The Quickie 2 HP, Stellato and Galaxy Lite folding wheelchairs are manually operated, self propelled mechanical wheelchairs, and may also be used as attendant propelled transport devices. They consist of folding mechanical aluminum frames for use by patients weighing up to 250 lbs.

AI/ML Overview

The provided document is a 510(k) summary for the Future Mobility Healthcare Inc. Galaxy Lite manual wheelchair. This type of medical device submission does not typically involve the kind of performance studies or acceptance criteria you've requested that are common for AI/ML or diagnostic devices.

Instead, the submission focuses on demonstrating "substantial equivalence" to predicate devices based on indications for use, design characteristics, and compliance with recognized standards.

Therefore, I cannot provide the specific details you've asked for regarding acceptance criteria, sample sizes, expert ground truth, MRMC studies, or standalone performance, as these are not relevant to this type of device submission.

Here's what I can extract from the document regarding the device and its compliance:

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

The document does not specify quantitative acceptance criteria in terms of performance metrics like sensitivity, specificity, or accuracy, as would be seen for AI/ML or diagnostic devices. Instead, the "acceptance criteria" are implied by adherence to established standards and similarity to predicate devices.

Acceptance Criteria (Implied)	Reported Device Performance/Compliance
Indication for Use Equivalence: Provide mobility to persons limited to a sitting position.	Same Indications for use: "providing mobility to persons limited to a sitting position."
Technical Characteristics Equivalence: Similar design, manual operation, self-propelled/attendant-propelled.	Similar key design technical characteristics: "The Quickie 2 HP, Stellato and Galaxy Lite are mechanical wheelchairs which have technical similarities. The Quickie 2 HP and Galaxy Lite contain an adjustable rear wheel location and provide similar performance. The Quickie 2 HP, Stellato and Galaxy Lite folding wheelchairs are manually operated, self propelled mechanical wheelchairs, and may also be used as attendant propelled transport devices. They consist of folding mechanical aluminum frames..."
Patient Weight Limit Equivalence: Accommodate patients up to 250 lbs.	Used by patients weighing up to 250 lbs. (Matches description of predicate devices.)
Safety and Effectiveness Standards Compliance: Developed in accordance with relevant ISO standards.	Compliance with ISO 7176: "Future Mobility HealthCare Galaxy Lite folding mechanical wheelchair was developed in accordance with ISO 7176, parts 1, 5, 7, 8 and 11." (These parts relate to dimensional characteristics, test methods for stability, determination of seating and wheel dimensions, static, impact and fatigue strengths, and test dummies, among others, for wheelchairs).

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

This information is not provided because it's not applicable to a 510(k) submission for a mechanical wheelchair based on substantial equivalence and standards compliance. There isn't a "test set" in the sense of a dataset for algorithmic evaluation. The "testing" refers to physical product testing against ISO standards.

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. Ground truth for a test set is specific to diagnostic or AI/ML performance evaluation, not to a mechanical device's substantial equivalence.

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

Not applicable.

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

Not applicable. This type of study is for evaluating human-AI interaction in diagnostic tasks, which is not relevant to a manual wheelchair.

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

Not applicable. There is no algorithm in this mechanical device.

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

Not applicable. For this device, "ground truth" would relate to the physical properties and performance of the wheelchair as measured against engineering standards (e.g., stability, strength), rather than a diagnostic outcome.

8. The sample size for the training set

Not applicable. This device does not use a "training set" for an algorithm.

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

Not applicable.

Summary

{0}------------------------------------------------

K102031

Future Mobility Healthcare Inc. FDA Submittal - 510(k) GALAXY LITE

510(k) Summary

Submitted by:

OCT 2 0 2010

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: July 7, 2010

Trade Name: Galaxy Lite Folding mechanical wheelchair

Common Name: Manual Wheelchair

Classification Name: Wheelchair, Mechanical

Predicate Devices:

LEGALLYMARKETEDPREDICATEDEVICES	MANUFACTURERNAME	REGULATORYCLASS ANDPRODUCT CODE	510(K)REGISTRATIONNUMBER
Quickie 2 HP	Motion Design Inc(Sunrise MedicalDesign Inc)	Class I/IOR	K890050
Stellato	Future MobilityHealthcare, In.	Class I/IOR	K061010

{1}------------------------------------------------

Future Mobility Healthcare Inc. FDA Submittal - 510(k) GALAXY LITE

The rational of declaring the Future Mobility Healthcare Galaxy Lite 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 Quickie 2 HP, Stellato and Galaxy Lite > are mechanical wheelchairs which have technical similarities. The Quickie 2 HP and Galaxy Lite contain an adjustable rear wheel location and provide similar performance.
The Quickie 2 HP, Stellato and Galaxy Lite folding wheelchairs are manually operated, self propelled mechanical wheelchairs, and may also be used as attendant propelled transport devices. They consist of folding mechanical aluminum frames for use by patients weighing up to 250 lbs.

Conclusion:

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

{2}------------------------------------------------

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 caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus.

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

Future Mobility HealthCare Inc. % Mr. Abdul Panchbhaya President & CEO 3223 Orlando Drive Mississauga, Ontario Canada L4V 1C5

OCT 2 0 2010

Re: K102031

Trade/Device Name: Future Mobility Healthcare Inc. Galaxy Lite Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: Class I Product Code: IOR Dated: September 3, 2010 Received: September 3, 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.

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 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

{3}------------------------------------------------

Page 2 - Mr. Abdul Panchbhaya

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, "Mishranding 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark N. Millians

Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Indication for Use

510(k) Number (if known):	K102031
	OCT. 20 2010
Device Name:	Future Mobility Healthcare Inc. Galaxy Lite
Indication for Use:
The Future Mobility Healthcare Inc. Galaxy Lite Wheelchair is intended to provide mobility to persons limited to a sitting position.

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 IF NEEDED)

Concurrence of CDRH, Office of Devise Evaluation (ODE)

..............................................................................................................................................................................

Kammel D. Taylor

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

102031 K 510(k) Number ــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــ

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).