(86 days)
The Manual Wheelchair is to provide mobility to persons restricted to a sitting position.
The Aluminum Manual 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.
Main components:
Main frame, handle sleeve, back upholstery, seat upholstery, armrest, side panel, rear wheel with handle ring, rear wheel axle, legrest, footplate, front fork, front wheels, cross bar.
Main materials:
Main frame, cross bar, legrest: Aluminum, silver/blue coating
Back upholstery, seat upholstery: Cover is polyester non-woven, inside with flame resistant foam
Handle sleeve, handle sleeve, side panel, handle ring, footplate: PVC
Tire of rear wheels, front wheels, armrest pad: PU
The document provided is a 510(k) summary for a Manual Wheelchair (SIVFH2A102) and not an AI/ML medical device. Therefore, the questions related to AI/ML device performance (such as sample size for test/training sets, data provenance, expert ground truth, MRMC studies, standalone performance, etc.) are not applicable to this submission.
This 510(k) submission demonstrates substantial equivalence to a predicate device (K181795 AST Model MA012 and MS019 Rehab Wheelchair) primarily through non-clinical performance testing to consensus standards and a usability study.
Here's the information that can be extracted from the provided document regarding acceptance criteria and device testing:
Device: Manual Wheelchair SIVFH2A102
Predicate Device: K181795 AST Model MA012 and MS019 Rehab Wheelchair
1. Table of Acceptance Criteria and Reported Device Performance
For a mechanical device like a wheelchair, "acceptance criteria" are typically defined by meeting the requirements of specific international consensus standards for safety and performance. The "reported device performance" is essentially a statement of compliance with these standards.
| Acceptance Criteria (Standard Requirement) | Reported Device Performance (Compliance) |
|---|---|
| ISO 7176-1:2014: Determination of static stability | Meets ISO 7176-1:2014 |
| ISO 7176-3:2012: Determination of effectiveness of brakes | Meets ISO 7176-3:2012 |
| ISO 7176-5:2008: Determination of dimensions, mass and maneuvering space | Meets ISO 7176-5:2008 |
| ISO 7176-7:1998: Measurement of seating and wheel dimensions | Meets ISO 7176-7:1998 |
| ISO 7176-8:2014: Requirements and test methods for static, impact and fatigue strengths | Meets ISO 7176-8:2014 |
| ISO 7176-11:2012: Test dummies (General requirement for testing) | Tests conducted following this standard |
| ISO 7176-13:1989: Determination of friction of test surface (General requirement for testing) | Tests conducted following this standard |
| ISO 7176-15:1996: Requirements for information disclosure, documentation and labeling | Meets ISO 7176-15:1996 |
| ISO 7176-16:2012: Resistance to ignition of postural support devices | Meets ISO 7176-16:2012 |
| ISO 7176-22:2014: Set-up procedures (General requirement for testing) | Tests conducted following this standard |
| ISO 10993-1:2009: Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process | Testing performed for biocompatibility |
| ISO 10993-5:2009: Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity | Testing performed for biocompatibility |
| ISO 10993-10:2010: Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity | Testing performed for biocompatibility |
| Usability Requirements: User manual comprehension and device operation | Meets usability requirement as defined in V&V test report |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: For the performance tests (e.g., static stability, brakes, strengths), typically a small number of physical samples of the device are tested. The document does not specify the exact number of physical units of the wheelchair that were tested.
- Data Provenance: The tests were conducted internally by the manufacturer, Jiangsu Horizon Medical Science & Technology Co., Ltd. The document does not specify the country of origin for the testing itself, but the manufacturer is based in China. This is a prospective submission for a new device, with testing specifically performed to support the 510(k).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not Applicable for a mechanical device. "Ground truth" in the context of AI/ML or diagnostic devices refers to a definitive classification or measurement established by experts (e.g., radiologists, pathologists) or a gold standard. For a wheelchair, performance is measured against objective engineering standards.
4. Adjudication Method for the Test Set
- Not Applicable for a mechanical device. Adjudication methods are relevant for subjective interpretations, common in clinical studies involving multiple readers.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No, Not Applicable. This type of study is relevant for diagnostic devices, particularly AI-powered ones, to assess how AI assistance impacts human reader performance. This is a mechanical device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No, Not Applicable. This refers to AI algorithm performance. The device is a mechanical wheelchair.
7. The Type of Ground Truth Used
- Not Applicable in the typical sense. The "ground truth" for this device's performance is established by the international consensus standards (ISO 7176 series, ISO 10993 series). Compliance with the objective test methods outlined in these standards serves as the evidence of performance and safety, rather than expert consensus on diagnostic images or pathology.
8. The Sample Size for the Training Set
- Not Applicable. This is a mechanical device, not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set was Established
- Not Applicable. As above, no training set is involved.
Additional Information from the Document:
- Usability Study: A usability study was performed with 15 participants. They read the user manual and were able to understand the questions and operate the device. This demonstrates that the instructions are sufficient for safe and proper use.
- Non-Clinical Testing Data: The submission relies heavily on non-clinical testing data to demonstrate substantial equivalence, arguing that the device meets "performance requirements per ISO 7176-1:2014, ISO 7176-3: 2012, etc." and is "safe and effective, and its performances meet the requirements of the pre-defined acceptance criteria and intended use."
- Clinical Data: The submission explicitly states: "According to the non-clinical test results, the proposed devices are as safe, as effective and perform as well as the predicate device. So the proposed device is Substantially Equivalent (SE) to the predicate device which is US legally market device." This implies no clinical studies were performed or relied upon for this 510(k) submission, typical for Class I devices or those demonstrating substantial equivalence through engineering performance and labeling.
§ 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).