The Jumao Manual Wheelchair is an indoor/outdoor wheelchair that has a base with four-wheels with a seat. The device can be disassembled for transport and it is foldable easily. Both the back and seat upholstery material is the same resistance-ignitability fabric.

AI/ML Overview

The provided text describes a 510(k) Premarket Notification for the Jumao Manual Wheelchair. The submission aims to demonstrate "Substantial Equivalence" to a predicate device, which is a common regulatory pathway for Class I medical devices in the United States. In such cases, the acceptance criteria and study data are primarily focused on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than proving performance against novel, independently established criteria through extensive clinical trials.

The document states that the Jumao Manual Wheelchair's design, materials, physical and performance characteristics, technological, and safety characteristics are identical to the predicate device, the Universal Wheelchair by Graham-Field Health Products, Inc. (510(k) K930411).

Therefore, the "study" proving the device meets acceptance criteria is a demonstration of substantial equivalence to this predicate device.

Here's an breakdown based on your request, with the understanding that for a 510(k) for a Class I device based on substantial equivalence, many of the typical "AI/algorithm study" questions are not directly applicable:

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria (Implied by Substantial Equivalence)	Reported Device Performance (Jumao Manual Wheelchair)
Intended Use: Provide mobility to persons restricted to a seated position.	Identical: Intended for medical purposes to provide mobility to persons restricted to a seated position.
Material Characteristics: Equivalent materials to predicate device.	Identical: Materials (e.g., back and seat upholstery resistance-ignitability fabric) are identical to the predicate device.
Physical Characteristics: Equivalent design and physical properties to predicate device.	Identical: Device design, physical properties are identical to the predicate device. Foldable, disassemblable for transport.
Performance Characteristics: Equivalent functional performance to predicate device.	Identical: All device functions, scientific concepts, and performance characteristics are identical to the predicate device.
Technological Characteristics: Equivalent technology to predicate device.	Identical: Technological characteristics are identical to the predicate device.
Safety Characteristics: Equivalent safety profile to predicate device.	Identical: Safety characteristics are identical to the predicate device. Complies with relevant ISO 7176 standards.

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

Sample Size: Not applicable in the context of this 510(k). There was no "test set" of subjects or data to evaluate algorithm performance in a clinical study. The evaluation was based on a comparison of engineering, material, and design specifications to the predicate device.
Data Provenance: Not applicable. The data primarily consists of engineering specifications, material lists, and design descriptions, compared directly to a predicate device's documented characteristics.

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

This is not applicable for this type of 510(k) submission. "Ground truth" in this context would be the established safety and effectiveness of the predicate device, which FDA has already cleared based on its own review. The current submission relies on the manufacturer's engineering and design expertise to demonstrate the new device's identity to the predicate.

4. Adjudication method for the test set

Not applicable. There was no test set requiring adjudication in the context of a clinical performance study. The FDA's review process itself involves adjudication by regulatory experts evaluating the submitted technical documentation against regulatory requirements and the predicate device's information.

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 device (manual wheelchair), not an AI-powered diagnostic or interpretive system. Therefore, MRMC studies and "human readers" interpreting data with or without AI are irrelevant.

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

Not applicable. This is not an algorithm or AI system.

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

The "ground truth" for the Jumao Manual Wheelchair's performance claims is the established safety and effectiveness of the legally marketed predicate device (Universal Wheelchair by Graham-Field Health Products, Inc., 510(k) K930411). The manufacturer asserts that all relevant characteristics are identical, thus implying identical safety and effectiveness. The performance is also shown to comply with relevant ISO 7176 standards, which are another form of established "ground truth" for wheelchair performance.

8. The sample size for the training set

Not applicable. There is no training set for an AI/algorithm as this is a mechanical device.

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

Not applicable. There is no training set for an AI/algorithm.

