(511 days)
The device is intended for medical purpose to provide mobility to persons restricted to a sitting position.
The Valentine Steel Wheelchair, model: 1000 is an indoor / outdoor wheelchair that has a base with four-wheeled with a seat. The device can be disassembled for transportation and it is foldable easily. The device is consistent with the ISO 7176 series standards and uses a standard sling type back and seat, and the upholstery fabric meets the flame retardant test.
The provided text describes a 510(k) premarket notification for a medical device, the Valentine Steel Wheelchair, model 1000. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting new clinical trials to prove safety and effectiveness. Therefore, many of the requested categories related to clinical studies and AI performance metrics are not applicable in this context.
Here's a breakdown of the available information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
For this type of device (a Class I mechanical wheelchair), the "acceptance criteria" are compliance with relevant international standards and equivalence to a predicate device. The device's "performance" is demonstrated by meeting these standards.
| Acceptance Criteria (Applicable Standards) | Reported Device Performance |
|---|---|
| ISO 7176-1:1999 (Static Stability) | Met (Complied with) |
| ISO 7176-3:2012 (Brake Effectiveness) | Met (Complied with) |
| ISO 7176-5:2008 (Dimensions, Mass, Maneuvering) | Met (Complied with) |
| ISO 7176-7:1998 (Seating & Wheel Dimensions) | Met (Complied with) |
| ISO 7176-8:1998 (Static, Impact, Fatigue Strengths) | Met (Complied with) |
| ISO 7176-11:2012 (Test Dummies) | Met (Complied with) |
| ISO 7176-13:1989 (Coefficient of Friction) | Met (Complied with) |
| ISO 7176-15:1996 (Information Disclosure, Documentation, Labeling) | Met (Complied with) |
| ISO 7176-16:2012 (Resistance to Ignition of Upholstered Parts) | Met (Complied with) |
| ANSI/RESNA WC Vol. 1 | Met (Complied with) |
| Substantial Equivalence to Predicate Device (Zhenjiang Assure Mechanical Wheelchair, model: A227, K112816) | Achieved (stated as "identical to and transferred from the predicate device" and "substantially equivalent") |
| Maximum Weight Bearing Capacity: 250 lbs/113.5 kgs | Device specifications state "250 lbs/113.5 kgs" (Same as predicate) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable in the context of this 510(k) submission. Performance testing refers to standardized tests on the device itself, not clinical testing with patient samples.
- Data Provenance: Not applicable. The "study" here refers to engineering and performance testing against international standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not applicable. Ground truth, in the sense of expert consensus on medical data, is not established for this type of device submission. The "ground truth" for compliance testing is defined by the parameters and methodologies outlined in the ISO and ANSI/RESNA standards.
- Qualifications of Experts: Not applicable. Testing would be performed by qualified personnel in test laboratories, but their qualifications are not detailed as expert medical opinion for ground truth.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. There is no ambiguous outcome from a test set requiring adjudication in this context. Results are measured against predefined standard thresholds.
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
- MRMC Study: No. This is a mechanical wheelchair, not an AI-powered diagnostic or assistive device.
- Effect Size of AI Improvement: Not applicable.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Performance: No. This is a mechanical device, not an algorithm.
7. The Type of Ground Truth Used
- Type of Ground Truth: The ground truth for this device's performance is established by engineering specifications and international consensus standards (ISO 7176 series and ANSI/RESNA WC vol. 1). Compliance with these standards is the "ground truth" for safety and basic effectiveness in a 510(k) context for a mechanical device.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This is not an AI/machine learning device.
9. How the Ground Truth for the Training Set was Established
- Ground Truth for Training Set Establishment: Not applicable.
Summary of Device Acceptance and Study:
The Valentine Steel Wheelchair, model 1000, meets its acceptance criteria by demonstrating compliance with a comprehensive set of ISO 7176 series standards and ANSI/RESNA WC vol. 1. The "study" proving this involves performance testing conducted by the manufacturer against the specific requirements and test methods outlined in these international standards. The submission also establishes equivalence to a previously cleared predicate device, the Zhenjiang Assure Mechanical Wheelchair, model: A227 (K112816), by noting that the subject device is actually "identical to and transferred from" the predicate device and has the same intended use and technological characteristics. This approach allows the device to be cleared under a 510(k) without the need for extensive new clinical trials, as established by the FDA's substantial equivalence pathway for Class I devices.
§ 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).