LERADO, AVANTICARE MECHANICAL WHEELCHAIR, MR-9000 by LERADO OVERSEA LTD. TWN BRANCH (BVI)

The AVANTICARE Mechanical Wheelchair, MR-9000 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 is a 510(k) summary for the LERADO AVANTICARE Mechanical Wheelchair, MR-9000. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain detailed acceptance criteria and a study proving the device meets those criteria in the format requested.

Here's an analysis based on the information provided, and what is missing:

Information Provided:

Acceptance Criteria: The document states, "Mechanical Wheelchair, MR-9000 meets the applicable AVANTICARE performance requirements as specified in ANSI/RESNA WC vol. 1 and ISO 7176 Wheelchair Standards." These standards contain detailed performance and safety requirements, which serve as the acceptance criteria. However, the specific individual criteria (e.g., maximum weight capacity, braking effectiveness, durability cycles) from these standards are not listed in the provided text, nor are the specific results for each criterion.
Study That Proves the Device Meets Acceptance Criteria: The document simply states that the device "meets the applicable performance requirements." It does not provide details of the study conducted to demonstrate this. There is no mention of a testing report, the methodology, or the results against each specific requirement.
Device Performance: No specific performance metrics (e.g., weight capacity, speed, range) are reported, beyond the general statement of meeting the standards.
Sample Size: Not mentioned.
Data Provenance: Not mentioned (country of origin, retrospective/prospective).
Number of Experts/Qualifications: Not applicable for this type of mechanical device testing.
Adjudication Method: Not applicable.
Multi Reader Multi Case (MRMC) Comparative Effectiveness Study: Not applicable. This type of study is for evaluating diagnostic or screening systems where human readers are involved.
Standalone Performance: The core assertion is that the device (algorithm equivalent) meets the standards, but the details of the standalone testing are not provided.
Type of Ground Truth: For mechanical devices, "ground truth" often refers to objective measurements against established technical standards. The ground truth here would be the specified requirements within ANSI/RESNA WC vol. 1 and ISO 7176.
Sample Size for Training Set: Not applicable for a mechanical device.
How Ground Truth for Training Set was Established: Not applicable.

Based on the provided text, I cannot complete the requested tables and sections with specific values and details. The document only offers a high-level statement that the device meets relevant standards.

Here's how I would present the information, highlighting what's missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (from ANSI/RESNA WC vol. 1 and ISO 7176)	Reported Device Performance
Specific criteria not detailed in the provided text.	Specific performance metrics not detailed in the provided text.
Examples of applicable criteria would include:	The document generally states:
* • Static, impact, and fatigue strength tests*	• Meets applicable AVANTICARE performance requirements as specified in ANSI/RESNA WC vol. 1 and ISO 7176 Wheelchair Standards.
* • Braking stability and effectiveness*
* • User weight capacity*
* • Dimensions and maneuverability*
* • Flammability of upholstery*	• Upholstery fabric meets the California Technical Bulletin CAL 117 standard for flame retardant.

Note: The provided text indicates that the device meets the California Technical Bulletin CAL 117 standard for flame retardant upholstery, and the general performance requirements of ANSI/RESNA WC vol. 1 and ISO 7176. However, it does not enumerate the specific criteria from these standards nor the quantitative results of the device against each criterion.

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

Sample Size for Test Set: Not specified in the provided document.
Data Provenance: Not specified, but generally, testing for such devices would occur at a certified testing facility, likely in Taiwan (where the manufacturer is located) or a recognized international lab. The document does not specify if the tests were performed retrospectively or prospectively relative to the filing date, but regulatory testing is typically conducted prior to submission.

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

This question is not applicable to the performance testing of a mechanical wheelchair. Ground truth for such devices is established by objective measurements and tests against industry standards by qualified technicians/engineers at testing facilities, not by medical experts forming a consensus on an image or medical condition.

4. Adjudication method for the test set

Not applicable for the performance testing of a mechanical wheelchair.

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 a mechanical wheelchair, not an AI-assisted diagnostic or screening tool.

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

Yes, the performance testing described ("Mechanical Wheelchair, MR-9000 meets the applicable AVANTICARE performance requirements...") implicitly refers to standalone testing of the device itself, against various physical stress, durability, and safety parameters stipulated in the ANSI/RESNA and ISO standards. The results of these tests, while not detailed, are the basis for the claim of meeting the standards.

7. The type of ground truth used

The ground truth for this mechanical device testing would be the objective, predefined technical specifications and performance limits outlined in the ANSI/RESNA WC vol. 1 and ISO 7176 Wheelchair Standards, as well as the California Technical Bulletin CAL 117 standard. Test equipment and methodologies are designed to objectively measure if the device's performance meets these numerical and qualitative criteria.

8. The sample size for the training set

Not applicable. Mechanical device design and testing do not typically involve a "training set" in the context of machine learning or AI.