Summary

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OCT 0 7 2008

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CHAPTER 5. 510(K) SUMMARY

This 510(k) summary of safety and effectiveness for Jumao Manual Wheelchair is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92

Applicant:	Danyang Jumao Healthcare Equipment Co., Ltd.
Address:	No.89 Shuangfeng Road, Jiepai town, Danyang, Jiangsu, P.R.China
Contact Person:	Qing Wang
Telephone:	(86 511)- 86379811
Email:	kenwqing@gmail.com
Date of Preparation:	July 28, 2008
Device Name:	JUMAO MANUAL WHEELCHAIR
Classification Name:	Manual Wheelchair
Device Class:	Class I
Product Code:	IOR
Classification Panel	Physical Medicine
Type of submission	Traditional 510K

Table 5-1 General Information

Intended use:

The Jumao Manual Wheelchair is intended for medical purposes to provide mobility to persons restricted to a seated position.

Indications for Use:

The Jumao Manual Wheelchair is intended for medical purposes to provide mobility to persons restricted to a seated position. Jumao Manual Wheelchair is not designed, sold, or intended for use except as indicated.

Device Description

All device functions, scientific concepts, significant physical and performance characteristics (i.e. device design, materials, physical properties, etc.) are identical to the design and manufacture described in Predicate Device.

Predicate Device:

ﻬﺎ ﻓﻬﻮ: ﻳﻬﺎﺟﻪ ﺍﻟﻤﺘﻮﺳﻂ ﺍﻟﺘﻲ ﺗﻬﺪﻑ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﺘﻲ ﺗﻌﺘﺒﺮ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﺘﻲ ﺗﻌﺘﺒﺮ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﺘﻲ ﺗﻌﺘﺒﺮ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﺘﻲ ﺗﻌﺘﺒﺮ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﺘﻲ ﺗﻌﺘﺒﺮ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﺘﻲ ﺗﻌﺘﺒﺮ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﺘﻲ ﺗﻌﺘﺒﺮ ﺍﻟﻤﺘﺤﺪﺓ

Universal Wheelchair by Graham-Field Health Products, Inc. (Formerly Everest & Jennings), 510(k) K930411.

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Substantial Equivalence Information:

Technological/Safety Characteristics:

The Jumao Manual Wheelchair's technological and safety characteristics are identical to those described in the Predicated Device. The detailed comparison table is included in Chapter 10.

Performance Data:

The Jumao Manual Wheelchair's performance is shown to comply with the relevant ISO 7176 standards, identical to those described in the Predicated Device.

Conclusion:

The data submitted in this 510(K) Premarket Notification supports the finding that this device is substantially equivalent with respect to the intended use, technology, functionality, and safety features to the legally marketed Predicate Device. Therefore, we believe that this device meets the requirement for a "Substantial Equivalence" decision in accordance with the 510(K) guidelines.

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

OCT 0 7 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Danyang Jumao Healthcare Equipment % Regulatory Technology Services, I.L.C Mr. Mark Job 1394 25" Street, NW Buffalo, MN 55313

Re: K082784

Trade/Device Name: Jumao Manual Wheelchair Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: Class I Product Code: IOR Dated: September 22, 2008 Received: September 23, 2008

Dear Mr. Job:

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

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Page 2 - Mr. Mark Job

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 100-1050. This letter will allow you to begin marketing your device as described in your Scction 510(k) premarket notification. The FDA finding of substantial equivalence of your device to 10(x) marketed predicate device results in a classification for your device and thus, permitts 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliar, at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance awelms at (240) 276-3464. You may obtain other general information on your remonsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistances 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,

Mark N. Millman

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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CHAPTER 4. INDICATIONS FOR USE

510(k) Number (if known):

Device Name: Jumao Manual Wheelchair

Indications for Use: ক্তু

The Jumao Manual Wheelchair is intended for medical purposes to provide mobility to persons restricted to a seated position.

Prescription Use AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Rizal Luma Decena to tata

ign-Of Division of General, Restorative, and Neurological Devices

510(k) Number L082784

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).