(56 days)
The Frontier Series Power Wheelchairs are battery-operated devices with wheels that are intended for medical purposes to provide mobility to persons restricted to a sitting position who have the capability of operating a power wheelchair.
The Frontier Series Power Wheelchairs have four configurations: V4 RWD, V4 FWD, V6, and C73. The Frontier Series Power Wheelchairs are designed for everyday use for both indoor and outdoor environments including care facilities and private residences. The subject devices are intended to provide mobility to persons who are restricted or limited to a sitting position. The Frontier Series Power Wheelchairs are battery powered, electric motor driven devices that can be used on both indoor and outdoor surfaces (i.e., concrete, asphalt, indoor flooring such as carpet, gravel, grass, and bark/woodchips).
This is a 510(k) premarket notification for the "Frontier Series Power Wheelchairs". This document is a submission to the FDA to demonstrate that the new device is "substantially equivalent" to already legally marketed predicate devices. Therefore, the "acceptance criteria" here refers to the performance of the device relative to established standards and the predicate devices, rather than strict statistical thresholds for an AI algorithm.
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are established by adherence to recognized international standards and comparison to predicate devices, showing that any differences do not affect safety or effectiveness. The reported device performance is demonstrated by meeting these standards and having similar or identical characteristics to the predicate devices.
| Acceptance Criteria / Performance Metric | Reported Device Performance / Evaluation |
|---|---|
| Indications for Use (Substantial Equivalence) | The Frontier Series Power Wheelchairs are battery-operated devices with wheels that are intended for medical purposes to provide mobility to persons restricted to a sitting position who have the capability of operating a power wheelchair. This is described as "Substantially equivalent to predicate devices." |
| Product Codes / Regulation Number (Substantial Equivalence) | ITI / 21 CFR 890.3860. Described as "Identical to the primary predicate. No impact on safety and effectiveness." |
| Regulation Description (Substantial Equivalence) | Powered Wheelchair. Described as "Identical to the primary predicate. No impact on safety and effectiveness." |
| Maximum User Weight (Substantial Equivalence) | Frontier V4 FWD: 400 lbs, Frontier V4 RWD: 400 lbs, Frontier V6: 400 lbs, Frontier V6 C73: 400 lbs. Described as "Identical to the primary predicate. No impact on safety and effectiveness." (Primary predicate K030783 also 400 lbs). |
| Storage Temperature (Substantial Equivalence) | -40 to 70 °C. Described as "Identical to the primary predicate. No impact on safety and effectiveness." (Primary predicate K030783 also -40 to 70 °C). |
| Location for Use (Substantial Equivalence) | Indoors and outdoors including care facilities, and residences. Described as "Identical to the primary predicate. No impact on safety and effectiveness." |
| Frame Material (Substantial Equivalence) | Steel. Described as "Identical to the primary predicate." (Primary predicate K030783 also Steel). |
| Base Overall Dimensions (Substantial Equivalence) | Varied across models (e.g., Frontier V4 FWD AT tires: 39.2 x 28 inches). Described as "Substantially equivalent to the predicate and reference devices. No impact on safety and effectiveness." |
| Rolling Base Weight (Substantial Equivalence) | 260 lbs (with batteries). Described as "Substantially equivalent to the predicate device. No impact on safety and effectiveness." (Primary predicate K030783: 130 lbs; K142457: 152 lbs) - Note: While a difference exists, the claim is "No impact on safety and effectiveness.". |
| Power Source (Substantial Equivalence) | Batteries. Described as "Identical to the primary predicate. No impact on safety and effectiveness." |
| Battery Details (Substantial Equivalence) | Two (2) 73 Ahr. Described as "Identical to the primary predicate. No impact on safety and effectiveness." (Reference device K172384: 24V (2x12V)/73 Ah/20h). |
| Castor Wheel Size (Substantial Equivalence) | 8.25 x 2.5 inches. Described as "Identical to the primary predicate. No impact on safety and effectiveness." (Predicate K030783 and K142457 listed as 'Unknown'). |
