(49 days)
The indication for use of the Invacare® TDX® SP2-HD with Captain's Seat is to provide mobility and positioning to persons limited to a sitting position.
The subject device is an update to the existing previously cleared Invacare® TDX® SP2 Power Wheelchair (K170507) with LiNX Electronics and Ultra Low Maxx Seating System. The updated subject version of the Invacare® TDX® SP2 Power Wheelchair has the following changes:
- Increase in the weight capacity of the previously cleared device from 300 lb to 450 lb.
Invacare® TDX® SP2 Power Wheelchair is a battery-powered, motor-driven powered wheelchair, controlled by the LiNX® control system with enhanced suspension and additional back, arm and leg rest types. The subject device is a rigid or "non-folding" type power wheelchair base with center-wheel drive capability, two casters in the rear and two casters in the front. It is powered by two 12-volt DC batteries and two 4-pole single stage drive motors. No new accessories were added to the new device.
The provided text describes a 510(k) premarket notification for a powered wheelchair, the Invacare® TDX® SP2-HD with Captain's Seat. This document focuses on demonstrating substantial equivalence to a previously cleared predicate device (Invacare® TDX® SP2 Power Wheelchair, K170507), primarily by performing non-clinical testing to meet recognized consensus standards.
Here's an analysis of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document states that "The acceptance criteria for the full verification of the design and acceptance criteria for each section of the Rehabilitation Engineering and Assistive Technology Society of North America (RESNA) testing standard was met." However, it does not provide a specific table detailing the acceptance criteria for each test and the corresponding reported performance of the device.
It lists the following design characteristics and notes some differences compared to the predicate device, which could be interpreted as performance metrics:
| Description | Subject Device Invacare® TDX® SP2-HD with Captain's Seat | Predicate Device Invacare® TDX® SP2 Power Wheelchair | Met Acceptance Criteria (Implied) |
|---|---|---|---|
| Weight Capacity | 450lb. | 300lb. | Yes (improved) |
| Speed | 5mph | 5mph or 5.8mph | Yes |
| Range (GP24 Batteries) | > 20.7 miles | > 20.7 miles | Yes |
| Stopping Distance | 45.7" to 69.3" (depending on chair configuration) | 45.7" to 69.3" (depending on chair configuration) | Yes |
| Incline Capability | 9° | 9° | Yes |
| Ground Clearance | > 2.5" | > 2.5" | Yes |
| Obstacle Climbing (Forward) | 2.95" | 2.95" | Yes |
| Obstacle Climbing (Reverse) | 0.98" | 0.98" | Yes |
| Motor Gearbox Sound Level | 54dBa | 54dBa | Yes |
| Base Width | 25.5" | 24" or 25.5" (depending on battery type) | Yes |
| Turning Diameter | 50.4" to 65.4" (depending on seat configuration) | 50.4" to 65.4" (depending on seat configuration) | Yes |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "Design verification and validation testing was performed on the subject device," but it does not specify the sample size used for the test set. It describes non-clinical testing, implying a prospective testing approach on physical units of the device. There is no information provided about the country of origin of the data.
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 product is a powered wheelchair and the testing described is non-clinical, focusing on engineering and performance standards (RESNA). Therefore, the concept of "ground truth established by experts" in the context of medical image analysis or diagnostics does not apply to this type of device and study. The "ground truth" here is the defined performance parameters and limits specified by the RESNA standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As described in point 3, this is non-clinical performance testing against established engineering standards, so there is no expert adjudication process for ground truth.
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 device is a powered wheelchair; it is not an AI-assisted diagnostic tool or system that would involve human readers or a MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical product (a powered wheelchair), not an algorithm or AI system. The "standalone" performance here relates to the wheelchair's physical performance characteristics according to engineering standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" in this context is the performance requirements and limits specified by recognized consensus standards, specifically ANSI/RESNA WC-1 and WC-2 series. The device's performance was compared against these established engineering standards.
8. The sample size for the training set
Not applicable. This device is a physical powered wheelchair, not a machine learning or AI model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As described in point 8, there is no training set for a physical device like a powered wheelchair.
§ 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).