The LERADOTECH SC scooter is motor driven, indoor and outdoor transportation vehicles with the intended use to provide mobility to disabled or elderly persons limited to a seated position.

Device Description

The LERADOTECH SC 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 pertains to a 510(k) premarket notification for a medical device, the LERADOTECH SC scooter. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a detailed clinical study proving performance against explicit acceptance criteria in the manner typically seen for novel diagnostic or therapeutic devices.

Therefore, the information requested in your prompt (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set ground truth) is not applicable to this type of regulatory submission for a scooter. The "study" here is primarily a comparison to a predicate device and adherence to performance standards, not a clinical trial with human subjects in the traditional sense.

Let's break down what is available and how it relates to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the performance characteristics of the predicate device (AVANTICARE SA4022) and compliance with relevant industry performance standards. The "reported device performance" for the LERADOTECH SC is its specifications, which are compared against the predicate.

Characteristic	Acceptance Criteria (Predicate: AVANTICARE SA4022 (K051538))	Reported Device Performance (LERADOTECH SC)	Met Criteria? (Based on substantial equivalence claim)
Operation Mode	Thumb operated potentiometer throttle control lever	Thumb operated potentiometer throttle control lever	Yes
Battery	Lead-Acid 12V × 36AH × 2PCS	Lead-Acid 12V x 75AH × 2PCS	Yes (Difference noted, but not raising new safety/effectiveness questions)
Battery Level Indicator	Not explicitly stated (implied no)	Yes	Yes (An enhancement, not a deviation that would raise new questions)
Charger	HP 24V 3/5AMP (Automatic Type) off-board	HP 24V, 5 AMP (Automatic Type) off-board	Yes (Minor difference in amperage, still automatic/off-board)
Front Wheel	10" x 2" foam filled tire × 2 PCs, Rim: aluminum alloy	13" x 5" pneumatic tire × 2 PCs	Yes (Difference noted, but not raising new safety/effectiveness questions)
Bumpers	Front/Rear: It's constructed by engineering plastics	Front: It's constructed by steel tube, Rear: It's constructed by engineering plastics	Yes (Difference noted, but not raising new safety/effectiveness questions)
Armrest	Not explicitly stated (implied no)	Yes, Foldable	Yes (An enhancement)
Tiller Foldable	Not explicitly stated (implied no)	Yes	Yes (An enhancement)
Backrest Recline & Recline Angle Indicator	Not explicitly stated (implied no)	Yes	Yes (An enhancement)
Headrest	Not explicitly stated (implied yes/standard)	No	Yes (A minor difference in feature, not altering intended function/safety)
Height Adjustable	Not explicitly stated (implied yes/standard)	No	Yes (A minor difference in feature, not altering intended function/safety)
Rear Wheel	10" x 2" foam filled tire × 2 PCs, Rim: aluminum alloy	13" x 5" pneumatic tire × 2 PCS	Yes (Difference noted, but not raising new safety/effectiveness questions)
Brake System	Intelligent regenerative electromagnetic brake	Intelligent regenerative electromagnetic brake and hand brake	Yes (An enhancement)
Intended Use	Mobility for disabled or elderly persons limited to a seated position (indoor/outdoor)	Mobility for disabled or elderly persons limited to a seated position (indoor/outdoor)	Yes
Maximum Loading	135 kg (300 lbs)	205 kg (450 lbs)	Yes (An enhancement, suggests improved structural integrity)
Overall Height	980 mm (38.5")	1260 mm (50")	Yes (Difference noted, but not altering intended function/safety)
Overall Length	1160 mm (45.7")	1370 mm (54")	Yes (Difference noted, but not altering intended function/safety)
Overall Width	540 mm (21.3")	730 mm (29")	Yes (Difference noted, but not altering intended function/safety)
Motor Output	350W x DC24V × 5100 RPM, 1PC	950W x DC24V × 1PC	Yes (Higher output, suggests improved performance/power, not raising new safety/effectiveness questions)
Controller	Dynamic DS72K01	Dynamic DS16K01	Yes (Different model, assumed to meet functional requirements)
Rear Wheel Drive	Not explicitly detailed	Sealed transaxle direct drive	Yes (Assumed comparable or improved drive mechanism)
Performance Standards	Compliance with various ANSI/RESNA, ISO, CISPR, IEC, and California flammability standards.	Compliance with various ANSI/RESNA, ISO, CISPR, IEC, and California flammability standards as listed in Section 3.2.	Yes

Study Description and How Acceptance Criteria Are Met

The "study" presented is a substantial equivalence comparison and adherence to recognized performance standards. The sponsor (LERADO CHINA LIMITED) asserts that the LERADOTECH SC scooter is substantially equivalent to the AVANTICARE SA4022 (K051538) manufactured by the same company.

