The LERADO Power Wheelchair, PB 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 LERADO Power Wheelchair, PB. It does not describe an AI/ML powered medical device, but rather a traditional powered wheelchair seeking substantial equivalence to a predicate device. Therefore, much of the requested information regarding acceptance criteria for an AI/ML device and specific study details (like sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment) is not applicable or present in this document.

However, I can extract information related to the device's performance testing and comparison to the predicate device to infer some "acceptance criteria" through the lens of substantial equivalence.

Here's the closest interpretation of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred from comparison to predicate and standards)	Reported Device Performance (LERADO Power Wheelchair, PB)
Safety and Performance Standards:	Passed EMC Report ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995. Electronic systems (motor, batteries, recharge) UL certified.
Intended Use: Mobility for persons restricted to a seated position.	Intended use is the same as the predicate device.
Strength and Fatigue Tests: Meet requirements.	Mainframes meet strength and fatigue tests.
Weight Capabilities: Equivalent to predicate.	Same as predicate.
Maximum Speed: Equivalent to predicate.	Same as predicate.
Suspension of Cross Brace: Equivalent to predicate.	Same as predicate.
Footplates: Equivalent to predicate.	Same as predicate.
Armrest: Equivalent to predicate.	Same as predicate.
Warranty: Equivalent to predicate.	Same as predicate.
Back Upholstery Material: Equivalent to predicate.	Same as predicate.
Electronic Controller Certification: UL certified.	Dynamic DA series controller is UL certified.
Incline Capability: Safe operation up to 10 degrees.	Can drive under 10 degrees. Owner's Manual specifies limit of 10 degrees.
Cruising Range per Charge: Discussed in comparison.	22.5 miles. (Predicate: 15 miles)
Overall Dimensions: Discussed in comparison.	Similar to predicate, but with some differences.

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

Sample Size for Test Set: Not applicable or not specified in the document. This is not an AI/ML device where a 'test set' of data would be used to evaluate an algorithm's performance. The "test set" here would refer to the physical device undergoing performance testing.
Data Provenance: The device underwent performance testing according to international standards (listed above). The document doesn't specify if these tests involved human subjects or specific data sets in the way an AI/ML study would. It refers to the testing of the physical wheelchair.

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

Not applicable. This is a traditional device. The "ground truth" is established by the specifications and performance standards themselves, not by expert consensus on data interpretation.

4. Adjudication method for the test set

Not applicable for the type of device and submission. Adjudication methods like 2+1 or 3+1 are typically used for expert review of medical images or other complex data where varying interpretations are possible to establish a consensus ground truth, which is not relevant here.

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

No. This is not an AI/ML device, and no MRMC study was performed or is relevant for this type of submission.

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

No. This is not an AI/ML device.

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

The "ground truth" for this device's performance is established by engineering and safety standards (e.g., ANSI / RESNA WC/Vol.2-1998, CISPR 11, EN61000-3-2, IEC61000-3-3, UL certification) which the device is tested against. The claim of substantial equivalence is based on meeting these standards and having similar performance characteristics to a legally marketed predicate device.

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. As there is no training set for an AI/ML model, there is no ground truth to be established for such a set.

Summary

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K070433

Image /page/0/Picture/1 description: The image shows the logo for Lerado Group. The logo is in black and white and features the word "LERADO" in large, bold letters. Above the word "LERADO" is a triangular shape that resembles a mountain. Below the word "LERADO" is the word "GROUP" in smaller letters. Below the word "GROUP" are some Chinese characters.

LERADO CHINA LIMITED No. 22, Kuang Fu Road, Chia Tai Industrial Tai Pao City, Chia Yi Hsien, Taiwan, ROC Tel: 886-5-2475629 Fax: 886-5-2379672 E-mail:edwardl@lerado.com.rw http:// www.lerado.com

MAR 16 2007

February 5, 2007

510(k) SUMMARY "

Submitter's Name: Lerado China Limited

No. 22, Kuang Fu Road, Chia Tai Industrial,Tai Pao City, Chia Yi Hsien, 612, Taiwan, ROC

Date summary prepared:

Device Name:

Proprietary Name: LERADQ Power Wheelchair, PB Common or Usual Name: Powered Wheelchair Classification Name: 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: WU'S Powered Wheelchair, MAMBO 36X (K050010)

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Image /page/1/Picture/0 description: The image shows the logo for LERADO GROUP. The logo is in black and white and features the company name in large, bold letters. Above the word "GROUP" is a triangular shape that resembles a mountain. Below the company name are some Chinese characters.

LERADO CHINA LIMITED No. 22, Kuang Fu Road, Chia Tai Industrial Tai Pao City, Chia Yi Hsien, Taiwan, ROC Tel: 886-5-2475629 Fax: 886-5-2379672 E-mail:edwardl@lerado.com.tw http:// www.lerado.com

C.2 COMPARISON SUMMARY

( We place the related information for the predicate device in the following pages. )

We can know from the above table that the intended use between the two devices is Mainframes of two devices are not foldable and all meet the strength and the same. fatigue tests, thus they are similar for the material aspects. The overall dimensions are similar. The weight capabilities, maximum speed, suspension of cross brace, footplates, armrest, and the warranty are all the same. Back upholstery material is also the same fabric.

Especially the electronic systems between two devices are the same suppliers, and all passed by the UL certificated, for instance the motor, batteries, and recharge. Though for the electronic controller, the predicate used by Penny & Giles and the subject device used by Dynamic DA series that are also passed by the UL certificated. Thus the same safety level for the two devices is assured.

There is different incline capability for the two devices. The new device can drive under 10 degrees and the predicate device claim 5 degrees slope. We place the specification limit of 10 degrees in the page 2 of the Owner's Manual. Thus, the user is not allowed to operate the device on the incline angle higher than the specified angle. The safety levels of the two devices are the same when operating the devices on the different inclines. They are substantially equivalent.

The cruising range per charge is different, the new device is 22.5 miles and 15 miles for the predicate device. Certainly the real range depends on the practical environments, i.e., weight, surface, incline, and temperature. For the real life use, the two devices are substantially equivalent.

To sum up, the major differences existing are the overall dimensions, cruising range, and the incline degrees are differences between the two devices. The overall So the new device is substantially appearance differences are not safety aspect. 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 device have the same intended use the same technological aspects and only minor dimensions and material differences exist. We believe that FDA can decide the subject device and the predicate device are substantially equivalent.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with three strands instead of the usual one or two.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Lerado China Limited % Dr. Ke-Min Jen Official Correspondent No. 58, Fu-Chiun St. Hsin-Chu Citv. 30067 Taiwan, Republic of China

MAR 1 6 2007

Re: K070433

Trade/Device Name: Lerado Power Wheelchair, PB Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: Class II Product Code: ITI Dated: February 5, 2007 Received: February 14, 2007

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 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.

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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 (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 vours.

Mark N. Melkerson 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

510 (K) Number ( If Known ):__________________________________________________________________________________________________________________________________________________

Device Name: LERADO, Power Wheelchair, PB

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 _ V

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

Page	1 of 1
510(k) Number	K070433

Regulation Number and Section

§ 890.3860 Powered wheelchair.

(a)
Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class II (performance standards).