The Stannah power Chair is intended as a device to provide personal transport for a person with walking difficulties. It is specifically designed to for indoor use in a domestic type environment.

Device Description

The Power Chair is a powered wheelchair based around a high quality office chair. Attached to the chair is a proprietary controller unit, which can be mounted on either side of the seat. The motion is operated by the user hand via a joystick. The attachment method allows the controller to be positioned further forward or backwards relative to the chair for comfort and convenience of the user.

The chair is attached to a base assembly containing the drive motors, drive wheels, castor wheels and batteries, by a Gas Strut (anti-rotate) which enables the chair to be raised or lowered within set limits. Operation may be either manual, using a hand lever, or with a powered version option, via a separate control on the controller unit. The powered height adjustment can not be made while the power chair is driving in any direction. The Base is a profiled and of folded sheet steel fabrication, to which the two drive motor/gearboxes, two drive wheels, five castor wheels and a footrest assembly are mounted directly.

AI/ML Overview

This 510(k) submission for the Stannah Power Chair Model 201 does not provide a table of acceptance criteria or a detailed study proving the device meets specific performance metrics in the way one would expect for an AI/ML medical device. This is a premarket notification for a Class II medical device (a powered wheelchair) from 2001, and the regulatory requirements and documentation style are very different from what would be expected for an AI system today.

The "Performance Data" section in the document describes compliance with existing industry standards for powered wheelchairs rather than, for example, a clinical trial with statistical performance metrics against a medical condition.

However, I will extract the information that is present and interpret it in the context of device performance and what might be considered "acceptance criteria" for a traditional medical device like a wheelchair at that time (compliance with recognized standards).

Here's an analysis based on the provided document:

Acceptance Criteria and Reported Device Performance

For this traditional medical device (powered wheelchair), the "acceptance criteria" are compliance with established performance standards for such devices. The reported "performance" is that the device meets those standards.

Acceptance Criteria (Reference to Standard)	Reported Device Performance
BS/ISO Powered Wheelchair Standard #ISO 7176 parts 1-16 (appropriate sections)	"In all instances, the Stannah Power Chair Model 201 met the required performance criteria and functioned as intended."
ISO EMC Draft Standard 7176-14 ("Draft ISO EMC Group Proposal: Electromagnetic Compatibility Addition" dated April 3rd, 1995)	"In all instances, the Stannah Power Chair Model 201 met the required performance criteria and functioned as intended."

Study Details (as inferable for a traditional device, not an AI study)

Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated as a "test set" in the context of a data-driven model. For a physical product like a wheelchair, it would involve testing of prototypes or production units. The document implies at least one "Stannah Power Chair Model 201" underwent testing against the standards. There is no mention of country of origin of "data" in the AI sense, nor is there a distinction between retrospective or prospective study data.
- Data Provenance: The testing was conducted by Stannah Power Chair Ltd. against international standards (BS/ISO, ISO EMC).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the AI/ML sense. "Ground truth" for a wheelchair's performance is determined by physical testing against engineering specifications and safety standards, not by expert interpretation of data. The standards themselves are developed by expert committees, but that's a different context.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Performance against engineering standards is typically measured objectively (e.g., speed, range, stability tests) rather than through subjective adjudication.
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 is not an AI-assisted device, nor is it a diagnostic device requiring human reader interpretation.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm; it's a physical device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for the device's performance is defined by established engineering and safety standards (BS/ISO 7176 series and ISO EMC 7176-14). Compliance is measured through physical tests of the device's operational characteristics (e.g., stability, maneuverability, electromagnetic compatibility).
The sample size for the training set:
- Not applicable. This is not an AI/ML device that requires a training set.
How the ground truth for the training set was established:
- Not applicable.

Summary for AI/ML Context vs. Traditional Device:

This document is a classic 510(k) premarket notification for a physical medical device from the early 2000s. The entire framework of questions provided (acceptance criteria, sample sizes, ground truth establishment, MRMC studies, training/test sets) is geared towards the evaluation of AI/ML software as a medical device (SaMD) or AI-enabled medical devices. These concepts simply do not apply to the Stannah Power Chair Model 201 as presented in this submission.

The "study" in this context is the performance testing conducted by the manufacturer against recognized international standards for powered wheelchairs and electromagnetic compatibility. The "proof" is the manufacturer's assertion that the device "met the required performance criteria and functioned as intended" in all instances of these tests. This level of detail was sufficient for a substantial equivalence determination for this type of device at that time.

Summary

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K 994083

10F >

APR - 4 2001

510(k) SUMMARY

Stannah Power Chair Ltd. Model 201 Power Chair

Submitters Name, Address, Telephone Number, Contact Person and Date Prepared.

