(28 days)
The intended use of this device (folding manual wheelchair) is the same as the predicate device, Sunrise's Quickie 2HP folding wheelchair (K890050). It is intended to provide mobility to physically impaired individuals. The manual wheelchair is intended for on-going "everyday" use.
The specific medical conditions for which the device is indicated are listed as, but not limited to:
Spinal chord injury
Stoke/CVA
Post Polio Syndrome
Spina Bifada
Amputee
Multiple Scierosis
Arthrogriposis
Muscular Dystrophy
Lower and upper extremity paralysis
The TiSport X and XC manual titanium wheelchairs are folding everyday chairs.
The TiSport X and TiSport XC manual titanium wheelchairs are folding everyday chairs.
Here's an analysis of the acceptance criteria and study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| ISO 7176 Standards: | Meets the requirements of ISO 7176 Parts 1, 3, 5, 7, and 8 Standards. (Other parts not applicable) |
| Parts 1 (Determination of Static, Impact and Fatigue Strength) | Met |
| Parts 3 (Determination of Effectiveness of Brakes) | Met |
| Parts 5 (Determination of Dimensions, Mass and Manoeuvring Space) | Met |
| Parts 7 (Measurement of Seating and Wheel Dimensions and Mass) | Met |
| Parts 8 (Requirements and Test Methods for Static, Impact and Fatigue Strength) | Met |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the sample size for the test set used to demonstrate compliance with the ISO 7176 standards.
The data provenance is not explicitly mentioned (e.g., country of origin, retrospective or prospective). However, it is an engineering test of the physical product, likely conducted in a controlled laboratory environment.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:
This type of testing (ISO 7176 standards for wheelchairs) typically involves engineering and quality assurance professionals, not medical "experts" in the context of clinical ground truth. The "ground truth" here is compliance with established international engineering standards. The document does not specify the number or qualifications of the individuals who performed or validated these tests, but it would involve personnel trained in mechanical testing and quality control.
4. Adjudication Method for the Test Set:
Adjudication methods like 2+1 or 3+1 consensus are not applicable to the type of engineering compliance testing described. The results are objective measurements against predefined thresholds within the ISO standards. The evaluation would be based on whether the test results fall within the acceptable parameters defined by each part of the ISO 7176 standard.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:
No MRMC comparative effectiveness study was done. This device is a manual wheelchair, and the testing focuses on its mechanical performance and safety standards, not on AI assistance to human readers or clinicians.
6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done:
This is not applicable. The device is a physical product (manual wheelchair), not an algorithm or AI system. The testing is for the standalone performance of the physical device.
7. The Type of Ground Truth Used:
The ground truth used is compliance with international engineering standards (ISO 7176 Parts 1, 3, 5, 7, and 8). This is a form of objective, empirical measurement against predefined criteria.
8. The Sample Size for the Training Set:
This is not applicable. There is no AI or machine learning component to this device, so there is no "training set." The testing performed is physical product testing.
9. How the Ground Truth for the Training Set Was Established:
This is not applicable as there is no training set.
§ 890.3850 Mechanical wheelchair.
(a)
Identification. A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class I (general controls).