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The device is intended for medical purposes to provide mobility to persons restricted to a seated position.

The Jiangsu Healthy Way Steel Mechanical Wheelchair 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 uses a standard sling type back and seat, the upholstery fabric meets the resistant to ignition source smouldering cigarette, and match flame equivalent.

The provided text describes a 510(k) summary for a "Jiangsu Healthy Way Steel Mechanical Wheelchair." This document is a premarket notification for a medical device and focuses on demonstrating substantial equivalence to a legally marketed predicate device, not on proving that the device meets specific acceptance criteria through a clinical study with AI or human readers.

Therefore, the requested information about acceptance criteria, study sample sizes, expert involvement, adjudication methods, MRMC studies, standalone algorithm performance, and ground truth establishment for AI-assisted image interpretation cannot be extracted from this document, as it is not relevant to a 510(k) submission for a mechanical wheelchair.

The document indicates that the wheelchair meets applicable performance requirements as specified in various ANSI/RESNA WC vol. 1 and ISO 7176 Wheelchair series standards. However, it does not provide a table of acceptance criteria with reported numerical performance values in the format typically seen for a new technology or AI-driven medical device.

Here's what can be extracted and what cannot:

What can be extracted:

• Device Name: Jiangsu Healthy Way Steel Mechanical Wheelchair
• Intended Use: To provide mobility to persons restricted to a seated position.
• Performance Testing Literature: The document lists several ISO and EN standards that the product meets, such as:
  • EN 1021-1 /-2 Assessment of the ignition of upholstered furniture, 2006.
  • ISO7176-1 Wheelchairs Part 1: Determination of Static Stability, 1999.
  • ISO7176-3 Wheelchairs Part 3: Determination of effectiveness of brakes, 2003.
  • And others related to dimensions, strengths, and ignition resistance.
• Predicate Device: KAIYANG Steel Wheelchair (K101999)
• Substantial Equivalence Basis: Similar structure (steel), foldable mainframe, same weight capacity, similar removable armrest and detachable footrest, same flame-retardant upholstery material meeting California Technical standard.

What cannot be extracted (as it's not applicable to this type of device and submission):

1. A table of acceptance criteria and the reported device performance: While the document states compliance with standards, it doesn't provide a table of specific numerical acceptance criteria (e.g., minimum accuracy, sensitivity, specificity) and reported performance metrics for an AI/imaging device.
2. Sample sizes used for the test set and the data provenance: Not relevant for a mechanical wheelchair.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not relevant.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not relevant.
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 relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not relevant.
8. The sample size for the training set: Not relevant.
9. How the ground truth for the training set was established: Not relevant.

In summary, the provided document is a 510(k) submission for a mechanical wheelchair, which relies on demonstrating compliance with established performance standards and substantial equivalence to a predicate device, rather than the type of clinical performance study data you'd expect for an AI or imaging diagnostic device.

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