(10 days)
The device is a product which changes people position not only from sitting to standing and standing to sitting but also reclines and lifts the seat and back position. The product provides indoor and outdoor mobility.
The ALILIFE Stand Up Powered Wheelchair, HC-300 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) summary for the ALILIFE Stand Up Powered Wheelchair, HC-300. This document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed performance study with acceptance criteria and results in the way one might expect for an AI/CAD diagnostic device.
Therefore, many of the requested categories for describing an AI/CAD study are not applicable or cannot be extracted from this specific document.
Here's an attempt to answer the questions based only on the provided text, indicating where information is not available:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria in the format of a table with specific numerical targets or thresholds for performance metrics. Instead, it relies on demonstrating compliance with recognized standards and similarity to a predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance | Comments |
|---|---|---|
| Material Strength & Fatigue (Implied: Meet relevant standards) | "Mainframes materials of the two devices all meet the strength and fatigue tests" | No specific numerical performance metrics are given, only a qualitative statement of meeting tests. |
| EMC Compliance (e.g., CISPR 11:1990) | "EMC Report ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995. IEC61000-3-3: 1995" | Compliance is indicated by referencing an 'EMC Report' and relevant standards. No performance data (e.g., dB values) is provided. |
| Electrical Safety (Implied: UL certification) | "the two devices use the same supplier for battery and recharge which are all passed by the UL certificated." | Statement of UL certification for battery/recharge, no specific performance data. |
| Substantial Equivalence (Overall comparison to predicate) | "The new device is substantially equivalent to the predicate devices in this aspect." | This is the overarching "performance" claim for a 510(k). The detailed comparison highlights similarities and minor differences. |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This is not a study involving a test set of data (e.g., medical images) to evaluate an algorithm's diagnostic performance. The "testing" referred to is engineering and safety testing of the physical device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. There is no diagnostic "ground truth" establishment in this type of device submission.
4. Adjudication Method for the Test Set
Not applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. This is a submission for a physical medical device (powered wheelchair), not an AI/CAD system for diagnostic assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done
Not applicable.
7. The Type of Ground Truth Used
Not applicable in the context of diagnostic AI/CAD. The "ground truth" for this device would be its physical components meeting engineering specifications, safety standards, and functional requirements.
8. The Sample Size for the Training Set
Not applicable. There is no "training set" for an AI algorithm described in this document.
9. How the Ground Truth for the Training Set was Established
Not applicable.
§ 890.3900 Standup wheelchair.
(a)
Identification. A standup wheelchair is a device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. The device incorporates an external manually controlled mechanical system that is intended to raise a paraplegic to an upright position by means of an elevating seat.(b)
Classification. Class II (performance standards).