| Range (Substantial Equivalence) | 15-20 miles. Described as "Identical to the primary predicate. No impact on safety and effectiveness." (Predicate K030783 and K142457 listed as 'Unknown'). |
| Anti-pitch Mechanism for Climbing (Substantial Equivalence) | None. Described as "Identical to the primary predicate. No impact on safety and effectiveness." (Predicates K030783 and K142457: "Additional anti-pitch lock out"). Note: This is a stated difference with the predicate, but claimed "No impact on safety and effectiveness.". |
| Lift Range (Substantial Equivalence) | 0-12 inches. Described as "Identical to the primary predicate. No impact on safety and effectiveness." |
| Tilt Range (Substantial Equivalence) | 0-50 degrees. Described as "Identical to the primary predicate. No impact on safety and effectiveness." |
| Recline Range (Substantial Equivalence) | 0-170 degrees. Described as "Identical to the primary predicate. No impact on safety and effectiveness." (Reference device K172384: 0-172 degrees - Note: claimed identical despite slight difference). |
| Suspension (Substantial Equivalence) | Independent drive wheel suspension with shock absorber on pivoting swing arm and articulated castors to ensure all wheels maintain adhesion at all surface angles. Described as "Identical to the primary predicate. No impact on safety and effectiveness." |
| Maximum Speed (Substantial Equivalence) | 6 mph. Described as "Identical to the primary predicate. No impact on safety and effectiveness." (Reference device K172384: 6 mph (with an option of 8)). |
| Minimum Braking Distance at Maximum Speed (Substantial Equivalence) | 1.8 meters. Described as "Identical to the primary predicate. No impact on safety and effectiveness." (Predicate K030783 and K142457 listed as 'Unknown'). |
| User Controller (Substantial Equivalence) | Joystick and hand control buttons. Described as "Identical to the primary predicate. No impact on safety and effectiveness." |
| Joystick Mount (Substantial Equivalence) | Joystick and hand control buttons (implies variable, but then states Fixed mount, height adjustable, swing-away). Described as "Identical to the predicate and reference devices. No impact on safety and effectiveness." |
| Software (Substantial Equivalence) | R-Net from PGDT. Described as "Identical to the primary predicate. No impact on safety and effectiveness." (Primary predicate K030783 uses VR2 from PGDT; Reference device K172384 uses R-Net from PGDT). Note: This is a stated difference with the primary predicate, but claimed "No impact on safety and effectiveness" due to similarity to the reference device. |
| Seat Height (minimum, inches) (Substantial Equivalence) | 17.1 inches. Described as "Identical to the primary predicate. No impact on safety and effectiveness." (Primary predicate K030783: 16.2 inches). Note: claimed identical despite slight difference. |
| Seat Width (inches) (Substantial Equivalence) | 16-24 inches. Described as "Identical to the primary predicate. No impact on safety and effectiveness." (Primary predicate K030783: 12-24 inches). |
| Armrest (Substantial Equivalence) | Height adjustable, removable, flip up option. Described as "Identical to the primary predicate. No impact on safety and effectiveness." (Predicate K030783 and K142457 listed as 'Unknown'). |
| Footrest (Substantial Equivalence) | Rigid footplate, flip up nylon. Described as "Identical to the primary predicate. No impact on safety and effectiveness." (Predicate K030783 and K142457 listed as 'Unknown'). |
| Static stability (per ISO 7176-1) | Performed. Results indicated substantial equivalence. |
| Dynamic stability (per ISO 7176-2) | Performed. Results indicated substantial equivalence. |
| Effectiveness of brakes (per ISO 7176-3) | Performed. Results indicated substantial equivalence. |
| Energy consumption (per ISO 7176-4) | Performed. Results indicated substantial equivalence. |
| Dimensions, mass, and maneuvering space (per ISO 7176-5) | Performed. Results indicated substantial equivalence. |
| Maximum speed, acceleration, and deceleration (per ISO 7176-6) | Performed. Results indicated substantial equivalence. |
| Measurement of seat and wheel dimensions (per ISO 7176-7) | Performed. Results indicated substantial equivalence. |
| Static, impact, and fatigue (per ISO 7176-8) | Performed. Results indicated substantial equivalence. |
