THERADYNE ROVER POWERED WHEELCHAIR by KURT MFG. CO.

The provided text describes a 510(k) summary for the "Theradyne Rover Express™ Powered Wheelchair." This document focuses on establishing substantial equivalence to a predicate device rather than detailing specific clinical studies for performance metrics. As a result, much of the requested information regarding acceptance criteria, study design, and ground truth for an AI/device performance evaluation is not present in the provided text.

Here's an analysis based on the given document:

Acceptance Criteria and Reported Device Performance

The document states that the Rover Express™ Powered Wheelchair was examined and tested according to FDA's Guidance Documents, with successful results that "did not raise any issues of safety and effectiveness of the device." However, specific numerical acceptance criteria (e.g., minimum torque, battery life, turning radius) and detailed performance metrics are not explicitly reported in the format of a table within the provided text.

The conclusion reiterates that the device is "substantially equivalent to previously marketed powered wheelchairs as demonstrated by its conformance to FDA recognized consensus standards and FDA's Guidance Documents." This implies that the 'acceptance criteria' were adherence to these standards and guidance documents, which the device met.

Acceptance Criteria (Implied)	Reported Device Performance
Conformance to FDA recognized consensus standards	Conformed to FDA recognized consensus standards
Conformance to FDA's Guidance Documents	Conformed to FDA's Guidance Documents
(Specific performance metrics derived from these standards)	Not explicitly detailed in the provided document
No issues of safety and effectiveness	No issues of safety and effectiveness raised

Study Information (Based on a traditional medical device, not an AI/diagnostic device)

2. Sample size used for the test set and the data provenance:

The document does not describe a clinical "test set" in the context of an AI or diagnostic study. The testing performed was "functional & safety testing" of the physical wheelchair device.
The sample size for this functional and safety testing is not specified.
Data provenance is not applicable in the context of clinical data for an AI algorithm. The testing was of the manufactured device itself.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable as the document describes a physical medical device (powered wheelchair) and its compliance testing, not a diagnostic or AI device that requires expert-established ground truth.

4. Adjudication method for the test set:

This is not applicable for the type of device and testing described.

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:

This is not applicable. The device is a powered wheelchair; it does not involve human readers or AI assistance in a diagnostic context.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This is not applicable. The device is a powered wheelchair; it is not an algorithm.

7. The type of ground truth used:

For a physical device like a powered wheelchair, "ground truth" would relate to its physical specifications and performance against engineering standards. The document implicitly states that the 'ground truth' was established by "FDA recognized consensus standards and FDA's Guidance Documents."

8. The sample size for the training set:

This is not applicable. There is no mention of a training set for an AI algorithm as this is a physical medical device.

9. How the ground truth for the training set was established:

This is not applicable as there is no training set for an AI algorithm.

Summary of Missing Information:

The provided 510(k) summary is for a physical medical device (Theradyne Rover Express™ Powered Wheelchair) and focuses on demonstrating substantial equivalence through compliance with recognized standards and guidance documents. It does not contain any information related to AI performance, clinical study results with human readers, ground truth for diagnostic classifications, or typical metrics associated with AI/diagnostic device evaluation. Therefore, most of the specific questions asked regarding AI evaluation criteria cannot be answered from this document.

Summary

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AUG 12 699

K 98>774

A. 510(K) Summary

510(K) SUMMARY

SUBMITTER:	Theradyne Healthcare Products, a Division of Kurt Manufacturing Company.
CONTACT PERSON:	Phil Schlangen 1325 Quincy Street, Northeast Minneapolis, MN 55413
DATE PREPARED:	July 19, 1999
TRADE NAME:	Theradyne Rover Express™ Powered Wheelchair
CLASSIFICATION NAME AND NUMBER PRODUCT CODE:	Wheelchair, Powered Class II, 21 CFR 890.3860, Code: ITI
PREDICATE DEVICE(S):	The Theradyne Rover Express™ Powered Wheelchair is substantially equivalent to previously marketed powered wheelchairs, as demonstrated by its conformance to FDA recognized consensus standards and FDA's guidance documents.
DEVICE DESCRIPTION:	The Theradyne Rover Express™ Powered Wheelchair.
INTENDED USE:	The Theradyne Rover Express™ Powered Wheelchair is intended for medical purposes to provide mobility to persons restricted to a sitting position.
FUNCTIONAL & SAFETY TESTING:	The Theradyne Rover Express™ Powered Wheelchair was examined and tested as provided in FDA's Guidance Documents, except for any deviations noted in the Declaration of Conformity and Summary Report. The results of examination and testing were successful, and did not raise any issues of safety and effectiveness of the device.
CONCLUSION:	The Theradyne Rover Express™ Wheelchair is substantially equivalent to previously marketed powered wheelchairs as demonstrated by its conformance to FDA recognized consensus standards and FDA's Guidance Documents.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 12 1999

Mr. Phil Schlangen Kurt Manufacturing Company Theradyne Healthcare Products 1325 Ouincy Street NE Minneapolis, Minnesota 55413

Re: K982724

Trade Name: Theradyne Rover Express Powered Wheelchair Regulatory Class: II Product Code: ITI Dated: July 20, 1999 Received: July 21, 1999

Dear Mr. Schlangen:

We have reviewed your Section 510(k) notification of intent to market the device referenced above, and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general control provisions of the Act. The general control provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General Regulation (21 CFR Part 820), and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Phil Schlangen

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Page

510(k) Number (if known):

Device Name: Theradyne Rover Express™ Powered Wheelchair

Indications for Use:

The Theradyne Rover Express™ Powered Wheelchair is intended for medical purposes to provide mobility to persons restricted to a sitting position.

Concurrence of CDRH, Office of Device Evaluation (ODE)

biotte

Division Sign-Off) Division of General Restorative D 510(k) Number

Over-the-Counter Use

Abbreviated 510(k) Premarket Notification - Theradyne Rover™ Powered Wheelchair August 3, 1998

Regulation Number and Section

§ 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).