The SOLEUS POWERED WHEELCHAIR, FAD-2 is an indoor / outdoor Powered Wheelchair that is battery operated. It has a base with four-wheeled with a seat. The movement of the Wheelchair is controlled by the rider who uses hand controls located at the top of the steering column. The device can be disassembled for transport and is provided with an onboard battery charger.

AI/ML Overview

The provided text is a 510(k) summary for the SOLEUS POWERED WHEELCHAIR, FAD-2. It describes the device, its intended use, and claims substantial equivalence to a predicate device. However, it does not include a study that details acceptance criteria and proves the device meets them in the way typically associated with AI/ML-based medical devices or effectiveness studies.

The "Performance Testing" section primarily lists standards to which the device was tested, which are safety and electrical compatibility standards for powered wheelchairs, not performance metrics related to a specific clinical outcome or algorithm.

Therefore, I cannot fulfill your request for:

A table of acceptance criteria and reported device performance.
Sample size and data provenance for a test set.
Number and qualifications of experts for ground truth.
Adjudication method.
MRMC comparative effectiveness study results.
Standalone algorithm performance.
Type of ground truth (beyond meeting engineering standards).
Training set sample size.
How training set ground truth was established.

This document is a regulatory submission for a physical medical device (a powered wheelchair) and focuses on demonstrating its safety and equivalence to an existing device, rather than evaluating the performance of a diagnostic or predictive algorithm.

Here's what the document does provide regarding "performance" and "acceptance criteria" from a regulatory perspective for this type of device:

"Acceptance Criteria" (Implied by Regulatory Standards) and "Reported Device Performance":

Acceptance Criteria (Implied by Standard)	Reported Device Performance
EMC Report	Passed
ANSI / RESNA WC/Vol.2-1998	Passed
CISPR 11: 1990	Passed
EN61000-3-2: 1995	Passed
IEC61000-3-3: 1995	Passed
EN 12184	Passed
WC / Vol.2:1998 (Radiated Immunity)	Passed (30 V/m)
UL certificated components (batteries, recharger)	Used components from the same suppliers, all UL certificated. Assures same safety level.
Resistance ignition test (foldable frame, back upholstery)	Passed test by SGS.

Explanation of Missing Information:

The type of "study" described in the prompt is generally conducted for devices that perform an analytical function (like AI/ML algorithms). This 510(k) pertains to a powered wheelchair, which is a mechanical/electrical device. The "performance testing" referenced is about its safety, electrical compatibility, and mechanical integrity according to established engineering and safety standards (e.g., ANSI/RESNA, CISPR, IEC, EN, UL).

Therefore, there is no mention of:

Sample sized used for the test set and the data provenance: Not applicable for a physical device being tested against engineering standards.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for these tests is defined by the technical specifications of the standards themselves (e.g., passing specific electrical discharge thresholds, structural integrity under load).
Adjudication method: Not applicable.
Multi reader multi case (MRMC) comparative effectiveness study: Not applicable, as this is for evaluating human performance with/without AI assistance.
Standalone (i.e. algorithm only without human-in-the loop performance): Not applicable for a powered wheelchair.
The type of ground truth used: Ground truth here refers to meeting the specified technical requirements of the listed international and national standards for safety and performance of powered wheelchairs.
The sample size for the training set: Not applicable; there is no "training set" in the context of this device's regulatory submission.
How the ground truth for the training set was established: Not applicable.

The "study" in this context is the performance testing against the listed standards, which ensures the device is safe and functions as intended, demonstrating substantial equivalence to the predicate device in these aspects.

Summary

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

K043511

SOLEUS CHAMP INTERNATIONAL CO., LTD.

No.1-6, Kung Fu Rd., Liao Bao Village, Ta Ya Hsiang, Taichung Hsien, Taiwan, 428, R.O.C. Tel: 886-4-2560-1853 Fax: 886-4-2560-1142 E-mail: kspeed97@ms27.hinet.net

MAR 1 4 2005

દ દ 510(k) SUMMARY "

Submitter's Name: SOLEUS CHAMP INTERNATIONAL CO., LTD.

