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Propper EO LINE™ is indicated to be an ethylene oxide sterilization integrator for use in EO sterilizers with 10% ethylene oxide : 90% HCFC gas mixtures. Its function is to monitor the exposure conditions for EO sterilization and to ensure that the four critical parameters: EO gas concentration, temperature, humidity and exposure time have been met.

Propper EO LINE™ Ethylene Oxide Sterilization Integrator

This document is a 510(k) clearance letter from the FDA for a medical device called "Propper EO LINE™ Ethylene Oxide Sterilization Integrator". It doesn't contain a detailed study report with specific acceptance criteria and performance data. Instead, it indicates that a study was done and found the device to be "comparable" to a predicate device.

Therefore, I cannot provide a detailed answer to your request regarding acceptance criteria and study particulars.

However, I can extract the following limited information based on the provided text:

1. A table of acceptance criteria and the reported device performance
Not available in this document. The document states:

• "The performance of Propper EO LINE™ Integrator was comparable to SteriGage® EO Integrator when tested in a Joslyn BIER vessel."
  This implies that the acceptance criterion was likely "comparable performance" to the predicate device (SteriGage® EO Integrator), but the specific metrics for comparability are not detailed.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not available in this document.

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/available. This device is an integrator for sterilization, not a diagnostic device requiring expert interpretation. The ground truth would be based on physical/chemical sterilization parameters.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable/available.

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. This is not an AI-based diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm-based device. It is a physical sterilization integrator.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The type of ground truth for a sterilization integrator would typically be the successful or unsuccessful sterilization based on established physical (temperature, humidity, time) and chemical (EO gas concentration) parameters, often confirmed by biological indicators. The document mentions: "ensure that the four critical parameters: EO gas concentration, temperature, humidity and exposure time have been met."

8. The sample size for the training set
Not applicable/available. Sterilization integrators are typically tested and validated, not "trained" in the machine learning sense.

9. How the ground truth for the training set was established
Not applicable/available.

In summary, the provided document is an FDA clearance letter, not the detailed study report itself. It indicates that a "comparable" study was performed against a predicate device (SteriGage® EO Integrator) using a Joslyn BIER vessel, but it does not contain the specifics of that study.

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