LogoFDA 510(k) Search
K Number
K120032
Device Name
MECHANICAL WHEELCHAIR
Manufacturer
AIKIN HEALTHCARE CO., LTD
Date Cleared
2012-04-13

(100 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

The Mechanical Wheelchair is intended to provide mobility to persons restricted to a sitting position.

Device Description

Not Found

AI/ML Overview

This document is an FDA 510(k) clearance letter for a Mechanical Wheelchair. It does not contain information about acceptance criteria or a study proving device performance in the context of AI or machine learning. The letter confirms substantial equivalence to a predicate device, which is a regulatory pathway for Class I and II medical devices that typically relies on the device meeting established performance standards rather than requiring extensive clinical trials or AI-specific performance metrics.

Therefore, I cannot provide the requested information from the provided text, as it describes a traditional mechanical medical device and not an AI-enabled one.

Here's why each point cannot be answered:

  1. A table of acceptance criteria and the reported device performance: Not available. This is a clearance letter, not a performance report for an AI device.
  2. Sample size used for the test set and the data provenance: Not applicable. There's no AI test set mentioned.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There's no AI ground truth establishment described.
  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 for a mechanical wheelchair, not an AI-assisted device 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.
  8. The sample size for the training set: Not applicable.
  9. How the ground truth for the training set was established: Not applicable.

The document discusses regulatory clearance for a physical product (a mechanical wheelchair) and does not involve AI/ML performance evaluation.

§ 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).