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The YUYUE K2/K4 wheelchair is indicated for providing mobility to persons limited to a sitting position.

The YUYUE K2/K4 wheelchair is a wheelchair that provides mobility to persons limited to a sitting position. It consists of rigid, mechanical, steel frame and nylon upholstery back and seat that meet 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 YUYUE K2/K4 wheelchair is intended for the use in indoors and outdoors, over smooth surface (all standard indoor flooring surfaces, concrete, asphalt and pocked dirt) that free of large obstacles and inclines greater than 9 degrees.

This is a premarket notification for a wheelchair and does not contain information about AI/ML algorithm acceptance criteria or study details. Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth.

The document describes the YUYUE K2/K4 wheelchair and states that it meets various ISO and ASTM standards related to wheelchair performance, safety, and biocompatibility. It also mentions equivalence to a predicate device (Danyang Huayi K2 wheelchair K080207).

Summary of available information:

• Device: YUYUE K2/K4 wheelchair
• Intended Use: Providing mobility to persons limited to a sitting position.
• Standards Met:
  • 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 7176-15: Requirements for information disclosure, documentation and labeling.
  • ISO 7176-16: Resistance to ignition of upholstered parts – requirements and test methods.
  • ISO 10993-5-2009: Biological Evaluation of Medical Devices – Part5: Testes for in vitro Cytotoxicity
  • ASTM D751:2006 Section 11-Procedure A- Tensile Strength
  • Section A, Part I and Section D, Part II of California Technical Bulletin 117 Requirement: Test Procedure and Apparatus for Testing the Flame Retardance of Resilient Filling Materials Used in Upholstered Furniture.
  • Section E, Part I of California Technical Bulletin 117 Requirement: Test Procedure and Apparatus for Testing the Flame Retardance of Resilient Filling Materials Used in Upholstered Furniture.
• Comparison: Substantially equivalent to Danyang Huayi K2 wheelchair (K080207) in terms of structure and performance.

Missing Information (as per your request, because this is not an AI/ML device submission):

1. A table of acceptance criteria and the reported device performance
2. Sample sized used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method
5. If a multi reader multi case (MRMC) comparative effectiveness study was done
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

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