CIE FOLDAWAY WHEELCHAIR by CARLSBAD INTERNATIONAL EXPORT, INC.

The provided document is a 510(k) clearance letter for a "CIE Foldable Wheelchair (Travel Companion)". This type of document from the FDA is for medical devices and focuses on establishing substantial equivalence to a predicate device, rather than detailed performance studies and acceptance criteria as would be found in a Premarket Approval (PMA) application or a more complex 510(k) submission for novel devices or software.

Therefore, the information requested regarding acceptance criteria and detailed study data is not present in this document. The FDA's substantial equivalence determination for this device likely relied on comparisons of technical specifications, materials, and intended use with an already marketed wheelchair, rather than a clinical performance study with defined acceptance criteria.

Here's why the requested information cannot be extracted from the provided text:

Type of Device: A manual wheelchair (even a foldable one) is a relatively low-risk device, classified as Class I. The regulatory pathway for such devices, especially decades ago (this letter is from 2005), typically focuses on demonstrating that the new device is as safe and effective as existing legally marketed devices, not on proving new clinical efficacy through extensive trials.
Content of 510(k) Letter: This letter is the FDA's decision letter, stating that substantial equivalence has been found. It summarizes the regulatory outcome, but it does not contain the actual data from the submission that led to that decision. The 510(k) submission itself would have included information comparing the new device to a predicate, potentially listing specifications and standards met, but not typically detailed clinical study results with acceptance criteria.
Lack of "Algorithm" or "AI": The questions about "AI," "standalone algorithm performance," "human readers with/without AI assistance," and "training set" are completely irrelevant to a manual wheelchair, which is a mechanical device.

To directly answer your request based only on the provided text, I must state that the information is not available. The document does not contain:

A table of acceptance criteria and reported device performance.
Sample size for test set and data provenance.
Number of experts or their qualifications for ground truth.
Adjudication method for the test set.
MRMC comparative effectiveness study or related effect sizes.
Standalone algorithm performance.
Type of ground truth used.
Sample size for the training set.
How ground truth for the training set was established.

Summary

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 9 2005

Mrs. Laura Meyer Carlsbad International Export, Inc. 1954 Kellogg Avenue Carlsbad, California 92008-6581

Re: K050345

Trade/Device Name: CIE Foldable Wheelchair (Travel Companion) Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: I Product Code: IOR Dated: March 9, 2005 Received: March 9, 2005

Dear Mrs. Meyer:

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 (OS) regulation (21 CFR Part 820): and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

Page 2 - Mrs. Laura Meyer

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 (240) 276-0120 . 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/industry/support/index.html.

Sincerely yours,

Stupt Rhodes

Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

INDICATIONS FOR USE

510 K Number K050345

Devise Name CIE Foldable Wheelchair ( Travel Companion )

Indications for use:

The intended use is to provide mobility to persons limited to a sitting position, or who are unable to walk for long periods of time.

Prescription use ( Part 21 CFR 801 Subpart D) and or

Over the Counter Use X (21 CFR 807 Subpart C)

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

Concurrence of CDRH, office of Device Evaluation ( ODE

Styt Rhodes

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

K050345 510(k) Number__

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).