(27 days)
The ForU KV10HB powered wheelchair is motor driven, indoor and outdoor transportation vehicles with the intended use to provide mobility to disabled or elderly persons limited to a seated position.
The ForU powered wheelchair is an indoor/outdoor powered wheelchair that is battery operated. The design of this wheelchair is basically similar to other powered wheelchairs that are already on the market. But the ForU KV10HB is kind oh a new class of lightweight powered wheelchair. By providing a powered wheelchair that breaks down into two manageable components (seat frame, body frame with motors and battery pack), a user can have a more practical alternative when traveling long distances by bus, train, etc.
This document is a 510(k) premarket notification for the ForU KV10HB powered wheelchair, seeking substantial equivalence to a predicate device (CWD01, K062888). As such, it primarily focuses on comparing specifications to demonstrate equivalence rather than presenting an independent study with defined acceptance criteria and performance metrics for the ForU KV10HB in isolation.
Therefore, many of the requested elements regarding acceptance criteria, study details, and ground truth establishment are not directly applicable or explicitly stated in this type of regulatory submission. The goal here is to show similarity to an already approved device, not necessarily to prove independent performance against specific thresholds in a detailed clinical or technical study.
However, based on the provided text, I can extract information related to the comparison table and address the relevant questions.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria in a 510(k) submission are implicitly defined by the specifications of the predicate device. The applicant essentially claims that their device's performance is "substantially equivalent" to the predicate, meaning any differences do not raise new questions of safety or effectiveness. The table below presents the comparative data provided. An "acceptance criterion" column is added, reflecting the predicate's performance, and the "reported device performance" reflects the ForU KV10HB.
| Feature / Performance Metric | Acceptance Criterion (CWD01 K062888) | Reported Device Performance (ForU KV10HB) |
|---|---|---|
| Intended Use | Medical purposes to provide mobility to persons restricted to a sitting position. | Motor driven, indoor and outdoor transportation vehicles with the intended use to provide mobility to disabled or elderly persons limited to a seated position. |
| Maximum Loading | 136 kg (300 lbs) | 165 kg (350 lbs) |
| Overall Height | 1130 mm (44.5") | 1140 mm (44.9") |
| Overall Length | 900 mm (35.4") | 1032 mm (40.6") |
| Overall Width | 650 mm (25.6") | 644 mm (25.4") |
| Motor Output | 260W x DC24V × 2Pcs | DC 24V, 200 W, 2 Pcs |
| Controller | Dynamic Shark | PG VR2 |
| Battery | Lead-Acid 12V × 35AH × 2PCs | Gel/Seal Lead-Acid 12V × 50AH × 2PCs |
| Charger | DC 24V 5A, off-board | DC 24V 5 AMP (Automatic Type) on-board |
| Front/Rear Wheel | 6" pneumatic tire × 2 PCs | 6" Solid tire × 2 PCs |
| Middle Wheel | 10" PU foaming tire × 2 PCs | 12.8" Solid tire × 2 PCs |
| Armrest | Removable | Fixed |
| Break system | Intelligent regenerative electromagnetic brake | Braking distance |
| Forward: 0.9 m (35.4") at max speed | ||
| Net Weight (w/ batteries) | 83.5kg (183.7 lbs) | 98 kg (215.6 lbs) |
| Slope Grade Ability | 12 degree | 10 degree |
| Per-charge Distance | 40 km (24 miles) | Up to 37 km (23.1 miles) |
| Maximum Speed | 5 km/h (3.2 mph) | Up to 6.5 km/hr (4.1 mph), variable |
| Suspension | Cross brace | Front/Rear: No, Middle: Yes |
| Horn | Yes | (Not explicitly stated for ForU KV10HB in table, implying difference or absence) |
2. Sample Size Used for the Test Set and Data Provenance
This document describes a regulatory comparison for substantial equivalence, not a clinical trial or performance study with a "test set" of individuals or a defined dataset. The "data provenance" is the manufacturer's self-reported specifications for their device (ForU KV10HB) and specifications for the predicate device (CWD01) as understood from its 510(k) submission. Both devices are manufactured in Taiwan, suggesting the data originates from Taiwan. It is a comparison of device specifications, not retrospective or prospective patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Applicable to clinical studies, not product specification comparisons. No experts were explicitly mentioned as establishing "ground truth" for the comparative data presented. The "ground truth" here is the published specifications of the predicate device and the manufacturer's own specifications for their new device.
4. Adjudication Method for the Test Set
Not applicable. There was no "test set" in the sense of clinical cases or data requiring adjudication. The comparison is based on published and self-declared device specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This is a 510(k) submission for a physical medical device (powered wheelchair), not an AI or imaging device that would typically undergo an MRMC study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not an algorithm or AI device. The submission focuses on the physical and functional aspects of a powered wheelchair.
7. The Type of Ground Truth Used
The "ground truth" for this submission are the published design specifications and performance characteristics of the predicate device (CWD01) and the newly submitted device (ForU KV10HB). This includes physical dimensions, motor specifications, battery type, speed, range, and weight.
8. The Sample Size for the Training Set
Not applicable. There is no "training set" in the context of this 510(k) submission for a physical medical device. This is not a machine learning or AI algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable for the same reasons as 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).