The mechanism for meeting "acceptance criteria" is two-fold:

Direct Comparison to Predicate: The LERADOTECH SC's specifications are compared feature-by-feature to the predicate device. Where there are differences (e.g., battery capacity, wheel size, maximum loading, motor output, specific controller model), the sponsor explicitly states that these "do not alter the intended function and use of the device, nor do they raise any new questions pertaining to safety or effectiveness." In some cases, the new device exhibits improved specifications (e.g., higher maximum loading, higher motor output, additional safety features like a hand brake, or convenience features like a battery level indicator or foldable armrest).
Compliance with Recognized Performance Standards: The device has been tested against and meets the applicable performance requirements specified in a list of international and national standards:
- ANSI/RESNA WC/Vo1.1 section 1-1998 / ISO7176-1-1999 (Determination of static stability)
- ANSI/RESNA WC/Vo1.1 section 6-1998 / ISO7176-6-2001 (Determination of max speed, acceleration and deceleration of electric wheelchair)
- ANSI/RESNA WC/Vo1.2 section 21-1998 / ISO7176-21-2003 (EMC of powered wheelchairs and motorized scooters)
- CISPR 11-1990 (Industrial, scientific and medical (ISM) Radio-Frequency equipment - electromagnetic disturbance characteristics - limits and methods of measurement)
- IEC 61000-4-2-1995 (EMC - Electrostatic discharge immunity test (ESD))
- IEC 61000-4-3-1995 (EMC - Radiated, RF, electromagnetic field immunity test)
- California Bureau of Home Furnishings 116 (Flammability Standards)

By demonstrating substantial equivalence to a legally marketed predicate and showing compliance with these recognized safety and performance standards, the device is deemed to meet the necessary "acceptance criteria" for market clearance in a 510(k) context.

Not Applicable/Not Provided Information for this Type of Device Submission:

As mentioned, most of the specific clinical study-related questions are not relevant here because this is a mechanical mobility device, not an AI/diagnostic/therapeutic device requiring clinical validation in the same way.

2. Sample size used for the test set and the data provenance: Not applicable. Performance is based on engineering testing to standards and comparison of specifications. No "test set" of patient data is used in this context.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for engineered performance is defined by the standards and the predicate device's specifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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/diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the technical performance aspects, the "ground truth" is established by the specifications of the predicate device and the test limits/methodologies defined in the cited national and international performance standards (e.g., for stability, speed, EMC, flammability).
8. The sample size for the training set: Not applicable. No training set as this is not a machine learning device.
9. How the ground truth for the training set was established: Not applicable.

Summary

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K070802

Image /page/0/Picture/1 description: The image shows the logo for Lerado Group. The logo is black and white and features the word "LERADO" in large, bold letters. The "A" in "LERADO" is replaced by a triangle shape. Below the word "LERADO" is the word "GROUP" in smaller letters.

ERADO CHINA LIM No.22, Kuang Fu Rd., Chia Tai Industrial Park, Tai Pao City, Chia Yi Hsien, Taiwan TEL: +886-5-2475629 FAX: +886-5-2379672 website:http://www.lerado.com/

510(k) Summary

Device

APR 1 3 2007

Trade name: LERADOTECH SC 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

AVANTICARE SA4022(K051538)/ LERADO CHINA LIMITED

Intend use of device

LERADOTECH SC 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 LERADOTECH SC scooter is substantially equivalent to the AVANTICARE SA4022 (K051538) manufactured by LERADO CHINA LIMITED.

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 LERADOTECH SC scooter is substantially equivalent to legally marketed devices currently in commercial distribution.

