The Millennium Series Wheelchair is manually operated mechanical wheelchair. It is designed to be durable with folding frame. The range of sizes and configurations are available to accommodate the needs of each user. The wheelchair is suitable to provide mobility to user for both indoors and outdoors with firm surface that is free of climbing obstacles.

The Millennium Series Mechanical Wheelchair consists of typical components found on most manual wheelchair. The wheelchair consists of metal frame constructed of round steel tubing that is welded, seat and back upholsteries, removable footrests/legrests, front casters and rear wheels. The upholstery fabric meets the California Technical Bulletin CAL 117 Standard for flame retardancy.

AI/ML Overview

The provided text does not contain details about acceptance criteria, device performance, or a study that uses specific performance metrics (like accuracy, sensitivity, specificity, or AUC) to prove the device meets said criteria.

Instead, this document is a 510(k) submission for a mechanical wheelchair, focusing on substantial equivalence to a predicate device. Here's a breakdown of what is present and how it relates to your request:

1. Table of Acceptance Criteria and Reported Device Performance:

Not Applicable. The submission does not define specific performance metrics like accuracy, sensitivity, or other quantitative measures typically found in studies for AI/software devices. For a mechanical wheelchair, "performance" is generally defined by meeting safety and functional standards, not diagnostic accuracy.
The document states: "Required tests for mechanical wheelchair listed in the Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Mechanical and Powered Wheelchairs, and Motorized Three Wheeled Vehicles, July 1995, were conducted and the results are included in the subject 510(k) submission." This indicates that some testing was done, but the specific acceptance criteria and results are not detailed in this summary. They would be in the full submission, but not in a format suitable for the table requested for device performance in the context of an AI/diagnostic device.

2. Sample Size Used for the Test Set and Data Provenance:

Not Applicable. This is a hardware device (mechanical wheelchair). The concept of a "test set" for performance evaluation in the way it's used for AI or diagnostic devices does not apply here. There's no data (like images or patient records) being analyzed.
Testing would likely involve physical trials on a limited number of wheelchair prototypes, but this is not a data-driven validation study for an AI algorithm.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not Applicable. This is a hardware device. There is no "ground truth" to be established by experts in the context of diagnostic accuracy.

4. Adjudication Method for the Test Set:

Not Applicable. As there's no "test set" in the diagnostic sense, there's no adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No. The document explicitly states: "Comparative performance testing and clinical evaluations were not submitted as part of this 510(k)." This directly indicates that no MRMC study or clinical comparative effectiveness study was performed or included.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Not Applicable. This is a mechanical device, not an algorithm. There is no standalone algorithm performance to evaluate.

7. The Type of Ground Truth Used:

Not Applicable. This is a mechanical device. The concept of "ground truth" as it applies to diagnostic or AI performance (e.g., pathology, clinical outcomes, expert consensus) is not relevant. The "truth" for a wheelchair would be its structural integrity, maneuverability, safety, and compliance with standards.

8. The Sample Size for the Training Set:

Not Applicable. This is a mechanical device. There is no AI algorithm being trained, therefore no training set.

9. How the Ground Truth for the Training Set Was Established:

Not Applicable. As there is no training set.

Summary regarding your request:

The provided 510(k) summary for the Millennium Series Mechanical Wheelchairs is for a hardware (mechanical) device seeking market clearance based on substantial equivalence to a predicate device. It does not involve AI, diagnostics, or data-driven performance assessments in the way your questions are formulated. Therefore, most of the requested information (acceptance criteria for accuracy/performance metrics, sample sizes for test/training sets, expert ground truth, MRMC studies) is not applicable to this document. The "testing" mentioned refers to compliance with established standards for mechanical wheelchairs, not the type of performance evaluation relevant to AI or diagnostic software.

Summary

{0}------------------------------------------------

DEC 1 2 2002

510(k) SUMMARY

Submitter's name:	Evermed Corporation
Submitter's address:	4999 E. La Palma Ave.Anaheim, CA 92807
Submitter's phone number:	(714) 777-9997
Date summary prepared:	December 04, 2002
Proprietary name:	Millennium Series Mechanical Wheelchairs
Common or usual name:	Wheelchair
Classification name:	Wheelchair, mechanical
Predicate device:	Tracer Series Mechanical Wheelchairs manufactured byInvacare Corp. (K935398)

Intend use of device:

The Millennium Series Mechanical Wheelchair provides enhanced mobility to physically challenged persons limited to a sitting position.

Technological Characteristics and Substantial Equivalence:

Device description:

{1}------------------------------------------------

The users manual of Millennium Series Mechanical Wheelchair provides information on warnings, cautions and operation instruction of the wheelchair.

Substantial equivalence:

The Millennum Series Mechanical Wheelchairs is substantially equivalent to the Tracer Series Mechanical Wheelchair manufactured by Invacre Corp. (K935398). They both have the same technological characteristics and intended use of the device.

Testing conducted:

Required tests for mechanical wheelchair listed in the Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Mechanical and Powered Wheelchairs, and Motorized Three Wheeled Vehicles, July 1995, were conducted and the results are included in the subject 510(k) submission.

Performance testing:

Comparative performance testing and clinical evaluations were not submitted as part of this 510(k).

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and head. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged in a circular fashion around the eagle.

Public Health Service

ood and Drug Administratio 9200 Corporate Boulevard Rockville MD 20850

Evermed Corporation Calvin Chang 4999 East La Palma Avenue Anaheim, California 92807

Re: K024030

Trade/Device Name: Millennium Series Mechanical Wheelchairs Regulation Number: 890.3850 Regulation Name: Wheelchair, mechanical Regulatory Class: Class I Product Code: IOR Dated: December 4, 2002 Received: December 6, 2002

Dear Mr. Chang:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in

{3}------------------------------------------------

Page 2 - Mr. Calvin Chang

the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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), 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.qov/cdrh/dsma/dsmamain.html

Sincerely yours.

R. Mark A. Millman

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

Enclosure

{4}------------------------------------------------

Indications for Use Statement

510(k) Number (if known): __ K O2 4030

Device name: Millennium Series Mechanical Wheelchairs

Indications for Use:

Indications for Use: The Millennium Series Mechanical Wheelchair provides enhanced mobility to physically challenged persons limited to a sitting position.

for Mark N Millers

Division Sign-Off) Division of General, Restorative and Neurological Devices Koz4030

10(k) Number --

(Please do not write below this line)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) · OR

Over-The-Counter Use

510(k) Notification - Millennium Series Mechancial Wheelchairs

Regulation Number and Section

§ 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).