(58 days)
The intended use of the X8 power wheelchair is to provide mobility to persons limited to a sitting position, who have the capability of operating a power wheelchair.
The Extreme 4x4- X8 is a battery powered, electric motor driven device with the intended function of providing mobility to persons limited to a sitting position, that have the capability of operating a powered wheelchair. It is a four-wheel drive format wheelchair as its basic configuration with direct drive motors on all four wheels. The wheelchair frame is a non-folding type. The frame of the unit is of welded steel construction. The wheelchair consists of the following basic components: frame w/four motors, joystick, seat, armrests, and footrests.
The provided text is a 510(k) summary for a power wheelchair (Extreme 4x4-X8). This document primarily focuses on demonstrating substantial equivalence to a predicate device through a comparison table and general declarations, rather than presenting a detailed study with acceptance criteria and performance data in the typical sense of a clinical or performance study for an AI/software medical device.
Therefore, many of the requested categories (e.g., sample size for test/training set, number of experts, adjudication methods, MRMC study, standalone performance) are not applicable to this type of submission. The device is a physical power wheelchair, not an AI/software device.
However, I can extract the closest information available from the text regarding "acceptance criteria" (interpreted as performance specifications for the device) and "device performance" (as reported in the comparison to the predicate).
Here's the information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
For this physical power wheelchair, "acceptance criteria" are implied by the performance characteristics of the predicate device (K000796, Extreme 4x4-X4) which the new device (Extreme 4x4-X8) aims to meet or exceed. The "reported device performance" refers to the specifications of the Extreme 4x4-X8.
| Performance Metric | Acceptance Criteria (Predicate Device K000796) | Reported Device Performance (Extreme 4x4-X8) |
|---|---|---|
| Type | Wheelchair, Power | Wheelchair, Power |
| Intended Use | To provide mobility to persons limited to a sitting position, who have the capability of operating a power wheelchair | To provide mobility to persons limited to a sitting position, who have the capability of operating a power wheelchair |
| Where Used | Designed to operate indoors and over a variety of outdoor surfaces including soft/rough terrain with inclines up to 1 in 14 | Designed to operate indoors and over a variety of outdoor surfaces including soft/rough terrain with inclines up to 1 in 14 |
| Design | Compact, rigid | Compact, with front frame articulation |
| Construction | Steel frame | Steel frame |
| Overall length | 43.3" | 45.25" |
| Overall width | 28" | 28" |
| Wheel Size | 4 x Ø14" | 4 x Ø14" |
| Rolling Base Weight (No Seat, No Batteries) | 159 lbs. | 145 lbs. |
| Range | 19 miles | 25 miles |
| Maximum Speed | 5 mph | 6.5 mph |
| Maximum Weight Capacity | 400 lbs | 400 lbs |
| Controller | Dynamic DX-PMB2 electronic control and joystick | Dynamic DX2-PMA70L electronic control and joystick |
| Motors | Four 24V, 4 pole direct drive motors/gearbox | Four 24V, 4 pole direct drive gear in line motors/gearbox |
| Suspension | None | None |
| Batteries | Two 73 Amp/hour | Two 73 Amp/hour |
| Seat Width | 16"-24" | 16"-24" |
| Seating | Upholstery meets California 117 specifications for fire retardancy | Upholstery meets California 117 specifications for fire retardancy |
| Footrest | 1 piece rigid footplate, flip up footplates and others | 1 or 2 piece, fixed or flip up, angle and height adjustable rigid footplates, and others |
| Armrest | Height adjustable, removable | Height adjustable, removable |
| Safety Features | Electromagnetic brake engaged when chair is stationary. When electromagnetic brakes are disengaged, chair cannot be driven. | Electromagnetic brake engaged when chair is stationary. When electromagnetic brakes are disengaged, chair cannot be driven. Drive is inhibited with some seat positioning functions. |
Study Proving Device Meets Acceptance Criteria:
The document describes the submission as a "510(k) Premarket Notification" for the Extreme 4x4-X8 power wheelchair. The "study" proving the device meets the acceptance criteria is implicitly the comparison to the legally marketed predicate device (Extreme 4x4-X4, K000796), as presented in the "Device Comparison Table" and the "Substantial Equivalence" section. The claim is that the X8 has the "same intended function and use as the X4" with "minor modifications" that improve performance (e.g., articulated frame, higher speed/torque motors, latest electronic software/hardware). The FDA's letter states they "determined the device is substantially equivalent...to legally marketed predicate devices." This substantial equivalence determination serves as the "proof" in the context of a 510(k) pathway for this type of device.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. This submission is for a physical medical device (power wheelchair), and the provided document does not detail a clinical "test set" or data provenance in the way one would for an AI/software device. The comparison is based on engineering specifications and design features.
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)
- Not applicable. There is no "ground truth" derived from expert consensus mentioned for a test set in this document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. There is no adjudication method mentioned.
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 not an AI/software device, and no MRMC study was performed or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI/software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. The "ground truth" equivalent in this context is the safety and effectiveness profile of the predicate device, established through its prior marketing clearance and compliance with performance standards typical for power wheelchairs. The new device demonstrates substantial equivalency to this established baseline.
8. The sample size for the training set
- Not applicable. This is not an AI/software device, and there is no concept of a "training set" in the provided documentation.
9. How the ground truth for the training set was established
- Not applicable. (See point 8).
§ 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).