(38 days)
The FR168W Powered Wheelchair provides transportation for an elderly or disabled person. It can be used in a variety of indoor and outdoor settings.
The FR168W Powered Wheelchair is an indoor/outdoor powered wheelchair that is battery operated. The product has a base with six wheels, an adjustable seat with armrests, an adjustable footrest, and a controller attached to one armrest. The controller allows the rider to control the movement of the chair. The chair can be disassembled for transport and is provided with a battery charger.
The provided text is a 510(k) summary for the FR168W Powered Wheelchair. It describes the device, its intended use, and its substantial equivalence to a predicate device (Jazzy Power Chair).
However, the documentation explicitly states: "Comparative performance testing and clinical evaluations were not submitted as part of this 510(k)."
Therefore, based on the provided text, I cannot describe acceptance criteria or a study that proves the device meets specific acceptance criteria in the manner requested (i.e., with performance metrics, sample sizes, ground truth establishment, or expert involvement). The submission relies on establishing substantial equivalence to a legally marketed predicate device rather than presenting a performance study with detailed acceptance criteria and results.
Given the constraints of the provided document, here's an answer that states what is available and explains what is not available:
Acceptance Criteria and Device Performance Study (Based on Provided Document)
1. Table of Acceptance Criteria and Reported Device Performance:
The 510(k) summary for the FR168W Powered Wheelchair does not provide a table of specific quantitative acceptance criteria or reported device performance metrics from a formal study. The submission establishes substantial equivalence through a comparison of technological characteristics and intended use with a predicate device.
The "Testing conducted" section states: "Tests listed in the Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Mechanical and Powered Wheelchairs, and Motorized Three Wheeled Vehicles, July 1995, were conducted and the results included in the subject 510(k) submission." However, the specific acceptance criteria and results of these tests are not detailed in this public 510(k) summary.
2. Sample Size Used for the Test Set and Data Provenance:
No information is provided regarding a sample size for a test set, as comparative performance testing and clinical evaluations were not submitted as part of this 510(k). The submission focuses on demonstrating substantial equivalence to a predicate device.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
Not applicable. As no comparative performance or clinical evaluations were submitted, there was no ground truth to establish by experts in the context of device performance.
4. Adjudication Method for the Test Set:
Not applicable. No test set requiring expert adjudication was described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC study was performed or submitted. The document explicitly states: "Comparative performance testing and clinical evaluations were not submitted as part of this 510(k)." Therefore, there is no information on the effect size of human readers improving with or without AI assistance.
6. Standalone (Algorithm Only) Performance Study:
Not applicable. The device is a powered wheelchair; it does not involve algorithms or AI that would require a standalone performance study in the way this question implies for software or diagnostic devices.
7. Type of Ground Truth Used:
Not applicable. The submission for this traditional medical device (powered wheelchair) did not involve a "ground truth" in the context of expert consensus, pathology, or outcomes data for a diagnostic or AI-driven device. Substantial equivalence was demonstrated by comparing features and intended use to an existing predicate device.
8. Sample Size for the Training Set:
Not applicable. This device is a powered wheelchair, not an AI/ML algorithm that would require a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. This question is irrelevant for the type of device and submission described.
§ 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).