(48 days)
Indications Huayi K3/K4 lightweight wheelchair is indicated for providing mobility to persons limited to a sitting position.
The Danyang Huayi K3/k4 wheelchair is a lightweight wheelchair that provides mobility to persons limited to a sitting position. It consists of rigid, mechanical, steel and aluminum frame and nylon upholstery back and seat that meet ISO 7176-16: Resistance to ignition of Upholstered parts. It has two 24" rear wheels and two 8" front casters for turning and maneuverability. The Danyang Huayi K3/K4 wheelchair is intended for the use in indoors and outdoors, over smooth surface (all standard indoor flooring surfaces, concrete, asphalt and pocked dirt) that free of large obstacles and inclines greater than 9 degrees.
The provided document describes the Danyang Huayi K3/K4 lightweight wheelchair, which is a Class I mechanical wheelchair. The primary method of proving substantial equivalence to a predicate device is through conformance to established standards.
Here's an analysis based on the provided text, addressing your specific points:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard Conformance) | Reported Device Performance |
|---|---|
| ISO 7176-1: Determination of static stability | Met |
| ISO 7176-3: Determination of efficiency of brakes | Met |
| ISO 7176-5: Determination of overall dimension, mass, and turning space | Met |
| ISO 7176-7: Measurement of seating and wheel dimensions | Met |
| ISO 7176-8: Requirements and test methods for static, impact, and fatigue strengths | Met |
| ISO 7176-11: Test dummies | Met |
| ISO 7176-13: Determination of friction of test surface | Met |
| ISO 7176-15: Requirements for information disclosure, documentation, and labeling | Met |
| ISO 7176-16: Resistance to ignition of upholstered parts | Met |
| ISO 10993-5-1999: Test for in vitro Cytotoxicity | Met |
| ASTM D751:89 Section 11 Procedure A: Tensile Strength | Met |
| California Technical Bulletin 117 (Parts A, I, D, II, E, 1): Flame Retardance of Resilient Filling Materials | Met |
2. Sample Size for the Test Set and Data Provenance
The document does not explicitly state the sample size for individual tests conducted to meet each ISO or ASTM standard. It generally states that "The Danyang Huayi K3/K4 wheelchair production meets the following standards" and that the device "raises no safety and efficiency issues or makes any claims that differ from the predicate device cited".
The data provenance is from China, as Danyang Huayi Medical Equipment & Supply Co., LTD is a Chinese company. The nature of the testing is generally prospective, as it would involve testing the manufactured wheelchairs against the specified standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. For mechanical device testing against standards, the "ground truth" is typically defined by the standard's specifications and test procedures, rather than expert consensus in the way it might be for a diagnostic image analysis algorithm. The expertise lies in the engineers and technicians performing the standardized tests correctly.
4. Adjudication Method for the Test Set
This information is not provided. Given the nature of mechanical testing against established standards, the adjudication method would typically involve direct measurement and comparison with the standard's pass/fail criteria, rather than multi-reader adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is more common for diagnostic imaging AI algorithms where the "reader" is a human interpreting images. For a mechanical wheelchair, the assessment focuses on physical performance against engineering standards.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This question is not applicable as the device is a mechanical wheelchair, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" used is defined by the specifications and test methods outlined in the various ISO, ASTM, and California Technical Bulletin standards. These standards provide objective, measurable criteria for attributes like static stability, brake efficiency, dimensions, strength, and material properties.
8. The Sample Size for the Training Set
This question is not applicable. The Danyang Huayi K3/K4 wheelchair is a mechanical device, not an AI algorithm. Therefore, there is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as there is no training set for a mechanical device.
§ 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).