The A&I Scooter SC-301 is an indoor / outdoor Powered Scooter that is battery operated. It has a base with four-wheeled with a seat. The movement of the Scooter 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 document is a 510(k) premarket notification for a medical device called the "A&I Scooter, SC-301," which is a motorized three-wheeled vehicle. This type of document is used to demonstrate that a new device is substantially equivalent to a legally marketed predicate device, rather than proving its effectiveness through clinical trials with specific acceptance criteria as you've outlined for AI/ML devices.

Therefore, the information regarding acceptance criteria, study design elements (sample sizes, ground truth, experts, adjudication, MRMC studies, standalone performance, training data), is not applicable to this document.

Instead, the "performance testing" section of this 510(k) document refers to engineering and safety standards, and the "study" is a comparison to a predicate device.

Here's an analysis based on the information provided, tailored to a 510(k) submission for a non-AI/ML device:

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

For this device, "acceptance criteria" are not reported as specific performance metrics like sensitivity or specificity. Instead, the device is deemed acceptable if it meets established safety and electromagnetic compatibility (EMC) standards and is substantially equivalent to a legally marketed predicate device.

Acceptance Criteria (Standards Met)	Reported Device Performance
EMC Report ANSI / RESNA WC/Vol.2-1998	Device aligns with these standards.
CISPR 11: 1990	Device aligns with these standards.
EN61000-3-2: 1995	Device aligns with these standards.
IEC61000-3-3: 1995	Device aligns with these standards.
Substantial Equivalence to Predicate Device (WU's 3-Wheeled Neo Scooter, WT-T3D (K032488))	The new device has the same intended uses, back upholstery, maximum speed, warranty, and electronic systems (suppliers, UL certified batteries/recharge, electronic controllers). Minor differences are in overall dimension, size of tires, and weight, which are deemed not to affect safety.
UL certification for electronic systems (batteries, recharge, controllers)	Electronic systems are UL certified.
Resistance ignition test for back upholstery (by SGS)	Back upholstery passed the resistance ignition test.

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

Not Applicable: This type of information is not relevant for the 510(k) submission of this medical device. The "test set" here refers to the actual scooter undergoing engineering and safety tests, not a dataset for an AI model. There is no data provenance in the context of clinical or image data.

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: This information is not relevant as there is no "ground truth" established by human experts in the context of an AI/ML model for this device. The standards compliance is assessed by testing facilities (e.g., SGS for ignition test) and regulatory bodies.

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

Not Applicable: There is no adjudication method described as there's no "ground truth" for an AI/ML model being assessed. Compliance with standards is evaluated through specified test procedures.

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, so no MRMC study was conducted or is relevant.

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

Not Applicable: This is not an AI/ML device, so no standalone algorithm performance was assessed. The device itself is a standalone product.

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

Not Applicable: There is no ground truth in the context of clinical outcomes or diagnostic accuracy for this device. "Ground truth" for this product would be adherence to engineering specifications and safety standards defined by organizations like ANSI/RESNA, CISPR, EN, and IEC.

8. The sample size for the training set

Not Applicable: This is not an AI/ML device, so there is no training set.

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

Not Applicable: This is not an AI/ML device, so there is no training set ground truth to establish.

Summary

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WELL SUCCESS BIOTECH. INC

6F, No.70, Zi You Road, Hsinchu City, 300, Taiwan. R.O.C. TEL:886-3-5357667 FAX : 886-3-5357669 E-mail:i5357667@yahoo.com.tw

K041187

MAY 2 5 2004

દ ત્ 510(k) SUMMARY "

Submitter's Name: WELL SUCCESS Biotech. Inc.

6F, No.70, Zi You Road, Hsinchu City, 300, Taiwan, R.O.C.

Date summary prepared:

Device Name:

Proprietary Name:

Common or Usual Name: Classification Name:

May 1, 2004

A&I Scooter, SC-301 ( Trade name: A&I, A&E, J&C ) Electrical Scooter Motorized 3-Wheeled Vehicle, Class II, 21 CFR 890.3800

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 Scooters, controller, and their chargers requirements and test methods)

Legally marketed device for substantial equivalence comparison: WU's 3-Wheeled Neo Scooter, WT-T3D (K032488)

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C.2 COMPARISON SUMMARY

( We place the related information for the predicate device in the following pages, including the visual appearance, 510k information on the FDA website, and the comparison and summary table. )

The intended uses, back upholstery, maximum speed, and warranty period between the new device SC-301 and the predicate device WT-T3D are all the same. Especially the electronic systems between two devices are the same suppliers and all passed by the UL certificated including the batteries and recharge, and the electronic controllers between the two devices are also passed by the UL certificated. Besides, the back upholstery is the same material, and also passed the resistance ignition test by SGS. Thus the same safety level for the two devices is assured.

The major difference existing for new device is more agile and easy to fold for storage or transportation and the predicate device is for general use. So the sizes and visual appearance among them have differences, and there is no safety level difference.

To sum up, the overall dimension, the size of tires, and the weight 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.

Based on the above the information and the analysis, we know that the subject device and the predicate devices have the same intended use, the same technological aspects and only minor dimensions or data differences exist. We believe that FDA can decide the subject device and the predicate device are substantially equivalent.

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WELL SUCCESS BIOTECH. INC.

6F, No.70, Zi You Road, Hsinchu City, 300, Taiwan, R.O.C. TEL:886-3-5357667 FAX:886-3-5357669 E-mail:j5357667@yahoo.com.tw

Summary for substantial cquivalence comparison:

The electronic systems between the two devices are all passed by the UI, certificated, including the elcctronic controllers, the batteries and recharge. Besides, the two devices are the same maximum speed and back upholstery. Thus the same safety level for the two devices is assured. The major differences existing of the two Powered Scooters are the different overall dimension and weight between the two The overall appearance and weight differences are not safety aspect. devices. So the new device is substantially equivalent to the predicate devices in this aspect.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is an emblem that features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body.

Public Health Service

MAY 25 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K041187

Trade/Device Name: A & I Scooter, SC-301 Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: II Product Code: INI Dated: May 1, 2004 Received: May 6, 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 Codc 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.

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Page 2 - Dr. Ke-Min Jen

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

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,

L. Mark A. Milburn

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

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of Page l

510 (K) NUMBER ( IF KNOW ):___TBA

DEVICE NAME: A&I Scooter, SC-301

INDICATIONS FOR USE:

The device is intended for medical purposes to provide mobility to persons restricted to 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)

Mach N Millan

for (Division Sign-Off

Division of General, Restorative, and Neurological Devices

510(k) aber K04 1187

Regulation Number and Section

§ 890.3800 Motorized three-wheeled vehicle.

(a)
Identification. A motorized three-wheeled vehicle is a gasoline-fueled or battery-powered device intended for medical purposes that is used for outside transportation by disabled persons.(b)
Classification. Class II (performance standards).