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K Number
K982158
Device Name
SCOUT
Manufacturer
BURKE, INC.
Date Cleared
1998-08-31

(73 days)

Product Code
ITI
Regulation Number
890.3860
Type
Traditional
Panel
PM
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Motorized battery powered wheelchair for mobility purposes by disabled persons.

Device Description

Not Found

AI/ML Overview

This 510(k) submission (K982158) is for a "Power Wheelchair" and focuses on regulatory clearance based on substantial equivalence to a predicate device. It does not contain information about specific acceptance criteria or performance studies of the device against such criteria. The document is a clearance letter from the FDA, stating that the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide the requested information regarding acceptance criteria and performance studies. The document does not describe:

  1. A table of acceptance criteria and reported device performance.
  2. Sample sizes or data provenance for a test set.
  3. Number or qualifications of experts to establish ground truth.
  4. Adjudication methods.
  5. MRMC comparative effectiveness studies.
  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.

This type of information would typically be found in a more detailed technical review or a summary of safety and effectiveness, which are not part of this FDA clearance letter.

§ 890.3860 Powered wheelchair.

(a)
Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class II (performance standards).