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The device is a power wheelchair intended to provide mobility to persons restricted to a sitting position.

The device is a power wheelchair.
Common Name: Powered Wheelchair
Trade Name: "SupaChair" Powered Wheelchair
Classification Name: Powered Wheelchair
Regulation Number: 890.3860
Product Code: ITI
Device Class: Class 2
Model: COMBI 18/ COMBI 20/ COMBI 18SP/ COMBI 20SP

The provided text is a 510(k) premarket notification for a powered wheelchair, the "SupaChair." It outlines the device's technical specifications, intended use, and a comparison to a predicate device to establish substantial equivalence. However, this document does not describe acceptance criteria, a study that proves the device meets those criteria, or the detailed aspects of a clinical study for an AI/ML powered device.

The information provided relates to a physical medical device (a powered wheelchair), not an AI/ML algorithm. Therefore, many of the requested elements (like "multi reader multi case (MRMC) comparative effectiveness study," "standalone (i.e. algorithm only without human-in-the-loop) performance," "ground truth establishment," "training set sample size," etc.) are not applicable to the content of this document.

The document focuses on demonstrating substantial equivalence to an existing predicate device based on technical characteristics and non-clinical testing (ISO standards for powered wheelchairs), rather than performance metrics of an AI/ML algorithm against a defined ground truth.

Therefore, I cannot extract the requested information from the provided text as it is not present. The document focuses on mechanical, electrical, and physical performance of a wheelchair, not the analytical or clinical performance of a diagnostic AI.

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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.

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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