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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.
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:
- 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.
- Sample sized used for the test set and the data provenance: No information on test set size or data origin is given.
- Number of experts used to establish the ground truth... and qualifications: No information is provided regarding experts or ground truth establishment.
- Adjudication method: Not mentioned.
- Multi reader multi case (MRMC) comparative effectiveness study: Not mentioned.
- Standalone (i.e. algorithm only without human-in-the loop performance): Not applicable as this is a physical device, not an AI algorithm.
- The type of ground truth used: Not specified.
- The sample size for the training set: Not applicable as this is a physical device, not an AI algorithm.
- 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.
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Image /page/0/Picture/0 description: The image shows the text "DataTran Inc." followed by a black square, a right arrow, and an empty square. The text is in a simple, sans-serif font and is the main focus of the image. The symbols are aligned horizontally with the text.
Kg50025
Man/Machine System Innovators
December 26, 1994
Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Bld. Rockville, Maryland 20850
Re: 510(k) Self Propelled Robotic Wheel(SPRW), Owner / Operator No. 9011753
Attention: Document Mail Clerk
"This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requrements of the Safe Medical Device Act of 1990 and 21 CFR 807.92." With this letter DataTran Inc., the developer of the Self Propelled Robotic Wheel (SPRW) requests that the Office of Device Evaluation (ODE) review the enclosed Premarket Notification 510(k) submission.
SEP
3 1996
This 510k will show that the SPRW has a "predicate device" which was sold by SOLO PRODUCTS INC., on the interstate market, during the years 1975 to 1983. It began to be sold prior to May 28, 1976; and in accordance with the Federal Food, Drug and Cosmetic Act, 513(i)(1)(A),(1)(2), if ODE agrees, it is requested that they transmit to DataTran, a "Substantially Equivalent 510(k) letter."
DataTran has determined that the SPRW, when mounted on a wheelchair frame, converts manually operated wheelchairs to powered wheelchairs, and falls under class II as defined by 21 CFR 807. 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.
The features described in the section of the Premarket Notification 510(k) entitled, SAFETY AND EFFECTIVENESS OF THE SPRW, are as follows: 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.
Notwithstanding that there is at least one "predicate device" that the SPRW is "substantially equivalent" to, the SPRW system includes innovations such as the infrared transmission link. These features are subject of a patent application which has been formally allowed for filing by the US Patent Office, to issue in mid 1995. This link is at least as safe and reliable as any signal transmission path used by the "predicate devices" for controlling speed and direction of the wheelchair. In no way do the innovations alter the "intended use" or the technologies used for the "predicate devices." The prime motivation for introducing the innovations is safety and effectiveness for the SPRW system.
Within the enclosed 510(k) there is information which is proprietary to DataTran Inc., It is requested that those who review the contents of the 510(k) maintain this confidentiality.
E.A. Avakian, President
Emik A. Avakian, President Contact person
12-26-94
Date
67 Applewood Drive · Chicopee, MA 01022 · (413) 593-9574
§ 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).