(344 days)
Panthera mechanical wheelchairs are manually operated multifunctional wheelchairs designed for indoor / outdoor use and intended to provide mobility to persons that have the capability of operating a mechanical wheelchair.
Panthera mechanical wheelchairs are of a spoke and hub design and made of chrome-molly steel to construct the chassis (frame and back rest), except for the X model which uses carbon fiber reinforced composite (CFRC) instead of chrome-molly steel. All Panthera mechanical wheelchairs have rubber tires, while the casters are of a semi-solid polymer-based design. The seat cushions and backs are made from flame retardant polyurethane coated polyester fabric, over a foam core. The primary differences in the models of wheelchairs are in their dimensions, gross weight carrying capacities, adjustability features, wheels, accessories and hardware options.
This document describes the Panthera AB mechanical wheelchairs (Bambino 3, S3, S3 Swing, U3, U3 Light, and X) and their substantial equivalence to predicate devices (Bambino, S2, S2 Swing, U2, and U2 Light).
The following information addresses the acceptance criteria and the study that proves the device meets the acceptance criteria.
1. A table of acceptance criteria and the reported device performance
The acceptance criteria for the Panthera mechanical wheelchairs are based on various ISO and EN standards related to the safety and performance of wheelchairs and biocompatibility. The reported device performance indicates that the design inputs and performance specifications for the modified subject devices have been met.
| Standard/Test Category | Acceptance Criteria (based on standard requirements) | Reported Device Performance |
|---|---|---|
| Biocompatibility | ISO 10993-1 | Met |
| Cytotoxicity | ISO 10993-5 | Met |
| Chemical Characterization | ISO 10993-18 | Met |
| Toxicological Risk Assessment | ISO 10993-17 | Met |
| Wheelchair Performance Testing | EN 12183 (Manual Wheelchairs. Requirements and Test Methods), which includes: | Met |
| - Static Stability | ISO 7176-1 | Met |
| - Brakes | ISO 7176-3 | Met |
| - Static, Impact, Fatigue Strengths | ISO 7176-8 | Met |
| - Test Dummies | ISO 7176-11 | Met |
| - Information, Documentation, Labeling | ISO 7176-15 | Met |
| - Crash | ISO 7176-19 | Met |
| - Set-up Procedures | ISO 7176-22 | Met |
| Resistance to Ignition of Postural Support Devices | ISO 7176-16 | Met |
| Dimensional Verification | Panthera internal specifications | Met |
| Risk Analysis | ISO 14971 | Met |
| Quality System Regulation | 21 CFR Part 820 (including Design Controls) | Met |
| Labeling | 21 CFR Part 801 | Met |
| Unique Device Identification | 21 CFR Part 830 | Met |
| FDA Guidance Document for Premarket Notification [510(k)] Applications for Mechanical and Powered Wheelchairs, and Motorized Three-Wheeled Vehicles | Compliance | Met |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample sizes for the individual non-clinical tests. However, it indicates that "Panthera submitted their devices for the following non-clinical tests," implying that the tests were performed on the subject devices. The provenance of the data is from Panthera AB, a Swedish company, but the testing would have been conducted by certified labs to the specified international standards. These tests are prospective in nature, as they involve testing the actual devices to verify their compliance with the standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This section is not applicable to the provided document. The device in question is a mechanical wheelchair, and the performance evaluation relies on non-clinical, objective engineering and safety standards (e.g., strength, stability, biocompatibility). It does not involve expert interpretation or subjective assessment typically seen in medical imaging or diagnostic devices where "ground truth" is established by experts. The "ground truth" here is the adherence to established international and national standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving expert review of subjective data to resolve disagreements. The non-clinical performance testing of a mechanical wheelchair against objective engineering standards does not involve such 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
This is not applicable. The device is a mechanical wheelchair and does not involve AI assistance or human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a mechanical wheelchair and does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For this device, the "ground truth" for performance is established by universally recognized and validated international and national standards for medical devices, specifically mechanical wheelchairs, and biocompatibility. This includes:
- ISO and EN Standards: Such as ISO 10993 series (biocompatibility), EN 12183, and ISO 7176 series (wheelchair performance).
- Regulatory Compliance: Adherence to FDA regulations like 21 CFR Part 820 (Quality System Regulation), 21 CFR Part 801 (Labeling), and 21 CFR Part 830 (Unique Device Identification).
- Manufacturer's Internal Specifications: For dimensional verification.
These standards define objective, measurable criteria that the device must meet to ensure safety and effectiveness.
8. The sample size for the training set
This is not applicable. There is no "training set" in the context of non-clinical performance testing for a mechanical wheelchair. The device's compliance is assessed against predefined engineering and safety standards.
9. How the ground truth for the training set was established
This is not applicable, as there is no training set for this type of device evaluation.
§ 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).