(26 days)
Motorized five-wheeled battery powered scooter intended for medical purposes by disabled persons and other non-medical purposes.
The Fusion is an indoor/outdoor scooter that is battery operated. Fusic standard technology seating, thumb operated throttle, digital controller rarger, motor, brake, transaxle, frame material and till we have used for years on our - - Saver units. The Fusion frame separates for transport and has removable batteries anc تحتوب Accessories include a front light and a basket.
The provided text describes a 510(k) premarket notification for a medical device called "Fusion" (later referred to as PaceSaver Fusion), a 3-wheel power scooter.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state "acceptance criteria" in a numerical or pass/fail threshold format for performance metrics. Instead, it refers to compliance with applicable Testing Standards. The reported device performance is that the Fusion "passed the necessary testing to recognized consensus standards."
| Acceptance Criteria (Standards Met) | Reported Device Performance |
|---|---|
| ANSI/RESNA WC/01 Determination of Static Stability | Passed necessary testing |
| ANSI/RESNA WC/02 Determination of Dynamic Stability | Passed necessary testing |
| ANSI/RESNA WC/03 Effectiveness of Brakes | Passed necessary testing |
| ANSI/RESNA WC/04 Determination of Energy Consumption - Theoretical Range | Passed necessary testing |
| ANSI/RESNA WC/05 Overall Dimensions, Mass, and Turning Space | Passed necessary testing |
| ANSI/RESNA WC/06 Determination of Maximum Speed, Acceleration, and Retardation of Electric Wheelchairs | Passed necessary testing |
| ANSI/RESNA WC/08 Test Methods for Static, Impact, and Fatigue Strengths | Passed necessary testing |
| ANSI/RESNA WC/09 Climatic Tests | Passed necessary testing |
| ANSI/RESNA WC/10 Obstacle Climbing | Passed necessary testing |
| ANSI/RESNA WC/15 Documentation and Labeling | Passed necessary testing |
| ANSI/RESNA WC/93 Maximum Overall Dimensions | Passed necessary testing |
The document implies that meeting these standards constitutes the acceptance criteria.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not specify a separate "test set" or its sample size. The testing refers to the device (Fusion) itself being subjected to the standards listed. It does not involve a cohort of subjects or data collection in the way a clinical study would.
- Data Provenance: Not applicable in the traditional sense of retrospective or prospective human clinical data. The data provenance would be from the engineering and product testing performed on the device by Burke, Inc.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. The ground truth for the device's performance is established by its compliance with the specified ANSI/RESNA standards, which define objective measurement methods and pass/fail criteria. It does not rely on expert consensus for interpreting results.
4. Adjudication Method for the Test Set:
Not applicable. There's no mention of an adjudication process as there would be in a study involving human interpretation. The testing is based on objective measurements against engineering standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not performed. The document explicitly states: "Clinical testing is not appropriate and not required for the proposed device. Clinical testing was not performed." Therefore, there is no effect size of human reader improvement with or without AI assistance as AI is not part of this device.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a physical power scooter, not an algorithm or a software-as-a-medical-device (SaMD). There is no "algorithm only" performance to evaluate.
7. The Type of Ground Truth Used:
The ground truth used is compliance with recognized consensus standards (ANSI/RESNA WC series). These standards provide objective criteria and methodologies for evaluating the mechanical and performance characteristics of power wheelchairs and scooters.
8. The Sample Size for the Training Set:
Not applicable. There is no mention of a "training set" as this is not an AI/ML device requiring training data. The testing involves the physical device itself.
9. How the Ground Truth for the Training Set was Established:
Not applicable, as there is no training set for this device.
§ 890.3800 Motorized three-wheeled vehicle.
(a)
Identification. A motorized three-wheeled vehicle is a gasoline-fueled or battery-powered device intended for medical purposes that is used for outside transportation by disabled persons.(b)
Classification. Class II (performance standards).