The device consists of a chromed steel frame with cross bars, slung fabric seat and back, fixed or removable armrests, fixed or removable foot/legrests. Front caster wheels for steering, rear push handles for attendant-assisted propulsion, rear drive wheels with handrims for self-propulsion, and lever-style wheel locks.

AI/ML Overview

The provided text describes a 510(k) summary for a manual wheelchair and the FDA's clearance letter. It does not contain information about the acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML device. The device described is a physical manual wheelchair, and the 510(k) summary focuses on demonstrating substantial equivalence to predicate devices based on design features and compliance with a flammability test for its fabric, not performance metrics common to AI/ML devices.

Therefore, I cannot provide the requested information for an AI/ML device based on the given input.

If the request was intended for a medical device in general, the provided text includes some information relevant to product specifications and a single test:

1. Table of Acceptance Criteria and Reported Device Performance:

Criteria	Acceptance / Predicate Value (Invacare Tracer Wheelchair - K935398)	Reported Device Performance (Sigma Manual Wheelchair)
Seat Height	20"	20"
Widths	14"-22"	14"-22"
Rear Wheels	24"	24"
Front Casters	8"	8"
Product Weight	44 lbs	43 lbs
Weight Limit	250 lbs.	250 lbs.
Fabric Flammability	NFPA 701-89 Flame Resistant Textile and Films test (implied by predicate, explicitly stated for the submitted device)	Meets NFPA 701-89 Flame Resistant Textile and Films test

2. Sample size used for the test set and the data provenance: Not applicable. The "test set" consists of comparing the specifications of one submitted device model to a predicate device and a single fabric flammability test.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Specifications like dimensions and weight limits are objective measurements. Fabric flammability is determined by standardized tests, not expert consensus in this context.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Performance is based on direct measurement and standardized testing.

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 physical wheelchair, not an AI/ML device.

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

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
* For physical dimensions and weight: Direct measurement/specification.
* For fabric flammability: Results from a standardized ignitability test (NFPA 701-89).

8. The sample size for the training set: Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.

Summary

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

JAN 1 3 2000

510(k) SUMMARY

This is an Initial 510(k) Summary in accordance with 21 CFR 807.92 (a)

Submitted by: Sigma Distribution & Supply, Inc. (1) 701 West Harvard Street Glendale, CA 91204 Phone (818) 246-4624 Contact: Arthur Keshishyan Prepared 10/28/1999
SIGMA MANUAL WHEELCHAIR (2) Propriety Name: Common Name: Manual Wheelchair Classification Name: Manual, wheelchair

(3) Examples of four legally marketed devices of substantial equivalence, together with their 510(k) numbers are as follows:

Mechanical Wheelchair 980.3850, K945175 Tracer Series Wheelchairs, K35398 Bantex Brand Wheelchairs, K915262

The device consists of a chromed steel frame with cross bars, slung fabric seat (4) and back, fixed or removable armrests, fixed or removable foot/legrests. Front caster wheels for steering, rear push handles for attendant-assisted propulsion, rear drive wheels with handrims for self-propulsion, and lever-style wheel locks.

(5) The wheelchair is to be used for transportation of disabled persons.

(6) The wheelchair exhibits no material differences from the predicate devices listed in number (3) above. Please see the enclosed catalog pages of FOSHAN DONGFANG MEDICAL EQUIPMENT MANUFACTORY compared with the dimensions of Invacare Tracer Series wheelchairs (510(k) #K935398) for a comparison of design features, which we believe to be equivalent to our submitted wheelchair. Some items for comparison are listed below. Furhter the fabric of the subited whhelchair mcets the NFPA 701-89 Flame Resistant Textile and Films test.

	Our Submitted Wheelchair	Invacare Tracer Wheelchair (510(k) #K93539
1. Seat Ht.	20"	20"
2. Widths	14"-22"	14"-22"
3. Rear Wheels	24"	24"
4. Front Casters	8"	8"
Product Wt.	43lbs	44lbs
Weight Limit:	250 lbs.	250 lbs.

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

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is enclosed in a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the top half of the circle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 3 2000

Mr. Arthur Keshishyan Sigma Distribution & Supply, Inc. 701 West Harvard Street Glendale, California 91204

Re: K993963 Trade Name: Sigma Manual Wheelchair Regulatory Class: I Product Codc: IOR Dated: November 8, 1999 Received: November 22, 1999

Dear Mr. Keshishyan:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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.

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

Page 2 - Mr. John T. Mogensen

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Mark. .1 Mull...

James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

KG143963 510(k) Number ::K992389-Device Namc: SIGMA MANUAL WHEELCHAIR

Indication For Use:

For transportation of disabled persons.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use __

Over the Counter Use

Monk n Milken

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K993963

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).