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K Number
K050345
Device Name
CIE FOLDAWAY WHEELCHAIR
Manufacturer
CARLSBAD INTERNATIONAL EXPORT, INC.
Date Cleared
2005-03-29

(46 days)

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

The intended use is to provide mobility to persons limited to a sitting position, or who are unable to walk for long periods of time.

Device Description

Not Found

AI/ML Overview

The provided document is a 510(k) clearance letter for a "CIE Foldable Wheelchair (Travel Companion)". This type of document from the FDA is for medical devices and focuses on establishing substantial equivalence to a predicate device, rather than detailed performance studies and acceptance criteria as would be found in a Premarket Approval (PMA) application or a more complex 510(k) submission for novel devices or software.

Therefore, the information requested regarding acceptance criteria and detailed study data is not present in this document. The FDA's substantial equivalence determination for this device likely relied on comparisons of technical specifications, materials, and intended use with an already marketed wheelchair, rather than a clinical performance study with defined acceptance criteria.

Here's why the requested information cannot be extracted from the provided text:

  • Type of Device: A manual wheelchair (even a foldable one) is a relatively low-risk device, classified as Class I. The regulatory pathway for such devices, especially decades ago (this letter is from 2005), typically focuses on demonstrating that the new device is as safe and effective as existing legally marketed devices, not on proving new clinical efficacy through extensive trials.
  • Content of 510(k) Letter: This letter is the FDA's decision letter, stating that substantial equivalence has been found. It summarizes the regulatory outcome, but it does not contain the actual data from the submission that led to that decision. The 510(k) submission itself would have included information comparing the new device to a predicate, potentially listing specifications and standards met, but not typically detailed clinical study results with acceptance criteria.
  • Lack of "Algorithm" or "AI": The questions about "AI," "standalone algorithm performance," "human readers with/without AI assistance," and "training set" are completely irrelevant to a manual wheelchair, which is a mechanical device.

To directly answer your request based only on the provided text, I must state that the information is not available. The document does not contain:

  1. A table of acceptance criteria and reported device performance.
  2. Sample size for test set and data provenance.
  3. Number of experts or their qualifications for ground truth.
  4. Adjudication method for the test set.
  5. MRMC comparative effectiveness study or related effect sizes.
  6. Standalone algorithm performance.
  7. Type of ground truth used.
  8. Sample size for the training set.
  9. How ground truth for the training set was established.

§ 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).