The Future Mobility Healthcare Inc. Super Chair for Kids by Orion Wheelchair is intended to provide mobility to persons limited to a sitting position.

Device Description

The ORIONII, Zippie TS and Super Chair for Kids by Orion tilt in space wheelchairs are manually operated, self propelled mechanical wheelchairs, and may also be used as attendant propelled transport devices. They consist of mechanical steel frames for use by patients weighing up to 150 lbs.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the "Super Chair for Kids by Orion Tilt in Space mechanical wheelchair." This is a mechanical wheelchair, not an AI/ML-driven diagnostic or medical device that typically requires extensive acceptance criteria, performance studies, or ground truth establishment in the way the prompt describes.

The 510(k) submission process for this type of device focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, rather than establishing de novo performance metrics through clinical trials or complex diagnostic studies. Therefore, many of the requested categories (like sample size for test set, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, training set details) are not applicable to this specific submission.

Here's an analysis based on the provided document and the nature of a mechanical wheelchair 510(k):

1. Table of Acceptance Criteria and Reported Device Performance

For a mechanical wheelchair, "acceptance criteria" primarily relate to safety standards and functional equivalence to predicate devices, rather than diagnostic accuracy metrics.

Acceptance Criteria (Demonstrated Equivalence to Predicate)	Reported Device Performance (as demonstrated by equivalence)
Same Indications for Use: Providing mobility to persons limited to a sitting position.	The "Super Chair for Kids by Orion" is intended to provide mobility to persons limited to a sitting position, which is the same as the predicate devices (Zippie TS, ORION II).
Similar Key Design Technical Characteristics: Mechanical wheelchairs.	The "Super Chair for Kids by Orion" is a mechanical wheelchair, similar to the ORION II and Zippie TS.
Operational Mode: Manually operated, self-propelled, and/or attendant-propelled.	The "Super Chair for Kids by Orion" is a manually operated, self-propelled mechanical wheelchair, and can also be used as an attendant-propelled transport device, consistent with predicate devices.
Construction: Mechanical steel frames.	The "Super Chair for Kids by Orion" consists of mechanical steel frames.
Patient Weight Capacity: Up to 150 lbs.	Designed for use by patients weighing up to 150 lbs.
Motor Vehicle Transport Tie-Down Systems: Satisfy safety standards per ANSI/RESNA WC/Vol.1, Annex A of Section 19.	The "Super Chair for Kids by Orion" is designed with motor vehicle transport tie-down systems that satisfy safety standards in accordance with procedures set forth in Annex A of Section 19, ANSI/RESNA WC/Vol.1 Wheelchairs Used as Seats in Motor Vehicles (similar to Zippie TS).
Compliance with ISO 7176 standards: Parts 1, 5, 7, 8, 11, and 19.	The "Future Mobility HealthCare Super Chair for Kids by Orion folding mechanical wheelchair was developed in accordance with ISO 7176, parts 1, 5, 7, 8, 11 and 19." These standards cover aspects like general requirements, dimensions, static, impact and fatigue strength, and seating of wheeled mobility devices in motor vehicles. This demonstrates safety and effectiveness.
Material Equivalence (implicitly demonstrated by similar design)	Assumed to use materials comparable to predicate devices for safety and durability.

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

Not Applicable. This is a mechanical device, not a diagnostic algorithm. The "testing" involved demonstrating compliance with international standards (ISO 7176) and technical equivalence to existing devices. This typically involves engineering testing and comparison of specifications, not a "test set" of patient data.

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

Not Applicable. The concept of "ground truth" as it applies to diagnostic accuracy from expert interpretation is not relevant for a mechanical wheelchair. Device functionality and safety are assessed against engineering standards and comparison with predicate devices.

4. Adjudication Method for the Test Set:

Not Applicable. No human-interpreted "test set" in the diagnostic sense was involved.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size of how much human readers improve with AI vs without AI assistance:

Not Applicable. This device is a mechanical wheelchair, not an AI-driven diagnostic tool. No human readers or AI assistance are involved in its primary function.

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

Not Applicable. This device does not involve an algorithm.

7. The Type of Ground Truth Used:

For this type of device, the "ground truth" (or equivalent) is established by engineering standards compliance (ISO 7176) and the established safety and effectiveness of the legally marketed predicate devices. The claim of substantial equivalence is the "proof."

8. The Sample Size for the Training Set:

Not Applicable. This is a mechanical device, not an AI/ML algorithm that requires a "training set."

9. How the Ground Truth for the Training Set was Established:

Not Applicable. As there is no training set, there is no ground truth to establish for it.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study proving the device meets acceptance criteria is fundamentally a technical comparison and demonstration of compliance with recognized standards.

