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

Intended for medical purposes to provide mobility to persons restricted to a sitting position

Device Description

The NISSIN series Mechanical Wheelchair consists of typical components found on most wheelchairs, such as push handles, armrests, backrest, seat frame, cushion, footrest and casters. Many of these components are available in a range of sizes, shapes, angles, forms, materials or coverings. Theses variations allow the chairs to be configured to meet the specific desires and needs of the user.

AI/ML Overview

The provided text describes a 510(k) summary for the NISSIN Mechanical Wheelchair, a declaration of substantial equivalence, and its intended use. However, it does not include information about specific acceptance criteria, a study proving device performance against those criteria, or details regarding sample sizes, expert ground truth establishment, or comparative effectiveness studies. The primary goal of this submission is to demonstrate substantial equivalence to a predicate device, not necessarily to present a detailed performance study with quantitative acceptance criteria.

Therefore, many of the requested elements for a detailed performance study are not present in the provided documentation.

Here's a breakdown of the available information in relation to your request:

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

Acceptance Criteria: Not explicitly stated as quantitative metrics. The acceptance criteria for this 510(k) submission are implicitly demonstrating compliance with:
- The "Guidance document for the preparation of premarket notification [510(k)] applications for mechanical and powered wheelchairs, and motorized three-wheeled vehicles" (July 26, 1995, reformatted 12/18/97).
- ISO 7176 standards.
- The general controls provisions of the Federal Food, Drug, and Cosmetic Act.
Reported Device Performance: The document states that "Data was provided that demonstrated compliance with the Guidance document [...] and ISO 7176. All issues of safety and effectiveness have been addressed." Specific quantitative performance metrics (e.g., durability, weight capacity, maneuverability) and their values are not detailed in this summary.

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 given text. The submission refers to "data was provided" but does not specify the nature, sample size, or provenance of this data.

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. For a mechanical device like a wheelchair, "ground truth" as it relates to expert consensus for diagnostic image interpretation is not a relevant concept. Device performance (e.g., strength, stability, durability) is typically assessed through engineering tests and adherence to standards, not expert medical opinion on a "test set" in the diagnostic sense.

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

This information is not applicable and not provided. See point 3.

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. This type of study is relevant for AI-powered diagnostic or assistive devices involving human interpretation, not for 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. This concept relates to AI algorithms, not a mechanical wheelchair.

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

The "ground truth" for a mechanical wheelchair's safety and effectiveness is established through adherence to recognized engineering standards (like ISO 7176) and regulatory guidance documents. This involves physical testing, material specifications, and design verification, rather than medical "ground truth" derived from expert consensus, pathology, or outcomes data in the context of diagnostic devices.

8. The sample size for the training set

This information is not applicable and not provided. A training set is relevant for machine learning models, which is not what this submission is about.

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

This information is not applicable and not provided. See point 8.

In summary: The provided 510(k) summary focuses on demonstrating "substantial equivalence" of the NISSIN Mechanical Wheelchair to a predicate device (Quickie Suspension Wheelchair Series Model XTR). This process heavily relies on demonstrating compliance with established standards (ISO 7176) and guidance documents for wheelchairs, ensuring that the new device meets general safety and effectiveness requirements. It does not present a detailed clinical study with specific performance metrics, expert adjudication, or AI-related evaluations as described in your request.

Summary

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K05-252/

SEP 2 6 2005

510(k) Summary: NISSIN Mechanical Wheelchair

Summary of Safety and Effectiveness:

Submitted:	September 7, 2005
Name of Firm:	NISSIN MEDICAL INDUSTRIES (NISSIN) Company, LTDDarren Reeves, U.S. AgentLocation: 8-7 HanenishiYoyohasi, Aichi-Prefecture, Japan
510(k) Contact:	Darren Reeves866-393-4954
Trade Name:	NISSIN series Mechanical Wheelchair
Common Name:	Mechanical Wheelchair
Classification:	21 CFR Part 890.3850 Mechanical wheelchair

Device Product Code: IOR.

Substantially

Quickie Suspension Wheelchair Series Model XTR by Sunrise Equivalent Device: Medical (K982989)

Device Description:

Intended Use:

The NISSIN series Mechanical Wheelchair is intended 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 wheelchairs, and motorized three-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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular fashion around the eagle.

SEP 26 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Nissin Medical Industries Company, LTD c/o Mr. Darren Reeves DP Distribution & Consulting 15637 Fox Cove Circle Moseley, Virginia 23120

Re: K052521

Trade/Device Name: Mechanical Wheelchair Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: I Product Code: IOR Dated: September 12, 2005 Received: September 14, 2005

Dear Mr. Reeves:

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 - Mr. Darren Reeves

This letter will allow you to begin marketing your device as described in your Section 510(k) This icter will anow you to ogain maining of substantial equivalence of your device to a legally prematicated 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 If you desire specific aarroliance at (240) 276-0120. Also, please note the regulation entitled, Coniact the Office of Computer in the time (21CFR Part 807.97). You may obtain Misoranding of Tereferee to presence to presentibilities under the Act from the Division of Small other general 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 N. Melkerson 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

ので、

the submit and the submit of the sub-

510(k) Number (if known): K052521

Device Name: Mechanical Wheelchalr

Indications For Use:

Intended for medical purposes to provide mobility to persons restricted to a sitting position

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

Over-The-Counter Use (21 CFR 807 Subpart C)

(Registration and Listing are submitted and in process)

(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

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510(k) NumberkOS 25 21

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).