(28 days)
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
The Middle Wheel Drive Power Chair, CWD01 is an indoor / outdoor Powered Wheelchair that is battery operated. It has a base with four-wheeled with a seat. The movement of the Wheelchair is controlled by the rider who uses hand controls located at the top of the steering column. The device can be disassembled for transport and is provided with an onboard battery charger.
The provided text describes a 510(k) premarket notification for a powered wheelchair, the Middle Wheel Drive Power Chair, CWD01. The submission focuses on demonstrating substantial equivalence to a predicate device (EPW POWERED WHEELCHAIR GP-201, K023148) rather than presenting a study to prove the device meets specific acceptance criteria.
Therefore, many of the requested details about acceptance criteria, specific device performance, sample sizes, ground truth establishment, expert adjudication, and comparative effectiveness studies are not present in this document, as they are typically associated with performance studies for novel devices or when demonstrating clinical superiority/non-inferiority.
Based on the provided information, here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in the traditional sense of a performance study. Instead, it compares the subject device's specifications to those of a predicate device to demonstrate substantial equivalence. The "performance testing" mentioned refers to compliance with safety and electrical standards, not specific clinical performance metrics.
| ITEM | Subject Device (CWD01) | Predicate Device (GP-201) | Comments |
|---|---|---|---|
| Intended Use | Same | Provide mobility to persons restricted to a sitting position | Claimed to be the same. |
| Overall length | 90 cm / 35.4" | 38" | Similar, minor dimensional difference. |
| Overall width | 65 cm / 25.6" | 24" | Similar, minor dimensional difference. |
| Overall Height | 113 cm / 44.5" | 18" from seat | Not directly comparable due to different measurement points, but overall dimensions are considered similar. |
| Weight limit | 136 kgs / 300 lbs | 350 lbs | Subject device has a lower weight limit. |
| Maximum speed | 5 km/hr (3.2 mph) | 5.0 mph | Subject device is slower; considered acceptable as slower speed does not raise new safety concerns. |
| Electronics | Dynamic Shark controller | Dynamic DL controller | Different controller types from the same supplier ("Dynamic"). Claimed to be substantially equivalent. |
| Batteries Type | U1, 35Ah gel cell 12VDC | U1, 30Ah gel cell 12VDC | Similar U1 type, subject device has slightly higher Ah. |
| Range per charge | 24 miles (40 km) | 22 miles | Similar, subject device has slightly higher range due to battery difference. |
| Recharger | SAME | 24 VDC (UL 1310 certified) | Same resource, certified by UL 1310. |
| Incline | 12 degree | 6 degrees | Subject device handles a steeper incline. |
| Other Standards | ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995 | Not explicitly stated but assumed to meet relevant standards for a predicate. | Compliance with these standards indicates meeting safety and performance aspects for powered wheelchairs. |
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 is a 510(k) submission based on substantial equivalence to a predicate device, not a performance study involving a patient test set. The "performance testing" refers to engineering and safety standard compliance, not clinical data from patients.
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 was no clinical test set for which ground truth needed to be established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There was no clinical test set requiring 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
Not applicable. This device is a powered wheelchair and does not involve AI or human readers for interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a powered wheelchair, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. There was no clinical test set requiring ground truth. The "ground truth" here is compliance with established engineering and safety standards for powered wheelchairs.
8. The sample size for the training set
Not applicable. There was no training set for an algorithm.
9. How the ground truth for the training set was established
Not applicable. There was no training set. The "ground truth" for the device's design and manufacturing is adherence to regulatory and industry standards for safety and performance of powered wheelchairs.
§ 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).