MANUAL RIGID MOBILITY WHEELCHAIR by FREEDOM DESIGNS, INC.

This document is a 510(k) clearance letter for the CGX Wheelchair (K080270). It states that the device is substantially equivalent to legally marketed predicate devices. However, this type of FDA clearance letter for a mechanical wheelchair does not typically include detailed information about acceptance criteria, study designs, sample sizes, expert qualifications, or comparative effectiveness studies related to performance metrics like accuracy, sensitivity, or specificity. These types of detailed performance evaluations are generally required for more complex devices, particularly those involving algorithms, diagnostics, or therapeutic effects.

Therefore, most of the requested information cannot be extracted from this document because it is not present. This document primarily focuses on regulatory clearance based on substantial equivalence to existing devices, not on a detailed analysis of a new device's performance against specific quantitative acceptance criteria or its impact on human reader performance.

Here's a breakdown of what can be confirmed or inferred from the provided text, and what cannot:

1. A table of acceptance criteria and the reported device performance

Cannot be provided. This document does not list specific acceptance criteria or quantitative performance metrics for the CGX Wheelchair. For mechanical wheelchairs, acceptance criteria are typically related to safety, durability, and basic functionality, which are demonstrated through testing that isn't detailed in this 510(k) letter.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Cannot be provided. The document does not mention any specific test set, sample sizes, or data provenance. The substantial equivalence determination for a mechanical wheelchair would involve testing based on recognized standards (e.g., ISO for wheelchairs).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable/Cannot be provided. "Ground truth" as understood in the context of diagnostic AI/ML devices (e.g., expert consensus on medical images) is not relevant for a mechanical wheelchair's 510(k) submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/Cannot be provided. This concept is not relevant for the type of device and submission described.

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/Cannot be provided. An MRMC study is relevant for diagnostic imaging devices where human interpretation is involved. This is a mechanical wheelchair.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable/Cannot be provided. "Standalone algorithm performance" is not relevant for a mechanical wheelchair.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable/Cannot be provided. The concept of "ground truth" in the context of medical efficacy or diagnosis is not applicable to an entirely mechanical device like a wheelchair in its 510(k) submission. Safety and performance are typically assessed through engineering tests and adherence to standards.

8. The sample size for the training set

Not applicable/Cannot be provided. This concept is only applicable to AI/ML or statistical models, not a mechanical wheelchair.

9. How the ground truth for the training set was established

Not applicable/Cannot be provided. This concept is only applicable to AI/ML or statistical models, not a mechanical wheelchair.

Information that can be extracted from the document:

Device Name: CGX Wheelchair
510(k) Number: K080270
Applicant: Freedom Designs, Inc. (Mr. Bob Gardner)
Regulation Number: 21 CFR 890.3850
Regulation Name: Mechanical wheelchair
Regulatory Class: Class I
Product Code: IOR
Date of Decision/Letter: April 16, 2008
Indications For Use: "This wheelchair is designed as a transport base for pediatric and adult clients."
Prescription Use/Over-The-Counter Use: Marked as "Over-The-Counter Use".

Summary

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Freedom Designs, Inc. % Mr. Bob Gardner 2241 Madera Road Simi Valley, CA 93065

APR 1 6 2008

K080270 Re:

Trade/Device Name: CGX Wheelchair Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: Class I Product Code: IOR Dated: February 25, 2008 Received: February 25, 2008

Dear Mr. Gardner:

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. Bob Gardner

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Wilkerson

Mark N. Melkerson 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): K080270

Device Name: CGX Wheelchair

Indications For Use:

This wheelchair is designed as a transport base for pediatric and adult clients.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use × (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Net Re al for

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

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510(k) Number K080270

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).