stability | Bench tests performed and met requirements. |
| Performance - Dynamic Stability | - ISO 7176-2: Wheelchairs - Part 2: Determination of dynamic stability of electric wheelchairs | Bench tests performed and met requirements. |
| Performance - Brakes | - ISO 7176-3: Wheelchairs Part 3: Determination of effectiveness of brakes | Bench tests performed and met requirements. |
| Performance - Theoretical Distance Range | - ISO 7176-4: Wheelchairs - Part 4: Energy consumption of electric wheelchairs and scooters for determination of theoretical distance range | Bench tests performed and met requirements. |
| Performance - Dimensions, Mass, Maneuvering Space | - ISO 7176-5: Wheelchairs - Part 5: Determination of overall dimensions, mass and manoeuvring space | Bench tests performed and met requirements. |
| Performance - Speed, Acceleration, Deceleration | - ISO 7176-6: Wheelchairs - Part 6: Determination of maximum speed, acceleration and deceleration of electric wheelchairs | Bench tests performed and met requirements. |
| Performance - Seating & Wheel Dimensions | - ISO 7176-7: Wheelchairs - Part 7: Measurement of seating and wheel dimensions | Bench tests performed and met requirements. |
| Performance - Static, Impact, Fatigue Strengths | - ISO 7176-8: Wheelchairs - Part 8: Requirements and test methods for static, impact and fatigue strengths | Bench tests performed and met requirements. |
| Performance - Climatic Tests | - ISO 7176-9: Wheelchairs Part 9: Climatic tests for electric wheelchairs | Bench tests performed and met requirements. |
| Performance - Obstacle Climbing | - ISO 7176-10: Wheelchairs Part 10: Determination of obstacle-climbing ability of electrically powered wheelchairs | Bench tests performed and met requirements. |
| Documentation & Labeling | - ISO 7176-15: Wheelchairs - Part 15: Requirements for information disclosure, documentation and labeling | Bench tests performed and met requirements. |
| Postural Support Ignition Resistance | - ISO 7176-16: Wheelchairs Part 16: Resistance to ignition of postural support devices | Bench tests performed and met requirements. |
| Set-up Procedures | - ISO 7176-22: Wheelchairs Part 22: Set-up procedures | Bench tests performed and met requirements. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in a way that aligns with AI/software performance studies. The "test set" here refers to the specific physical device (C.T.M. Mobility Scooter, HS-115) that underwent the non-clinical bench tests. The data provenance would be "bench test results" from the manufacturer's testing or a certified lab. The document does not specify the number of units tested, but typically for such physical device testing, it would involve a representative sample or even a single prototype tested against specified standards. The country of origin of the device is Taiwan.
3. 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)
Not applicable. The "ground truth" for this device's performance is established by the specified ISO, IEC, and EN standards, which define objective, measurable parameters and test methods. There are no human "experts" establishing a subjective ground truth similar to clinical diagnosis.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. The tests are objective measurements against published standards, not subjective interpretations requiring adjudication.
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 a physical mobility device and its submission does not involve AI or human "readers" (e.g., radiologists, pathologists).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm-based device. The "standalone performance" refers to the device itself (the scooter) meeting the specified performance and safety standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the device's acceptable performance is defined by adherence to recognized international consensus standards (ISO, IEC, EN). These standards specify the methods and acceptable ranges for various physical and electrical properties, safety features, and performance capabilities.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not a machine learning or AI 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).