(231 days)
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
The Shanghai Phoenix Mechanical Wheelchair is indoor / outdoor wheelchair that has a base with four-wheeled with a seat. The device can be disassembled for transport and it is foldable easily. The device uses a standard sling type back and seat, the upholstery fabric meets the resistant to ignition source smouldering cigarette. and match flame equivalent.
The provided document K130848 describes the Shanghai Phoenix Mechanical Wheelchair and its substantial equivalence to a predicate device, as well as the performance tests conducted to meet relevant international standards.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that the Shanghai Phoenix Mechanical Wheelchair meets the applicable performance requirements as specified in ANSI/RESNA WC vol. 1 and ISO 7176 Wheelchair series relevant standards. This means the acceptance criteria are defined by these standards. The device's reported performance is its successful compliance with these standards.
| Acceptance Criteria (from ISO 7176 / EN 12183 standards) | Reported Device Performance |
|---|---|
| ISO 7176-1: Determination of Static Stability | Met standard requirements |
| ISO 7176-3: Determination of effectiveness of brakes | Met standard requirements |
| ISO 7176-5: Determination of overall dimensions, mass and maneuvering space | Met standard requirements |
| ISO 7176-7: Measurement of seating and wheel dimensions | Met standard requirements |
| ISO 7176-8: Requirements and test methods for static, impact and fatigue strengths | Met standard requirements |
| ISO 7176-11: Test dummies | Relevant methodologies followed |
| ISO 7176-13: Determination of coefficient of friction of test surfaces | Met standard requirements |
| ISO 7176-15: Requirements for information disclosure, documentation and labelling | Met standard requirements |
| ISO 7176-16: Resistance to ignition of upholstered parts | Met standard requirements |
| ISO 7176-22: Set-up procedures | Relevant methodologies followed |
| EN 12183: Manually propelled wheelchairs Requirements and test methods | Met standard requirements |
| EN 1021-1 /-2: Assessment of the ignition of upholstered furniture | Met standard requirements |
| Weight Capacity | 100 Kgs / 220 lbs |
| Flammability (upholstery fabric) | Meets resistance to ignition source smouldering cigarette and match flame equivalent |
Note: The document states "Shanghai Phoenix Mechanical Wheelchair meets the applicable performance requirements as specified in ANSI/RESNA WC vol. 1 and ISO 7176 Wheelchair series relevant standards". This implies that the device successfully passed all tests outlined in these standards, thus demonstrating compliance. Specific numerical results for each test were not provided in this summary.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample size (number of wheelchairs) used for the performance testing.
The testing is described as "Literature for Performance Testing," which typically refers to laboratory testing of physical samples, not clinical data.
Data Provenance: The tests relate to international and European standards (ISO and EN). The manufacturer is based in Shanghai, China, suggesting the testing was likely conducted in accordance with these international standards, potentially in specialized testing facilities in China or elsewhere. It is a prospective evaluation of the manufactured device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
For engineering performance standards like those referenced (ISO 7176, EN 12183), "ground truth" is typically established by the standard itself and verified by accredited testing laboratories and their qualified engineers/technicians. These tests are objective measurements (e.g., static stability, brake effectiveness, dimensions, strength, flammability) against predefined criteria, rather than subjective expert consensus on medical images or diagnoses. Therefore, the concept of "experts establishing ground truth" in the clinical sense doesn't directly apply here. The "experts" would be the personnel at the testing lab who execute and interpret the standard tests.
4. Adjudication Method for the Test Set
Adjudication methods like "2+1" or "3+1" are characteristic of clinical studies involving subjective assessments (e.g., radiologists reviewing images). For objective engineering performance tests against international standards, there is no "adjudication method" in this sense. The test results are either within the acceptable range specified by the standard or they are not. If a deviation occurs, the device fails the test for that criterion.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance in tasks like image interpretation, which is not applicable to the performance testing of a mechanical wheelchair.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone (algorithm-only) performance study was not done. This concept applies to AI algorithms, and this document pertains to a mechanical medical device, not an AI system.
7. The Type of Ground Truth Used
The "ground truth" for the device's performance is the objective, quantifiable criteria defined by the referenced international and European engineering standards (ISO 7176 series, EN 12183, EN 1021-1/-2). These standards specify test methods, measurement procedures, and acceptable ranges or thresholds for various performance aspects (e.g., static stability angles, brake force, material ignition resistance, strength under load).
8. The Sample Size for the Training Set
This document describes the performance testing of a physical medical device (mechanical wheelchair). The concept of a "training set" is relevant for machine learning algorithms. Therefore, a training set sample size is not applicable in this context.
9. How the Ground Truth for the Training Set was Established
As mentioned above, the concept of a "training set" is not applicable to the performance testing of this mechanical device. Ground truth for the performance of the wheelchair is established by the engineering standards themselves and their specified test methodologies.
§ 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).