JAN MAO WHEELCHAIR, MODEL JMC612-F18EPP by JAN MAO INDUSTRIES CO., LTD.

The JAN MAO Wheelchair, JMC612-F18EPP 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 submission describes a medical device, the JAN MAO Wheelchair, JMC612-F18EPP, and its substantial equivalence to a predicate device. However, it does not include information about AI algorithms or advanced performance studies typically associated with "acceptance criteria" and "device performance" in the context of AI/ML devices.

Therefore, many of the requested sections (2, 3, 4, 5, 6, 7, 8, 9) cannot be answered from the provided text as they relate to AI/ML device studies. The information available pertains to traditional medical device regulatory submissions.

Here's an analysis based on the provided text, focusing on the available information:

Analysis of the Provided Text:

The document describes a 510(k) premarket notification for a mechanical wheelchair. The primary method for demonstrating "device performance" and meeting "acceptance criteria" in this context is through compliance with recognized standards and comparison to a legally marketed predicate device.

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Standards Compliance)	Reported Device Performance
ANSI/RESNA WC vol. 1	Meets applicable requirements
ISO 7176 Wheelchair Standards	Meets applicable requirements
California Technical Bulletin CAL 117 (Flame Retardant)	Upholstery meets standard
Overall dimensions similar to predicate device	Overall dimensions are similar
Same weight capacity as predicate device	Same weight capacity
Back upholstery material the same resistance ignitability fabric as predicate device	Back upholstery material is the same resistance-ignitability fabric

Note: The specific numerical acceptance limits or detailed test results for ANSI/RESNA or ISO 7176 are not provided in this summary. The submission simply states that the device "meets the applicable performance requirements."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. For a mechanical device like a wheelchair, "test set" typically refers to the units produced for testing against engineering standards. The sample size and data provenance are not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable and not provided. "Ground truth" and "expert consensus" are terms primarily used in the context of AI/ML or diagnostic device studies. For a mechanical wheelchair, compliance with standards is typically verified through engineering tests, not expert consensus on ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable and not provided. Adjudication methods are relevant for studies involving human interpretation or subjective assessments, not for objective engineering tests of a mechanical device.

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

This information is not applicable and not provided. MRMC studies and the concept of "human readers improving with AI" are specific to AI-assisted diagnostic or interpretive devices. This is a mechanical wheelchair.

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

This information is not applicable and not provided. There is no algorithm mentioned in the context of this mechanical wheelchair.

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

This information is not applicable and not provided. As mentioned previously, "ground truth" is not a concept typically applied to the performance assessment of a mechanical device like a wheelchair in a regulatory submission like this. Performance is largely determined by adherence to engineering specifications and safety standards.

8. The sample size for the training set

This information is not applicable and not provided. There is no "training set" as this is not an AI/ML device.

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

This information is not applicable and not provided. There is no "training set" nor "ground truth" in the AI/ML sense for this device.

Study Proving Device Meets Acceptance Criteria:

The study that proves the device meets the acceptance criteria is performance testing against recognized national and international wheelchair standards.

Study Name (Implied): Performance Testing of JAN MAO Wheelchair, JMC612-F18EPP
Standards Used: ANSI/RESNA WC vol. 1 and ISO 7176 Wheelchair Standards. The upholstery fabric also met the California Technical Bulletin CAL 117 standard for flame retardant.
Result: The device "meets the applicable performance requirements as specified" in these standards.
Methodology (Implied): This type of testing typically involves a series of physical and mechanical tests specified by the standards, such as fatigue testing, static stability, braking efficacy, dimensional checks, and material flammability tests. The specifics of these tests are not detailed in the summary.
Substantial Equivalence Comparison: The submission also relies on comparison to a legally marketed predicate device, the AVANTICARE Mechanical Wheelchair, MR-9000 (K050708), to demonstrate substantial equivalence. Key attributes compared include intended use, foldability, overall dimensions, weight capacity, and upholstery material. The differences (removable armrest and swing-away footrest) were deemed not to impact safety.

Summary

{0}------------------------------------------------

K051482 JUN 2 9 2005 1/2

JMe
ISO 9000
進貿實業有限公司
JAN MAO INDUSTRIES CO., LTD.
1F. No. 22 Alley 20 Lanc142. Sec. 6. Roosevelt Rd..
Wen-Shar Dist., Taiper. Taiwan, R. O. C.
TEL: 886-2-2930-0381 FAX: 886-2-2931-2455
E-mail Address: Jewe88@m27.hinet.net

510(k) SUMMARY "

Submitter's Name: JAN MAO INDUSTRIES CO., LTD. No.181, Chu Liao Road, Ta Su Hsiang, Kao Hsiung Hsian, TAIWAN, 840, ROC

Date summary prepared:

Device Name:

Proprietary Name:

Common or Usual Name: Classification Name:

May 27, 2005

JAN MAO. Wheelchair, JMC612-F18EPP 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 restricted to a seated position.

Description of the device:

Performance Testing:

JAN MAO Wheelchair, JMC612-F18EPP meets the applicable 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, MR-9000 ( K050708 )

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K051482

Me 進貿實業有限公司
JAN MAO INDUSTRIES CO., LTD.
ISO 9002

No. 22. Alley 20 Lane142. Sec. 6. Roosevelt Rd.
Wen-Soar Dist., Taipei, Taiwan. R. O. C.
TEL: 886-2-2930-0381 FAX: 886-2-2933-3455
E-mail Address: jewel88@ms27.hinet.net

2/2

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 and same weight capacity. Back upholstery material is also the same resistance -ignitability fabric and also meets the California Technical Bulletin CAL 117 standard for flame retardant. The major differences existing are the overall dimension. Besides, the predicate device is fixed frame and the new device is removable desk-length armrest and swing-away detachable elevating footrest. The overall appearance differences are not safety aspect. So the new device is substantially equivalent to the predicate device.

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Image /page/2/Picture/13 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three wavy lines above two wavy lines.

JUN 2 9 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Jan Mao Industries Company, Ltd. C/o Dr. Ke-Min Jen ROC Chinese-European Industrial Research Society No. 58. Fu-Chiun Street Hsin-Chu City, China (Taiwan) 300

Re: K051482

Trade/Device Name: JAN MAO, Wheelchair JMC612-F18EPP Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: I Product Code: IOR Dated: May 27, 2005 Received: June 3, 2005

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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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/industry/support/index.html.

Sincerely yours,

Stupt Charles

iam 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

510 (K) Number ( If Known ): K

Device Name: JAN MAO, Wheelchair JMC612-F18EPP

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)

Hyet Murda
(Division Sign-Off)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of General, Restorative. and Neurological Devices

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510(k) Number K051482

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).