LogoFDA 510(k) Search
K Number
K021605
Device Name
MEDGEM
Manufacturer
HEALTHETECH, INC.
Date Cleared
2002-06-14

(29 days)

Product Code
BZL
Regulation Number
868.1730
Type
Special
Panel
AN
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The MedGem is intended for use in clinical and research applications to measure oxygen uptake.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain the detailed information necessary to answer your request regarding the acceptance criteria and the study that proves the device meets them. The document is an FDA 510(k) clearance letter for the MedGem device, stating its intended use and regulatory classification. It does not include:

  1. A table of acceptance criteria and reported device performance.
  2. Sample sizes or data provenance for a test set.
  3. Information on experts used to establish ground truth.
  4. Adjudication methods.
  5. Results of a multi-reader multi-case (MRMC) comparative effectiveness study or any effect sizes related to AI assistance.
  6. Results of a standalone algorithm performance study.
  7. The type of ground truth used.
  8. Sample size for the training set.
  9. How ground truth for the training set was established.

The document primarily focuses on the regulatory clearance of the device based on substantial equivalence to a predicate device, rather than a detailed performance study report.

§ 868.1730 Oxygen uptake computer.

(a)
Identification. An oxygen uptake computer is a device intended to compute the amount of oxygen consumed by a patient and may include components for determining expired gas volume and composition.(b)
Classification. Class II (performance standards).