The intended use of the Stealth Products Powered Seating System is to provide pressure relief to persons confined to a wheelchair, by providing a method of tilting and reclining the wheelchair seat and back.
The intended function and use of the Stealth Products Powered Seating System for Power Wheelchairs is to provide pressure relief to power wheelchair users, by providing a means of tilting and reclining the seat and back.

Device Description

The Stealth Products Powered Seating System for power wheelchairs is a battery powered, motorized seating system, designed for use with power wheelchairs. It's intended function and use is to provide pressure relief to power wheelchair users, by providing a means of tilting and reclining the seat and back.

The system consists primarily of a main frame assembly, a system mounting plate, linear actuators and a toggle switch assembly. The main frame assembly supports the patient during use of the seating system. The system mounting plate is the interface between the Stealth Seating System and the wheelchair. The linear actuator provides the motion needed to position the system, and the toggle switch assembly is the means by which the tilt/recline functions are activated.

The Stealth Powered Seating System is designed to adapt to wheelchairs with round, square, or rectangular frames. Minimum frame requirements are 1 ½" diameter x .09 wall for round frames and a 1" mounting surface x .09 wall for square and rectangular frames.

AI/ML Overview

The provided text describes a 510(k) Premarket Notification for the "Stealth Products Powered Seating System for Power Wheelchairs." While it states that performance and functional testing were conducted, the document does not provide specific acceptance criteria or detailed study results demonstrating how the device meets those criteria.

It only states: "In all cases, the Stealth System passed its' performance requirements and met specifications."

Therefore, I cannot populate the requested table and details because the information is not present in the provided text.

Here's a breakdown of the specific information that is missing from the document:

A table of acceptance criteria and the reported device performance: This is not present. The document generally states the system "passed its' performance requirements and met specifications" but does not enumerate these requirements or specific performance metrics.
Sample size used for the test set and the data provenance: Not mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical study with a "ground truth" seems to have been conducted or reported. The tests conducted were "performance and functional testing," implying engineering or bench testing.
Adjudication method for the test set: Not applicable.
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 powered seating system, not an AI diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as detailed above.
The sample size for the training set: Not applicable, as this is not an AI/machine learning device.
How the ground truth for the training set was established: Not applicable.

Summary

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FEB 1 1 2005

510(k) Premarket Notification

Powered Seating System

K 050264

510(k) SUMMARY

STEALTH PRODUCTS POWERED SEATING SYSTEM FOR POWERED WHEELCHAIRS

Submitter

Stealth Products, Inc. 103 John Kelly Drive P.O. Box 468 Burnet, Texas 78611 Phone: (800) 965-9229 Fax: (800) 806-1225

Contact Person

Edward A. Kroll President Spectre Solutions 5905 Fawn Lane Cleveland, Ohio 44141 Phone: (440) 546-9810 Fax: (440) 546-9124

Date Prepared: February 1, 2005

Name of Device

Stealth Products Powered Seating System for Power Wheelchairs

Common or Usual Name

Power Wheelchair Seating System

Classification Name

Wheelchair, Powered

Predicate Devices

Invacare Corporations' Model 2G Tilt/Recline Seating System for Power Wheelchairs (K991119) and Accelerated Rehab Designs, Inc. Model T-2000 Power Tilt Seating System (K992804).

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Intended Use

Device Description

Substantial Equivalence

The Stealth Products Powered Seating System is substantially equivalent to Invacare Corporations' Model 2G Tilt/Recline Seating System for Power Wheelchairs (K991119) and the Accelerated Rehab Designs, Inc. Model T-2000 Power Tilt Seating System (K992804).

Performance Data

Stealth Products has conducted performance and functional testing on the Stealth Products Powered Seating System. In all cases, the Stealth System passed its' performance requirements and met specifications.

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

FEB 1 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Stealth Products, Inc. C/o Edward A. Kroll President, Representative Consultant Spectre Solutions 5905 Fawn Lane Cleveland, Ohio 44141

Re: K050264

Trade/Device Name: Stealth Products Powered Seating System for Power Wheelchairs Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: II Product Code: ITI Dated: February 2, 2005 Received: February 4, 2005

Dear Mr. Kroll:

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 for abo cased or 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. Kroll

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will anow you to cognifinding of substantial equivalence of your device to a legally premarket notification - 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 acries in 1940) 276-0120 . Also, please note the regulation entitled, Colliation of Compunance as (21 t motification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other gelleral information on Jour responser 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,

sincerely yours,

Mark A. Melkersen

Celia M. Witten, Ph.D., M.D. 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): TBD_______________________________________________________________________________________________________________________________________________

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

The intended function and use of the Stealth Products Powered Seating System for Power i he intended function and use of the Steath. Free belief to power wheelchair users, by whechenan's is to provide of tilting and reclining the seat and back.

Prescription UseAND/OR(Part 21 CFR 801 Subpart D)
Over-The-Counter Use(21 CFR 801 Subpart C)	X

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

(Division Sign-Off)

Division of General. Restorative, and Neurological Devices

16(k) Number K05 0264

Regulation Number and Section

§ 890.3860 Powered wheelchair.

(a)
Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class II (performance standards).