The C.T.M. Mobility Scooter HS-528 is an indoor/outdoor scooter that is battery operated. It has a base with four wheels, a padded seat with adjustable armrests, and a steering column allowing the rider to control the scooter. It is capable of transport and is provided with an off-board battery charger.

AI/ML Overview

This document is a 510(k) summary for the C.T.M. Mobility Scooter HS-528. It states that "Comparative performance testing and clinical evaluations were not submitted as part of this 510(k)." Therefore, there is no information in the provided text for acceptance criteria or specific study details proving the device meets those criteria.

However, the document does state: "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." This implies that the device was tested against the standards outlined in that guidance document, even if the specific results are not provided.

Without the actual study results and acceptance criteria from the guidance document, I cannot complete the table or answer most of the requested questions.

Here's a breakdown of what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Inferred from Guidance Document)	Reported Device Performance (Not provided in the summary)
As per the "Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Mechanical and Scooters, and Motorized Three Wheeled Vehicles, July 1995"	Not specified in the provided 510(k) summary. The summary states: "Comparative performance testing and clinical evaluations were not submitted as part of this 510(k)."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not provided.
Data Provenance: Not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable as no clinical or comparative performance testing was submitted, and therefore no ground truth established by experts for a test set is mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable as no clinical or comparative performance testing was submitted.

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

No. The document explicitly states: "Comparative performance testing and clinical evaluations were not submitted as part of this 510(k)." This device is a mobility scooter, not an AI-assisted diagnostic tool, so an MRMC study is not relevant here.

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

Not applicable. This is a physical device (mobility scooter), not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable as no clinical or comparative performance testing was submitted to require a ground truth. Performance would have been measured against engineering standards specified in the guidance document.

8. The sample size for the training set

Not applicable. This is a physical device, and the testing described references compliance with guidance documents for physical product safety and performance, not machine learning model training.

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

Not applicable for the same reasons as #8.

Summary

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C.T.M. Mobility Scooter HS-528 510(k) Notification

JUL - 6 2009

10090735

510(k) SUMMARY

Submitter's name:	C.T.M. Homecare Product, Inc.6191 Schaefer Ave., Suite B, Chino, CA 91710
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Contact name and address:

Linda J. Bovard, Bovard Consulting, LLC 29611 Simmons Road, Eugene, OR 97405 . (541) 345-5431

3/16/09 Date summary prepared:

Device name:

Proprietary name: Common or usual name: Classification name:

C.T.M. Mobility Scooter HS-528 or Leo Electric scooter Motorized three-wheeled vehicle (890.3800). Motorized 3-wheeled vehicle (89 INI).

Legally marketed device for substantial equivalence comparison:

The predicate device is the Victory, 4 Wheel Scooter, Model #SC1740 submitted by Pride Mobility Products Corp. and cleared for marketing under 510(k) *K071949.

Description of the device:

The C.T.M. Mobility Scooter HS-528 is an indoor/outdoor scooter that is battery o The O.Tht has a base with four wheels, a padded seat with adjustable armrests, and operated. It has a base were mg column allowing the rider to control the scooter. nance outs of a lots of transport and is provided with an off-board battery charger.

Intended use of device:

The C.T.M. Mobility Scooter HS-528 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-528 and the Victory Scooter are r no do rill reacur are battery operated, have one motor, and have automatic braking very smilling. Do are battery chargers are provided with both scooters. Both scooters can Systembled for transport. The target population is identical and the use parameters are similar.

Testing conducted:

, contactor.
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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three bars representing its wings. The eagle is positioned to the right of a circular text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

JUL - 6 2009

Re: K090735

Trade/Device Name: C.T.M. Mobility Scooter HS-528 Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: II Product Code: INI Dated: May 8, 2009 Received: May 11, 2009

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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

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); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.

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Page 2 - Ms. Linda J. Bovard

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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 yours.

Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative 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-528

Indications for Use;

The C.T.M. Mobility Scooter HS-528 is an indoor/outdoor scooter that provides The C. F.m. Intonesial sabled 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
AND THE BELOW - NEEDED) NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K090735

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).