The Genemax Power Wheelchair, PW3 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 describes the Genemax Power Wheelchair, PW3, and its substantial equivalence to a predicate device (TEH LIN Power Wheelchair, TL-320 (K022697)). However, it does not contain acceptance criteria for device performance or a detailed study description that proves the device meets specific performance criteria.

Instead, it focuses on demonstrating substantial equivalence based on shared design characteristics, components, and general safety considerations. The performance testing section only lists compliance with certain standards, but does not provide quantitative acceptance criteria or results from those tests.

Therefore, I cannot fulfill all parts of your request with the provided information. I will, however, extract the relevant information concerning performance testing and the nature of the comparison study.

Here's a breakdown of what can be inferred and what is missing:

Acceptance Criteria and Study Details (Based on provided text)

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Not explicitly stated as quantitative acceptance criteria. The document focuses on demonstrating substantial equivalence to a predicate device by meeting general safety standards and having comparable or superior design/functionality.	Compliance with following standards: - EMC Report ANSI / RESNA WC/Vol.2-1998 (Electrically Powered Wheelchairs, controller, and their chargers - requirements and test methods) - CISPR 11: 1990 - EN61000-3-2: 1995 - IEC61000-3-3: 1995
Weight Capability (Implicit)	New device (PW3) can bear more weight (264.6 pounds) than predicate (242.5 pounds), a difference of 22.1 pounds. Considered "substantially equivalent" as the new device is superior.
Safety on Inclines (Implicit)	Safety levels are the same when operating on 12-degree inclines. Considered "substantially equivalent."
Braking Time, Distance, and Dynamic Stability (Implicit for Higher Speed)	New device has a higher maximum speed (5 mph) than predicate (2.62 mph). This implies acceptance criteria for braking time, distance, and dynamic stability for the higher speed were met, as it's stated, "The different maximum speeds do not lead any safety considerations and they are substantially equivalent in this aspect."

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

Sample Size: Not specified. The document refers to "Performance Testing" based on standards, which typically involves testing a limited number of devices to ensure compliance. It does not mention a specific "test set" in terms of patient data or clinical samples.
Data Provenance: The device manufacturer is "Genemax Medical Products Industry Corp." based in Taichung, Taiwan, R.O.C. The performance testing was done in relation to international standards (ANSI, RESNA, CISPR, EN, IEC). The location where these tests were physically performed is not explicitly stated, beyond the manufacturer's location. The study is not a clinical study involving human subjects or patient data, but rather engineering/device performance testing. Thus, it's not "retrospective or prospective" in the sense of clinical data.

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

Not Applicable. This type of information is typically relevant for studies involving subjective review (e.g., image interpretation by radiologists). The provided text describes engineering performance testing against established standards for a medical device (power wheelchair). The "ground truth" here is compliance with technical specifications and safety standards, not a diagnostic interpretation established by human experts.

4. Adjudication method for the test set:

Not Applicable. As above, this applies to scenarios requiring expert consensus on subjective data (e.g., medical diagnoses). Here, performance is assessed against objective engineering standards.

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 a power wheelchair, not an AI diagnostic or assistance device. Therefore, no MRMC study with human readers or AI assistance was performed or described.

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

Yes, in spirit, but not in the context of an "algorithm." The performance testing described (EMC, ANSI/RESNA, CISPR, EN, IEC standards) evaluates the device itself (the power wheelchair) in a "standalone" manner against predefined technical and safety specifications, without human interaction being part of the evaluation method for the device's core performance in these tests. It is not an algorithm's performance being assessed.

7. The type of ground truth used:

Engineering Standards and Specifications. The "ground truth" for the performance testing is adherence to the technical requirements and safety parameters defined within the listed standards (ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995) and the device's own design specifications (e.g., maximum weight capacity, speed, incline capability).

8. The sample size for the training set:

Not Applicable. This is not an AI/machine learning study. There is no concept of a "training set" for this type of device and performance testing.

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

Not Applicable. As above, no training set is relevant here.

Summary of the "Study" described:

The document describes a substantial equivalence comparison study to a predicate device (TEH LIN Power Wheelchair, TL-320 (K022697)). The "study" involves comparing technical specifications and design features and performing general performance testing against established international standards. The primary goal is to demonstrate that despite minor differences (like appearance, dimensions, weight limit, and maximum speed), the new device (Genemax PW3) is as safe and effective as the predicate device. The performance testing focuses on compliance with electrical and general safety standards for powered wheelchairs.

