The SINON SN-L402 Foldable Wheelchair is an indoor / outdoor wheelchair that has a base with four-wheeled with a seat. The device can be disassembled for transport and it is foldable easily. The device uses a standard sling type back and seat, the upholstery fabric meets the California Technical Bulletin CAL 117 standard for flame retardant.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device (SINON SN-L402 Lightweight Wheelchair). It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove acceptance criteria based on specific performance metrics or clinical outcomes.

Therefore, many of the requested categories in the prompt (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable because the document does not present a clinical or performance study of the type that would involve these elements.

Here's the information that can be extracted from the provided text based on your prompt:

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Applicable performance requirements as specified in ANSI/RESNA WC Vol. 1 and ISO 7176 Wheelchair Standards.	SINON SN-L402 Lightweight Wheelchair meets the applicable performance requirements as specified in ANSI/RESNA WC Vol. 1 and ISO 7176 Wheelchair Standards.
Intended use: provide mobility to persons restricted to a seated position.	SINON SN-L402 Lightweight Wheelchair is intended for medical purposes to provide mobility to persons restricted to a seated position.
Weight limit: 100 kgs.	The weight limit is 100 kgs.
Foldable mainframe.	The mainframe is foldable.
Back upholstery material: resistance-ignitability fabric (meeting California Technical Bulletin CAL 117 standard for flame retardant).	The back upholstery material is resistance-ignitability fabric and meets the California Technical Bulletin CAL 117 standard for flame retardant.

2. Sample size used for the test set and the data provenance

Not applicable / Not provided. The document states that the device "meets the applicable performance requirements" of standards but does not detail a specific test set or clinical study with patient samples. The testing appears to be primarily engineering/product performance testing against established standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable / Not provided. Ground truth, in the context of clinical studies, is not referenced as this is a device performance and substantial equivalence submission.

4. Adjudication method for the test set

Not applicable / Not provided.

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 device is a mechanical wheelchair, not an AI-assisted diagnostic or imaging device.

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

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

7. The type of ground truth used

For product performance: Compliance with ANSI/RESNA WC Vol. 1 and ISO 7176 Wheelchair Standards served as the basis for evaluating performance. In mechanical testing, the "ground truth" is often defined by the pass/fail criteria set forth by these recognized industry standards.
For substantial equivalence: The predicate device (BIOTECH B900 SUPER LIGHT Wheelchair, K020472) served as the basis for comparison.

8. The sample size for the training set

Not applicable / Not provided. No "training set" in the context of an algorithm or machine learning is mentioned.

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

Not applicable / Not provided.

Summary

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

K041465

May 28, 2004

JUL 2 3 2004

N CORPORATION

Sec. 1, Mei Chuan W.Road, Taichung 403 Taiwan TEL : 886-4-23726181 FAX : 886-4-23750574

http://www.sinon.com tw E-mail service(insinon com tw

510(k) SUMMARY "

Submitter's Name: SINON Corporation No. 23, Sec. 1, Mei Chuan W. Road, Taichung, Taiwan, 403, ROC

Date summary prepared: Device Name:

Proprietary Name:

SINON

Common or Usual Name: Classification Name:

SN-L402 Lightweight Wheelchair Mechanical Wheelchair Mechanical Wheelchair, Class I, 21 CFR 890.3850

Indications for Use:

The device is intended for medical purposes to provide mobility to persons restricted to a seated position.

Description of the device:

Performance Testing:

SN-L402 Lightweight Wheelchair meet the applicable performance requirements as specified in ANSI/RESNA WC vol. 1 and ISO 7176 Wheelchair Standards,

Legally marketed device for substantial equivalence comparison: BIOTECH B900 SUPER LIGHT Wheelchair ( K020472 ).

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

SINON CORPORATION 23, Sec. 1, Mei Chuan W.Road, Taichung 403, Taiwan TEL : 886-4-23726181 FAX : 886-4-23750574 http://www.sinon.com tw_ E-mail service(@sinon.com tw

C.2 COMPARISON SUMMARY

( We place the related information for the predicate device in the following pages. )

The new device SN-L402 and predicate device BIOTECH B900 have the same intended use, and the weight limit 100kgs between the two devices is the same. Mainframes of two devices are foldable. The overall dimensions are similar. Back upholstery material is also the same resistance-ignitability fabric. The major differences existing are the overall dimension, and the size of tires are differences between the two devices. The overall appearance differences are not safety aspect. So the new device is substantially equivalent to the predicate devices in this aspect.

The seat heights between the new device and the predicate device have small difference, not leading to any safety hazard. The hanger and rear axle designs are same. The weights of the two devices are similar. - At last the optional accessories for the new device are more than those of the predicate one, and the users have more adversity to choose the needed accessories to accommodate their needs.

Based on the above the information and the analysis, we know that the new device and the predicate device have the same technological aspects and the same intended use, except for tiny appearance differences. We believe that FDA can decide the subject device and the predicate device are substantially equivalent,

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

SINON CORPORATION 23, Sec. 1, Mei Chuan W.Road, Taichung 403, Taiwan FAX : 886-4-23750574 TEL:886-4-23726181 http://www.sinon.com/tw_E-mail.service@sinon.com tw

Summary for substantial equivalence comparison:

The new device and the predicate device have the same intended use and the weight limit 100kgs between the two devices is the same. Mainframes of two devices arc foldable. The overall dimensions are similar. Back upholstery material is also the same resistance ignitability fabric. The major differences existing of the two Mechanical Wheelchairs are the different overall dimension and weight between the two devices. The overall appearance and weight differences are not safety aspect. So the new device is substantially equivalent to the predicate devices in this aspect.

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

Image /page/3/Picture/1 description: The image is a black and white logo. The logo features a stylized bird in flight, composed of three curved lines that suggest feathers. The bird is oriented towards the right. Surrounding the bird is a circular border containing text. The text reads "INSTITUTE OF HUMAN SERVICES - USA". The logo appears to be a seal or emblem, possibly representing a government or non-profit organization focused on human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 3 2004

Sinon Corporation C/o Dr. Ke-Min Jen ROC Chinese-European Industrial Research Society No. 58, Fu-Chiun St. Hsin-Chu City, China (Taiwan) 300

Re: K041465

Trade/Device Name: SINON SN-L402 Lightweight Wheelchair Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: I Product Code: IOR Dated: May 28, 2004 Received: June 2, 2004

Dear Dr. Jen:

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 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.

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

Page 2 - Dr. Ke-Min Jen

This letter will allow you to begin marketing your device as described in your Section 510(k) rms loter watification. 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 (301) 594-4659. 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,

Mark N Milliken

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

510 (K) NUMBER ( IF KNOW ): _ TBA DEVICE NAME: SINON SN-L402 Lightweight Wheelchair

INDICATIONS FOR USE:

The device is intended for medical purposes to provide mobility to person restricted to a sitting position.

R. Mark A. Millican

(Division Sign .- C Division of General, Restorative. and Neurological Devices

510(k) Number_

K041465

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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).