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510(k) Data Aggregation
(117 days)
The device is a power wheelchair intended to provide mobility to persons restricted to a sitting position
The device is a powered wheelchair intended to provide mobility to persons restricted to a sitting position. It is available in three models: SAFARI, SAFARI SPORT, and MINI. It is battery operated and has brake systems.
The provided text describes the "SupaChair" Powered Wheelchair and its substantial equivalence to a predicate device for FDA 510(k) clearance. Here's a breakdown of the acceptance criteria and the study information, focusing on the available details:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally based on compliance with ISO 7176 series standards. The document states that "All test results are in compliance with it and were similar to predicate device." However, specific numerical acceptance criteria (e.g., minimum stability angle, maximum braking distance) and the exact performance values for the "SupaChair" are not explicitly detailed in the provided text. The table below summarizes the types of tests conducted and infers that compliance to the respective standard constitutes the acceptance criteria.
| Acceptance Criteria (Inferred from ISO 7176 Standards) | Reported Device Performance ("SupaChair") |
|---|---|
| Static stability in accordance with ISO 7176-1 | Compliant with ISO 7176-1 |
| Dynamic stability in accordance with ISO 7176-2 | Compliant with ISO 7176-2 |
| Efficiency of brakes in accordance with ISO 7176-3 | Compliant with ISO 7176-3 |
| Theoretical distance range in accordance with ISO 7176-4 | Compliant with ISO 7176-4 |
| Overall dimensions, mass, turning diameter in accordance with ISO 7176-5 | Compliant with ISO 7176-5 |
| Maximum speed, acceleration, retardation in accordance with ISO 7176-6 | Compliant with ISO 7176-6 |
| Seating and wheel dimensions in accordance with ISO 7176-7 | Compliant with ISO 7176-7 |
| Static, impact, and fatigue strengths in accordance with ISO 7176-8 | Compliant with ISO 7176-8 |
| Climatic tests in accordance with ISO 7176-9 | Compliant with ISO 7176-9 |
| Obstacle-climbing ability in accordance with ISO 7176-10 | Compliant with ISO 7176-10 |
| Test dummies in accordance with ISO 7176-11 | Compliant with ISO 7176-11 |
| Determination of coefficient of friction of test surfaces in accordance with ISO 7176-13 | Compliant with ISO 7176-13 |
| Power and control system in accordance with ISO 7176-14 | Compliant with ISO 7176-14 |
| Information disclosure, documentation, and labeling in accordance with ISO 7176-15 | Compliant with ISO 7176-15 |
| EMC test in accordance with ISO 7176-21 (EN 12184) | Compliant with ISO 7176-21 (EN 12184) |
| Batteries and chargers for powered wheelchairs in accordance with ISO 7176-25 | Compliant with ISO 7176-25 |
| Secondary cells and batteries (IEC 62133) | Compliant with IEC 62133 |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size of devices used for testing. However, the tests are "non-clinical testing" and refer to "series test" performed on the "SupaChair" powered wheelchair. This suggests that the tests were conducted on physical units of the device.
The data provenance is from Taiwan (R.O.C.), as the applicant is "EUROGREEN INTERNATIONAL INC." located in Changhua County, Taiwan. The tests are prospective in nature, as they are performed to confirm the device's safety and effectiveness before clearance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. For non-clinical device testing like this, "ground truth" is typically established by comparing performance against objective international standards (like ISO 7176) rather than expert consensus on a dataset. The "experts" would be the engineers and technicians conducting and verifying the tests in accordance with these standards.
4. Adjudication Method for the Test Set
This information is not applicable/provided. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies involving interpretation of medical images or data by human readers. The tests described are non-clinical, objective performance tests against engineering standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI/radiological diagnosis devices. The "SupaChair" is a physical medical device (powered wheelchair), and its performance is evaluated through engineering and safety standards, not through human reader interpretation of data or images.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
N/A. This question is primarily applicable to AI/software-as-a-medical-device. The "SupaChair" is a physical powered wheelchair. The performance referred to is the physical device's performance against established safety and engineering standards.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical testing of the SupaChair is based on compliance with international engineering and safety standards, specifically the ISO 7176 series and IEC 62133. This is an objective, standardized metric rather than expert consensus, pathology, or outcomes data in the traditional sense. The phrase "All test results are in compliance with it" indicates that the established ground truth for safety and effectiveness is meeting these specified standard requirements.
8. The Sample Size for the Training Set
N/A. This concept of a "training set" is relevant for machine learning or AI models. The "SupaChair" is a physical medical device, and its development and testing do not involve AI training sets.
9. How the Ground Truth for the Training Set Was Established
N/A. As mentioned above, there is no "training set" for this type of device.
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