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K Number
K021390
Device Name
PMX COMPACT RESUCITATOR
Manufacturer
CHEEN HOUNG ENT. CO. LTD.
Date Cleared
2002-10-04

(155 days)

Product Code
BTM
Regulation Number
868.5915
Type
Traditional
Panel
AN
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The PMX COMPACT RESUSCITATOR are manual resuscitators incorporating a bag and valve, intended to provide emergency ventilation or ventilation during patient transport. The infant model is intended for patients weighing between 5 to 12 kgs, the child model is intended for patients weighing between 10 to 30 kgs, and the adult model is intended for patients weighing more than 30 kgs approximate weight. The PMX COMPACT RESUSCITATOR provided in reusable models and in the disposable models.

Device Description

manual resuscitators incorporating a bag and valve

AI/ML Overview

The provided document is a 510(k) clearance letter for the PMX Compact Resuscitator, classifying it as an Emergency Manual Ventilator. This type of regulatory submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed clinical study data with specific acceptance criteria and performance metrics of the new device in the same way an AI/ML device submission would.

Therefore, the document does not contain the information requested in the prompt regarding:

  • A table of acceptance criteria and reported device performance.
  • Sample size used for the test set and data provenance.
  • Number of experts used to establish ground truth and their qualifications.
  • Adjudication method for the test set.
  • Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done or its effect size.
  • Whether 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.

This is expected for a traditional medical device like a manual resuscitator, where performance is typically evaluated through bench testing, materials compatibility, and comparison to established standards and the predicate device's performance, rather than complex clinical studies with ground truth establishment and expert consensus as seen in AI/ML solutions.

§ 868.5915 Manual emergency ventilator.

(a)
Identification. A manual emergency ventilator is a device, usually incorporating a bag and valve, intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway.(b)
Classification. Class II (performance standards).