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K Number
K011565
Device Name
INFANT OXYGEN TREATMENT HOOD
Manufacturer
GULF COAST HYPERBARICS, INC.
Date Cleared
2001-08-16

(87 days)

Product Code
CBF
Regulation Number
868.5470
Type
Traditional
Panel
AN
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The new Infant Oxygen Treatment Hood is designed to administer oxygen, under supervision of a physician, to infants or small children within a mukiplace hyperbaric chamber without physically having to hold the infant or child.

Device Description

Infant Oxygen Treatment Hood

AI/ML Overview

I'm sorry, but the provided text is a 510(k) clearance letter from the FDA for an "Infant Oxygen Treatment Hood." This document confirms that the device is substantially equivalent to a legally marketed predicate device and can proceed to market.

However, a 510(k) clearance letter typically does not contain the detailed information you are requesting regarding acceptance criteria and specific studies, sample sizes, expert qualifications, or ground truth establishment for software or AI-driven medical devices. These types of details are usually found in the original 510(k) submission document itself, which is not provided here.

Therefore, I cannot extract the following information from the given text:

  • A table of acceptance criteria and the reported device performance
  • Sample sizes used for the test set and the data provenance
  • Number of experts used to establish the ground truth for the test set and their qualifications
  • Adjudication method for the test set
  • If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size
  • If a standalone (algorithm only) performance study was done
  • The type of ground truth used
  • The sample size for the training set
  • How the ground truth for the training set was established

The document focuses on the regulatory clearance process rather than the technical study results.

§ 868.5470 Hyperbaric chamber.

(a)
Identification. A hyperbaric chamber is a device that is intended to increase the environmental oxygen pressure to promote the movement of oxygen from the environment to a patient's tissue by means of pressurization that is greater than atmospheric pressure. This device does not include topical oxygen chambers for extremities (§ 878.5650).(b)
Classification. Class II (performance standards).