The Karma 800 Series Manual Wheelchair is a user propelled mechanical wheelchair. Its intended function and use is to provide mobility to persons limited to a sitting position.

The product is designed to be a lightweight, everyday wheelchair for both indoor use. It is a folding, or non-rigid type of wheelchair. The product consist primarily of an aluminum allov frame with cross braces, large rear wheels with hand rims for propelling the chair, and smaller front pivoting casters for steering and turning.

The frame is constructed of round, aluminum alloy tubing that is welded. The seat-to-floor heights are adjustable via dual rear axle positions. The slung fabric seat and back meets the requirements of California 117 specifications for flame retardancy. Swing back armrest and swing away footrest are standard features.

AI/ML Overview

Here's an analysis of the provided documents regarding the Karma 800 Series Manual Wheelchair, focusing on the requested information:

The provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. Instead, it is a 510(k) summary for a manual wheelchair, which primarily focuses on demonstrating substantial equivalence to a predicate device, rather than detailed performance studies against specific acceptance criteria.

Therefore, for most of your questions, the answer will be "Not applicable" or "No information provided" based on the given text.

Here's the breakdown of the information that is available or explicitly missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
No specific acceptance criteria are listed in the document.	The document states "Performance Data: NA".

Explanation: The 510(k) summary explicitly states "Performance Data: NA" (Not Applicable). This is common for Class I medical devices like manual wheelchairs, where substantial equivalence to a predicate device is often demonstrated through technological equivalence and adherence to general controls, rather than extensive new performance testing against specific quantitative criteria.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: No information provided.
Data Provenance (country of origin, retrospective/prospective): No information provided.

Explanation: Since no performance study is described, there is no test set or associated data provenance mentioned.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Number of Experts: No information provided.
Qualifications of Experts: No information provided.

Explanation: This is relevant for studies involving human interpretation or subjective assessment, which is not described here.

4. Adjudication Method for the Test Set

Adjudication Method: No information provided.

Explanation: As no study or ground truth establishment process is detailed, no adjudication method is mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

Was an MRMC study done? No.
Effect size of human readers with AI vs. without AI assistance: Not applicable (no AI involved).

Explanation: This device is a manual wheelchair, a mechanical device. It does not involve AI, and thus no MRMC study or AI-assisted performance evaluation would be applicable.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop) Performance Study Was Done

Was a standalone performance study done? No.

Explanation: This question pertains to AI/algorithmic performance, which is not relevant for a manual wheelchair. The "Performance Data: NA" indicates no specific performance study was conducted.

7. The Type of Ground Truth Used

Type of Ground Truth: Not applicable.

Explanation: Ground truth is typically established in studies where an algorithm or human interpretation is being evaluated against a known standard (e.g., pathology for a cancer diagnosis AI). For a manual wheelchair, the "ground truth" of its function is its ability to provide mobility, which is generally established through design specifications, manufacturing quality control, and adherence to established standards rather than a clinical study with a "ground truth" diagnosis.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable.

Explanation: This device does not involve a machine learning model, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established

Method for Establishing Ground Truth: Not applicable.

Explanation: As there is no training set, this question is not relevant.

Summary of what the documents do provide:

Intended Use: To provide mobility to persons limited to a sitting position.
Technological Description: User-propelled mechanical wheelchair, lightweight, folding, aluminum alloy frame, cross braces, large rear wheels with hand rims, front pivoting casters, adjustable seat-to-floor heights, flame-retardant fabric seat/back, swing-back armrest, swing-away footrest.
Predicate Device: Karma Manual Folding Wheelchair (K950195).
Substantial Equivalence: Based on similar intended function, use, and basic mechanical components (aluminum alloy folding frame, wheels, casters).
Regulatory Class: I
Product Code: IOR
Manufacturer: Karma Medical Products, Co., LTD.
Submitter/Correspondent: Vestil Manufacturing Corporation
Date of FDA Review: June 14, 2002.
FDA Decision: Found substantially equivalent to the predicate device.

Summary

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-PH2

JUN 1 4 2002

510(k) Summary

Karma 800 Series Manual Wheelchair

Intended Use

The intended use of the Karma 800 Series Manual Wheelchair is to provide mobility to persons limited to a sitting position.

Technological Description

Device Description:

The Karma 800 Series Manual Wheelchair is a user propelled mechanical wheelchair. Its intended function and use is to provide mobility to persons limited to a sitting position.

Substantial Equivalence

The product that is substantially equivalent to the Karma 800 Series Manual Wheelchair is Karma Manual Folding Wheelchair (K950195).

Each of these products is a manually operated, manual mechanical wheelchair with the same intended function and use which is to provide mobility to persons limited to a seated position. All products consist basically of an aluminum alloy folding frame with braces to support the wheelchair, large rear wheels, and smaller front pivoting casters for turning and steering.

Performance Data

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510(k) Summary

Vestil Manufacturing Corporation's 510(k) Premarket Notification Karma 800 Series Manual Wheelchair

Submitter's Name, Address, Telephone, Fax Number, and Contact Name

Karma Medical Products, Co., LTD. No. 2363 Section 2, Da-Shiue Road Min-Hsiung Shiang Chia-Yi Hsien, 621. Taiwan Phone: 886 5 206 6688 Fax: 886 5 206 7788

Manufacturer's Name, Address, Telephone, and Fax Number

Same as Above

Name of Device Karma 800 Series Manual Wheelchair

Name of Applicant/Submission Correspondent, Address, Phone, Fax Number, and Contact Name

Vestil Manufacturing Corporation 900 Growth Parkway Angola, IN 46703 Phone 260.668.5677 Fax: 260.668.8967 Rick Michael - rick@vestil.com

Date Prepared

Mav 2002

Common or Usual Name

Manual Wheelchair

Classification

Wheelchair, Mechanical 89IOR

Predicate Device

The product that is substantially equivalent to the Karma 800 Series Manual Wheelchair is the Karm: Manual Folding Wheelchair (K950195).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is 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 right, stacked on top of each other. The profiles are connected by a flowing, ribbon-like shape at the bottom.

Public Health Service

'JUN 1 4 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Rick Michael North America Sales Manager Vestil Manufacturing Company 900 Growth Parkway Angola, IN 46703

Re: K021866

Trade Name: Karma 800 Series Regulatory Number: 890.3850 Regulatory Name: Mechanical wheelchair Regulatory Class: I Product Code: IOR Dated: June 6, 2002 Received: June 6, 2002

Dear Mr. Michael:

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. Rick Michael

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 and additionally 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, 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 Mellheusen

Celia 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

510(k) Number (if known):

Device Name: KARMA 800 SERIES

Indications For Use:

THE INTENDED USE OF THE KARMA 800 SERIES MANUAL WHEELCHAIR IS TO PROVIDE MOBILITY TO PERSONS LIMITED TO A SITTING POSITION.

FDA/CDRH/ODE/DMC

JUN 6 '02
1 35 PM

RECEIVED

(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)

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Over-The-Counter Use √

(Optional Format 1-2-96)

Mark N. Wilkerson

on-()ff) vision of General, Restorative and Neurological Devices

510(k) Number K021866

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).