(118 days)
The standard IKON 40 is a manual wheelchair device that is intended to be used to provide mobility to persons ages 12 and over (adolescents and adults) with a weight capacity of 300 lbs. The device is to be used as a means of mobility for persons limited to a sitting position.
The IKON 40 is a foldable, ultra-lightweight and fully adjustable manual wheelchair.
This document is a 510(k) Premarket Notification from the FDA for a manual wheelchair (IKON 40). It details the device's characteristics and compares it to a predicate device to establish substantial equivalence.
Based on the provided text, the device in question is a manual wheelchair, not an AI/imaging device. Therefore, a discussion of "AI performance metrics, ground truth, experts, and training/test sets" is not applicable.
The document focuses on substantiating the equivalence of the IKON 40 Manual Wheelchair to a legally marketed predicate device (MyOn HC™ Manual Wheelchair) through non-clinical performance testing and technical characteristic comparison, rather than AI-driven diagnostic or assistive capabilities.
Here's a breakdown of the relevant information provided:
Acceptance Criteria and Device Performance (for a Manual Wheelchair)
The acceptance criteria for a mechanical wheelchair are typically demonstrated through compliance with established industry standards for safety, durability, and functionality. The "reported device performance" is the successful completion and compliance with these standards.
1. Table of Acceptance Criteria and Reported Device Performance (as inferred from the document):
| Acceptance Criteria (Standard Compliance) | Reported Device Performance (Met/Compliant) |
|---|---|
| ANSI / RESNA - ISO 7176-1:2014 (Static stability) | Met |
| ANSI / RESNA ISO 7176-3:2012 (Effectiveness of brakes) | Met |
| ANSI / RESNA - ISO 7176-5:2008 (Dimensions, mass, maneuvering space) | Met |
| ANSI / RESNA - ISO 7176-7:1998 (Seating and wheel dimensions) | Met |
| ANSI / RESNA - ISO 7176-8:2014 (Static, impact, fatigue strengths) | Met |
| ANSI / RESNA - ISO 7176-11 (Test Dummies) | Met |
| ANSI / RESNA – ISO 7176-13 (Coefficient of friction) | Met |
| ANSI / RESNA - ISO 7176-15:1996 (Information disclosure, documentation, labeling) | Met |
| ANSI / RESNA WC/Volume 1 2009, Section16 (Resistance to Ignition of Upholstered Parts) | Met |
| CAL117:2013, Section 1 (Flammability Testing) | Met |
| ISO 8191-1:1987 & 8191-2:1988 (Flammability Testing) | Met |
Study Proving Device Meets Acceptance Criteria:
The study that proves the device meets the acceptance criteria is described under "Performance Testing Data: Non-Clinical Testing" on page 6 of the document.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not specify a "sample size" in terms of number of units tested. For mechanical devices undergoing standard compliance testing, it's typically a specific number of prototypes or production units (e.g., 1-3 units of each configuration) to demonstrate compliance with the specified test methods. The document states "Testing was performed by a non-clinical laboratory on the IKON 40."
- Data Provenance: The testing was non-clinical laboratory testing. The document does not specify a country of origin for the testing itself, but the manufacturer (Broda Seating) is based in Kitchener, ON, Canada. The testing involves physical and mechanical evaluations of the wheelchair's various components and overall structure against predefined standards. This is inherently prospective testing, as it's performed specifically for the purpose of this submission.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
This question is not applicable as the device is a manual wheelchair, not an AI/imaging device. "Ground truth" in this context is established by the test standards themselves and objective measurements/observations during physical testing, not expert consensus on images.
4. Adjudication Method for the Test Set:
This question is not applicable as the device is a manual wheelchair. Adjudication methods like 2+1 or 3+1 are used for human review of data, typically in AI or clinical studies. For mechanical testing, the results are objectively measured against the specified standard's pass/fail criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
This question is not applicable as the device is a manual wheelchair. MRMC studies are relevant for evaluating the impact of AI on human reader performance in diagnostic tasks.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This question is not applicable as the device is a manual wheelchair. "Standalone performance" refers to the performance of an algorithm without human intervention, which is not relevant here.
7. The Type of Ground Truth Used:
The "ground truth" for a mechanical device like a wheelchair is established by the international and national performance standards themselves (e.g., ANSI / RESNA ISO 7176 series, CAL117). These standards define the test methods and the acceptable ranges or pass/fail criteria for static stability, brake effectiveness, dimensions, strengths, flammability, etc. The "truth" is whether the device physically meets these empirically defined and externally validated criteria.
8. The Sample Size for the Training Set:
This question is not applicable as the device is a manual wheelchair and does not involve AI or machine learning algorithms that require a "training set."
9. How the Ground Truth for the Training Set Was Established:
This question is not applicable as there is no training set for a manual wheelchair.
§ 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).