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

Not applicable.

Summary

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Image /page/0/Picture/0 description: The image shows a logo for Lerado Group, with the text "LERADO" in large, stylized letters above the words "LERADO GROUP" in smaller font. A triangle is used as the "A" in Lerado. Below the English text is Chinese text. Above the logo is the date "APR 26 2005".

K050708

RADO OVERSEA LTD. TWN BRANCH(BVD) No 22, Kuang Fu Road, Chia Tai Industrial Tai Pao City, Chia Yi Hsien, Taiwan, ROC Fax: 886-5-2379672 Tel: 886-5-2475520 E-mail.edwardl.@mail.lerado.com http:// www.lerado.com

દ ૯ 510(k) SUMMARY "

Submitter's Name: Lerado Oversea Ltd. Twn Branch (BVI) No. 22, Kuang Fu Road, Chia Tai Industrial,Tai Pao City, Chia Yi Taiwan, ROC. Hsien, 612,

Date summary prepared:

March 11, 2005

Device Name:

Proprietary Name:

LERADO,

Common or Usual Name: Classification Name:

AVANTICARE Mechanical Wheelchair, MR-9000 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 restricts to a seated position.

Description of the device:

Performance Testing:

Mechanical Wheelchair, MR-9000 meets the applicable AVANTICARE performance requirements as specified in ANSI/RESNA WC vol. 1 and ISO 7176 Wheelchair Standards.

Legally marketed device for substantial equivalence comparison:

AVANTICARE Mechanical Wheelchair, MS-8000 ( K050290 )

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K050708

2/2

Image /page/1/Picture/2 description: The image shows the logo for LEARDO GROUP. The logo is black and white and features the company name in a stylized font. Above the company name is a triangular shape. Below the company name is the Chinese translation of the company name.

LERADO OVERSEA LTD. TWN BRANCH(BVI) No 22, Kuang Fu Road, Chia Tai Industrial Tai Pao City, Chia Yi Hsien, Taiwan, ROC Fax: 886-5-2379672 Tel: 886-5-2475520 E-mail :edwardl :@mail.lerado.com http:// www.lerado.com

Summary for substantial equivalence comparison:

The new device and the predicate device have the same intended use Mainframes of two devices are foldable. The overall dimensions are similar. Back upholstery material is also the same resistance -ignitability fabric and also meets the California Technical Bulletin CAL 117 standard for flame The major differences existing are the overall dimension and retardant. the weight capacity. The overall appearance differences are not safety So the new device is substantially equivalent to the predicate device.. aspect.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its wings. The eagle is positioned inside a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circle's perimeter.

Public Health Service

APR 2 6 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Lerado Oversea Ltd. TWN Branch (BVI) C/o Dr. Ke-Min Jen ROC Chinese-European Industrial No. 22, Kuang Fu Road Chia Tai Industrial Tai Pao City Chia Yi Hsien, Taiwan ROC

Re: K050708

R030700
Trade/Device Name: Lerado, Avanticare Mechanical Wheelchair, MR-9000 Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: I Product Code: IOR Dated: March 30, 2005 Received: April 7, 2005

Dear Dr. Ke-Min Jen:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we nave levice your beeting of 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 enciosure) to legally marketed proutents, or to devices that have been reclassified in accordance enacifient uail of the Medical Device I.Meneral Act (Act) that do not require approval of a with the provisions of the readial PMA). You may, therefore, market the device, subject to the general prematics approval approvation (1111). controls provisions of the rec. The general seuring 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 elaisined (ood also regulations affecting your device can be found in the Subject to such additional controlly - Entrally - 1-11-2001 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 I'DA I lease be advised that 1 127 a roundevice complies with other requirements of the Act or any Federal flas made a decemmiations administered by other Federal agencies. You must comply with all the Act of C statules and regulations administered of ourself on and listing (21 CFR Part 807); labeling (21 CFR Part requirements, mending, but not mined to requirements as set forth in the quality systems (QS) regulation (2) CFR 801), good mailtracturing 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 I his letter will anow you to ovegin manential equivalence of your device to a legally marketed predicate notification. The IT2A iniding of substantial equivalence 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 the If you desire specific at rice for your ave a views note the regulation entitled, "Misbranding by Office of Compunatic at (240) 276 - 1120, p.m. 907.97). You may obtain other general information on reference to premation (21 OFF C Fer C Fe' C Fe' C L C C Small Manufacturers, International and Consumer your responsibilities ander and 110-11-2019 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Stypk Rurder

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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Indications for Use

and the started to the state the state of the more of the may be and

510 (K) Number ( If Known ):__________________________________________________________________________________________________________________________________________________ K

12-26-2018 - 11:42

Device Name: LERADO, AVANTICARE Mechanical Wheelchair, MR-9000

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)

1 87 Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign-Off Division of General, Restorative, and Neurological Devices

510(k) Number: K050708

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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).