(30 days)
The Danyang Huayi® H035 Basic Wheelchair is indicated for providing mobility to persons limited to a sitting position.
The Danyang Huayi H035 Basic Wheelchair is a wheelchair that provides mobility to persons limited to a sitting position. It consists of rigid, mechanical, steel frame and nylon upholstery that meets ISO 7176-16: Resistance to ignition of Upholstered parts. It has two 24" rear wheels and two 8" front casters for turning and maneuverability. The Danyang Huayi H035 wheelchair is intended for use indoors and outdoors, over smooth a surface (all standard indoor flooring surfaces, concrete, asphalt and pocked dirt) that are free of large obstacles and inclines greater than 9 degrees.
The provided text describes a 510(k) premarket notification for the "Danyang Huayi H035 Basic Wheelchair". This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a device meets specific acceptance criteria based on its performance metrics.
Therefore, the requested information components related to acceptance criteria, detailed study design, sample sizes for training/test sets, expert adjudication, MRMC studies, standalone performance, and ground truth establishment are not applicable or available within the provided text.
The document states that the Danyang Huayi H035 Basic Wheelchair conforms to several ISO standards, which represent a form of acceptance criteria for manufacturing and certain performance aspects, but not a clinical study proving its performance against specific clinical outcomes or AI-driven metrics.
Here's a breakdown of the available and unavailable information based on your request:
1. Table of acceptance criteria and the reported device performance:
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Acceptance Criteria (Conformance to Standards): The device production meets the following ISO standards:
- ISO 7176-1: Determination of static stability
- ISO 7176-3: Determination of efficiency of brakes
- ISO 7176-5: Determination of overall dimension, mass and turning space
- ISO 7176-7: Measurement of seating and wheel dimensions
- ISO 7176-8: Requirements and test methods for static, impact and fatigue strengths
- ISO 7176-11: Test dummies
- ISO 7176-13: Determination of friction of test surface
- ISO 7171-15: Requirements for information disclosure, documentation and labeling
- ISO 7171-16: Resistance to ignition of upholstered parts requirements and test methods
- ISO 7176-16: Resistance to ignition of Upholstered parts (mentioned in description)
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Reported Device Performance: The document only states that the "Danyang Huayi H035 Basic Wheelchair production meets the following standards" and that it is "substantially equivalent products in all areas impacting safety and effectiveness" to the predicate device. It does not provide specific performance metrics (e.g., braking distance, turning radius values, stability angles) beyond confirming conformity to the standards.
2. Sample sized used for the test set and the data provenance: Not applicable. This is not a study assessing AI/device performance on a test set but a submission for substantial equivalence based on design and conformance to standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable. This device is a basic wheelchair, not an AI-driven diagnostic or assistive technology for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of an AI/diagnostic device study. The "ground truth" here is the adherence to design specifications and ISO standards, and the comparison to a legally marketed predicate device (Access Point Medical, AXS-1 Basic Wheelchair (K050280)).
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.
In summary: The provided 510(k) submission for the Danyang Huayi H035 Basic Wheelchair is a regulatory document focused on demonstrating substantial equivalence to a predicate device and adherence to relevant international standards for manufacturing and basic functionality. It does not contain information about clinical studies, performance metrics against specific acceptance criteria for a diagnostic or AI device, or details about training/test sets as would be relevant for such technologies.
§ 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).