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K Number
K022924
Device Name
SHERPA MOBILITY SYSTEM (MANUAL WHEELCHAIR)
Manufacturer
OTTO BACK HEALTHCARE, LP
Date Cleared
2002-10-17

(43 days)

Product Code
IOR
Regulation Number
890.3850
Type
Traditional
Panel
PM
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Manual transportation device for person who are unable to walk or have a . walking impediment, propulsion by an attendant.

Device Description

Manual Wheelchair

AI/ML Overview

This document is a 510(k) submission for a manual wheelchair and does not contain information about the acceptance criteria or a study proving device performance as it relates to AI or software.

The provided text is a 510(k) summary and the FDA's clearance letter for the "Sherpa Mobility System (Manual Wheelchair)." This type of submission is for medical devices and focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed performance studies with acceptance criteria in the context of advanced algorithms or AI.

Therefore, I cannot extract the requested information as it is not present in the provided document. The document describes a traditional mechanical device (a manual wheelchair) and its regulatory clearance process, not a device involving complex performance metrics tied to AI or specific acceptance criteria for such algorithms.

Specifically, the document lacks the following information:

  • A table of acceptance criteria and reported device performance: This is not typically part of a 510(k) summary for a mechanical device like a wheelchair, which focuses on safety and substantial equivalence to a predicate.
  • Sample size used for the test set and data provenance: No "test set" in the context of an algorithm is mentioned.
  • Number of experts used to establish ground truth: Not applicable to a manual wheelchair.
  • Adjudication method: Not applicable.
  • Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
  • Standalone (algorithm only) performance: Not applicable as there is no algorithm.
  • Type of ground truth used: Not applicable.
  • Sample size for the training set: No "training set" in the context of an algorithm is mentioned.
  • How the ground truth for the training set was established: Not applicable.

§ 890.3850 Mechanical wheelchair.

(a)
Identification. A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class I (general controls).