The ORION II Medical device and the Orion (Heavy Duty 350lbs and 500lbs) are mechanical wheelchairs which have technical similarities such as a tilt, and recline capabilities. Both devices contain an adjustable back angle and provide similar performance. The modifications consist of wider frames with a reinforced design to withstand the higher weight capacities of 350lbs and 500lbs. This modification is intended to allow the weight capacity of the wheelchair to increase from 250lbs to 350lbs for the additional widths ranging from 21" to 24", and to 500lbs for additional widths ranging from 24" to 32".

AI/ML Overview

The provided text describes a 510(k) summary for a medical device, specifically a modified manual wheelchair (ORION II Heavy Duty). It focuses on demonstrating substantial equivalence to a predicate device based on similar indications for use, design characteristics, and compliance with recognized standards.

However, the provided text does not contain information about acceptance criteria or a study proving the device meets specific performance metrics in the context of an AI/algorithm-driven device. The submission is for a mechanical wheelchair, and the "study" referred to is the demonstration of compliance with ISO 7176 standards for wheelchairs.

Therefore, most of the requested information regarding AI/algorithm performance (such as sample sizes for test/training sets, experts for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth types) is not applicable to this document.

Here's a breakdown based on the available information:

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

Acceptance Criteria (Demonstrated Compliance)	Reported Device Performance
Similar Indications for Use	Provides mobility to persons limited to a sitting position (Same as predicate)
Similar Key Design Technical Characteristics	Mechanical wheelchair with tilt and recline capabilities, adjustable back angle, similar performance (Similar to predicate)
Withstand higher weight capacities	Modified with wider frames and reinforced design to withstand 350lbs (for 21"-24" widths) and 500lbs (for 24"-32" widths). This is an improvement over the original 250lbs capacity.
Compliance with ISO 7176 standards	Developed and concluded to be safe and effective in accordance with ISO 7176, parts 1, 5, 7, 8, and 11.
Substantial Equivalence to Predicate Device	Determined substantially equivalent to the ORION II Wheelchair (K061010) (FDA-reviewed).

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

Not applicable. This submission is for a mechanical wheelchair, not an AI/algorithm-driven device that would typically have a "test set" in the context of data evaluation. The "test" involved demonstrating compliance with ISO standards through engineering design and potentially physical testing, not data analysis.

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 in the context of expert consensus is not relevant for this mechanical device submission. Compliance with ISO standards likely involves engineers and quality assurance personnel.

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

Not applicable. Adjudication methods are not relevant for this type of device submission.

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 is a mechanical device, not an AI-assisted diagnostic or treatment system.

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

Not applicable. This is a mechanical device, not an algorithm.

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

For compliance with ISO 7176 standards, the "ground truth" would be the engineering specifications, test protocols, and performance requirements outlined in those standards. The device's performance is measured against these established benchmarks.

8. The sample size for the training set

Not applicable. This is a mechanical device.

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

Not applicable. This is a mechanical device.

Summary of the "Study" (Compliance Demonstration):

The "study" or demonstration of the device meeting acceptance criteria for this mechanical wheelchair involves:

Engineering Design and Analysis: The modifications to the ORION II (wider frames, reinforced design) were specifically engineered to allow for higher weight capacities (350lbs and 500lbs) compared to the predicate device's 250lbs.
Compliance with Recognized Standards: The core of the demonstration is the declaration that the device was "developed in accordance with ISO 7176, parts 1, 5, 7, 8 and 11." These are international standards for wheelchairs that specify requirements and test methods for aspects such as:
- ISO 7176-1: Determination of static stability
- ISO 7176-5: Determination of dimensions, mass, and manoeuvring space
- ISO 7176-7: Seating and wheel dimensions
- ISO 7176-8: Requirements and test methods for static, impact and fatigue strengths
- ISO 7176-11: Test dummies
  This compliance indicates that the wheelchair underwent various tests (e.g., static stability, strength, fatigue) and met the specified performance criteria outlined in these standards for its stated weight capacities.
Substantial Equivalence Argument: The entire submission serves as a "study" to prove substantial equivalence to the predicate device (ORION II Wheelchair K061010) by comparing indications for use, technological characteristics, and demonstrating that any differences (like increased weight capacity) do not raise new questions of safety or effectiveness, particularly given the compliance with relevant ISO standards.

