C.T.M. MOBILITTY SCOOTER # HS-295 by C.T.M. HOMECARE PRODUCT, INC.

The C.T.M. Mobility Scooter HS-295 is an indoor/outdoor scooter that is battery operated. It has a base with four wheels, a padded seat with adjustable armrests, and hand controls at the top of the steering column which allow the rider to control the movement of the scooter. It can be disassembled for transport and is provided with an on-board battery charger.

AI/ML Overview

The provided text is related to a 510(k) submission for a mobility scooter, which is a medical device. However, this document does not contain information about acceptance criteria or a study that proves the device meets those criteria in the context of an AI/ML medical device.

Here's why and what information is missing:

Why the provided text is not relevant to the requested information:

Device Type: The device is a "C.T.M. Mobility Scooter HS-295," an electric scooter for transportation. This is a mechanical device, not an AI/ML software or algorithm.
Testing Conducted: The summary explicitly states: "Comparative performance testing and clinical evaluations were not submitted as part of this 510(k)." It mentions that "Tests listed in the Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Mechanical and Scooters, and Motorized Three Wheeled Vehicles, July 1995, were conducted." This refers to standard mechanical and safety testing for such vehicles, not performance metrics for an AI/ML algorithm.
Lack of AI/ML Specifics: There is no mention of algorithms, machine learning, deep learning, diagnostic accuracy, image analysis, or any other characteristic of an AI/ML medical device.

Therefore, I cannot provide the requested information based on the input text. The questions you've asked (about acceptance criteria for an AI/ML model, sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.) are specifically geared towards the evaluation of AI/ML software as a medical device. This document describes a physical mobility scooter.

Summary

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C.T.M. Mobility Scooter HS-295 510(k) Notification

K070603

510(k) SUMMARY

Submitter's name:	C.T.M. Homecare Product, Inc.13825 Norton Ave., Chino, CA 91710			MAR 20 2007
Contact name and address:	Linda J. Bovard, Bovard Consulting, LLC29611 Simmons Road, Eugene, OR 97405(541) 345-5431
Date summary prepared:	February 28, 2007
Device name:
Proprietary name:	C.T.M. Mobility Scooter HS-295
Common or usual name:	Electric scooter
Classification name:	Motorized three-wheeled vehicle (890.3800). Motorized3-wheeled vehicle (89 INI).
Legally marketed device for substantial equivalence comparison:	The predicate device for this submission is the C.T.M. Mobility Scooter HS-250

submitted by C.T.M. Homecare Product, Inc. and cleared under 510(k) *K032919.

Description of the device:

Intended use of device:

The C.T.M. Mobility Scooter HS-295 is an indoor/outdoor scooter that provides transportation for a disabled or elderly person.

Technological characteristics:

The device features of the C.T.M. Mobility Scooter HS-295 and the HS-250 are very similar, Both are battery operated, have one motor, and have automatic braking systems. Battery chargers are provided with both scooters, but the HS-295 charger is on-board. Both scooters can be disassembled for transport. The target population is identical and the use parameters are similar.

Testing conducted:

Tests listed in the Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Mechanical and Scooters, and Motorized Three Wheeled Vehicles, July 1995, were conducted and the results included in the submission.

Performance testing:

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

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Image /page/1/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with flowing lines, representing the human services aspect. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

C.T.M. Homecare Product, Inc. % Bovard Consulting, LLC Ms. Linda J. Bovard President 29611 Simmons Road Eugene, Oregon 97405

MAR 2 0 2007

Re: K070603

Trade/Device Name: C.T.M. Mobility Scooter #HS-295 Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: Class II Product Code: INI. MOV Dated: February 28, 2007 Received: March 5, 2007

Dear Ms. Bovard:

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. Iisting 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. 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

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Page 2 – Ms. Linda J. Bovard

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 its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely your

for
Mark N. Melkerson

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

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name: C.T.M. Mobility Scooter HS-295

Indications for Use:

The C.T.M. Mobility Scooter HS-295 is an indoor/outdoor scooter that provides transportation for a disabled or elderly person.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use X (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510(k) Number K070603

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).