(167 days)
The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.
Cutie Mini S16 is battery operated and configured with two rear pneumatic wheels as the drive wheels and two front pneumatic wheels as the steering wheels. The device uses the upper panel control to control the turning tiller column mechanism to control the front wheel as the steering directions. 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 to allow the device to sustain an impact without damage to the power scooter safety system and with an independent suspension. Tuning tiller column is equipped with the head light, back mirrors, and a swivel seat with the flipping arm-rests, and a lever to move the seat backward and forward. Cutie Mini S16 maximum weight capacity is 300 lbs (135 kg), and the maximum speed is 3.6 mile/hr ( 6 km/hr). Owing to the feature of the body structure, the two rear wheels can always contact the surface, and the device can drive on the rough surface.
Here's an analysis of the provided text regarding acceptance criteria and supporting studies:
This document is a 510(k) premarket notification for a medical device (HEARTWAY Power Mobility Scooter, Cutie Mini S16). For devices like this, the "acceptance criteria" are generally demonstrating substantial equivalence to a predicate device by meeting recognized consensus standards for performance and safety. The document primarily focuses on comparing the new device to a predicate device (HEARTWAY Lightweight Power Mobility Scooter, S34) and showing that performance tests confirm its safety and effectiveness.
Here's the breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
For this type of device, "acceptance criteria" are usually aligned with international consensus standards for performance and safety. The reported device performance is indicated by its compliance with these standards and its specific design parameters.
| Acceptance Criteria (Standard Compliance / Performance Parameter) | Reported Device Performance (Subject Device: Heartway Power Mobility Scooter, Cutie Mini S16) | Predicate Device Performance (Heartway Lightweight Power Mobility Scooter, S34) | Basis for Acceptance (Compliance to Standard / Comparison) |
|---|---|---|---|
| EMC Test: ANSI / RESNA WC-2:2009 (Section 21), CISPR 11:2009, IEC 61000 series | Compliant | Presumed Compliant (as predicate) | Certification of compliance to recognized standards. |
| Static Stability: ISO 7176-1:1999 | Compliant | Compliant | Certification of compliance. |
| Dynamic Stability: ISO 7176-2:2001 | Compliant | Compliant | Certification of compliance. |
| Brake Effectiveness: ISO 7176-3:2012 | Compliant | Compliant | Certification of compliance. |
| Energy Consumption (Theoretical Range): ISO 7176-4:2008 | Compliant (Range: 30 km / 19 miles) | Compliant (Range: 10-15 km / 6-9 miles) | Certification of compliance. Subject device has longer range, presenting no new safety issues. |
| Overall Dimensions, Mass, Maneuvering Space: ISO 7176-5:2008 | Compliant (Larger dimensions, 83kg / 183lb w/ batteries, 1020mm / 40.1" turning radius) | Compliant (Smaller dimensions, 43.6kg / 96lb w/ batteries, 950mm / 37.4" turning radius) | Certification of compliance. Differences noted and addressed in comparison discussion (e.g., larger turning radius offset by lower max speed due to higher center of gravity). |
| Maximum Speed, Acceleration, Deceleration: ISO 7176-6:2001 | Compliant (Max speed: 6.0 km/hr / 3.6 mile/hr) | Compliant (Max speed: 7.8 km/hr / 4.875 mile/hr) | Certification of compliance. Subject device's lower speed is a safety measure due to higher center of gravity. |
| Seating Dimensions: ISO 7176-7:1998 | Compliant (Seat width: 570mm / 22.5", Seat height: 635mm / 25") | Compliant (Seat width: 570mm / 22.5", Seat height: 408mm / 16") | Certification of compliance. Higher seat height addressed in comparison discussion. |
| Static, Impact, Fatigue Strength: ISO 7176-8:1998 | Compliant (Frame material: Aluminum Alloy pipe) | Compliant (Frame material: Carbon Steel Pipe) | Certification of compliance. Different materials passed same strength tests. |
| Climatic Tests: ISO 7176-9:2009 | Compliant | Compliant | Certification of compliance. |
| Obstacle-Climbing Ability: ISO 7176-10:2008 | Compliant (Ability: 60mm / 2.4") | Compliant (Ability: 50mm / 2.0") | Certification of compliance. Subject device has larger ability. |
| Test Dummies: ISO 7176-11:2012 | Compliant | Compliant | Certification of compliance. |
| Coefficient of Friction of Test Surfaces: ISO 7176-13:1989 | Compliant | Compliant | Certification of compliance. |
