(104 days)
The VCS S3T scooter is motor driven, indoor and outdoor transportation vehicles with the intended use to provide mobility to disabled or elderly persons limited to a seated position.
The VCS S3T scooter is motor driven, indoor and outdoor transportation vehicles with the intended use to provide mobility to disabled or elderly persons limited to a seated position. The VCS S3T scooter is with a 136 kg (300 lbs) weight capacity. The scooter is basic conventional rear wheel drive, rigid frame vehicle that are battery powered. It consists primarily of a welded steel frame, rear signal lights, a sealed transaxle motor drive system, electromagnetic braking system, electric motor controller, two batteries with an on-board charger and an adjustable seat. It also includes a tiller handle for steering and a thumb operated potentiometer throttle control lever to engage and disengage the scooter motion in both the forward and reverse directions. The scooter is powered by two 12 volt lead-acid DC batteries with 25 km (15 miles) with 21AH which maximum speed upto 6.6 km/hr (4.1 mph).
The provided text describes a 510(k) summary for the VCS S3T scooter, which is a motorized three-wheeled vehicle intended for transportation of disabled or elderly persons. The summary primarily focuses on demonstrating substantial equivalence to a predicate device through comparison of design, function, features, and compliance with non-clinical performance standards.
Based on the provided information, there is no study conducted to prove the device meets acceptance criteria in the typical sense of a clinical or analytical performance study with specific device performance metrics.
Instead, the "acceptance criteria" can be interpreted as demonstrating compliance with established performance standards for wheelchairs and motorized scooters, and the "study" is the non-clinical testing performed against these standards.
Here's an analysis based on your requested information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Standard Compliance) | Reported Device Performance |
|---|---|
| ANSI/RESNA WC/Vo1.1 section 1-1998 / ISO7176-1-1999 (Determination of static stability) | Compliant (Implied by "results of compliance testing to existing ANSI/RESNA, ISO 7176 and IEC standards, demonstrate the device to be substantially equivalent to the predicate in terms of meeting performance criteria") |
| ANSI/RESNA WC/Vo1.1 section 8-1998 / ISO7176-8-1998 (Static, impact and fatigue strengths-Requirements and test methods) | Compliant (Implied as above) |
| ANSI/RESNA WC/Vo1.2 section 21-1998 / ISO7176-21-2003 (Requirements and test methods for electromagnetic compatibility of powered wheelchairs and motorized scooters) | Compliant (Implied as above) |
| CISPR 11-1990 (Industrial, scientific and medical (ISM) Radio-Frequency equipment- electromagnetic disturbance characteristics – limits and methods of measurement) | Compliant (Implied as above) |
| IEC 61000-4-2-1995 (EMC-Electrostatic discharge immunity test (ESD)) | Compliant (Implied as above) |
| IEC 61000-4-3-1995 (EMC-Testing and measurement techniques-Radiated, RF, electromagnetic field immunity test) | Compliant (Implied as above) |
| California Bureau of Home Furnishings 116 (Flammability Standards) | Compliant (Implied as above) |
Important Note: The document states that "results of compliance testing to existing ANSI/RESNA, ISO 7176 and IEC standards, demonstrate the device to be substantially equivalent to the predicate in terms of meeting performance criteria and functioning as intended." However, it does not provide the specific numeric data or detailed results of these tests for the VCS S3T scooter. It only lists the standards tested against.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly stated. For non-clinical performance testing of a physical device, the "sample size" would typically refer to the number of devices tested. It is common for such tests to be performed on a small number of production units (e.g., 1-3 units). The document does not specify this.
- Data Provenance: The testing was conducted by Vehicles Technology Co., LTD. in Taiwan, as indicated by the sponsor's and manufacturer's information. It is non-clinical performance testing.
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. This information is relevant for studies involving subjective human assessment or interpretation (e.g., medical imaging, clinical diagnosis). For non-clinical performance testing against engineering standards, "ground truth" is established by the specifications defined in the standards themselves, and the testing is typically performed by qualified engineers or technicians in a testing laboratory without the need for expert consensus in the medical sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. As noted above, this concept applies to studies with subjective human interpretations. For objective engineering performance tests, the results are typically determined by measurements against defined limits, not by adjudication among human readers.
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
- No. This is not an AI-powered device or a diagnostic device. Therefore, an MRMC comparative effectiveness study is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical product (a motorized scooter), not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the non-clinical tests is represented by the specified limits and methodologies defined within the referenced international and national performance standards (e.g., ANSI/RESNA, ISO, IEC, CISPR, California Bureau of Home Furnishings). The device is deemed to meet the criteria if its performance falls within the acceptable ranges and passes the tests defined by these standards.
8. The sample size for the training set
- Not applicable. This device is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. As above, no training set or AI/ML algorithm is involved.
§ 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).