The AIR, Inc. Model "Flight" mechanical wheelchair is an indoor/outdoor wheelchair that has a base with two larger rear wheels and two smaller front wheels and a seat. The device can be easily folded for transport.

AI/ML Overview

The provided 510(k) summary for the "Flight" mechanical wheelchair describes a performance study aimed at demonstrating substantial equivalence to a predicate device. This is largely based on compliance with voluntary standards rather than a typical clinical performance study for an AI-powered diagnostic device.

Here's an analysis of the acceptance criteria and the study, structured to address your specific points:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance	Comments
Voluntary Standards (Performance)	ANSI/RESNA WC Vol 1: Applicable standards for mechanical wheelchairs	Meets applicable ANSI/RESNA standards	This is a general statement that the device meets the relevant standards. Specific numerical values for the standards are not provided in this document.
Voluntary Standards (Safety/Flammability)	ANSI/RESNA WC Vol 1, Section 16: Determination of flammability	Upholstery meets ANSI/RESNA WC Vol 1, Section 16	Confirms compliance with a specific safety standard related to upholstery flammability.
Intended Use Equivalence	Same intended use as predicate device	"Model Flight Mechanical Wheelchairs are indicated for providing mobility to persons limited to a sitting position." (Matches predicate)	The primary indication for use is identical to that of the predicate device, demonstrating functional equivalence.
Physical Characteristics Equivalence	Comparable weight bearing capacity	"Both devices have the same weight bearing capacity"	Directly states equivalence in a key performance aspect.
Functionality Equivalence	Foldable for transportation/stowage	"both devices are foldable for transportation or stowage"	Directly states equivalence in a key functional aspect.
Dimensional Similarity	Overall dimensions similar to predicate	"The overall dimensions are similar."	A qualitative assessment of similarity.
Safety Differences	Differences between new device and predicate are not safety-related	"The differences between the new device and the predicate are chiefly in the frame materials and in overall dimensions. These differences are not safety related"	A critical assertion for demonstrating substantial equivalence.

Note: This 510(k) summary is for a mechanical wheelchair, not an AI/diagnostic device. Therefore, the concept of "device performance" here relates to meeting engineering and safety standards, and functional equivalence, rather than diagnostic accuracy metrics like sensitivity or specificity.

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

Sample Size for Test Set: Not applicable in the context of this 510(k). The "performance testing" described refers to engineering tests against specified standards rather than a clinical trial with a "test set" of patient data. The device itself (one or more units of the Flight wheelchair) would be the "test subject" for these engineering tests.
Data Provenance: Not applicable. The "data" comes from engineering tests performed on the physical device, not from patient populations or clinical data.

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

Not applicable. Ground truth, in the context of a diagnostic device, typically refers to a definitive diagnosis or outcome. For a mechanical wheelchair, the "ground truth" for its performance is determined by whether it physically meets the specified engineering standards (e.g., strength, durability, flammability under controlled test conditions). This doesn't involve human expert interpretation of patient data to establish ground truth.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1 or 3+1) are used to resolve discrepancies in expert interpretation of clinical data. Since this involves engineering tests rather than clinical data interpretation, adjudication is not relevant.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. MRMC studies are typically performed for diagnostic devices to assess the impact of a new technology (like AI) on physician performance. The "Flight" wheelchair is a mechanical device, and its evaluation focuses on engineering compliance and functional equivalence, not on improving human reader performance.

Effect size of how much human readers improve with AI vs. without AI assistance: Not applicable, as this is not an AI-assisted diagnostic device.

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

Yes, in a sense, a "standalone" evaluation was done. The "Flight" mechanical wheelchair was tested on its own to determine if it met the specified ANSI/RESNA standards. This is an evaluation of the device's inherent physical performance characteristics, independent of human interaction beyond operating the test equipment.

