COACH 888W by WHEELCHAIR & SCOOTER EXPRESS

The provided document is a 510(k) clearance letter from the FDA for a powered wheelchair (Coach 888W). It's a regulatory document confirming substantial equivalence to a predicate device, not a study report detailing acceptance criteria and performance data. Therefore, the requested information about acceptance criteria, study details, sample sizes, ground truth establishment, and expert qualifications is not available in this document.

Companies must conduct testing and provide data to the FDA to demonstrate substantial equivalence, but this particular letter is the result of that process, not the detailed report of the studies themselves.

To answer your request, here's what can be inferred or stated about the information that is not present:

Information Not Found in the Document:

1. A table of acceptance criteria and the reported device performance: This document does not contain a table of acceptance criteria or performance data for the Coach 888W. Regulatory letters like this generally summarize the FDA's decision, not the underlying test results.
2. Sample size used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned, as this device is a powered wheelchair and likely evaluated based on engineering and safety standards, not interpretation by medical experts to establish a "ground truth" in the way an AI diagnostic tool might.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not mentioned.
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. MRMC studies are relevant for diagnostic AI devices where human readers interpret images or data. This is a powered wheelchair, not a diagnostic AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable for a powered wheelchair.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of a diagnostic "ground truth" for this type of device. The "ground truth" for a powered wheelchair would relate to its ability to meet performance and safety standards, not a diagnostic outcome.
8. The sample size for the training set: Not applicable; powered wheelchairs are not typically "trained" in the machine learning sense.
9. How the ground truth for the training set was established: Not applicable.

What the document DOES tell us:

Device Name: Coach 888W
Regulation Number: 890.3860 (Powered wheelchair)
Regulatory Class: II
Product Code: ITI
Indications for Use: To provide an optional means of mobility for physically challenged people.
FDA Finding: Substantially equivalent to legally marketed predicate devices.
Date of Clearance: July 10, 2003

In summary, this document is a regulatory approval notice and does not contain the detailed technical study information you've requested. That kind of information would typically be found in the 510(k) submission itself, not the clearance letter.

Summary

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Image /page/0/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. Inside the circle is a symbol consisting of three stylized lines that resemble a person with outstretched arms. The seal is black and white and appears to be a logo or emblem.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 0 2003

Mr. Chris Tinsley Wheelchair & Scooter Express L.C. 4905-A San Jacinto Houston, TX 77004

Re: K030760

Trade/Device Name: Coach 888W Regulation Number: 890.3860 Regulation Name: Powered wheelchair Regulatory Class: II Product Code: ITI Dated: February 26, 2003 Received: June 20, 2003

Dear Mr. Tinsley:

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. Chris Tinsley

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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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,

Miriam C. Provost

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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510 (k) Number (if known): ___________________________________________________________________________________________________________________________________________________

Device Name: Coach 888W

Indications for Use: To provide an optional means of mobility for physically challenged people.

(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) OR

Over-The-Counter Use v

Muriam C. Provost

Division Sion-Off Division of General, Restorative and Neurological Devices

(Optional Format 1-2-96)

K030760 510(k) Number ________________________________________________________________________________________________________________________________________________________________

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).