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For transportation of disabled persons.

The device consists of a folding chromed steel frame with cross braces, slung fabric seat and back, fixed or removable armrests, fixed or removable foot/legrests, front caster wheels for steering, rear push handles for attendant-assisted propulsion, rear drive wheels with handrims for self-propulsion, and lever-style wheel locks.

It appears this document describes a 510(k) summary for a Manual Wheelchair manufactured by G. Hirsch and Company, Inc., submitted on July 24, 1998.

This document is a regulatory filing for a medical device (a manual wheelchair) to demonstrate its substantial equivalence to previously marketed devices. It does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria in the way a clinical or technical validation study would for a diagnostic or AI-based device.

The provided text focuses on the following:

• Substantial Equivalence: The primary goal of a 510(k) submission is to demonstrate that a new device is as safe and effective as a legally marketed predicate device. This is typically done through a comparison of design features, materials, and intended use, rather than extensive performance testing against defined acceptance criteria.
• Comparison of Design Features: The document provides a table comparing key physical characteristics of the G. Hirsch wheelchair to an Invacare Tracer Wheelchair (K935398) to show similarity.

Therefore, the requested information elements related to formal acceptance criteria, device performance results from a study, sample sizes, ground truth establishment, expert adjudication, or MRMC studies are not present in this document.

The context of this document is a regulatory submission for a simple mechanical device (a wheelchair), where substantial equivalence demonstration typically relies on design similarity and known performance of predicate devices, not on data-driven performance studies as one would expect for, say, an AI diagnostic algorithm.

Summary of what can be extracted from the document:

• 1. A table of acceptance criteria and the reported device performance: Not applicable. The document presents a comparison of physical specifications for demonstrating substantial equivalence to a predicate device, not performance against acceptance criteria from a validation study.
• 2. Sample sized used for the test set and the data provenance: Not applicable. No test set or data provenance is mentioned as this is a comparison of design features.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth or experts for performance evaluation are discussed.
• 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 manual wheelchair, not an AI-based diagnostic tool.
• 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.
• 8. The sample size for the training set: Not applicable. This is not an AI/machine learning device.
• 9. How the ground truth for the training set was established: Not applicable.

In conclusion, this document details a 510(k) premarket notification for a manual wheelchair and does not contain the type of acceptance criteria or study results typically found for performance-driven devices, especially those involving AI or advanced diagnostics.

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