C.T.M. POWER CHAIR, MODEL HS-1500 by C.T.M. HOMECARE PRODUCT, INC.

The C.T.M. Power Chair HS-1500 is an indoor/outdoor powered wheelchair that is battery operated. It has a base with four wheels, a padded seat with adjustable armrests, and a controller attached to one armrest which allows the rider to control the movement of the chair. It can be disassembled for transport and is provided with an on-board battery charger.

AI/ML Overview

This document, K073686, describes a 510(k) submission for a powered wheelchair, the C.T.M. Power Chair HS-1500. This type of device does not typically involve the kinds of studies and acceptance criteria commonly associated with AI/ML-based medical devices or diagnostic tools. Therefore, much of the requested information regarding AI/ML study design, ground truth, and expert evaluation is not applicable or available in this submission.

Here's a breakdown based on the provided text, addressing the points where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

The submission states: "Tests 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 included in the submission."

However, the specific acceptance criteria (e.g., maximum speed, turning radius, battery life, weight capacity, stability, braking performance) and the reported performance results against these criteria are not detailed in this summary document. They would have been part of the more extensive 510(k) submission not included here.

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

This information is not provided in the summary. For a physical device like a wheelchair, "test set" would refer to the units of the product that underwent performance and safety testing. The number of units tested is not stated, nor is the provenance of the data (e.g., in-house testing, third-party lab). The testing appears to be physical performance and safety testing of the device itself, not data-driven evaluations.

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

Not applicable. For a powered wheelchair, "ground truth" would refer to established engineering standards, safety regulations, and performance specifications from the relevant guidance documents (as mentioned in the text). There isn't "ground truth" in the sense of expert annotation of medical images or other data for an AI algorithm. The performance is assessed against predefined physical and mechanical thresholds.

4. Adjudication Method for the Test Set

Not applicable. This concept pertains to resolving discrepancies in expert opinions or data labels, which is not relevant for the type of testing described for a powered wheelchair.

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

No. The submission explicitly states: "Comparative performance testing and clinical evaluations were not submitted as part of this 510(k)." MRMC studies are typically used to evaluate the impact of AI on human reader performance, which is not relevant for this device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. There is no AI algorithm being evaluated for this medical device. The device is a physical powered wheelchair.

7. The Type of Ground Truth Used

The "ground truth" implicitly used would be adherence to the safety and performance standards outlined 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." This would encompass physical measurements, load testing, endurance testing, braking tests, stability tests, etc. No "expert consensus," "pathology," or "outcomes data" in the typical AI context are mentioned for establishing ground truth for this device.

8. The Sample Size for the Training Set

Not applicable. This device is a physical product, not an AI/ML algorithm. There is no "training set" in the context of machine learning.

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

Not applicable, as there is no training set for an AI algorithm.

In Summary:

The K073686 submission is for a traditional medical device (a powered wheelchair) seeking substantial equivalence to a predicate device. The evaluation focuses on meeting established physical and mechanical performance standards and safety requirements rather than on the performance of a diagnostic algorithm or AI system. Therefore, most of the detailed questions regarding AI/ML study design are not addressed in this document.

Summary

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K073686

510(k) SUMMARY

FES 27 - -

Submitter's name:	C.T.M. Homecare Product, Inc.
	13825 Norton Ave., Chino, CA 91710

Linda J. Bovard, Bovard Consulting, LLC, Eugene, OR Contact name: (541) 345-5431

Date summary prepared: December 24, 2007

Device name:

Proprietary name: C.T.M. Power Chair HS-1500 Common or usual name: Power chair Classification name: Powered wheelchair (890.3860). Powered wheelchair (89 ITI)

Legally marketed device for substantial equivalence comparison:

The predicate device for this submission is the Alanté submitted by Golden Technologies, Inc. and cleared for marketing under 510(k) *K011153.

Description of the device:

Intended use of device:

The C.T.M. Power Chair HS-1500 is an indoor/outdoor powered wheelchair that provides transportation for a disabled or elderly person.

Technological characteristics:

The device features of the C.T.M. Power Chair HS-1500 and the Alanté are very similar. Both are battery operated, have two motors, and have automatic braking systems. Battery chargers are provided with both wheelchairs, but the HS-1500 charger is onboard. Both power chairs can be disassembled for transport, but the HS-1500 does not require any tools. 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 Powered Wheelchairs, 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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The text is in all caps and is evenly spaced around the circle.

FEB 2 7 2008

Food and Drug Administration

Public Health Service

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

Re: K073686

Trade/Device Name: C.T.M. Power Chair HS-1500 Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: Class II Product Code: 89ITI Dated: December 24, 2007 Received: December 28, 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, 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.

9200 Corporate Boulevard Rockville MD 20850

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Page 2 - Ms. Linda J. Bovard

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 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 postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 Mulhusan

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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C.T.M. Power Chair HS-1500 510(k) Notification

Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: C.T.M. Power Chair HS-1500

Indications for Use:

The C.T.M. Power Chair HS-1500 is an indoor/outdoor powered wheelchair 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) l Vivision of General, Restorative, and Neurological Devices

10(k) Number

16736 YL

Regulation Number and Section

§ 890.3860 Powered wheelchair.

(a)
Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class II (performance standards).