(191 days)
The C.T.M. Mobility Scooter HS-328 in an indoor/outdoor scooter that provides transportation for a disabled or elderly person.
The C.T.M. Mobility Scooter HS-328 is an indoor/outdoor scooter that is powered by two 22Ah lead-acid batteries, equipped with four pneumatic wheels, capacity of 136 kilograms and a lightweight adjustable seat. It a rear wheel drive scooter with theoretical driving ranges of 17.5 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.
Based on the provided document, the device in question is the "C.T.M. Mobility Scooter, HS-328." This document is a 510(k) premarket notification and primarily focuses on demonstrating substantial equivalence to a predicate device (C.T.M. Mobility Scooter #HS-295), rather than proving that a new AI/algorithm-based device meets specific acceptance criteria through a clinical study.
Therefore, the requested information regarding acceptance criteria, study design, ground truth establishment, expert involvement, and statistical analyses for an AI/algorithm performance study (like an MRMC study or standalone algorithm performance) is not available in this document. The document explicitly states:
"This 510(k) submission does not utilize clinical study for establishing substantial equivalence therefore this section does not apply." (Page 10)
The "studies" mentioned are non-clinical bench tests and compliance with recognized consensus standards (e.g., ISO, IEC) for performance, electrical safety, biocompatibility, and EMC. These tests are conducted to show that the physical characteristics and basic functionality of the mobility scooter are safe and perform as expected, and that any differences from the predicate device do not raise new questions of safety or effectiveness. They are not the type of AI/algorithm performance studies you've asked about.
Given this, I cannot fill out the requested table or provide details for points 2-9 as they pertain to a type of study not conducted or reported in this document.
However, I can extract the closest information to "acceptance criteria" and "reported device performance" as presented for the physical device, primarily through comparison to its predicate.
Table of Acceptance Criteria (as implied by comparison to predicate) and Reported Device Performance
For the C.T.M. Mobility Scooter HS-328, "acceptance criteria" are implied by its substantial equivalence to the predicate device (HS-295) and its compliance with relevant standards. The "reported device performance" is essentially the specifications of the new device and the assertion that differences from the predicate do not affect safety or effectiveness.
| Category | Acceptance Criteria (Implied by Predicate/Standards) | Reported Device Performance (HS-328) |
|---|---|---|
| Primary Indication for Use | Same as Predicate: Indoor/outdoor transportation for a disabled or elderly person. | The C.T.M. Mobility Scooter HS-328 is an indoor/outdoor scooter that provides transportation for a disabled or elderly person. |
| Classification Name/Product Code | Same as Predicate: Motorized three-wheeled vehicle / INI. | Motorized three-wheeled vehicle / INI. |
| Safety (via Non-Clinical Tests & Standards) | Compliance with: |
- ISO10993-5 (Biocompatibility)
- ISO10993-10 (Biocompatibility)
- IEC60601-1 (Electrical safety)
- IEC60601-1-2 (EMC)
- IEC62304 (Software, by controller)
- ISO7176 series (various performance & safety aspects)
- Crucially, differences vs. predicate must not affect safety. | All safety tests performed and meet requirements of listed FDA Recognized Consensus Standards. "All the differences don't affect the safety and performance after verified by safety and performance test." |
| Performance (via Non-Clinical Tests & Standards)| Compliance with ISO7176 series standards for: - Static/dynamic stability
- Brake effectiveness
- Energy consumption/theoretical distance range
- Dimensions, mass, maneuvering space
- Maximum speed, acceleration, deceleration
- Wheel dimensions
- Static, impact, fatigue strengths
- Climatic tests
- Obstacle-climbing ability
- Power/control systems
- EMC | Bench tests performed in accordance with FDA Recognized Consensus Standards (ISO 7176 series). All tests passed requirements to demonstrate substantial equivalence. |
| Key Performance Parameters | General equivalence or improvement over predicate without creating new safety/effectiveness questions.
(Specific numerical criteria aren't provided beyond comparison table) | Overall Length: 1120 mm / 44" (vs. 1013 mm / 39.8" for HS-295)
Overall Width: 590 mm / 23.2" (vs. 509 mm / 19.9" for HS-295)
Overall Height: 935 mm / 36.8" (vs. 887 mm / 34.9" for HS-295)
Product weight (With battery): 55 kg / 121.3 lbs (vs. 49 kg / 109 lbs for HS-295)
Weight Of Heaviest Piece: 17 kg / 37.5 lbs (vs. 17.8 kg / 39.2 lbs for HS-295)
Braking distance: 1.3m/51.2" (vs. 1.7m/66.9" for HS-295)
Front & Rear Wheels: 225 mm / 9" (vs. 200 mm / 8" for HS-295)
Maximum distance of travel on fully charged battery: 17.5 km / 10.9 Miles (vs. 10 km / 6.2 Miles for HS-295)
Ground Clearance: 52 mm / 2" (vs. 40 mm / 1.6" for HS-295)
Curb Climbable: 40 mm / 1.6" (vs. 32.5 mm / 1.3" for HS-295)
Turning Radius: 1450 mm / 57.1" (vs. 1270 mm / 50" for HS-295) |
| Technological Characteristics | Similar design features, rear-wheel drive, Electro-Mechanical brakes, dismantles for transport, Dynamic Rhino 50 controllers. Differences in motor size, capacity, and battery output must not affect safety/performance. | Has same 4 wheels, rear-wheel drive technology, Electro-Mechanical brakes, dismantles for transport. Uses Dynamic Rhino 50 controllers. Has a single motor and two batteries (22Ah). |
Regarding AI/Algorithm-Specific Study Information (Points 2-9):
As stated above and explicitly in the document, no clinical study was performed or utilized for this 510(k) submission to establish substantial equivalence. Therefore, the following points are not applicable to this document:
- Sample size used for the test set and data provenance: N/A (no such test set for AI/algorithm performance was used).
- Number of experts used to establish ground truth for the test set and qualifications: N/A.
- Adjudication method for the test set: N/A.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study: N/A.
- Standalone (algorithm only without human-in-the-loop performance) study: N/A.
- Type of ground truth used: N/A (Ground truth, in the context of diagnostic AI, implies a reference standard for a clinical condition, which is not relevant for a mobility scooter).
- Sample size for the training set: N/A (no AI/ML training involved for this device submission).
- How the ground truth for the training set was established: N/A.
In summary, this document describes a traditional medical device (mobility scooter) cleared through the 510(k) pathway by demonstrating substantial equivalence to a predicate device, relying on non-clinical bench testing and compliance with recognized standards for safety and performance, rather than clinical studies or AI/algorithm performance evaluations.
§ 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).