Summary

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K042748

NOV 12 2004

Image /page/0/Picture/2 description: The image shows a logo with the word "donemax" in white letters against a black oval background. The word "donemax" is written in a stylized font, with the letters slightly rounded. The black oval shape provides a contrasting backdrop that makes the text stand out. The logo has a simple and clean design.

Genemax Medical Products Industry Corp.

No. 86, Lane 226, Tai-Ming Road, Wu-Jih, Taichung, Taiwan, 414, R.O.C. Tel: 886-4-2335 85(K) Fax: 886-4-2335 6779 e-mail: genemax(@ms3).hinet.net

દર 510(k) SUMMARY "

Submitter's Name: Genemax Medical Products Industry Corp. No. 86, Lane 226, Tai-Ming Rd., Wu-Jih Taichung, 414, Taiwan, R.O.C.

Date summary prepared:

Device Name:

Proprietary Name: Common or Usual Name: Classification Name:

Genemax Power Wheelchair, PW3 Powered Wheelchair Powered Wheelchair, Class II, 21 CFR 890.3860

Indications for Use:

The device is intended for medical purposes to provide mobility to persons restricts to a seated position.

Description of the device:

The Genemax Power Wheelchair, PW3 is an indoor / outdoor Powered Wheelchai 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.

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:

TEH LIN Power Wheelchair, TL-320 (K022697)

September 28, 2004

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Image /page/1/Picture/0 description: The image shows a black oval with the word "Donamax" written in white letters inside. The letters are stylized and slightly rounded, giving them a cartoonish appearance. The black oval provides a contrasting background that makes the word stand out.

Genemax Medical Products Industry Corp.

No. 86. Lane 226. Tui-Ming Road, Wu-Jih, Taichung, Taiwan, 414, R.O.C. Tel: 886-4-2335 8500 - Fax: 886-4-2335 6779 e-mail: genemax@ms31.hinet.net

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 the same. The batteries used are the same supplier and similar U1 type. The control systems for the two devices are used from same brand: Penny & Giles. The recharge for the two devices are also used the same supplier, and the chargers are also certified by Besides, the foldable frame, removable armrest type, same cruising range, same UL. footplates, same incline, and back upholstery are the same material that also be passed the resistance ignition test by SGS.

The weight capabilities for the two devices are different, and there is 22.1 pounds difference, between 264.6 pounds and 242.5 pounds. This means the new device can bear more weight than the predicate device. I The safety levels of the two devices are the same when operating the devices on the same 12 degrees inclines. They are substantially equivalent.

The maximum speed for the new device is 5 mph and 2.62 mph for the predicate Higher speed means the new device shall meet relevant requirements for the device. braking time, distance, and dynamic stability for safety considerations. The different maximum speeds do not lead any safety considerations and they are substantially equivalent in this aspect.

To sum up the mainly different of the two devices are only appearance dimensions, i.e., the overall dimensions, the size of wheels, seat dimensions, weight limit, and maximum speed. For the regular operator, these differences for the two devices do not lead to any performance differences, and the two devices are substantially equivalent.

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" around the perimeter. Inside the circle is a stylized symbol featuring three abstract shapes that resemble human figures or waves, arranged in a dynamic, flowing pattern.

Public Health Service

NOV 1 2 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Genemax Medical Products Industry Corp. C/o Dr. Jen Ke-Min Roc Chinese-European Industrial Research Society No. 58, Fu-Chiun St. Hsin-Chu City, China (Taiwan) 300

Re: K042748

Trade/Device Name: GENEMAX Power Wheelchair, PW3 Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: II Product Code: ITI Dated: September 29, 2004 Received: October 4, 2004

Dear Dr. Ke-Min:

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. Jen Ke-Min

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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark A. Millam

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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Indications for Use

K042748 510 (K) Number ( If Known ):__________________________________________________________________________________________________________________________________________________

Device Name: GENEMAX Power Wheelchair, PW3

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)

Concurence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of General, Restorative,
and Neurological Devices

Page 1 of

510(k) Number K042748

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).