The Future Mobility HealthCare Orion II wheelchair is a compact tilt-in-space wheelchair offering 45° of tilt, 30° of recline and adjustable seat-to-floor heights of 12 3/4' to 19". It consists of rigid, mechanical, steel frame and upholstery that meets the California Technical Bulletin CAL 117 standard for flame retardant. It has two rear wheels (12", 20", 22" or 24" in diameter) and two front casters (4", 5", 7" or 8" in diameter) for turning and maneuverability.

AI/ML Overview

This submission for the Future Mobility HealthCare Inc. Orion II Wheelchair is a 510(k) premarket notification. A 510(k) submission primarily demonstrates substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific performance acceptance criteria through the kind of detailed study data you're asking for in points 2-9.

Therefore, most of the information requested in your prompt (e.g., sample size for test set, number of experts for ground truth, MRMC studies, standalone performance) is not applicable to this type of regulatory submission for this device. The document provided does not contain a study of the type you describe.

Here's an analysis based on the information provided, fitting it to your requested structure where possible, and noting where the information is absent or not applicable due to the nature of a 510(k) for a mechanical wheelchair:

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) of a mechanical wheelchair, "acceptance criteria" are generally tied to demonstrating equivalence in design, materials, and intended use as compared to a predicate device. Performance is assessed through compliance with recognized standards.

Acceptance Criteria (Inferred from 510(k) for EQ)	Reported Device Performance and Compliance
Indications for Use: Provide mobility to persons limited to a sitting position.	Orion II: Intended to provide mobility to persons limited to a sitting position. (Matches predicate)
Key Design/Technical Characteristics: Tilt and recline capabilities (45° tilt, 30° recline), adjustable back angle, similar seat depth/widths.	Orion II: Offers 45° of tilt, 30° of recline, adjustable seat-to-floor heights (12 ¾" to 19"). Described as having a rigid, mechanical, steel frame. (Stated to be similar to predicate - Invacare Concept 45)
Materials: Resistance-ignitability fabric, meeting California Technical Bulletin CAL 117 for flame retardancy.	Orion II: Upholstery meets California Technical Bulletin CAL 117 standard for flame retardant. (Stated to be similar to predicate)
Safety and Effectiveness: Comparable risks, safety, and effectiveness to predicate.	Orion II: Stated that "The risks, safety or effectiveness and benefits for the Future Mobility HealthCare Orion II are also comparable." (This is a claim made in the submission, not a detailed performance report). The device was developed based on ANSI/RESNA Wheelchair Vol.1, which involves ISO 7176 standards, indicating adherence to general safety and performance guidelines for wheelchairs.
Size, Weight, and Performance: Similar to predicate.	Orion II: Claimed "Similar size, weight, and performance" to the Invacare Concept 45 Medical device. (No specific values provided in this summary to compare)
Regulatory Class & Product Code: Class I / IOR	Orion II: Classified as Class I / IOR, consistent with the predicate.

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 / Not provided. This 510(k) summary does not describe a clinical performance study with a test set of patients or data in the way you might find for an AI/diagnostic device. The "test" for a mechanical wheelchair 510(k) involves demonstrating mechanical equivalence and adherence to engineering standards (like ANSI/RESNA, ISO 7176).

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 / Not provided. As there is no clinical performance study with "ground truth" to establish for a mechanical wheelchair 510(k). Ground truth in this context would typically relate to a diagnostic outcome, which is not relevant here.

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

Not applicable / Not provided. See point 3.

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. MRMC studies are relevant for diagnostic/AI devices. This is a mechanical wheelchair.

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

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

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

Not applicable / Not provided in this context. The "ground truth" for a mechanical device's safety and effectiveness relies on engineering standards, material specifications, and mechanical testing to ensure the components perform as intended (e.g., tilt mechanism holds weight, frame doesn't fail). These tests are typically outlined in the full 510(k) submission but are not detailed in this summary.

8. The sample size for the training set

Not applicable / Not provided. As there is no "training set" for a mechanical wheelchair undergoing a 510(k) for substantial equivalence.

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

Not applicable / Not provided. See point 8.

