(14 days)
The intended use of the Golden Spyder is to provide mobility to persons limited to a seated position that are capable of operating a powered wheelchair.
The intended use of the Golden Spyder is to provide mobility for those persons limited to a seated position that are capable of operating a simple hand control.
The Golden Spyder is a six wheeled battery powered wheelchair. It has a Dynamics Shark controller which is used to operate the Golden Spyder. The main frame of the wheelchair is made of welded steel construction. The main frame also consists of a battery box. The center drive wheels are mounted on the drive shafts of separate motor/gear assemblies, one on the left side of the wheelchair, the other on the right side. It would frame via a four-post mounting system. The seat connected, to the drive and near the center wheels to aid in traction. All seating Concentrates the ascrowing to the Golden Spyder comes standard with two easily removable 12-volt batteries and an on or off board charger. It has an operating range of 15-20 miles on a full charge. The weight capacity is 300-lbs and it has a maximum speed of 5-mph.
The provided text describes a 510(k) premarket notification for a powered wheelchair, the Golden Spyder. The primary purpose of this notification is to demonstrate substantial equivalence to a predicate device, not to present a study proving the device meets specific acceptance criteria based on clinical performance metrics typically associated with AI/software devices.
Therefore, many of the requested sections regarding AI device performance studies, ground truth establishment, sample sizes for training/test sets, expert adjudication, and MRMC studies are not applicable or cannot be extracted from this document, as this is a traditional medical device (a wheelchair) and not an AI-powered device being evaluated.
Here's an analysis of the information that is available in the document:
1. Table of Acceptance Criteria and Reported Device Performance
For a traditional medical device like a wheelchair, acceptance criteria are generally based on compliance with recognized consensus standards for safety and performance rather than clinical performance metrics (like sensitivity, specificity, etc.) typically found in AI/software evaluations.
| Acceptance Criteria (Standard / Test) | Reported Device Performance / Evaluation |
|---|---|
| ANSI/RESNA WC/01 1990 Determination of Static Stability Testing | Non-clinical testing performed, device found substantially equivalent. |
| ANSI/RESNA WC/02 1991 Determination of Dynamic Stability Testing | Non-clinical testing performed, device found substantially equivalent. |
| ANSI/RESNA WC/03 1990 Determination of the Effectiveness of brakes | Non-clinical testing performed, device found substantially equivalent. |
| ANSI/RESNA WC/05 1990 Determination of overall Dimensions, Mass, and Turning Space | Non-clinical testing performed, device found substantially equivalent. |
| ANSI/RESNA WC/10 1990 Determination of Obstacle Climbing Ability | Non-clinical testing performed, device found substantially equivalent. |
| ANSI/RESNA WC/Vol. 2-1998 Requirements and Test Methods for Electromagnetic Compatibility of Electric Powered Wheelchairs and Scooters. | Non-clinical testing performed, device found substantially equivalent. |
| Overall Acceptance Criterion: Substantial Equivalence to Predicate Device (Alante, K011153) | Demonstrated through similar intended use, technological characteristics, and non-clinical testing. Differences do not raise new questions of safety or effectiveness. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable. This refers to a physical device evaluated against standards, not a data-driven model.
- Data Provenance: Not applicable. The evaluation is of the physical wheelchair.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. Ground truth as typically understood for AI models is not relevant here. The "ground truth" for a wheelchair's performance is its direct measurement against engineering and safety standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable.
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, as this is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable, as this is not an AI/algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For this device, the "ground truth" is adherence to established engineering and safety standards (e.g., stability, braking effectiveness, EMC). There's no clinical "ground truth" in the sense of a diagnosis or outcome that an AI would predict.
8. The sample size for the training set
- Not applicable. This is not an AI device trained on data.
9. How the ground truth for the training set was established
- Not applicable.
§ 890.3860 Powered wheelchair.
(a)
Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class II (performance standards).