Search Results

The EvoTech™ System, a washer/disinfector, is indicated for use with highlevel disinfectant CIDEX® OPA Concentrate and an enzymatic detergent (CIDEZYME GI) to achieve cleaning and high level disinfection of heat sensitive (>60℃) semi-critical endoscopes. Manual cleaning of medical devices (endoscopes) is not required prior to placement in the EvoTech System when selecting those cycles that contain a wash stage. (Manual cleaning is required when selecting the Disinfect Only or Disinfect/Alcohol Flush Cycles.)

The EvoTech™ System is a two-basin washer/disinfector utilizing an enzymatic detergent and a concentrated high-level disinfectant, CIDEX OPA Concentrate Solution. Both the detergent and high-level disinfectant are diluted in the system to in-use concentrations. The EvoTech System is capable of cleaning endoscopes that have not been manually cleaned prior to placing in the EvoTech System.

Here's a summary of the acceptance criteria and study details for the EvoTech™ System based on the provided text:

Acceptance Criteria and Device Performance

Study Details:

1. Sample sizes for the test set and data provenance:

   • Cleaning Studies (Simulated Use): Specific numbers are not provided, but it states "Both simulated use and in-use studies were completed." Endoscopes were "contaminated" for these tests. Data provenance is not specified but implies laboratory testing.
   • Cleaning Studies (In-Use/Clinical): Specific numbers are not provided, but it states "Endoscopes used in clinical procedures were processed through the 'wash only' cycle." This indicates prospective, clinical data. Data provenance (country of origin) is not specified.
   • High-Level Disinfection Study: Specific numbers are not provided, but it states "Endoscopes were contaminated with Mycobacterium terrae imbedded in soil." This implies laboratory testing.

2. Number of experts used to establish the ground truth for the test set and their qualifications:

   • This information is not provided in the given text. For the cleaning and disinfection studies, the ground truth was based on quantitative measures of residual soil (protein, TOC) and microbial reduction, not expert consensus in the traditional sense of image interpretation.

3. Adjudication method for the test set:

   • Adjudication methods (e.g., 2+1, 3+1) are typically relevant for qualitative assessments or disagreements in expert interpretation. Since the ground truth for cleaning and disinfection was based on quantitative measurements (ug/cm² and cfu/mL reduction), an adjudication method is not applicable and therefore not mentioned.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

   • This is a device for endoscope reprocessing, not an AI or diagnostic imaging device. Therefore, an MRMC study and effects on human reader improvement with AI assistance are not applicable and no such study was described.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • This is a standalone device (automated endoscope reprocessor) where its performance is evaluated directly without human intervention in the core reprocessing function. The studies described are essentially standalone performance evaluations of the EvoTech System's ability to clean and disinfect effectively.

6. The type of ground truth used:

   • Cleaning Studies: Quantitative measurement of residual protein and Total Organic Carbon (TOC) (ug/cm²).
   • High-Level Disinfection Study: Quantitative measurement of microbial reduction (colony-forming units per milliliter - cfu/mL reduction for Mycobacterium terrae).

7. The sample size for the training set:

   • This information is not applicable as the EvoTech System is an automated physical device, not a machine learning algorithm that requires a "training set" in the context of data-driven model development.

8. How the ground truth for the training set was established:

   • This information is not applicable for the same reason as point 7.

Ask a specific question about this device