No.1-6, Kung Fu Rd., Liao Bao Village,Ta Ya Hsiang, Taichung Hsien, Taiwan, 428, R.O.C.

Date summary prepared:

December 9, 2004

Device Name:

Proprietary Name: Common or Usual Name: Classification Name:

SOLEUS POWERED WHEELCHAIR, FAD-2 Powered Wheelchair Powered Wheelchair, Class II, 21 CFR 890.3860

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:

EMC Report ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995 (Electrically Powered Wheelchairs, controller, and their chargers - requirements and test methods)

Legally marketed device for substantial equivalence comparison: TEH LIN POWERED WHEELCHAIR MDG-201 (K022696)

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

SOLEUS CHAMP INTERNATIONAL CO., LTD.

No.1-6, Kung Fu Rd., Liao Bao Village, Ta Ya Hsiang, Taichung Hsien, Taiwan, 428, R.O.C. Tel: 886-4-2560-1853 Fax: 886-4-2560-1142 E-mail: kspeed97@ms27.hinet.net

Summary for substantial equivalence comparison:

The electronic systems between two devices are the same suppliers and all passed by the UL certificated, for instance the batteries and recharge. Thus the same safety level for the two devices is assured. Besides, the foldable frame and back upholstery are the same material that also be passed the resistance ignition test by The major differences existing of the two Powered Wheelchairs are the SGS. different overall dimension, and the sizes of tires are differences between the two The overall appearance differences are not safety aspect. Besides the two devices. devices use the different electric controllers but all passed by EN 12184, WC / Vol.2:1998, Radiated Immunity: 30 V/m. So the new device is substantially equivalent to the predicate devices in this aspect.

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three swooping lines representing its wings. The text "DEPARTMENT OF HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

MAR 1 4 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Dr. Ke Min Jen Official Correspondence Soleus Champ International Co., LTD. No. 1-6, Kung Fu Rd., Liao Bao Village Ta Ya Hsiang, Taichung Hsien, Taiwan, 428, ROC

Re: K043511

Trade/Device Name: Soleus Power Wheelchair, FAD-2 Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: II Product Code: ITI Dated: January 27, 2005 Received: February 22, 2005

Dear Dr. Ke Min Jen:

We have reviewed your Section 510(k) premarket notification of intent to market the device is died in we nave leviewed your Section 910(x) prematitilly equivalent (for the indications for use stated in the above and have determined the devices marketed in interstate commerce prior to May 28, 1976, enclosure) to regarly marketod produce Amendments, or to devices that have been reclassified in the chacinent date of the Frederal Food, Drug, and Cosmetic Act (Act) that do not require accondited with the provisions of the PMA). You may, therefore, market the device, subject to approval of a premaince approvial approvince to the general controls provisions of the Act include the general controls pro risins of an i seing 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 If your device is elassified (soc above) into major regulations affecting your device can be found in the Subject to Suen additions, 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 of Statules and legalatons administered of other in the mand listing (21 CFR Part 807); labeling (21 CFR requirements, meruding, but not mines es virements as set forth in the quality systems (QS) regulation I all 601), good minutectaring product radiation control product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

Page 2 -- Dr. Ke Min Jen

This letter will allow you to begin marketing your device as described in your Section 5 I0(k) premarket This letter will allow you to begin marketing your device of your device to a legally market. notification. The FDA Inding of substantal equivalience or 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 If you desire specific advice for your device on the regulation entitled, "Mishranding by the Office of Compliance at (240) 270-0120 . Yuso, production other general information on
reference to premarket notification" (21CFR Part 807.97). You may obtain other an reference to premiarket nonitation (21ct I F in Correst Small Manufacturers, International and your responsibilities under the Act from the Division of Shan Manada 44-47-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark Melbern

Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

043511 510 (K) Number ( If Known ):_

Device Name: SQLEUS Power Wheelchair, FAD-2_

Indications for Use:

The device is intended for medical purposes to provide mobility to persons restricted 1 a sitting position.

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)

Mark. A. Millham

Page_ 1__of __1

Division of Genera , Restorative, and Neurological Devices

510(k) Number K043511

Regulation Number and Section

N/A