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K Number
K950025
Device Name
SELF PROPELLED ROBOTIC WHEEL (SPRW)
Manufacturer
DATATRAN, INC.
Date Cleared
1996-09-03

(608 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

Not Found

Device Description

1.) All the components for driving the wheels are rigidly supported in a central disc structure forming the wheel cavity; 2.) The cavity is fully enclosed by cosmetic covers; 3.) The components have been chosen for longevity to outlast two or more wheelchair frames; 4.) The resulting wheels can be quickly interchanged with the standard wheels of a manually operated wheelchair; 5.) A direct gear drive; 6.) The pancake motor with a state of the art rare earth neodymium-Iron-Boron magnet, makes this motor one of the most powerful for it's size; 7.) The SPRW is the first time that, a wheel used for transportation, has rotating within it: it's own power source, power conversion means (electrical to mechanical), power electronics photo-optic signal transmission at the hub between rotating and non-rotating components.

AI/ML Overview

The provided text describes a 510(k) submission for a "Self Propelled Robotic Wheel (SPRW)" by DataTran Inc. and refers to compliance with the ANSI/RESNA 1991 Wheelchair Standard. However, it does not contain a detailed study description with specific acceptance criteria and detailed device performance metrics in the format requested.

The document states: "DataTran has 'Taken action to assure performance', by having made arrangements with the University of Pittsburgh to verify our assertion that the SPRW device/system is in compliance with the ANSI/RESNA 1991 Wheelchair Standard." This suggests a study was conducted or is planned, but the specifics of that study (acceptance criteria, reported device performance, sample sizes, ground truth establishment, etc.) are not provided in this excerpt.

Therefore, I cannot fulfill your request for:

  1. A table of acceptance criteria and the reported device performance: The specific criteria and performance values from the ANSI/RESNA 1991 standard, and how the SPRW performed against them, are not detailed here.
  2. Sample sized used for the test set and the data provenance: No information on test set size or data origin is given.
  3. Number of experts used to establish the ground truth... and qualifications: No information is provided regarding experts or ground truth establishment.
  4. Adjudication method: Not mentioned.
  5. Multi reader multi case (MRMC) comparative effectiveness study: Not mentioned.
  6. Standalone (i.e. algorithm only without human-in-the loop performance): Not applicable as this is a physical device, not an AI algorithm.
  7. The type of ground truth used: Not specified.
  8. The sample size for the training set: Not applicable as this is a physical device, not an AI algorithm.
  9. How the ground truth for the training set was established: Not applicable as this is a physical device, not an AI algorithm.

The document primarily focuses on establishing substantial equivalence to a predicate device and highlighting features of the SPRW, rather than presenting a performance study's detailed results against acceptance criteria.

§ 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).