The Comed K-Series Manual Wheelchair is a user-propelled, manually operated folding wheelchair that is indicated for use indoors and outdoors, over smooth surfaces (all standard indoor flooring surfaces, concrete, asphalt and pocked dirt) that are free of large obstacles and inclines greater than 9 degrees. It consists of a mechanical steel frame and nylon upholstery. Designed to be lightweight and foldable, the model is approximately 18" wide, approximately 16" deep, has a weight capacity of 220lbs, and weighs approximately 42lbs.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a manual wheelchair and does not contain information about acceptance criteria or a study proving that a device (in the context of AI/medical imaging devices) meets acceptance criteria.

The document discusses the Comed K-Series Manual Wheelchair, which is a physical product, not a software or AI device. The "acceptance criteria" referred to in the document are conformance to non-clinical standards for wheelchairs (ISO 7176 series), which are mechanical and physical performance tests.

Therefore, I cannot extract the requested information about acceptance criteria and studies for an AI/software device from this text as it is not present.

However, I can provide the information as it relates to the physical wheelchair and the standards it met:

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

Acceptance Criteria (Standard)	Reported Device Performance
ISO 7176-1: Determination of Static Stability	The new device meets this standard.
ISO 7176-3: Determination of Efficiency of Brakes	The new device meets this standard.
ISO 7176-5: Determination of Overall Dimension, Mass, and Turning Space	The new device meets this standard.
ISO 7176-7: Measurement of Seating and Wheel Dimensions	The new device meets this standard.
ISO 7176-8: Requirement and Test Methods for Static, Impact and Fatigue Strength	The new device meets this standard.
ISO 7176-11: Test Dummies	The new device meets this standard.
ISO 7176-13: Determination of Friction of Test Surface	The new device meets this standard.
ISO 7176-15: Requirements for Information Disclosure Documentation and Labeling	The new device meets this standard.
ISO 7176-16: Resistance to Ignition of Upholstered Parts- Requirement and Test Methods	The new device meets this standard.

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 applicable and not provided for a physical wheelchair tested against mechanical standards. The tests are typically conducted on a sample of the product itself by a testing laboratory.

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):
This information is not applicable. For mechanical standard testing, the "ground truth" is typically defined by the objective measurement procedures and criteria outlined in the ISO standards themselves, not by expert consensus in a clinical sense. Testing would be performed by qualified technicians/engineers in a certified lab.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable for mechanical standard testing of a physical product.

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:
This information is not applicable. This is a physical wheelchair, not an AI or imaging device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This information is not applicable. This is a physical wheelchair, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for this device's performance is adherence to the specifications and performance limits defined by the specific ISO standards (e.g., a certain amount of static stability, a specific braking efficiency, etc.). These are objective, measurable criteria.

8. The sample size for the training set:
This information is not applicable. The product is a physical device, and there is no "training set" in the context of machine learning.

9. How the ground truth for the training set was established:
This information is not applicable for the reasons stated above.

In summary, the provided document describes a 510(k) for a physical medical device (manual wheelchair) and not a software or AI-powered medical device. Therefore, the questions related to AI/software performance metrics (such as expert readers, training sets, ground truth for algorithms, MRMC studies) are not pertinent to this submission. The device's "acceptance criteria" were conformance to established international mechanical and safety standards for wheelchairs.

Summary

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510(k) SUMMARY (21 CFR 807.92)

This summary of 510(k) safety and effectiveness information is being submitted in

accordance with the requirement of 21 CFR 807.92

The assigned 510(k) number is: _

Premarket Notification [510(k)] Summary

A. General Information
Submitter's Name:	DANYANG COMED HEALTHCARE CO., LTD.
Address:	No. 3, Bei Er Huan Road
	212300, Danyang City
	Jiangsu Province, P.R. China
Telephone:	86511-86963500
Fax Number:	86511-86963700
Contact Person:	William Sun
Date Prepared:	March 13, 2012

B. Device

Trade Name:	Comed K-Series Manual Wheelchair
Common Name:	Wheelchair
Classification Name:	Wheelchair, Mechanical
Product Code:	IOR
Class:	I
Regulation Number:	21 CFR 890.3850

C. Identification of Legally Marketed Predicate Device

Name:	Danyang HUAYI H035 Basic Wheelchair
Manufacture:	Danyang Huayi Medical Supply & Equipment, Co. Ltd.
K Number:	K080114
Date Cleared:	15 February 2008

D. Description of the Device

E. Intended Use

Its intended use is to provide mobility to persons restricted to a sitting position.

