MANUAL WHEELCHAIR by G. HIRSCH AND CO., INC.

The device consists of a folding chromed steel frame with cross braces, slung fabric seat and back, fixed or removable armrests, fixed or removable foot/legrests, front caster wheels for steering, rear push handles for attendant-assisted propulsion, rear drive wheels with handrims for self-propulsion, and lever-style wheel locks.

AI/ML Overview

It appears this document describes a 510(k) summary for a Manual Wheelchair manufactured by G. Hirsch and Company, Inc., submitted on July 24, 1998.

This document is a regulatory filing for a medical device (a manual wheelchair) to demonstrate its substantial equivalence to previously marketed devices. It does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria in the way a clinical or technical validation study would for a diagnostic or AI-based device.

The provided text focuses on the following:

Substantial Equivalence: The primary goal of a 510(k) submission is to demonstrate that a new device is as safe and effective as a legally marketed predicate device. This is typically done through a comparison of design features, materials, and intended use, rather than extensive performance testing against defined acceptance criteria.
Comparison of Design Features: The document provides a table comparing key physical characteristics of the G. Hirsch wheelchair to an Invacare Tracer Wheelchair (K935398) to show similarity.

Therefore, the requested information elements related to formal acceptance criteria, device performance results from a study, sample sizes, ground truth establishment, expert adjudication, or MRMC studies are not present in this document.

The context of this document is a regulatory submission for a simple mechanical device (a wheelchair), where substantial equivalence demonstration typically relies on design similarity and known performance of predicate devices, not on data-driven performance studies as one would expect for, say, an AI diagnostic algorithm.

Summary of what can be extracted from the document:

1. A table of acceptance criteria and the reported device performance: Not applicable. The document presents a comparison of physical specifications for demonstrating substantial equivalence to a predicate device, not performance against acceptance criteria from a validation study.
2. Sample sized used for the test set and the data provenance: Not applicable. No test set or data provenance is mentioned as this is a comparison of design features.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth or experts for performance evaluation are discussed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 device is a manual wheelchair, not an AI-based diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable. This is not an AI/machine learning device.
9. How the ground truth for the training set was established: Not applicable.

In conclusion, this document details a 510(k) premarket notification for a manual wheelchair and does not contain the type of acceptance criteria or study results typically found for performance-driven devices, especially those involving AI or advanced diagnostics.

Summary

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

1 CI S R D FAITH CALL F τ

Image /page/0/Picture/1 description: The image shows the logo for G. Hirsch and Company Inc. The logo is in black and white, with the words "G. HIRSCH" in large, bold letters on a black background. Below that, the words "AND COMPANY INC." are in smaller letters on a white background.

AUG 3 1 1998

KG82607

510(k) SUMMARY

(a) This is an Initial 510(k) Summary in accordance with 21 CFR 807.92.

(1) Submitted by: G. Hirsch and Company, Inc. 1815 Rollins Road Burlingame, CA 94010-2204 Phone (650) 692-8770 Contact: Garv Hirsch Prepared 07/24/98

(2) Proprietary Name: Manual Wheelchair Common Name: Manual Wheelchair Classification Name: Wheelchair, Mechanical
(3) Examples of four legally marketed devices of substantial equivalence, together with their 510(k) numbers are as follows:

Mechanical Wheelchair 980.3850, K945175 Tracer Series Manual Wheelchairs, K35398 Bantex Brand Wheelchairs, K915262 Universal Wheelchair, K930411

(4) The device consists of a folding chromed steel frame with cross braces, slung fabric seat and back, fixed or removable armrests, fixed or removable foot/legrests, front caster wheels for steering, rear push handles for attendant-assisted propulsion, rear drive wheels with handrims for self-propulsion, and lever-style wheel locks.

(5) The wheelchair is to be used for transportation of disabled persons.

(6) The wheelchair exhibits no material differences from the predicate devices listed in number (3) above. Please see the enclosed catalog pages of Invacare Tracer Series wheelchairs (510(k) #K935398) for a comparison of design features, which we believe to be equivalent to our submitted wheelchair. Some items for comparison are listed below.

	Our submitted wheelchair	Invacare Tracer Wheelchair (510(k)#K935398)
1. Seat Ht.	20"	20"
2. Widths	14" – 22"	14" - 20"
3. Rear Wheels	24"	24"
4. Front Casters	8"	8"
3. Product Wt.	42 lbs.	44 lbs.
4. Weight Limit:	250 lbs.	250 lbs.

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 3 1 1998

Mr. Gary Hirsch President G. Hirsch and Company, Inc. 1815 Rollins Road 94010 Burlingame, California

Re: K982607 Manual Wheelchair Trade Name: Regulatory Class: I Product Code: IOR Dated: July 24, 1998 Received: July 27, 1998

Dear Mr. Hirsch:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ಡಿ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

{2}------------------------------------------------

Page 2 - Mr. Gary Hirsch

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at 1 its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D.
Director
Division of General and
Restorative Devices
Office of Device Evaluation

Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

510(k) Number (if known):_

Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications For Use:

ン

For transportation of disabled persons.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

te colly

(Division Sign-Off) Division of General Restorative Devices 16982607 510(k) Number.

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use
$$\not\exists$$

(Optional Format 1-2-96)

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).