Nature of the "Study": This was not a clinical trial in the traditional sense, but rather a bench and engineering testing verification combined with a comparative analysis against predicate devices.
Methodology:
1. Technical Specification Comparison: The manufacturer compared the design, materials, intended use, and functional characteristics of the "Super Chair for Kids by Orion" to the predicate devices (Zippie TS and ORION II).
2. Standards Compliance Testing: The device was developed and tested in accordance with ISO 7176 standards (parts 1, 5, 7, 8, 11, and 19). These standards cover various aspects of wheelchair performance, safety, and durability (e.g., dimensions, static strength, impact strength, fatigue strength, and securement in motor vehicles). The report explicitly states, "Future Mobility HealthCare Super Chair for Kids by Orion folding mechanical wheelchair was developed in accordance with ISO 7176, parts 1. 5. 7. 8. 11 and 19."
3. Demonstration of Substantial Equivalence: The manufacturer argued that the device shared the same indications for use, similar key technical characteristics, similar operational modes (manual, self-propelled, attendant-propelled), similar construction (steel frames), equivalent weight capacity (up to 150 lbs), and met the same safety standards for motor vehicle transport tie-down systems (ANSI/RESNA WC/Vol.1 Annex A Section 19) as the predicate devices.
Conclusion: Based on this comparison and compliance with international standards, it was concluded that the "Super Chair for Kids by Orion" is safe and effective and substantially equivalent to the identified predicate devices. The FDA's 510(k) clearance (K103073) formally acknowledges this determination of substantial equivalence.

Summary

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JAN - 3 2010

K103073

Future Mobility Healthcare Inc. FDA Submittal - 510(k) SUPER CHAIR FOR KIDS BY ORION

510(k) Summary

Submitted by:

Future Mobility HealthCare Inc. 3223 Orlando Drive Mississauga, ON, LAV 1C5 Tel. (1-888-737-4011)

Contact:

Mr. Abdul Panchbhaya Toll Free: 1-888-737-4011, Local: 905-671-1661 abdul@future-mobility.com

Date: October 11, 2010

Trade Name: Super Chair for Kids by Orion Tilt in Space mechanical wheelchair

Common Name: Manual Wheelchair

Classification Name: Wheelchair, Mechanical

Predicate Devices:

LEGALLYMARKETEDPREDICATEDEVICES	MANUFACTURERNAME	REGULATORYCLASS ANDPRODUCT CODE	510(K)REGISTRATIONNUMBER
Zippie TS	Sunrise Medical	Class I/IOR	K890050 K973673
ORION II	Future MobilityHealthcare, Inc.	Class I/IOR	K061010

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Future Mobility Healthcare Inc. FDA Submittal - 510(k) SUPER CHAIR FOR KIDS BY ORION

The rational of declaring the Future Mobility Healthcare Super Chair for Kids by Orion is substantially equivalent to the above predicate devices is based on the following:

Same Indications for use: providing mobility to persons limited to a sitting position.
Similar key design technical characteristics- The ORIONII, Zippie TS and Super Chair for Kids by Orion are mechanical wheelchairs which have technical similarities.
The ORION II, Zippie TS and Super Chair for Kids by Orion tilt in space wheelchairs are manually operated, self propelled mechanical wheelchairs, and may also be used as attendant propelled transport devices. They consist of mechanical steel frames for use by patients weighing up to 150 lbs.
V The Zippie TS and the Super Chair for Kids by Orion are designed with motor vehicle transport tie down systems that satisfy safety standard in accordance with procedures set forth in Annex A of Section 19, ANSI/RESNA WC/Vol.1 Wheelchairs Used as Seats in Motor Vehicles.

Conclusion:

Future Mobility HealthCare Super Chair for Kids by Orion folding mechanical wheelchair was developed in accordance with ISO 7176, parts 1. 5. 7. 8. 11 and 19. It is the conclusion that the Future Mobility HealthCare Super Chair for Kids by Orion is safe and effective, as well as substantially equivalent to the legally marketed device identified as the predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

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

Future Mobility Healthcare, Inc. % Mr. Abdulsamad Panchbhaya 3223 Orlando Drive Mississauga. Ontario Canada L4V 1C5

JAN - 3 20.0

Re: K103073

Trade/Device Name: Future Mobility Healthcare Inc. Super Chair for Kids by Orion Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: Class I Product Code: IOR Dated: October 11, 2010 Received: October 18, 2010

Dear Mr. Panchbhaya:

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 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 or any Federal statutes and regulations administered by other Federal agencies. You must

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Page 2 - Mr. Abdulsamad Panchbhava

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/ReportaProblem/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.

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

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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Indication for Use

510(k) Number (if known): K163073

Device Name: Future Mobility Healthcare Inc. Super Chair for Kids by Orion

Indication for Use:

The Future Mobility Healthcare Inc. Super Chair for Kids by Orion Wheelchair is intended to provide mobility to persons limited to a sitting position.

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

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

JAN - 3 2010

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

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Concurrence of CDRH, Office of Devise Evaluation (ODE)

Koumer Plage

on of Surgical, Orthopedic, and Restorative Devices

510(k) Number K103073

Regulation Number and Section

§ 890.3850 Mechanical wheelchair.

(a)
Identification. A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class I (general controls).