Summary of the Basis for Substantial Equivalence (as reported in the document):

The Orion II Wheelchair's substantial equivalence to the Invacare Concept 45 Wheelchair is based on:

Same Indications for Use: Both provide mobility to persons limited to a sitting position.
Similar Key Design Technical Characteristics: Both are mechanical wheelchairs with tilt (45°) and recline (30°) capabilities, adjustable back angles, and similar seat depth and widths.
Similar Size, Weight, and Performance: A general claim of similarity.
Similar Materials: Both use resistance-ignitability fabric meeting California Technical Bulletin CAL 117 for flame retardant standards.
Compliance with Standards: The Orion II was developed based on ANSI/RESNA Wheelchair Vol.1, which involves ISO 7176 standards.

The FDA's decision to clear the device (K061010) confirms their agreement that the provided information demonstrates substantial equivalence to the predicate device, allowing it to be marketed.

Summary

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Koloio

Future Mobility HealthCare FDA Submittal ORION II

SECTION 2.0 SUMMARY OF THE BASIS FOR SUBSTANTIAL EQUIVALENCE

MAY 2 3 2006

510(k) Summary

Submitter:

Future Mobility HealthCare Inc. 2775 Slough Street Mississauga, ON, L4T 1G2 Tel. (1-888-737-4011)

Contact:

Mr. William Salter Toll Free: 1-888-737-4011, Local: 905-671-1661 wtsalter@future-mobility.com

Date: December 12, 2005

Trade Name: Orion II Tilt-in-space wheelchair

Common Name: Wheelchair

Classification Name: Wheelchair, Mechanical

Predicate Devices:

We are making the claim that the Future Mobility Orion II is substantial equivalent to the predicated device listed in the chart below.

LEGALLYMARKETEDPREDICATE DEVICE	MANUFACTURENAME	REGULATORYCLASS ANDPRODUCTCODE	510(K)REGISTRATIONNUMBER
Concept 45	INVACARECORP.	Class I/IOR	K951138

The rationale of declaring the new Future Mobility HealthCare Orion II is substantial equivalent to the above predicate device is based on the following:

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Same Indications for use: providing mobility to persons limited to a sitting position.
Similar key design technical characteristics- The Invacare Concept 45 Medical device and the Orion II are mechanical wheelchairs which have technical similarities such as a tilt, and recline capabilities. Both devices contain an adjustable back angle and provide similar seat depth and widths.
Similar size, weight, and performance. >

Description:

Indications for Use:

The Orion II is indicated for providing mobility to persons limited to a sitting position.

Technological Comparison to the Predicate:

Technologically, the Future Mobility HealthCare Orion II wheelchair is substantially equivalent to the Invacare Concept 45 wheelchair. Both devices are compact tilt-nspace chairs which have the same indicated intended use with at least a 45 degree tilt and 30 degree recline option. Both material used are resistance- ignitability fabric and also meets the California Technical Bulletin CAL 117 standard for flame retardant. The risks, safety or effectiveness and benefits for the Future Mobility HealthCare Orion II are also comparable. The table of Comparison in Section 6.1 will provide additional information illustrating that the new Future Mobility HealthCare Orion II wheelchair is substantially equivalent to the Invacare Concept 45 wheelchair.

Conclusion:

Future Mobility HealthCare Orion II wheelchair was developed based on the standard ANSI/RESNA Wheelchair Vol.1 which involves ISO 7176. It is the conclusion that the Future Mobility HealthCare ORION II is safe and effective, as well as substantially equivalent to the device identified 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 and Human Services. The logo features a stylized eagle with three wing segments, representing the department's commitment to health, human services, and well-being. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged around the left side of the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 3 2006

Future Mobility HealthCare, Inc. % Mr. William Salter President & CEO 2775 Slough Street Mississauga, Ontario, L4T 1G2

Re: K061010

Trade/Device Name: Future Mobility HealthCare Inc. Orion II Wheelchair Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: I Product Code: IOR Dated: April 6, 2006 Received: April 12, 2006

Dear Mr. Salter:

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

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Page 2 - Mr. Bob Gardner

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. 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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Herbert Lehman

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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DC. Future Mobility HealthCare FDA Submittal ORION II

Indications for Use

061010 510(k) Number (if known

Device Name: Future Mobility HealthCare Inc. Orion II Wheelchair

Indications for Use:

The Future Mobility HealthCare Inc. Orion II 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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices

510(k) Number K061010

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).