(40 days)
OUR ELITE LIGHTWEIGHT WHEELCHAIR IS A MBCHANICAL DEVICE THAT TRANSPORT OCCUPANTS WHO ARE INMOBILE FROM ONE LOCATION TO ANOTHER. IN ORDER FOR ONE TO OPERATE THIS DEVICE AN ASSISTANT CAN PUSH THE WHEELCHAIR FROM BEHIND USING THE HANDLE BARS OR IF THE OCCUPANT HAS FUNCTION OF HIS/HER UPPER DORSO THEY CAN WHEEL THENSELVES AROUND BY USING THE HANDRIMS THAT IS ATTACHED TO THE WHEELS.
The frame of our Elite wheelchair is made from a high strength tensile steel called chromaly which is 28% lighter then the usual standard chrome-plated frame wheelchairs. The frame of the wheelchair is coated with a durable powder coated finish of blue, burgandy or black. It is a rigid frame that comes in two different arm styles: Fixed Full Length or Removable Wrap-Around Desk Length. Both arm styles comes with padded arms. The 24" wheels can be spoke aluminum rear wheels with pneumatic tires or mag wheels with hard rubber tires. Seat width on the wheelchair is either 18" or 16". The seat material is nylon spill proof upholstery. The rigging on the wheelchair is Cam-Action Swing Away Detachable Footrests or Detachable Elevating Legrests with calf pads that are padded for more comfort. Footplates are of aluminum material.
Dimension :
Overall Length without rigging: 31" Overall Width (opened): Between 25"-26" Overall Width (closed): Between 10.5"-11.5" Gross Weight without rigging: Between 29-30.5 Ibs
Since this wheelchair is non-powered there are two ways to propel the device, 1) is to have an assistant push the wheelchair from the back where the hand grips are or 2)if the occupant has mobility with their upper half of the torso he or she can use their arms on the handrims that are attached to the 24" wheel to self-propel themselves. The wheelchair is fully assembled and is packaged in a closed position in the wheelchair box. The only assembly required is the Rigging.
The provided text describes the 510(k) summary for the Elite Lightweight Wheelchair. Here's a breakdown of the acceptance criteria and the study information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily demonstrated by showing material properties and performance characteristics that are comparable to or exceed those of the predicate device (Everest and Jennings Lightning Wheelchair / Premier 2), and compliance with specific external standards for upholstery.
| Acceptance Criterion | Reported Device Performance (Elite Lightweight Wheelchair) |
|---|---|
| Material Frame (Chromaly) Chemical Compositions | Chromium 0.85%-1.25%, Carbon 0.12% - 0.18%, Magnesium 0.55% - 0.90%, Phosphorus 0.30%, Sulfur 0.30%, Silicon 0.15% - 0.35%, Molybdenum 0.15% - 0.35%. |
| Material Strength (Tube Size: 22.2mm * 1.0mm) | Outside Diameter: 22.16mm - 22.17mm |
| Tube Thickness: 1.01mm - 1.03mm | |
| Tube Straightness: .07mm - .12mm | |
| Hardness: 80.5mm - 80.0mm | |
| Elongation: 35mm - 36mm | |
| Tension Strength: 56.3mm - 56.8mm | |
| Yield Strength: 33.3mm - 33.0mm | |
| Eddy Current Test | Completed on the material (presumably passed). |
| Upholstery Material Flame Retardancy | Complies with California Technical Bulletin 117 (Section A, Part I and Section D, Part II). |
| 24" Rear Wheels (Nylon 80%, Fiber 20% plastic rims) Properties: | Ash Content: 20.4% |
| Izod Impact Strength (Notch, 23deg C): KG-CM/CM (Value not explicitly stated, but implies measurement) | |
| Tensile Strength at Break: KG/cm2 (Value not explicitly stated) | |
| Flexural Strength: KG/cm2 (Value not explicitly stated) | |
| Flexural Modulus: KG/cm2 (Value not explicitly stated) | |
| 8" Front Casters (High Impact P.P. rim, Thermoplastic Elastomers tire) Properties: | Flow Rate: 5 g/10min (ASTM D-1238) |
| Density: 0.892 g/cm3 (ASTM D-792) | |
| Tensile Strength at Break: 268 kg/cm3 (ASTM D-638) | |
| Elongation: 9.8% (ASTM D-638) | |
| Temperature of Deform: 83 deg C 4.6 kg/cm (ASTM D-648) | |
| Izod Impact Strength (23 deg C Notch): 9.5 kg-cm/cm (ASTM D-256) | |
| Maximum Weight Bearing Capacity | 250 lbs |
| Functionality | Transport occupants who are immobile; can be propelled by an assistant or self-propelled by the occupant. |
| Travel Surface | Can travel on any hard surfaces such as carpet, tile or concrete flooring. |
| Equivalence to Predicate Device | Demonstrated through comparison chart (Appendix II) showing overall features of Elite vs. Lightning. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a sample size in terms of a "test set" for a clinical study comparing the Elite Lightweight Wheelchair to the predicate device. The performance data presented are primarily from material strength tests and individual component tests (e.g., steel tube properties, upholstery flame retardancy, wheel/caster material properties).
- Test Set: Not applicable in the context of a typical software or AI device study. The "tests" are for material and component characteristics.
- Data Provenance: The material strength tests and Eddy Current test are performed on the steel material itself. The upholstery test was performed by SGS, presumably in compliance with California Technical Bulletin 117. Wheel material tests also cite specific ASTM standards, implying laboratory testing of the materials. There is no indication of country of origin for these tests, nor if they were retrospective or prospective, though material property tests are inherently prospective in nature (i.e., new materials are tested).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable. This is a submission for a mechanical device (wheelchair), not for an AI / software device that requires expert-established ground truth for diagnostic accuracy. The "ground truth" for the wheelchair is its physical properties and functionality as measured by engineering standards.
4. Adjudication Method for the Test Set
Not applicable. As described above, this is not a study assessing diagnostic accuracy requiring expert adjudication.
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
Not applicable. This is a submission for a mechanical device; an MRMC comparative effectiveness study is relevant for AI-assisted diagnostic tools, not wheelchairs.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a submission for a mechanical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device is established through:
- Engineering Specifications and Material Properties: Chemical compositions, dimensions, hardness, strength, density, etc., measured against established standards.
- Compliance with Industry Standards: Upholstery tested according to California Technical Bulletin 117, wheel/caster properties tested against ASTM standards (D-256, D-638, D-790, D-1238, D-792, D-648).
- Functional Equivalence: Comparison to a legally marketed predicate device (Everest and Jennings Lightning Wheelchair / Premier 2) through a comparison chart of features and intended use.
- Weight Bearing Capacity: A specific quantifiable performance metric.
8. The Sample Size for the Training Set
Not applicable. This is a mechanical device, not an AI/ML algorithm requiring a training set. Engineering design and material selection are based on established principles and supplier data, not machine learning training.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for a mechanical device in this context.
§ 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).