The GEN 2 mechanical wheelchair is a highly adaptable all-purpose wheelchair created for use in developing countries, while allowing for a healthy, personalized fit. The wheelchair features adjustable seating, large castor wheels, an extra-thick cushion and adjustable footrests.

AI/ML Overview

This is a 510(k) premarket notification for a mechanical wheelchair, not an AI/ML device. Therefore, the requested information regarding acceptance criteria and study details relevant to AI/ML device performance (like sample size for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance) is not applicable or present in the provided text.

The document discusses the substantial equivalence of the GEN 2 Mechanical Wheelchair to a predicate device based on design, materials, intended use, and non-clinical performance data against international standards for mechanical wheelchairs.

Here's the relevant information that can be extracted:

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

The document doesn't present a table of "acceptance criteria" in the typical sense for a pass/fail study like an AI/ML device. Instead, it compares the technological characteristics of the GEN 2 wheelchair to a predicate device (Ki Mobility Catalyst Wheelchair) to establish substantial equivalence.

Feature	Catalyst (Predicate Device)	GEN 2 (Proposed Device)
Intended Use	As a means of mobility for persons restricted to a sitting position.	To provide mobility to persons restricted to a seated position.
Frame material	6061-T6 Aluminum	Powder coated steel frame that meets ASTM A 53/A 53M-2005 and JIS G 3444-2004 standards
Frame widths	14-20"	13.5-19.5"
Overall widths	20.5-26.5"	29"
Seat depths	14-20"	11.5-17"
Back heights	8.5-19"	11.8-19"
Weight limit	220 lbs	220 lbs
Chair weight	23 lbs (without footrests)	36 lbs (with footrests)
Armrests	Flip back height adjustable desk and full length arm pads. Tubular swing-away.	Fixed in place to serve as armrests but not to restrict transfers.
Front end type	Swing-away, non-swing-away	Swing-away
Back type	Standard	Standard
Footrest hangers	70°, elevating leg rest	NA
Footplates	Composite, foam, angle adjustable	Polypropylene, 280 mm adjustable range with angles adjustable to 0, ± 7°, ± 14°, and ± 21°.
Extension tubes	Extra short, short, med, long	NA
Back upholstery	Low, med, tall, adjustable	Adjustable to 4 different heights
Axle plates	Standard, curved, amputee, offset	NA
Wheel sizes	22, 24, 26	26"
Wheel types	Spoke, composite mag, Octopus (performance spoke)	Spoke
Tire types	Pneumatic, full profile polyurethane, iron cap (puncture resistant), high pressure	Pneumatic
Handrims	Aluminum, plastic coated projections	Powder coated steel
Caster sizes	4, 5, 6, 8"	8"
Caster types	Poly, pneumatic, pneumatic with airless insert	Polypropylene
Forks sizes	4, 5, 6, 7" frog legs	5"
Wheel locks	Push to lock, pull to lock, low profile	Pull to lock
Anti tips tubes	Yes	No
Standards applied	Static Stability and Fatigue Strength, ANSI/RESNA std sections 1, 5, 7, 8, 16 and 93	ISO 7176-1, 3, 5, 7, 8, 15, 16
Tubing wall thickness	0.070" on frame except front vertical tube which is 0.1". X-tube is 0.070"	0.079" throughout
Tube properties	6061-T4 prior to welding. After welding, the component is treated up to T-6.	ASTM A 53/A 53M-2005 JIS G 3444-2004

The reported device performance for the GEN 2 Mechanical Wheelchair is that it underwent non-clinical testing to international standards, as listed below. The conclusion is that "The non-clinical test results demonstrate the GEN 2 Mechanical Wheelchair does not raise any issues regarding safety and effectiveness" and "supports a determination of substantial equivalence to mechanical wheelchairs previously cleared by FDA."

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

This information is not applicable to this type of device submission. The testing performed is non-clinical, focusing on mechanical properties and compliance with safety standards, rather than evaluating performance on a test set of data with human subjects or a dataset similar to AI/ML evaluations. There's no "test set" in the context of data used for algorithm evaluation.

The provenance of the data is that it comes from non-clinical testing against specified 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. There is no test set with ground truth established by experts as would be the case for an AI/ML diagnostic device. The evaluation is based on engineering and materials testing against international standards for wheelchair safety and performance.

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

Not applicable. No adjudication method is described because there isn't a test set with expert-established ground truth.

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 not an AI/ML device, and no MRMC study was conducted.

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

Not applicable. This is not an AI/ML algorithm.

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

The "ground truth" in this context refers to the international standards for mechanical wheelchairs (e.g., ISO 7176 series and their specified test methods, ASTM, JIS standards). The device's performance is compared against these engineering standards to ensure safety and effectiveness.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. This is not an AI/ML device that requires a training set or its associated ground truth establishment.

Summary

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

Image /page/0/Picture/0 description: The image shows the logo for the "Free Wheelchair Mission". The logo consists of a drawing of two wheels, one larger than the other, with the words "Free Wheelchair Mission" written below. Underneath the name is the text "TRANSFORMING LIVES THROUGH THE GIFT OF MOBILITY".

KII3713 PAGE 1 OF 4

MAY - 7 2012

510(K) SUMMARY (21 CFR 807.92)

GEN 2 MECHANICAL WHEELCHAIR

Free Wheelchair Mission 510(k) Owner: 15279 Alton Parkway, Suite 300 Irvine, CA 92618 Tel: 949-273-0858 Fax: 949-273-8471

Contact Person: Sharon Rockwell Tel: 714-695-9269 E-mail: srockwell@writeme.com

December, 2011 Date Prepared:

GEN 2 Mechanical Wheelchair Trade Name:

Mechanical Wheelchair Common Name:

Classification Name: Mechanical wheelchair per 21 CFR 890.3850, IOR

Ki Mobility Catalyst Wheelchair, K062660 Predicate Devices:

The GEN 2 mechanical wheelchair is a highly adaptable all-Device Description: purpose wheelchair created for use in developing countries, while allowing for a healthy, personalized fit. The wheelchair features adjustable seating, large castor wheels, an extra-thick cushion and adjustable footrests.

