(60 days)
The C.T.M. Mobility Scooter HS-268 is an indoor/outdoor scooter that provides transportation for a disabled or elderly person in age of 16 up to 85 year old.
The C.T.M. Mobility Scooter HS-268 is an indoor/outdoor scooter that is powered by 25.2Vdc, 11000mAh, 277.2Wh (min) and 25.2Vdc, 11600mAh, 292.32Wh (typ) Lithium battery, equipped with four wheels, capacity of 253.5 lbs and a lightweight seat. It's a rear wheel drive scooter with theoretical driving ranges of 9.3 miles. 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 folded/unfolded and is provided with an off-board battery charger. The maximum speed is 5 mph.
This document describes a 510(k) premarket notification for the "C.T.M. Mobility Scooter HS-268". The device is a motorized three-wheeled vehicle intended for transportation of disabled or elderly persons. The focus of the submission is to demonstrate substantial equivalence to a predicate device, the "Freerider Corporation Luggie Super (K151944)".
Based on the provided text, the device in question is a mobility scooter, not an AI/ML-based medical device. Therefore, many of the questions related to acceptance criteria and studies proving the device meets those criteria, particularly those concerning AI performance, ground truth, expert opinions, and multi-reader studies, are not applicable to this submission.
The acceptance criteria for this type of device are primarily met through the demonstration of adherence to recognized consensus standards for safety and performance, and through a comparison of physical and functional characteristics to a legally marketed predicate device.
Here's an attempt to answer the relevant questions based solely on the provided document, acknowledging the mismatch in the nature of the device and the requested AI/ML specific information:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are generally implied by the successful testing against the listed ISO, EN, and IEC standards, and the demonstration of "similar" or "same" characteristics when compared to the predicate device. The document does not provide specific numerical performance metrics for each criterion, but rather states that "All tests passed the requirement to demonstration that new device is as substantial equivalent as the predicate device."
| Category (Acceptance Criteria are inferred from successful testing against standards and substantial equivalence comparison) | Reported Device Performance (as stated or inferred from text) |
|---|---|
| Safety Tests (Non-clinical) | Passed requirements (demonstrating substantial equivalence to predicate) |
| Biocompatibility (ISO 10993-5, ISO 10993-10) | Met requirements for in vitro cytotoxicity and irritation/skin sensitization. |
| Electrical Safety (EN 60601-1:2006, IEC 60601-1-2) | Met requirements for basic safety, essential performance, and electromagnetic compatibility. |
| Power and Control Systems (ISO 7176-14) | Met requirements for power and control systems of electrically powered wheelchairs and scooters. |
| Electromagnetic Compatibility (ISO 7176-21) | Met requirements for EMI of electrically powered wheelchairs/scooters and battery chargers. |
| Battery Safety (IEC 62133) | Met safety requirements for secondary lithium cells and batteries. |
| Performance Tests (Non-clinical) | Passed requirements (demonstrating substantial equivalence to predicate) |
| Static Stability (ISO 7176-1) | Met requirements for static stability. |
| Dynamic Stability (ISO 7176-2) | Met requirements for dynamic stability. |
| Braking Effectiveness (ISO 7176-3) | Met requirements for braking effectiveness. |
| Energy Consumption & Range (ISO 7176-4) | Met requirements for energy consumption and determination of theoretical distance range (stated 9.3 miles). |
| Overall Dimensions, Mass, Manoeuvring Space (ISO 7176-5) | Met requirements. (Note: Stated as "dimension is bigger and heavier" than predicate, but not significantly). |
| Maximum Speed, Acceleration, Deceleration (ISO 7176-6) | Met requirements (stated max speed 5 mph). |
| Seating & Wheel Dimensions (ISO 7176-7) | Met requirements. |
| Static, Impact, Fatigue Strengths (ISO 7176-8) | Met requirements for strength. |
| Climatic Tests (ISO 7176-9) | Met requirements for climatic tests. |
| Obstacle-Climbing Ability (ISO 7176-10) | Met requirements for obstacle-climbing ability. |
| Test Dummies (ISO 7176-11) | Standards for test dummies were applied. |
| Coefficient of Friction of Test Surfaces (ISO 7176-13) | Standards for test surfaces were applied. |
| Information Disclosure, Documentation, Labeling (ISO 7176-15) | Met requirements. |
| Resistance to Ignition of Postural Support Devices (ISO 7176-16) | Met requirements. |
| Set-up Procedures (ISO 7176-22) | Standards for set-up procedures were applied. |
| Substantial Equivalence Features | Similar/Same to predicate (Freerider Corporation Luggie Super K151944) |
| Indications for Use | Similar: Transportation for disabled/elderly persons aged 16-85 (new device) vs. elderly/disabled (predicate). |
| Prescription Use/OTC | Same: Over-the-counter Use. |
| Generic Name | Same: Electric scooter. |
| Classification Name/Product Code | Same: 890.3800 Motorized 3-wheeled vehicle / INI. |
| Design Features | Similar: 4 wheels, rear-wheel drive, electro-mechanical brakes, Dynamic Rhino 50 controllers, single motor/battery. |
| Differences (Motor size, battery capacity/output, dimension/weight) | Do not affect safety and performance after verification by safety and performance tests. |
2. Sample sizes used for the test set and the data provenance
The document refers to "bench tests" and "safety tests" performed in accordance with consensus standards. These types of tests typically involve testing of a specific number of manufactured units to verify compliance. The exact "sample sizes" (number of units tested) are not explicitly stated in this document but would be defined by the relevant testing standards. Data provenance is not described beyond "bench tests were performed."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable. The "ground truth" for this device is established through engineering and performance testing against objective standards, not through expert clinical interpretation or consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This concept is relevant for studies involving human interpretation or subjective assessment, which is not the case for this type of device submission.
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 algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for this device is the objective performance and safety characteristics as defined by the technical standards (ISO, EN, IEC) and direct comparison to a predicate device's established characteristics. It is not based on clinical outcomes, pathology, or expert consensus in an interpretative sense.
8. The sample size for the training set
Not applicable. This device does not involve a "training set" as it is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. As above, this is not an AI/ML device, and thus there is no training set or associated ground truth establishment process in that context.
Summary for this device:
The submission demonstrates substantial equivalence by showing that the C.T.M. Mobility Scooter HS-268:
- Has similar indications for use and classification to a predicate device.
- Underwent non-clinical safety tests (biocompatibility, electrical safety) and performance bench tests (stability, braking, speed, etc.) according to FDA-recognized consensus standards (ISO, EN, IEC).
- All these tests "passed the requirement to demonstration that new device is as substantial equivalent as the predicate device."
- Differences from the predicate device (e.g., slightly larger dimensions, different motor/battery specifics) were assessed and determined not to "affect the safety and performance after verified by safety and performance test."
- No clinical studies were utilized for this 510(k) submission, as stated, due to the nature of the device and the substantial equivalence pathway chosen.
§ 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).