MODEL SEGAEGO 4D SCOOTER by DALTON MEDICAL CORP.

I am sorry, but the provided text does not contain the information requested in your prompt regarding acceptance criteria and a study proving device performance. The document is an FDA 510(k) clearance letter for a "Scooter Segaego 4D," classifying it as a motorized three-wheeled vehicle. It primarily discusses regulatory classification, substantial equivalence to a predicate device, and general controls provisions.

There is no mention of:

A table of acceptance criteria or reported device performance metrics.
Sample sizes or data provenance for a test set.
The number or qualifications of experts for ground truth establishment.
Adjudication methods.
Multi-reader multi-case (MRMC) comparative effectiveness studies.
Standalone algorithm performance studies.
Types of ground truth used (e.g., pathology, outcomes data).
Sample size for a training set or how its ground truth was established.

This document pertains to the regulatory clearance process for a medical device (a scooter), not a study evaluating its performance against specific acceptance criteria for a diagnostic or AI-driven aid.

Summary

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

Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The overall design is simple and conveys a sense of authority and care.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Dalton Medical Corporation % Mr. Will Ridgway Sales Manager 1103 Venture Court Carrollton, Texas 75006

JUL 27 2007

Re: K071282 Trade/Device Name: Scooter Segaego 4D Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: Class II Product Code: INI Dated: June 13, 2007 Received: June 13, 2007

Dear Mr. Ridgway:

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 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.

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

Page 2 -- Mr. Will Ridgway

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 (240) 276-0120 Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark A. Millan

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

Indications for Use

510(k) Number (if known):

Segaego 4D Device Name:

Indications For Use:

The intended use of the Segaego 4D is to provide mobility to persons limited to a seated position that are capable of operating a powered scooter.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

XX Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of in vitro Diagnostic Devices (OIVD)

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

510(k) Number K071282 Page 1 of _

Regulation Number and Section

§ 890.3800 Motorized three-wheeled vehicle.

(a)
Identification. A motorized three-wheeled vehicle is a gasoline-fueled or battery-powered device intended for medical purposes that is used for outside transportation by disabled persons.(b)
Classification. Class II (performance standards).