The GEN_2 is a manually operated device intended to provide Intended Use: mobility for persons restricted to a sitting position.

The Indications for Use are identical to those of the predicate devices.

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

Technological Characteristics:

Technological Characteristics: The GEN_2 mechanical wheelchair is substantially equivalent in design, materials, and intended use to the Ki Mobility Catalyst mechanical wheelchair as described in the table below:

Feature	Catalyst	GEN 2
Intended Use	As a means of mobility forpersons restricted to a sittingposition.	To provide mobility to personsrestricted to a seated position.
Frame material	6061-T6 Aluminum	Powder coated steel frame thatmeets ASTM A 53/A 53M-2005and JIS G 3444-2004 standards
Frame widths	14-20"	13.5-19.5"
Overall widths	20.5-26.5"	29"
Seat depths	14-20"	11.5-17"
Back heights	8.5-19"	11.8-19"
Weight limit	220 lbs	220 lbs
Chair weight	23 lbs (without footrests)	36 lbs (with footrests)
Armrests	Flip back height adjustable deskand full length arm pads.Tubular swing-away.	Fixed in place to serve asarmrests but not to restricttransfers.
Front end type	Swing-away, non-swing-away	Swing-away
Back type	Standard	Standard
Footrest hangers	70°, elevating leg rest	NA
Footplates	Composite, foam, angleadjustable	Polypropylene, 280 mmadjustable range with anglesadjustable to 0, ± 7°, ± 14°, and ±21°.
Extension tubes	Extra short, short, med, long	NA
Back upholstery	Low, med, tall, adjustable	Adjustable to 4 different heights
Axle plates	Standard, curved, amputee,offset	NA
Wheel sizes	22, 24, 26	26"
Wheel types	Spoke, composite mag, Octopus(performance spoke)	Spoke
Tire types	Pneumatic, full profilepolyurethane, iron cap(puncture resistant), highpressure	Pneumatic
Handrims	Aluminum, plastic coatedprojections	Powder coated steel
Feature	Catalyst	GEN 2
Caster sizes	4, 5, 6, 8"	8"
Caster types	Poly, pneumatic, pneumaticwith airless insert	Polypropylene
Forks sizes	4, 5, 6, 7" frog legs	5"
Wheel locks	Push to lock, pull to lock, lowprofile	Pull to lock
Anti tips tubes	Yes	No
Standards applied	Static Stability and FatigueStrength, ANSI/RESNA stdsections 1, 5, 7, 8, 16 and 93	ISO 7176-1, 3, 5, 7, 8, 15, 16
Tubing wall thickness	0.070" on frame except frontvertical tube which is 0.1". X-tube is 0.070"	0.079" throughout
Tube properties	6061-T4 prior to welding.After welding, the component istreated up to T-6.	ASTM A 53/A 53M-2005JIS G 3444-2004

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

The indications for use for the GEN 2 and the predicate device are identical. The size ranges in terms of frame width, seat depth, back depths, chair weight and weight limit overlap those of the predicate device. Most other features are very similar. The fundamental technology, welded tube frame, fire retardant upholstery, and wheel locks are the same. The information provided supports a substantial equivalence decision. Any differences in features to the predicate do not affect the performance of the device and do not raise new types of safety or effectiveness questions.

Non-Clinical
Non-clinical testing has been performed to mechanical wheelchair Performance Data: international standards including:

ISO 7176-1:1999 Determination of static stability
ISO 7176-3:2006 Determination of effectiveness of breaks
ISO 7176-5:2008 Determination of dimensions, mass and manoeuvring space
ISO 7176-7:1998 Measurement of seating and wheel dimensions
ISO 7176-8:1998 Requirements and test methods for static, impact and fatigue
ISO 7176-15:1996 Requirements for information disclosure, documentation and labeling
ISO 7176-16: 1997 Resistance to ignition of upholstered parts --Requirements and test methods

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

The ISO tests were conducted with methods that met the following standards:

ISO 7176-11:1992 Test dummies
ISO 7176-13: 1989 Determination of coefficient of friction of test surfaces

The non-clinical test results demonstrate the GEN 2 Mechanical Conclusions: Wheelchair does not raise any issues regarding safety and effectiveness. The testing supports a determination of substantial equivalence to mechanical wheelchairs previously cleared by FDA.

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

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of an eagle or bird-like figure with three wing-like shapes extending upwards and to the right.

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

Free Wheelchair Mission % Ms. Sharon Rockwell Consultant 5582 Chalon Road Yorba Linda, California 92886

MAY - 7 2012

、Re: K113713

Trade/Device Name: Free Wheelchair Mission GEN 2 Mechanical Wheelchair Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: Class I Product Code: IOR Dated: March 26, 2012 Received: March 27, 2012

Dear Ms. Rockwell:

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 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.

{5}------------------------------------------------

Page 2 - Ms. Sharon Rockwell

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.

Sincerely yours,
Eunel Keith

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

Enclosure

{6}------------------------------------------------

INDICATIONS FOR USE STATEMENT

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Free Wheelchair Mission GEN_2 Mechanical Wheelchair

Indications for Use:

The GEN 2 Mechanical Wheelchair is intended to provide mobility to persons restricted to a seated 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 Device Evaluation (ODE)

signature
Division Sign-Off

Page ( of )

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

510(k) Number K113713

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).