The C.T.M. Mobility Scooter HS-515 is an indoor/outdoor scooter that is battery operated. It has a base with three wheels, a padded seat with adjustable armrests, and hand controls at the top of the steering column allowing the rider to control the scooter. It can be disassembled for transport and is provided with an off-board battery charger.

AI/ML Overview

The provided document is a 510(k) summary for the C.T.M. Mobility Scooter HS-515. This type of submission is for medical devices that are mechanical or physical in nature, not AI/software-driven diagnostics or imaging systems. Therefore, many of the requested categories related to AI/software performance, such as sample sizes for test sets, expert ground truth, MRMC studies, and standalone algorithm performance, are not applicable to this device and its 510(k) submission.

Here's a breakdown of the available information based on your request:

Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in the format typically seen for AI/software performance studies. Instead, the "acceptance criteria" are implied by compliance with established performance tests for mechanical scooters, as outlined in FDA guidance documents.

Acceptance Criteria Category (Implied by FDA Guidance for Mechanical Scooters)	Reported Device Performance
Safety and Effectiveness (demonstrated via comparison to predicate)	"Non-clinical testing and specification comparison demonstrate that any differences in specifications or technology do not raise new questions of safety or effectiveness." The device was found "substantially equivalent" to the predicate device (Victory Three Wheel Scooter, Model SC610, K072165) based on regulatory classification, intended use, and similar technological characteristics.
Compliance with Performance Standards/Tests	"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." (The specific results or acceptance thresholds for these tests are not detailed in this 510(k) summary, but their successful completion implies meeting the FDA's expectations for mechanical scooters).
Technological Characteristics (similarity to predicate)	Very similar to the predicate: battery-operated, one motor, automatic braking systems, off-board battery chargers, can be disassembled for transport. Target population and use parameters are identical/similar. (Difference noted: controllers are different, but this was not deemed to raise new safety/effectiveness questions).

Study Information (as applicable to this device type)

Sample size used for the test set and the data provenance:
- N/A. This is a mechanical device. Performance testing involved physical tests on the scooter itself, not a "test set" in the data-driven sense. The document does not specify the number of units tested.
- Data provenance: The tests were "conducted and the results included in the submission." The country of origin for the testing is not specified, but the applicant is C.T.M. Homecare Product, Inc. in Chino, CA, and the contact is in Eugene, OR.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. Ground truth for a mechanical scooter primarily involves meeting engineering and safety specifications, which are assessed through direct physical testing and measurement, not expert review of data/images. The "ground truth" is adherence to established mechanical and electrical safety standards.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- N/A. Adjudication methods like 2+1 or 3+1 are used for reconciling discordant expert readings in diagnostic AI/software studies. This is not relevant for a mechanical scooter.
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:
- N/A. This is a mechanical mobility scooter, not an AI-assisted diagnostic or imaging device. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was conducted.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- N/A. This device does not have an "algorithm" in the context of AI/software performance. It is a physical product.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For a mechanical device like a scooter, the "ground truth" for performance is based on objective measurements from engineering tests and compliance with established performance standards and safety regulations (e.g., stability, braking effectiveness, speed, battery life, weight capacity). The summary states that "Tests listed in the Guidance Document... were conducted."
The sample size for the training set:
- N/A. This is a mechanical device, not an AI/software. There is no "training set" in the machine learning sense.
How the ground truth for the training set was established:
- N/A. As there is no training set, this question is not applicable.

Summary

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C.T.M. Mobility Scooter HS-515 510(k) Notification

K110567

510(k) SUMMARY

APR 2 2 2011

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

Contact name and address: Sheila Ramerman 927 Throne Drive Eugene, OR 97402 541-683-3017

2/24/2011 Date summary prepared:

Device name:

Proprietary name:	C.T.M. Mobility Scooter HS-515 or Leo
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 is the Victory Three Wheel Scooter, Model SC610 submitted by Pride Mobility Products Corp. and cleared for marketing under 510(k) * K072165.

Description of the device:

Intended use of device:

The C.T.M. Mobility Scooter HS-515 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-515 and the Victory Scooter are very similar. Both are battery operated, have one motor, and have automatic braking systems. Off-board battery chargers are provided with both scooters. Both scooters can be disassembled for transport. The target population is identical and the use parameters are similar. The controllers are different.

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.

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Performance testing:

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

Substantial Equivalence:

The HS-515 and the predicate device have the same regulatory classification and the same intended use, and similar technological characteristics. Non-clinical testing and specification comparison demonstrate that any differences in specifications or technology do not raise new questions of safety or effectiveness. The HS-515 is substantially equivalent to the predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a bird in flight.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

C.T.M. Homecare Product, Inc. % SJR Associates Ms. Sheila Ramerman 927 Throne Drive Eugene, Oregon 97402

APR 2 2 2011

Re: K110567

Trade/Device Name: C.T.M. Mobility Scooter HS-515 Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: Class II Product Code: INI Dated: February 25, 2011 Received: February 28, 2011-

Dear Ms. Ramerman:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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Page 2 - Ms. Sheila Ramerman

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 (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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 go to

http://www.fda.gov/MedicalDevices/Safety/Reportal?roblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address http://www.fda:gov/MedicalDevices/Resourcesfor You/Industry/default:htm:

Sincerely yours.

AS B. nh
for

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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C.T.M. Mobility Scooter HS-515 510(k) Notification

Indications for Use

510(k) Number (if known): ____________________

Device Name: C.T.M. Mobility Scooter HS-515

Indications for Use:

The C.T.M. Mobility Scooter HS-515 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 Surgical, Orthopedic, and Restorative Devices

510(k) Number K110567

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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).