(159 days)
The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.
Cutie S17 power scooter is battery powered and configured with four pneumatic wheels, a swivel seat, a turning tiller column, an upper panel control, a main frame, a rear bumper, a front bumper, and an anti-tipper. S17 power scooter is operated by two pneumatic rear wheels as the drive wheels and two pneumatic front wheels as the steering wheels, using the upper panel control to control the turning tiller column mechanism to control the front wheel as the power scooter steering direction mechanism. Upper panel control is able to control driving forward, driving backward, speed control and lighting function. The main frame is equipped with a rear bumper and a front bumper to allow the scooter to sustain an impact without damage to the power scooter safety system. Turning tiller column is equipped with the head light, back mirrors, a swivel seat with the flipping arm-rests, and a lever to move the seat backward and forward.
The provided text describes the HEARTWAY Power Mobility Scooter, Cutie S17, and its substantial equivalence to a predicate device. The information details performance testing against various ISO and ANSI/RESNA standards, but it does not contain acceptance criteria for an AI/ML powered device, nor does it describe a study specifically designed to prove a device meets such criteria.
The document is a 510(k) premarket notification for a physical medical device (a power mobility scooter), not an AI/ML powered medical device. Therefore, the requested information regarding acceptance criteria, sample sizes for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and how ground truth was established is not applicable to this document.
The document focuses on demonstrating that the new scooter (Cutie S17) is substantially equivalent to a previously cleared scooter (S34) by comparing their specifications and performance against recognized device safety and performance standards.
Here's a breakdown of what the document does provide, in relation to device performance:
1. A table of acceptance criteria and the reported device performance:
The document provides a comparison table between the subject device (Cutie S17) and the predicate device (S34), highlighting similarities and differences in specifications and performance attributes. It also lists various international standards that the subject device passed. While "acceptance criteria" for an AI/ML device are not present, the performance comparisons and the passing of these standards serve as the basis for the device's acceptable performance and safety.
| Comparison Items | Predicate Device (S34) | Subject Device (Cutie S17) | Remark |
|---|---|---|---|
| General | |||
| Manufacturer | HEARTWAY Medical Products Co., Ltd. | HEARTWAY Medical Products Co., Ltd. | Same manufacturer |
| Proprietary Name | Lightweight Power Mobility Scooter Series | Power Mobility Scooter Series | Heavier weight design |
| Model | S34 | Cutie S17 | Different models |
| 510K Number | K101142 | K151656 | New listing |
| Common or Usual Name | Powered Scooter | Powered Scooter | Same common name |
| Intended Use | Medical purposes to provide mobility... | Medical purposes to provide mobility... | Same intended use |
| Footplates | ABS | ABS | Same material |
| Incline | 10 degrees | 10 degrees | Same incline angle (Avoid operating over 10 degrees) |
| Back upholstery | Fabric | Fabric | Same upholstery |
| Armrest types | Flip-backward | Flip-backward | Same armrest |
| Wheel Lock | Push-to-Lock | Push-to-Lock | Same wheel lock |
| Patient Contacting Material | Seat PVC, Hand grip PVC, Safety belt PVC | Seat PVC, Hand grip PVC, Safety belt PVC | Same material |
| Biocompatibility | ISO 10993-1, -5, -10 (2009) | ISO 10993-1 (2009), -5 (2009), -10 (2010) | Same biocompatibility evaluation (with a year difference in one standard version, assumed similar content for evaluation) |
| Performance/Technical | |||
| Electronic controller | Penny & Giles S-Drive | Dynamic Rhino2 120 Amp | Different controllers, but subject device met software validation and ISO 7176-14 requirements, raising no safety/effectiveness concerns. |
| Frame Type/Material | Fixed / Carbon Steel Pipe | Fixed / Aluminum Alloy pipe | Same type, different material. Both passed strength and fatigue tests. |
| Dimensions (Overall L/W/H) | 39.0" (995 mm) / 19.3" (490 mm) / 37.0" (940 mm) | 51.9" (1320mm) / 26.3" (670mm) / 45.6" (1160mm) | Larger dimensions for subject device to accommodate heavier user, larger seat, wheels, and batteries. |
| Seat Dimension (W/H) | 22.5" (570 mm) / 16" (408 mm) | 18.1" (460 mm) / 18.1" (460 mm) | Smaller width, larger height for subject device, related to heavier user load. |
| Weight limit | 220 lbs (100 kgs) | 300 lbs (135 kgs) | Heavier user capacity for subject device. |