| Climatic test (per ISO 7176-9) | Performed. Results indicated substantial equivalence. |
| Obstacle climbing (per ISO 7176-10) | Performed. Results indicated substantial equivalence. |
| Test dummies (per ISO 7176-11) | Performed. Results indicated substantial equivalence. |
| Power and control systems for power wheelchairs (per ISO 7176-14) | Performed. Results indicated substantial equivalence. |
| Documentation and labeling (per ISO 7176-15) | Performed. Results indicated substantial equivalence. |
| Resistance to ignition (per ISO 7176-16) | Performed. Results indicated substantial equivalence. |
| Dynamic Test (per ISO 71716-19) | Performed. Results indicated substantial equivalence. |
| Vocabulary (per ISO 7176-26) | Performed. Results indicated substantial equivalence. |
| EMC testing (per ISO 7176-21) | Performed. Results indicated substantial equivalence. |
| Batteries and chargers per (per ISO 7176-25) | Performed. Results indicated substantial equivalence. |
| Biocompatibility (per ISO 10993-1 and ISO 10993-5) | Uses materials identical in composition, formulation processing, sterilization, and geometry to predicate devices. Same nature of tissue contact and duration. Also, "in vitro cytotoxicity (per ISO 10993-5)" was performed. Considered to have met requirements. |
| Software life cycle process (per IEC 62304) | Performed. Results indicated substantial equivalence. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This submission describes non-clinical performance and engineering testing on the device prototypes, not a clinical study on human subjects with a test set of data in the traditional sense of an AI/imaging device. The "test set" would be the physical Frontier Series Power Wheelchairs themselves, subjected to various standardized tests. No specific numerical sample size (e.g., how many wheelchairs were tested for each test) is provided in the document, other than implying the testing of "the subject devices." The provenance is manufacturing in Australia. The testing is presumably prospective for the purpose of this 510(k) submission.
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 is not applicable to this type of device submission. Ground truth, in the context of this 510(k), refers to the established standards (e.g., ISO 7176 series, ISO 10993 series, IEC 62304) and the performance characteristics of the predicate devices. The "experts" are the creators of these standards, and the engineers/testers who conduct measurements and compare the device's performance against these benchmarks and the predicate devices' specifications. No specific number or qualifications of such 'experts' are provided in this document beyond the general statement of "testing performed."
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. The evaluation is based on objective measurements against engineering standards and comparison of technical specifications to predicate devices, not subjective assessments requiring adjudication by multiple readers.
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 as the device is a power wheelchair, not an AI-assisted diagnostic or therapeutic tool that involves human readers or interpretation of medical cases.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This is a physical medical device (power wheelchair), not an algorithm or AI system.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for this submission is established by:
- International Standards: Complying with numerous ISO and IEC standards for wheelchairs (e.g., ISO 7176-1 for static stability, ISO 10993-1 for biocompatibility, IEC 62304 for software life cycle).
- Predicate Device Performance: Demonstrating that the subject device's technological characteristics and performance are similar or identical to legally marketed predicate devices, or that any differences do not raise new questions of safety or effectiveness.
8. The sample size for the training set
This is not applicable as the device is a physical power wheelchair, not an AI algorithm trained on a dataset. The design and manufacturing process would involve engineering iterations and testing, but not a "training set" in the context of machine learning.
9. How the ground truth for the training set was established
Not applicable. As described above, this is about adherence to engineering standards and comparison to predicate devices, not machine learning ground truth.
§ 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).