7. The Type of Ground Truth Used

The "ground truth" for the performance claims of the "Flight" mechanical wheelchair is based on engineering standards and specifications. The device is tested against predefined metrics and procedures outlined in documents like ANSI/RESNA WC Volume 1, Section 16 (for flammability) and other applicable standards for mechanical wheelchairs. Successful completion of these tests, demonstrating compliance with the numerical and qualitative requirements of the standards, constitutes the "ground truth" that the device performs as intended and meets safety requirements.

8. The Sample Size for the Training Set

Not applicable. The "Flight" mechanical wheelchair is a physical product, not an AI algorithm that requires a "training set" of data to learn from. Its design and manufacturing are based on engineering principles and material science, not machine learning.

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

Not applicable, as there is no training set for this type of device.

Summary

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Ko6//86

510(k) Summary MAY 12 2006 of Safety and Effectiveness

GENERAL INFORMATION A.

	1. Submitter's Name:	Aero Innovative Research, Inc.
--	----------------------	--------------------------------

1. Address:

Contact Person:

Date prepared:

Registration Number:

500 W. Clay Street Valley Center, KS 67147 Matt Cochran March 6, 2006 Applied For

B. DEVICE

1. Proprietary or Trade Name:	Flight
2. Common Name:	Mechanical Wheelchair
3. Classification Name:	Wheelchair, Mechanical
4. Classification Panel:	Physical Medicine
5. Product Code(s):	IOR
6. Class for New Device:	Class I
7. Regulation Number:	890.3850

C. INDICATIONS FOR USE

Model Flight Mechanical Wheelchairs are indicated for providing mobility to persons limited to a sitting position.

DESCRIPTION OF THE DEVICE D.

PERFORMANCE TESTING E.

The "Flight" mechanical wheelchair meets the applicable voluntary ANSI/RESNA standards for mechanical wheelchairs. The upholstery meets ANSI/RESNA WC Volume 1, Section 16: Determination of flammability.

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LEGALLY MARKETED DEVICE FOR SUBSTANTIAL F. EQUIVALENCE COMPARISON

1.	Manufacturer:	Otto Bock, LP
	2. Model:	Start Basic
	3. Cleared under:	K052681
	4. Date Cleared:	October 6, 2005
	5. Class:	Class I
	6. Regulation Number	890.3850
	7. Product Code(s):	IOR

SUMMARY OF SUBSTANTIAL EQUIVALENCE G. COMPARISON

The new device and the predicate device have the same intended use. Both devices have the same weight bearing capacity and both devices are foldable for transportation or stowage. The overall dimensions are similar. The differences between the new device and the predicate are chiefly in the frame materials and in overall dimensions. These differences are not safety related, so the new device is substantially equivalent to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" are arranged in a circular pattern around the caduceus.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 2 2006

Aero Innovative Research,Inc c/o Ms. Silvia Ankova Underwriters Laboratories, Inc. 333 Pfingsten Rd. Northbrook, Illinois 60062

Re: K061186

Trade/Device Name: Flight Regulation Name: Mechanical Wheelchair Regulatory Class: I Product Code: IOR Dated: April 24, 2006 Received: April 28, 2006

Dear Ms. Ankova:

We have reviewed your Section 510(k) premarket notification of intent to market the device w on re is 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 for associated in the 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. This letter will allow you to begin marketing your device as described in your Section 510(k)

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Page 2- Mr. Mark W. Sheehan

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/industry/support/index.html.

Sincerely yours,

Mark N. Millhiser

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

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510(k) No. If known

Indications For Use statement

Device Name:

Flight

Indications For Use:

Model Flight Mechanical Wheelchairs are indicated for providing mobility to persons limited to a sitting position.

Prescription Use	AND/OR	Over-The-Counter Use	X
(Per 21 CFR 801 Subpart D)		(Per 21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign-Off)

Division of General, Restorative

and Neurological Devices

(510(k)) Number	K061186
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Air, Inc.
Flight 510(k)

March 6, 2006

11/2 1998 11: 11:48 10:5

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).