| Power and Control System: ISO 7176-14:2008 | Compliant (Penny & Giles S-Drive 70A, UL E201162 certified recharger) | Compliant (Penny & Giles S-Drive 45A, UL E241359 certified recharger) | Certification of compliance. Same type of controller from same supplier, different volume, both UL certified. |
| Information Disclosure, Documentation, Labeling: ISO 7176-15:1996 | Compliant | Compliant | Certification of compliance. |
| Resistance to Ignition of Upholstered Parts: ISO 7176-16:2012 | Compliant (Back upholstery: Fabric) | Compliant (Back upholstery: Fabric) | Certification of compliance. |
| Electromagnetic Compatibility: ISO 7176-21:2009 | Compliant | Compliant | Certification of compliance. |
| Biocompatibility (Patient Contacting Materials): ISO 10993-1:2009, ISO 10993-5:2009, ISO 10993-10:2010 | Compliant (Seat PVC, Hand grip PVC, Seat belt PVC tested) | Compliant (ISO 10993-1:2009, ISO 10993-5:2009) | Certification of compliance. Subject device has "More testing" (ISO 10993-10:2010 adds irritation/skin sensitization). |
| Weight Limit: Max 135 kgs / 300 lbs | Meets (135 kgs / 300 lbs) | Lower (100 kgs / 220 lbs) | Demonstrated capability to support heavier users adequately. |
| Incline: Safer slope | 6 degrees | 10 degrees | Subject device offers a "Safer slope" capability (lower incline maximum reported as safer). |
2. Sample Size Used for the Test Set and the Data Provenance
The document details compliance with various ISO and ANSI/RESNA standards for performance testing. These standards typically involve specific test setups and a limited number of test units (e.g., one or a few devices) for physical and electrical performance evaluations rather than large "sample sizes" in the statistical sense (like patients in a clinical trial). The tests described are laboratory-based performance tests for the device itself.
- Sample Size: Not explicitly stated in terms of a "test set" sample size for statistical analysis (e.g., number of patients/cases). Instead, it refers to testing of the device(s) themselves. The implied sample size for each performance test is usually one or a few devices/components as per the specific test standard.
- Data Provenance: The tests are standard-based performance tests, likely conducted in a controlled laboratory environment by the manufacturer or a certified testing facility. The document refers to "Performance Testing" without specifying the location. Based on the manufacturer's location (Taiwan), it is likely conducted there or by an internationally recognized testing body.
- Retrospective or Prospective: These are laboratory performance tests performed on the device model, not a retrospective or prospective study on users.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. This is not a study involving expert assessment of images or clinical outcomes where a "ground truth" is established by human experts. The "ground truth" for these tests is defined by the objective measurement criteria and methodologies specified in the respective ISO and ANSI/RESNA standards. For example, static stability is measured by specific angles and forces, not by expert opinion.
4. Adjudication Method for the Test Set
Not applicable. There is no adjudication method described because there are no human-based assessments requiring reconciliation of opinions. The tests are objective measurements against defined standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
Not applicable. This is a 510(k) for a physical medical device (mobility scooter), not an AI/CAD (Computer-Aided Diagnosis) software. Therefore, no MRMC study or AI assistance is relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Not applicable. This device is not an algorithm or software requiring standalone performance testing.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" in this context is defined by the objective and measurable criteria set forth in the international consensus standards (ISO 7176 series, ANSI/RESNA WC-2, ISO 10993 series, etc.). For instance:
- Static Stability: Ground truth is specific angles (e.g., 6 degrees incline) at which the device must remain stable.
- Maximum Speed: Ground truth is the measurement of the device's actual maximum speed.
- Biocompatibility: Ground truth is the results of specific chemical and biological tests (e.g., cytotoxicity, irritation) as per ISO 10993.
These are objective, quantitative measurements, not subjective expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set
Not applicable. "Training set" refers to data used to train machine learning models. This document is about a physical device and its performance testing against engineering standards, not AI.
9. How the Ground Truth for the Training Set Was Established
Not applicable, for the same reason as point 8.
§ 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).