In essence, the "study" for this mechanical device is a combination of design validation, engineering testing, and adherence to established international performance and safety standards, rather than a clinical trial or algorithmic performance evaluation.

Summary

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Future Mobility Healthcare Inc.

K101277
JUN-4 2010

Future Mobility He Ilthcare Inc. FDA Submittal - SPE CIAL 510(k) ORION II (Heavy Duty 35015 and 500lbs)

510(k) Summary

Submitted by:

Future Mobility HealthCare Inc. 3223 Orlando Drive Mississauga, ON, L4V 1C5 Tel. (1-888-737-4011)

Contact:

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

Date: March 26, 2010

Trade Name: ORION 11 (Heavy Duty 350lbs and 500lbs) mechanical wheelcha

Common Name: Manual Wheelchair

Classification Name: Wheelchair, Mechanical

Predicate Device:

We are making the claim that the modified ORION 11 (Heavy Duty 350Ibs and S Olbs) is substantially equivalent to the prodicated device listed in the chart bclow.

LEGALLYMARKETEDPREDICATEDEVICE	MANUFACTURENAME	REGULATORYCLASS ANDPRODUCT CODE	510(K)REGISTRATIONNUMBER
ORION IIWheelchair	Future MobilityHealthcare Inc.	Class I/IOR	K061010

The rationale of declaring the modified Future Mobility HealthCare Orion 11 (He ivy Duty 350lbs and 500lbs) is substantial equivalent to the above predicate device is base on the following:

Same Indications for use: providing mobility to persons limited to a sitting p sition.

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Future Mobility Healthcare Inc.FDA Submittal - SPECIAL 510(k)ORION II (Heavy Duty 350lbs and 500lbs)
✓ Similar key design technical characteristics- The ORION II Medical device and the Orion(Heavy Duty 350lbs and 500lbs) are mechanical wheelchairs which have technicalsimilarities such as a tilt, and recline capabilities. Both devices contain an adjustable backangle and provide similar performance.
✓ The modifications consist of wider frames with a reinforced design to withstand the higherweight capacities of 350lbs and 500lbs. This modification is intended to allow the weightcapacity of the wheelchair to increase from 250lbs to 350lbs for the additional widthsranging from 21" to 24", and to 500lbs for additional widths ranging from 24" to 32".
Conclusion:Future Mobility HealthCare Orion II (Heavy Duty 350lbs and 500lbs) wheelchair wasdeveloped in accordance with ISO 7176, parts 1, 5, 7, 8 and 11. It is the conclusionthat the Future Mobility HealthCare ORION II (Heavy Duty 350lbs and 500lbs) issafe and effective, as well as substantially equivalent to the legally marketed deviceidentified as the predicate device.

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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 features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem.

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

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

JUN - 4 2010

Re: K101277

Trade/Device Name: Future Mobility Healthcare Inc. ORION II (Heavy Duty 3501bs and 500lbs)

Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: I Product Code: IOR Dated: April 26, 2010 Received: May 6, 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 comply with all the Act's requirements, including, but not limited to: registration and listing (21

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Page 2 - Mr. Abdulsamad Panchbhaya

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/CDRHQffices/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/ReportalProblem/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,

for

Mark N. Melkerson

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):

Device Name: Future Mobility Healthcarc Inc. ORION II (Heavy Duty 350lbs) nd 5001bs)

Indication for Use:

To provide mobility to persons limited to a sitting position.

Prescription Usc

AND/OR

Over-The-Counter Usc

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(Part 21 CFR 801 Subpart D)

(21 CFR 801 Subpart C

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

Concurrence of CDRH, Office of Devise Evaluation (ODE)

Signature Sign Off

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K101277

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).