(34 days)
The intended use of the Vari-Able, APB (Adaptable Positioning Base) mechanical wheelchair is to provide mobility to persons with a primary pediatric indication who are limited to a sitting position.
The Vari-Able, APB (Adaptable Positioning Base) is a manually operated, attendant controlled, manual, mechanical wheelchair and patient positioning system. It is designed to provide mobility and optimized positioning for patients who require long term accommodation due to conditions of severe physical motion restriction. Patients with diagnosis such as cerebal palsy, would typically benefit from the use of the Vari-Able, APB (Adaptable Positioning Base).
The product consists of a steel/aluminum frame, rear wheels (which can be substituted based on patient requirements), a seat pail, from with adjustments for seating configuration, and manual brakes, anti-tip wheels, footrests, and other components such as head and trunk support, and other components as needed. The APB will accommodate the positioning and seating systems currently available in the market.
The product is capable of many configurations of the frame, wheels, and components to accommodate patients with difficult to solve positioning requirements. Using the manual adjustments that can be made to the frame, the angle of the chair may be changed to accommodate the patient's needs.
The Vari-Able APB (Adaptable Positioning Base) also features weight shifting capabilities using manual tilt-in-space and recline features. This also can assist in positioning and feeding.
The product is designed to function indoors or outdoors on surfaces such as sidewalks and other public places.
The provided text describes a 510(k) summary for the Degage's Vari-Able APB Manual Wheelchair. Based on the content, here's a breakdown of the requested information, focusing on what is present and explicitly stating what is not available in this document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence with Predicate Device (Labac MTC (K921136)) in materials, construction, configuration, indications, and use. | The Vari-Able APB and the Labac MTC were tested using a methodology based on ANS/RESNA WC-1:1998, Volume 1-1776 - Requirements and Test Methods for Wheelchairs (Including Wheelchair Seating). Tests for backward, forward, sideways, posterior, and anterior stability indicate the two devices are substantially equivalent. |
2. Sample Size Used for the Test Set and Data Provenance
The document states that the "Vari-Able APB and the Labac MTC were tested," but it does not specify the sample size for the test set (e.g., number of wheelchairs, number of subjects).
The data provenance is not explicitly stated (e.g., country of origin of the data, retrospective or prospective). It can be inferred that the testing was likely conducted in the US by the submitter, given the FDA submission, but this is not definitively stated.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
There is no mention of experts being used to establish ground truth for this type of device (a mechanical wheelchair). The performance data refers to stability tests based on a recognized standard (ANS/RESNA WC-1:1998). "Ground truth" in this context would likely be objective measurements of physical properties against the standard, not expert consensus.
4. Adjudication Method for the Test Set
This is not applicable as there is no mention of expert consensus or subjective assessments that would require an adjudication method. Performance was assessed via objective stability tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No MRMC comparative effectiveness study was done or mentioned. This type of study is typically for diagnostic imaging or similar devices where reader interpretation is a key component.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable as the device is a mechanical wheelchair, not an algorithm or AI system. Its performance is inherent in its physical design and construction.
7. The Type of Ground Truth Used
For the performance data, the "ground truth" seems to be the objective measurements of stability as defined by the ANS/RESNA WC-1:1998 standard. There is no mention of pathology, expert consensus, or outcomes data used as ground truth for verifying the device's performance in this context.
8. The Sample Size for the Training Set
This is not applicable as the device is a mechanical wheelchair and does not involve a "training set" in the context of an AI or machine learning model.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reasons as #8.
§ 890.3850 Mechanical wheelchair.
(a)
Identification. A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class I (general controls).