(176 days)
The GEN_3 Mechanical Wheelchair is intended to provide mobility to persons restricted to a seated position.
The GEN 3 Mechanical Wheelchair is a folding, non-rigid type wheelchair designed for use over rough terrain in developing countries. The wheelchair features adjustable seating, large castor wheels, an extra-thick cushion and adjustable footrests.
The provided document is a 510(k) summary for the GEN 3 Mechanical Wheelchair, seeking substantial equivalence to the predicate device, the GEN 2 Mechanical Wheelchair. The document outlines acceptance criteria as the device's ability to meet specific ISO standards for wheelchairs and presents the results of non-clinical testing to demonstrate this.
Here's a breakdown of the requested information:
1. Table of acceptance criteria and reported device performance:
| Criteria / Standard | Reported Device Performance |
|---|---|
| Material Standards: | |
| Powder coated steel frame meets ASTM A 53/A 53M-2005 | GEN 3 uses powder coated steel frame that meets ASTM A 53/A 53M-2005. |
| Powder coated steel frame meets JIS G 3444-2004 | GEN 3 uses powder coated steel frame that meets JIS G 3444-2004. |
| Tube properties (ASTM A 53/A 53M-2005, JIS G 3444-2004) | GEN 3 uses tubing with properties meeting ASTM A 53/A 53M-2005 and JIS G 3444-2004. |
| Functional/Performance Standards (ISO 7176 series): | (Non-clinical testing was performed for these standards, and the conclusion states it met the requirements.) |
| ISO 7176-1:1999 (Determination of static stability) | Retesting was performed for this standard. Conclusion states "non-clinical test results demonstrate the modified GEN_2 Wheelchair... does not raise any issues regarding safety and effectiveness." (implies compliance) |
| ISO 7176-3: Not explicitly mentioned for retesting | Listed as a standard applied to both GEN 2 and GEN 3. (Implied compliance for GEN 3) |
| ISO 7176-5:2008 (Determination of dimensions, mass, and manoeuvring space) | Retesting was performed for this standard. Conclusion states "non-clinical test results demonstrate the modified GEN_2 Wheelchair... does not raise any issues regarding safety and effectiveness." (implies compliance) |
| ISO 7176-7:1998 (Measurement of seating and wheel dimensions) | Retesting was performed for this standard. Conclusion states "non-clinical test results demonstrate the modified GEN_2 Wheelchair... does not raise any issues regarding safety and effectiveness." (implies compliance) |
| ISO 7176-8:1998 (Requirements and test methods for static, impact, and fatigue strengths) | Retesting was performed for this standard. Conclusion states "non-clinical test results demonstrate the modified GEN_2 Wheelchair... does not raise any issues regarding safety and effectiveness." (implies compliance) |
| ISO 7176-11: Not explicitly mentioned for retesting | Listed as a standard applied to both GEN 2 and GEN 3. (Implied compliance for GEN 3) |
| ISO 7176-13: Not explicitly mentioned for retesting | Listed as a standard applied to both GEN 2 and GEN 3. (Implied compliance for GEN 3) |
| ISO 7176-15: Not explicitly mentioned for retesting | Listed as a standard applied to both GEN 2 and GEN 3. (Implied compliance for GEN 3) |
| ISO 7176-16: Not explicitly mentioned for retesting | Listed as a standard applied to both GEN 2 and GEN 3. (Implied compliance for GEN 3) |
| Clinical Performance: | Not applicable for this type of device and submission. The submission relies on non-clinical performance to demonstrate substantial equivalence to a predicate. |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not explicitly state the sample size (number of GEN 3 wheelchairs) used for the non-clinical retesting. It generally refers to "retesting" and "non-clinical test results" without specifying the quantity of devices tested.
- Data Provenance: The data provenance is from non-clinical laboratory testing performed in support of this 510(k) submission. It is prospective in the sense that the testing was conducted specifically for the GEN 3 device to demonstrate compliance with standards. The country of origin of the data is not specified in the provided text.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as the study is a non-clinical performance study based on international standards (ISO). Ground truth established by experts is typically relevant for studies involving human interpretation (e.g., image analysis, clinical diagnoses). The "ground truth" here is the adherence to the technical specifications and performance requirements of the ISO standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This is not applicable as the testing is non-clinical and objective, based on standardized measurement and mechanical testing protocols. Adjudication methods are typically used in clinical studies or studies involving human readers/interpreters where there might be disagreement in assessments.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This is not applicable. This is a submission for a mechanical wheelchair, not an AI-powered diagnostic device. Therefore, no MRMC study or AI assistance evaluation was performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This is not applicable. This submission is for a mechanical wheelchair, which does not involve an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this non-clinical study is defined by the ISO standards (technical specifications and performance requirements) listed in the document (e.g., ISO 7176-1, 5, 7, 8). The device is considered to meet the acceptance criteria if it successfully passes the tests outlined in these standards.
8. The sample size for the training set:
This is not applicable. There is no "training set" as this is a non-clinical evaluation of a physical device against predefined performance standards, not a machine learning model.
9. How the ground truth for the training set was established:
This is not applicable for the reasons stated in point 8.
§ 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).