Search Results

The device is intended for medical purpose to provide mobility to persons restricted to a sitting position.

The Zhenjiang Assure Mechanical Wheelchair,model:K1 is indoor/outdoor wheelchair that has a base with four-wheeled with a seat.The device can be disassembled for transport and it is foldable easily. The device is consistent with the ISO 7176 series standards and uses a standard sling type back and seat, the upholstery fabric meets the flame retardant test.

The provided text is a 510(k) summary for the Zhenjiang Assure Mechanical Wheelchair, Model:K1. This document focuses on demonstrating substantial equivalence to a predicate device and does not involve AI/ML technology or associated performance metrics like sensitivity, specificity, or AUC. Therefore, a table of acceptance criteria and reported device performance related to those metrics, along with details about studies involving test sets, ground truth establishment, expert adjudication, or MRMC studies, cannot be extracted from this text.

The document describes non-clinical performance testing against established ISO standards for wheelchairs to demonstrate safety and effectiveness.

Here's a breakdown of the available information based on your request:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table of acceptance criteria and reported device performance in the context of AI/ML metrics (e.g., sensitivity, specificity, AUC). Instead, it lists the international standards to which the device conforms for non-clinical performance. The "reported device performance" is essentially that the device is "compatible as requirement of" these ISO standards.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable and therefore not provided, as the studies are physical performance tests for a mechanical wheelchair, not data-driven AI/ML studies. The testing is based on risk assessment utilizing Failure Mode Effect Analysis (FMEA).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable and therefore not provided. The "ground truth" for a mechanical wheelchair's performance is determined by its adherence to specified engineering and safety standards (e.g., ISO 7176 series), which are validated through physical testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable and therefore not provided, as there is no expert adjudication of subjective assessments. The methods for verifying compliance with ISO standards are typically standardized testing procedures.

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 information is not applicable and therefore not provided. The submission is for a mechanical wheelchair, which does not involve human readers or AI assistance in its function or evaluation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable and therefore not provided. The device is a mechanical wheelchair and does not involve algorithms or AI.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

The "ground truth" for the device's performance is compliance with the technical specifications and safety requirements outlined in the referenced ISO 7176 series standards. These are empirically verifiable through physical testing.

8. The sample size for the training set

This information is not applicable and therefore not provided, as this is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established

This information is not applicable and therefore not provided, as this is not an AI/ML device that requires a training set.

Ask a specific question about this device