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(Continuous)	Table 6-1 The substantial equivalence comparison of the LERADOTECH SC and SA4022SA4022(K051538)	LERADOTECH SC
Operation mode	Thumb operated potentiometer throttle control lever
Battery	Lead-Acid 12V × 36AH × 2PCS	Lead-Acid 12V x 75AH × 2PCS
Battery level indicator		Yes
Charger	HP 24V 3/5AMP (Automatic Type) off-board	HP 24V, 5 AMP (Automatic Type) off-board
Front wheel	10" x 2" foam filled tire × 2 PCsRim: aluminum alloy	13" x 5" pneumatic tire × 2 PCs
Bumpers	Front/Rear: It's constructed by engineering plastics	Front: It's constructed by steel tubeRear: It's constructed by engineering plastics
Armrest		Yes, Foldable
Tiller foldable		Yes
Backrest reclineRecline angle indicator		Yes
Headrest		No
Height adjustable		No
Rear wheel	10" x 2" foam filled tire × 2 PCsRim: aluminum alloy	13" x 5" pneumatic tire × 2 PCS
Break system	Intelligent regenerative electromagnetic brake	Intelligent regenerative electromagnetic brake andhand brake
Table 6-1 The substantial equivalence comparison of the LERADOTECH SC and SA4022
	SA4022(K051538)	LERADOTECH SC
Intended use	Three scooters are motor driven, indoor and outdoor transportation vehicles with the intended use to providemobility to disabled or elderly persons limited to a seated position.
Maximum loading	135 kg (300 lbs)	205 kg (450 lbs)
Overall height	980 mm (38.5")	1260 mm (50")
Overall length	1160 mm (45.7")	1370 mm (54")
Overall width	540 mm (21.3")	730 mm (29")
Seat overall height	520 mm (20.5")
Seat overall width	457 mm (18")
Seat overall depth	406 mm (16")
Seat overall weight	15 kg (33 lbs)
Motor output	350W x DC24V × 5100 RPM, 1PC	950W x DC24V × 1PC
Controller	Dynamic DS72K01	Dynamic DS16K01
Differentialmechanism	Differential rate: 19.7: 1
Rear wheel drive		Sealed transaxle direct drive

· · ·

6-3

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comparison of the LERADOTECH SC and SA4022 Table 6-1 The substantial equivalence

6-2

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3.2 Performance standards

LERADOTECH SC scooter has been tested the applicable performance requirements specified in:

(1). ANSI/RESNA WC/Vo1.1 section 1-1998 / ISO7176-1-1999 Determination of static stability
(2). ANSI/RESNA WC/Vo1.1 section 6-1998 / ISO7176-6-2001 Determination of max speed, acceleration and deceleration of electric wheelchair
(3). ANSI/RESNA WC/Vo1.2 section 21-1998 / ISO7176-21-2003 Requirements and test methods for electromagnetic compatibility of powered wheelchairs and motorized scooters
(4). CISPR 11-1990 Industrial, scientific and medical (ISM) Radio-Frequency equipment- electromagnetic disturbance characteristics - limits and methods of measurement
(5). IEC 61000-4-2-1995 EMC-Electrostatic discharge immunity test (ESD)
(6). IEC 61000-4-3-1995 EMC-Testing and measurement techniques-Radiated, RF, electromagnetic field immunity test
(7). California Bureau of Home Furnishings 116 Flammability Standards.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and the words "HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white and has a simple, clean design. The eagle is facing to the right.

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Lerado China Limited % Ms. Junnata Chang 14F-2, No. 1, Zhuangjing Road, Lane 25 Bangiao, Taipei County China (Taiwan)

Re: K070802

Trade/Device Name: LERADOTECH SC scooter Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: Class II Product Code: INI Dated: March 15, 2007 Received: March 23, 2007

APR 1 3 2007

Dear Ms. Chang:

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. 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

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Page 2 - Ms. Junnata Chang

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 (240) 276-0120. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

For
Mark N. Melkerson
Director

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: LERADOTECH SC

Indications for Use:

The LERADOTECH SC scooter is motor driven, indoor and outdoor transportation vehicles with the intended use to provide mobility to disabled or elderly persons limited to a seated position.

Prescription Use Over-The-Counter Use X (Part 21 CFR 801 Subpart D) (Part 21 CFR 807 Subpart C) AND/OR (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

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

signature

Division Sign Division of Gey .. and Neurologi ... Dec

510(k) Number

(Posted November 13, 2003)

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).