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Image /page/1/Picture/0 description: The image shows the text "K120077 PAGE 2 OF 2" in a handwritten style. The text is arranged in two lines, with the first line containing the alphanumeric code "K120077" and the second line indicating the page number as "PAGE 2 OF 2". The handwriting appears to be in black ink on a white background.

F. Conformance To Standards

Both the new device and the predicate device were tested against the following non-clinical standards:

. ISO7176-1 Wheelchair: Determination of Static Stability
. ISO7176-3 Wheelchair: Determination of Efficiency of Brakes
. ISO7176-5 Determination of Overall Dimension, Mass, and Turning Space
. ISO7176-7 Measurement of Seating and Wheel Dimensions
ISO7176-8 Wheelchair Requirement and Test Methods of for Static, Impact and Fatigue Strength, .
. ISO7176-11 Wheelchair: Test Dummies
ISO7176-13 Determination of Friction of Test Surface .
ISO7176-15 Wheelchair: Requirements for Information Disclosure Documentation and Labeling
ISO7176-16 Wheelchair: Resistance to Ignition of Upholstered Parts- Requirement and Test . Methods.

The predicate and the new device meet all of the above named standards, indicating that the Comed K-Series Manual Wheelchair is as safe, as effective, and performs as well as the predicate device.

G. Comparison of Technological Characteristics

In comparison of technological characteristics, the new device is the same as the predicate device with respect to the frame material, footrests, rear axles, wheels, upholstery, wheel locks, weight capacity and approximate total weight (with armrest). The Comed K-Series Manual Wheelchair is slightly larger than the predicate device, which is a design change that was made to make users of the wheelchair more comfortable. The difference in size of the new device does not raise new questions of safety and effectiveness.

H. Conclusion of Substantial Equivalence

Based on the comparison of intended use, design, materials, and performance, we conclude that the new device is substantially equivalent to the predicate device and that it raises no new questions of safety and effectiveness.

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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is an abstract image of an eagle, with its wings spread. The eagle is facing to the right.

DEPARTMENT OF HEALTH & HUMAN SERVICES

DANYANG COMED HEALTHCARE CO., LTD.

% Rhonda Alexander, M.S, M.P.A

Senior Regulatory Specialist

Hampton, Virginia 23666

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

MAY 1 4 2012

Re: K120077

144 Research Drive

Trade/Device Name: COMED K-series Manual wheelchair Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: Class I Product Code: IOR Dated: April 19, 2012 Received: April 20, 2012

Dear Ms. Alexander:

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.

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Page 2 - Rhonda Alexander, M.S, M.P.A

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please n you desire speemo advice to: your coviters/CDRH/CDRHOffices/ucm115809.htm for go to mtp.//www.lua.gov.iller.com Radiological Health's (CDRH's) Office of Compliance. Also, please the Comer for Devices and Radiotograph by reference to premarket notification" (21CFR Part note the regulation entition, "Microsians" - "Andrerse 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 Tou may obtain of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

Sincerely yours,

(600) 050 2011 01 (2 4 0 1 0 1 (2 4 0 1 0 1 1 0 1 1 d 1 1 d ustry/default.htm.

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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Indications for Use

510(k) Number (if known):

Device Name: COMED K-series Manual wheelchair

Indications For Use:

Its intended use is to provide mobility to persons restricted to a sitting position.

AND/OR Over-The-Counter Use Prescription Use: × (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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vision Sign-Off)

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

510(k) Number K120077

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).