Stannah Power Chairs Ltd. Watt Close East Portway Ind. Estate Andover Hampshire SP10 3SD England

Contact Person:

Charles Edgell Director Stannah Power Chairs Ltd

December 1999 Date Prepared:

Name of Device and Name / Address of Sponsor

Stannah Power Chair Model 201

Stannah Power Chairs Ltd. Watt Close East Portway Ind. Estate Andover Hampshire SP10 3SD England

Common or Usual Name

Powered Wheelchair

Classification Name

Wheelchair, Powered

Predicative Devices

Pride Health Care "Jazzy" Powered Wheelchair (510(k) # K 945936 date 05/28/94)

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Intended Use

The Stannah power Chair is intended as a device to provide personal transport for a person with walking difficulties. It is specifically designed to for indoor use in a domestic type environment.

Technological Characteristics and Substantial Equivalence

Device Description:

Substantial Equivalence

The Stannah Power Chair Model 201 is substantially equivalent to other devices of comparable type that are currently being legally marketed within the United States of America. The comparable device quoted and compared is the Pride Health Care "Jazzy" powered wheel chair, (510(k) # K 945936 date 05/28/94).

Each of the products are battery powered, twin motor gearbox driven, mid wheel drive powered wheelchairs with the same intended function and use, which is to provide mobility to persons with walking difficulties, that have the capability of operating a powered wheelchair. They also offer excellent maneuverability due to their drive geometry. They are constructed of the same basic materials and have the same basic operational principles.

Performance Data

As required by the FDA's July 26th, 1995, draft publication entitled "Guidance Document for the Preparation of Pre-Market Notification [510(k)] Applications for Mechanical and Powered Wheelchairs, and Motorized Three Wheeled Vehicles". The Stannah Power Chair conforms to appropriate sections of BS/ISO Powered Wheelchair Standard #ISO 7176 parts 1-16.

The Power Chair was also tested in accordance with the ISO EMC Draft Standard 7176-14, (titled "Draft ISO EMC Group Proposal: Electromagnetic Compatibility Addition" dated April 3rd, 1995) for Powered Wheelchairs and Scooters. In all instances, the Stannah Power Chair Model 201 met the required performance criteria and functioned as intended.

K 99 4083

2002

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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR - 4 2001

Mr. Charles Edgell Commercial Director Stannah Power Chairs LTD. Watt Close East Portway Ind. Estate Andover, Hampshire SP10 3SD England

Re: K994083 Trade Name: Stannah Power Chair, Model 201 Regulatory Class: II Product Code: IPL Dated: February 8, 2001 Received: February 8, 2001

Dear Mr. Edgell:

We have reviewed your Section 510(k) notification of intent to market the device referenced we have teviewed your bocally in the device is substantially equivalent (for the indications for use above and we nave acteringled an marketed in interstate commerce prior to May 28, 1976, the stated in the encrease) to device mansents, or to devices that have been reclassified in enacificin dato of the Modical Dottee Federal Food, Drug, and Cosmetic Act (Act). You may, accordance with the provisions of the general controls provisions of the Act. The general therefore, mainer the do reasjeve equirements for annual registration, listing of devices, controls provisions or use ice, 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 (1 tenance I reproval), it they over in the Code of Federal Regulations, Title 21, Parts 800 to 895. A 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 mopolishing the GMP regulation 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.

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 nredicate device results in a classification for your device and thus, permits your device to proceed to the market.

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Page 2 - Mr. Charles Edgell

If you desire specific advice for your device on our labeling regulation (21 CFF Part 801 and IT you desire specific active for your astic devices), please contact the Office of Compliance at additionally 607.10 for in This daglestions on the promotion and advertising of your device, (201) 594-4039. Additionally, for questions of (301) 594-4639. Also, please note the regulation prease connact the Office or Compilance at (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small
information on your responsibilities under the Act 2011 442 (607 as stifs mornation on your responsibilities and its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Mark N. Melkerson

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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Page 1 of 1

510 (K) Number (If known): K994083

Device Name:

Stannah Power Chair Model 201

Indications for Use:

The Stannah Power Chair is intended as a device to provide personal The Stannan Fower Chair Is allement of the specifically transport for a for a for a domestic type environment.

(Please do not write below this line - continue on another page if needed)

Concurrence of CDRH, office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) Over - the Counter - Use (Optional Format 1-2-96)

L. Mark M. Milkman

(Division Sign-Off) (Division of General, Restorative and Neurological Devices

510(k) Number K994083

Regulation Number and Section

§ 890.3900 Standup wheelchair.

(a)
Identification. A standup wheelchair is a device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. The device incorporates an external manually controlled mechanical system that is intended to raise a paraplegic to an upright position by means of an elevating seat.(b)
Classification. Class II (performance standards).