(46 days)
To provide mobility to persons limited to a seated position.
The Kuschall Design K3/K4 series of manual wheelchairs are lightweight wheelchairs that provide mobility to persons limited to a sitting position. They consist of a rigid, mechanical, aluminum frame and a coated nylon upholstery that meets EN1021-1; Assessment of the Ignitability of Upholstered Furniture. They have larger rear wheels with handrims for pushing and steering. They have smaller front casters for turning and maneuverability. Different front casters are available. The K3 has 3 wheels, 2 large rear wheels and 1 front caster. The K4 has 4 wheels, 2 large rear wheels and 2 front casters.
The Kuschall Design K3/K4 series is available in various seat width's, depths, and heights and has an adjustable seat angle and tip stability. The camber is also adjustable to various increments.
They are sporty looking chairs with a more high performance feel that the standard version wheelchair. They are intended for the more active user.
The provided text describes the 510(k) premarket notification for the Kuschall Design K3/K4 series of manual wheelchairs. As such, it focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study for a novel device with specific acceptance criteria in the manner one might find for a software algorithm or a diagnostic tool.
Therefore, many of the requested categories related to algorithm performance, expert ground truth, and training data are not applicable to this submission. The "acceptance criteria" here refer to compliance with established performance standards for manual wheelchairs, and the "study" is the testing conducted against these standards.
Here's the information extracted and adapted to the prompt:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard Requirement) | Reported Device Performance (Compliance) |
|---|---|
| DIN EN 12182 (2/96): Manually Propelled Wheelchair Requirements and Test Methods | Met all requirements of DIN EN 12182 |
| DIN ISO 7176 Part 8 (1992): Wheelchairs Part 8: Requirements and Test Methods for Static, Impact and Fatigue Strengths | Met all requirements of DIN ISO 7176 Part 8 |
| EN 1021-1: Furniture Assessment of the Ignitability of Upholstered Furniture | Met all requirements of EN 1021-1 (specifically for the coated nylon upholstery) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the number of wheelchairs tested (sample size) for each standard.
The testing was conducted by TUV Product Service, an organization typically external to the manufacturer. The data provenance is implied to be from physical testing of the device, which is prospective in nature for the purpose of this submission. The country of origin of the testing is not specified, but TUV Product Service operates internationally.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This is not applicable. The "ground truth" for a physical device like a wheelchair is compliance with engineering and safety standards, directly measured by testing procedures rather than expert interpretation of data. The "experts" would be the engineers and technicians at TUV Product Service responsible for conducting the tests, whose qualifications are in performing and interpreting standard-based device testing.
4. Adjudication Method for the Test Set
This is not applicable. As machine performance is not being evaluated, there's no need for adjudication of expert opinions. Device performance is determined by passing or failing specified tests within the standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs. without AI assistance
This is not applicable. This submission is for a physical medical device (manual wheelchair), not a diagnostic or AI-powered software. Therefore, an MRMC study related to AI assistance is irrelevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable. No algorithm is being evaluated. The submission is for a physical medical device.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is defined by adherence to established international and European performance standards and test methods (DIN EN 12182, DIN ISO 7176 Part 8, EN 1021-1). This is essentially a form of engineering compliance and safety testing data.
8. The Sample Size for the Training Set
This is not applicable. The device is a physical product and does not involve a "training set" in the context of machine learning or algorithms. The design and manufacturing process would involve extensive engineering and design validation, but not a "training set" as defined for AI.
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).