The AVANTICARE SA4022 scoter is motor driven, indoor and outdoor transportation vehicles with the intended use to provide mobility to disabled or elderly persons limited to a seated po lition.

Device Description

The AVANTICARE SA4022 scooter is an indoor/outdoor transportation vehicles which is battery operated. The movement of the scooter is controlled by a tiller handle and a thumb operated potentiometer throttle control lever to engage and disengage the scooter motion in both the forward and reverse directions.

AI/ML Overview

The provided text is a 510(k) summary for the AVANTICARE SA4022 scooter, a motorized three-wheeled vehicle. The document explicitly states that there are minor differences in performance specifications between the AVANTICARE SA4022 scooter and its predicate device, the Bewell SC 20 (K043326). However, the submission asserts that "these differences do not alter the intended function and use of the device, nor do they raise any new questions pertaining to safety or effectiveness."

Crucially, the provided document does not contain explicit acceptance criteria or a detailed study demonstrating that the device meets specific performance criteria. The basis for substantial equivalence is the assertion that any differences in performance specifications are minor and do not impact safety or effectiveness.

Therefore, many of the requested details cannot be extracted from this document.

Here's an attempt to answer based on the provided text, with clear indications where the information is not present:

A table of acceptance criteria and the reported device performance

Acceptance Criterion	Reported Device Performance
Not explicitly stated in the document. The submission focuses on substantial equivalence to a predicate device rather than specific performance metrics.	"minor differences in performance specifications" compared to Bewell SC 20 (K043326). These differences are asserted not to alter intended function/use or raise new safety/effectiveness questions.

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size: Not specified.
- Data provenance: Not specified.
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 and not present in the document. The substantial equivalence argument is based on comparing device specifications and intended use against a legally marketed predicate device, not on clinical performance evaluated by experts against a ground truth.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable and not present.
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 and not present. This device is a mobility scooter, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable and not present.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. The "ground truth" in this context is the predicate device's established safety and effectiveness, implied by its legal market status.
The sample size for the training set
- Not applicable and not present. This device is not an AI/machine learning model that requires a training set.
How the ground truth for the training set was established
- Not applicable and not present.

Summary

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JUL 2 1 2005

K05/538

Image /page/0/Picture/3 description: The image shows a logo with the word "LERADO" in large, bold letters. A triangular shape is placed between the letters "R" and "D", resembling a mountain. Below the main word, the word "LERADO" is repeated in smaller letters, followed by the word "GROUP".

No.22, Kuang Fu Rd., Chia Tài Industrial Park, Tai Pao City, Chia Yì Hien, Tàirrache com +886-5-2379672 website: http://www.lerado.com/ TEL: +886-5-2475629

510(k) Summary

Device

Trade name: AVANTICARE SA4022 scooter

Common name: Electrical scooter

Classification name: Motorized three-wheeled vehicle

Medical specialty (Panel): Physical Medicine Device

Regulation number: 890.3800

Product Code: 89INI

Classification: Class II

Predicate devices

Bewell SC 20 (K043326)/Cycling and Health Tech Industry R&D Center/CHC Intend use of device

AVANTICARE SA4022 scooter is intended for an indoor/outdoor scooter that provides transportation for disabled or elderly persons limited to a seated position.

Device description:

Substantial equivalence:

The AVANTICARE SA4022 scooter is substantially equivalent to the Bewell SC 20 (K043326) manufactured by Cycling and Health Tech Industry R&D Center/CHC.

There are minor differences in performance specifications of the scooters, these differences do not alter the intended function and use of the device, nor do they raise any new questions pertaining to safety or effectiveness. Therefore, LERADO CHINA LIMITED believes that the AVANTICARE SA4022 scooter is substantially equivalent to legally marketed devices currently in commercial distribution.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the United States Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird-like figure, with three curved lines representing its body and wings.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 1 2005

Mr. Jeff Chang Lerado China Limited 16 F.-2, No. 462, Sec. 2 Chongde Rd., Beitun District Taichung, China (Taiwan) 40653

Re: K051538

Trade/Device Name: AVANTICARE SA4022 Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: II Product Code: INI Dated: May 12, 2005 Received: June 10, 2005

Dear Mr. Jeff Chang:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your because the device is substantially equivalent (for the indications felerenced above and nave decemblicate devices marketed predicate devices marketed in interstate for use stated in the cacrosure) to regars managers of the Medical Device Amendments, or to commerce prior to May 20, 1978, the encordance with the provisions of the Federal Food, Drug, devices that have been recuire in assee approval of a premarket approval application (PMA). alle Costlictic Act (71ct) that to not required to the general controls provisions of the Act. The I ou may, mercere, maniel the Act include requirements for annual registration, listing of general controls provisions of ractice, 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 If your device is classified (soc aborto) in existing major regulations affecting your device can may be subject to such additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Our acements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Frease of advised that I Dri 3 issualled or our device complies with other requirements of the Act that I DA has made a acternations administered by other Federal agencies. You must of any I catal surdles and regulations sincluding, but not limited to: registration and listing (21 comply with an the 110 110 Part 801); good manufacturing practice requirements as set CFR in the quality systems (21 CFR Part 820); and if applicable, the electronic forth in the quart) byevelle (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Jeff Chang

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin maing of substantial equivalence of your device to a legally premails. The first in the Brice 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 IT you ucate specific adrive for your accell 276-0120. Also, please note the regulation entitled, Connact the Office of Compulser in (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general miormation of your resumer 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,

Eichhorn

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

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Device descriptive information

3.1 Statement of indication for use

Statement of Indications for Use

510(k) Number (if known):

Device Name AVANTICARE SA4 122

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Indications for Use

The AVANTICARE SA4022 scoter is motor driven, indoor and outdoor transportation vehicles with the intended use to provide mobility to disabled or elderly persons limited to a seated po lition.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ Over-The-Counter Use -(Part 21 CFR 801 Subpart D) A. VD/OR (Part 21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELO'V THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of 1

Euh

Jision Sign-Off) vision of General, Restorative ad Neurological Devices

Number KOSIS38

(Posted November 13, 2003)

3-1

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).