The NISSIN Pediatric Series Wheelchair is intended to be used to empower persons physically challenged to a sitting position by providing a means of mobility.

Device Description

The NISSIN Pediatric Series Wheelchair consists of typical components found on most wheelchairs, THE NOON T ourants offices , backrest, seat frame, cushion, footrest and casters. Many of these suon do patil harities, an a range of sizes, shapes, angles, forms, materials or coverings. Components and a allow the chairs to be configured to meet the specific desires and needs of the user.

AI/ML Overview

This looks like a clearance document for a medical device that does not use AI. The questions you're asking are geared towards AI/ML-enabled devices, so many of the requested fields are not applicable.

However, I will extract the information that is available within the provided text.

Acceptance Criteria and Device Performance Study for NISSIN Pediatric Series Wheelchair

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Compliance with "Guidance document for the preparation of premarket notification [510(k)] applications for mechanical and powered preparation of promation in thee-wheeled vehicles" (July 26, 1995, reformatted 12/18/97)	Data demonstrated compliance with this guidance document.
Compliance with ISO 7176 (standards for wheelchairs)	Data submitted that demonstrated compliance with ISO 7176.
Addressing all issues of safety and effectiveness	All issues of safety and effectiveness have been addressed.

2. Sample size 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. The submission references compliance with guidance documents and ISO standards, which typically involve testing, but details about the specific test set sample size or data provenance are not included in this summary.

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 as the device is a mechanical wheelchair and not an AI/ML diagnostic tool requiring expert-established ground truth in the medical imaging sense. The "ground truth" for a mechanical device would be its adherence to engineering specifications and safety standards, which are evaluated through standardized tests rather than expert consensus on medical data.

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

This information is not applicable for a mechanical wheelchair. Adjudication methods like 2+1 or 3+1 are typically used in medical imaging studies involving multiple human readers for diagnostic agreement, 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

This information is not applicable as the device is a mechanical wheelchair and does not involve AI assistance for human readers.

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

This information is not applicable as the device is a mechanical wheelchair and does not involve an algorithm. Performance evaluation for such a device would be based on its physical characteristics and functionality.

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

The "ground truth" for this device's performance is its compliance with established engineering standards and regulatory guidance documents (e.g., ISO 7176 and the FDA's 510(k) guidance for mechanical wheelchairs). This is verified through physical testing and documentation of conformity, rather than medical "ground truth" types like pathology or expert consensus on clinical data.

8. The sample size for the training set

This information is not applicable as the device is a mechanical wheelchair and does not involve a training set as understood in AI/ML contexts.

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

This information is not applicable as the device is a mechanical wheelchair and does not involve a training set.

Summary

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510(k) Summary: NISSIN Pigleo Series Pediatric Wheelchair

Summary of Safety and Effectiveness:

FEB -- 5 2007

Submitted:	September 25, 2006
Name of Firm:Location:	NISSIN MEDICAL INDUSTRIES (NISSIN) Company, LTD35-2 Gongen, Okimura,Kitanagoya-shi, Aichi-Prefecture481-8681, Japan
510(k) U.S. Contact:	Takahiro Haruyama3551 Voyager Street, Suite 102Torrance, CA 90503(310) 370-8484 (Office)(310) 370-8454 (Fax)
Trade Name:	NISSIN Pediatric Wheelchair
Common Name:	Mechanical Wheelchair
Classification:	21 CFR Part 890.3850 Mechanical Wheelchair
Device Product Code:	IOR
SubstantiallyEquivalent Device:	Rodeo Models by Convaid (K032402).

Device Description:

Intended Use:

The NISSIN Pediatric Series Wheelchair to be used to empower persons physically challenged to a sitting position by providing a means of mobility.

Summary of Safety and Effectiveness:

Data was provided that demonstrated compliance with the Guidance document for the preparation of premarket notification [510(k)] applications for mechanical and powered preparation of promation in thee-wheeled vehicles (July 26, 1995, reformatted 12/18/97). In addition, data was submitted that demonstrated compliance with ISO 7176. All issues of safety and effectiveness have been addressed.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Nissin Medical Inc. % Takahiro Haruyama 3551 Voyager Court Suite 102 Torrance, California 90503

FEB - 5 2007

Re: K063521

Trade/Device Name: Nissin Pediatric Series Wheelchair Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: Class I Product Code: IOR Dated: December 17, 2006 Received: January 18, 2007

Dear Takahiro Haruvama:

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 – Takahiro Haruyama

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) 276-0210 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 yours

Mark N. Melkerson

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: K063521

Device Name: NISSIN Pediatric Series Wheelchair

Indications For use: The NISSIN Pediatric Series Wheelchair is intended to be used to empower persons physically challenged to a sitting position by providing a means of mobility.

Prescription Use X(Part 21 CFR 801 Subpart D)	AND Or	Over-The-Counter Use X(21 CFR 807 Subpart C)
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(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

510(k) Number	1063521
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Regulation Number and Section

§ 890.3100 Mechanical chair.

(a)
Identification. A mechanical chair is a manually operated device intended for medical purposes that is used to assist a disabled person in performing an activity that the person would otherwise find difficult to do or be unable to do. Examples of mechanical chairs include the following: A chair with an elevating seat used to raise a person from a sitting position to a standing position and a chair with casters used by a person to move from one place to another while sitting.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9.