| Suspension | Cross brace | Full | Full independent suspension for subject device provides more comfort by absorbing more impact. |
| Rear wheels | 8" x 3" solid type x 2 | 11" x 4" pneumatic type x 2 | Larger size & different type. Pneumatic tires with normal driving/maintenance have similar safety/effectiveness as solid tires. |
| Front Casters | 8" x 3" solid x 2 | 11" x 3.5" pneumatic x 2 | Larger size & different type. |
| Turning Radius | 37.4" (950 mm) | 40.1" (1020 mm) | Larger turning radius for subject device due to larger front/rear wheels. |
| Ground clearance | 2.8" (70 mm) | 3.93" (100 mm) | Larger ground clearance for subject device due to larger wheels. |
| Kerb climbing ability | 2.0" (50 mm) | 3.93" (100 mm) | Larger kerb climbing ability for subject device due to larger wheels. |
| Scooter weight (w/ batteries) | 96 lbs (43.6 kgs) | 247 lbs (110 kgs) | Heavier scooter weight for subject device due to larger size, wheels, and batteries. |
| Maximum speed | 4.8 mph (7.8 kph) | 3.6 mph (5.8 kph) | Smaller max speed for subject device. This limitation equalizes the higher center of gravity from a higher seat (due to heavier user load & larger battery) to bring more safety and reduce tip-over hazard. |
| Recharger type/Model | 24VDC (UL E241359 certified) / 4C24020A | 24VDC (E201162 certified) / 4C24050A | Different models with UL certificates. Charger for subject device is UL-certified, raising no safety/effectiveness concerns. |
| Motor | 3A, 24V, 270W | 10A, 24V, 700W | Larger power motor for subject device, enabling larger range. |
| Batteries Quantity/Type | Two / 12Ah 12VDC | Two / 50Ah 12VDC | Same quantity, larger capacity for subject device, leading to a larger travel range. |
| Range per full charging | 6 | 21 miles (34 km) | Larger range for subject device, considered a convenience, not a safety concern. |
| Warranty | 3 years: Main frame, 1 year: Controller/gear motor/batteries | 2 years: Main frame, 1.5 years: Controller, 1 year: gear motor | Shorter warranty periods for subject device, but not related to safety and effectiveness aspects, assuming users follow instructions. |
The study that proves the device meets the acceptance criteria (Non-Clinical Performance Testing):
The document states that the subject device (HEARTWAY Power Mobility Scooter, Cutie S17) underwent and passed performance tests according to the following international standards:
- Electromagnetic Compatibility: ANSI/RESNA WC-2, Section 21:2009 (with exclusions)
- Static Stability: ISO 7176-1:1999 (with exclusions)
- Dynamic Stability: ISO 7176-2:2001 (with exclusions)
- Brakes: ISO 7176-3:2012 (with exclusions)
- Energy Consumption (Range): ISO 7176-4:2008
- Dimensions, Mass, Maneuvering Space: ISO 7176-5:2008
- Maximum Speed, Acceleration, Deceleration: ISO 7176-6:2001
- Seating Dimensions: ISO 7176-7:1998
- Static, Impact, and Fatigue Strength: ISO 7176-8:1998
- Climatic Tests: ISO 7176-9:2009
- Obstacle-Climbing Ability: ISO 7176-10:2008
- Test Dummies: ISO 7176-11:2012
- Coefficient of Friction of Test Surfaces: ISO 7176-13:1989
- Power and Control System: ISO 7176-14:2008
- Information Disclosure, Documentation, Labeling: ISO 7176-15:1996
- Resistance to Ignition (Upholstered parts): ISO 7176-16:2012
Additionally, for biocompatibility, patient-contacting materials (seat PVC, hand grip PVC, seat belt PVC) were tested for compliance to ISO 10993-1:2009, ISO 10993-5:2009, and ISO 10993-10:2010.
The conclusion states: "At last, subject devices pass the performance tests according to Safety standards of ISO 7176 series and the EMC test of ANSI / RESNA WC-2, Section 21:2009. The overall performances of the subject devices are ensured." and "The conclusions drawn from the non-clinical tests demonstrate that the subject device is as safe, as effective, and performs as well as the legally marketed device identified in the submission."
Regarding the specific questions posed for AI/ML devices, the information is not present in this document because it is for a physical medical device:
- Sample sizes used for the test set and the data provenance: Not applicable. Performance testing is described as passing standards, not a statistical test set for an algorithm.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Functional and safety standards are used, not expert-labeled ground truth for an algorithm.
- Adjudication method: Not applicable. Standardized mechanical and electrical tests are performed.
- 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.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. "Ground truth" in this context refers to the requirements set by the international performance and safety standards, which the physical device must meet.
- The sample size for the training set: Not applicable. This is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable.
§ 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).