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Indications Huayi K3/K4 lightweight wheelchair is indicated for providing mobility to persons limited to a sitting position.

The Danyang Huayi K3/k4 wheelchair is a lightweight wheelchair that provides mobility to persons limited to a sitting position. It consists of rigid, mechanical, steel and aluminum 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 Danyang Huayi K3/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.

The provided document describes the Danyang Huayi K3/K4 lightweight wheelchair, which is a Class I mechanical wheelchair. The primary method of proving substantial equivalence to a predicate device is through conformance to established standards.

Here's an analysis based on the provided text, addressing your specific points:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

The document does not explicitly state the sample size for individual tests conducted to meet each ISO or ASTM standard. It generally states that "The Danyang Huayi K3/K4 wheelchair production meets the following standards" and that the device "raises no safety and efficiency issues or makes any claims that differ from the predicate device cited".

The data provenance is from China, as Danyang Huayi Medical Equipment & Supply Co., LTD is a Chinese company. The nature of the testing is generally prospective, as it would involve testing the manufactured wheelchairs against the specified standards.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not provided in the document. For mechanical device testing against standards, the "ground truth" is typically defined by the standard's specifications and test procedures, rather than expert consensus in the way it might be for a diagnostic image analysis algorithm. The expertise lies in the engineers and technicians performing the standardized tests correctly.

4. Adjudication Method for the Test Set

This information is not provided. Given the nature of mechanical testing against established standards, the adjudication method would typically involve direct measurement and comparison with the standard's pass/fail criteria, rather than multi-reader adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is more common for diagnostic imaging AI algorithms where the "reader" is a human interpreting images. For a mechanical wheelchair, the assessment focuses on physical performance against engineering standards.

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 mechanical wheelchair, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" used is defined by the specifications and test methods outlined in the various ISO, ASTM, and California Technical Bulletin standards. These standards provide objective, measurable criteria for attributes like static stability, brake efficiency, dimensions, strength, and material properties.

8. The Sample Size for the Training Set

This question is not applicable. The Danyang Huayi K3/K4 wheelchair is a mechanical device, not an AI algorithm. Therefore, there is no "training set" in the context of machine learning.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable as there is no training set for a mechanical device.

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The Danyang Huayi® K7 Wheelchair is indicated for providing mobility to persons limited to a sitting position.

The Danyang Huayi K7 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 Danyang Huavi K7 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.

The Danyang Huayi K7 Wheelchair is a mechanical wheelchair, and its acceptance criteria and performance are primarily based on conformance to international standards, rather than a clinical study measuring diagnostic performance of an AI-powered device.

Here's a breakdown of the requested information based on the provided document, adapted for a medical device that is not an AI diagnostic tool:

Acceptance Criteria and Device Performance (Danyang Huayi K7 Wheelchair)

The acceptance criteria for the Danyang Huayi K7 Wheelchair are defined by its successful conformance to a series of ISO standards for wheelchairs. The "reported device performance" in this context is the statement of conformity to these standards.

Additional Information (Not Applicable for a Non-AI Mechanical Device):

The following sections are designed to evaluate AI-powered diagnostic devices. Since the Danyang Huayi K7 Wheelchair is a mechanical mobility device, these criteria are not applicable and are addressed as such below.

2. Sample size used for the test set and the data provenance: Not applicable. This is a mechanical device, not an AI diagnostic tool using a test set of data. Testing would involve physical prototypes/production units.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a mechanical wheelchair is objective measurements and performance against engineering standards, not expert interpretation of data.
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 is not an AI diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a mechanical device, no algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The ground truth for this device is based on the objective measurements and performance criteria defined by the specified ISO standards for wheelchairs.
8. The sample size for the training set: Not applicable. This is a mechanical device, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

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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:

• 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)

• 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.

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