FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

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

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).