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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.

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The EvoTech System, a washer / disinfector, is indicated for use with the high level disinfectant CIDEX® OPA Concentrate, (MEC of 0.055%, minimum temperature of 50°C for a contact time of 5 minutes) for reprocessing heat sensitive (

The EvoTech™ System is a two-basin washer / disinfector utilizing a concentrated high-level disinfectant (CIDEX® OPA Concentrate – K032959) that is diluted within the system to an In-Use concentration. The system performs a leak test, a block test, pre-rinse, wash, disinfect, rinse, and alcohol flush on the endoscope being reprocessed. The disinfection temperature is 50-55°C. The In-Use disinfectant is discarded after each use by the system.

The provided document describes the safety and effectiveness summary for the EvoTech™ Integrated Endoscope Disinfection System. This device is a washer/disinfector intended for reprocessing flexible endoscopes.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

In Use Testing: "Sterility testing demonstrated no growth" when endoscopes used in a clinical environment were reprocessed in the EvoTech System without manual cleaning. This implies successful high-level disinfection. |
| Biocompatibility/Residual Levels | The level of OPA residual remaining on an endoscope should not cause toxic effects in humans. | Analysis indicated that "the level of OPA residual remaining on an endoscope is not likely to cause toxic effects in humans." |
| Material Compatibility | Minimal effect on materials commonly used in medical devices after multiple disinfection cycles over extended periods. | "Multiple disinfection cycles over extended periods of time resulted in minimal effect on the test articles. The effects seen were similar to those seen with the predicate device for the high level disinfectant - CIDEX OPA Solution K991487." |
| Predicate Equivalence | Device demonstrates substantial equivalence to the legally marketed predicate device (Medivators DSD-91 Disinfector K914145). | The overall conclusion states: "The data presented and the equivalence demonstrated to the predicate device support the claim of substantial equivalency for the EvoTech System." The material compatibility effects were explicitly stated to be similar to the predicate device. |

2. Sample size used for the test set and the data provenance

• Sample Size for Simulated Use Testing: Not explicitly stated how many endoscopes or samples were used for the Mycobacterium terrae reduction study.
• Sample Size for In Use Testing: Not explicitly stated how many clinical endoscopes were used for the sterility testing.
• Sample Size for Biocompatibility Testing: Not explicitly stated how many endoscopes were tested for OPA residual levels.
• Sample Size for Material Compatibility: Not explicitly stated how many material samples or endoscope types were tested.
• Data Provenance: The document does not specify the country of origin for the data. The data appears to be from laboratory and "in-use" (clinical environment) studies conducted for regulatory submission. It is prospective in nature as it details studies conducted to support the device's efficacy and safety.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• This information is not applicable to this type of device submission. The efficacy of a washer/disinfector is typically established through microbiological testing (e.g., Log reduction) and chemical analysis, not through expert consensus on diagnostic images or clinical assessments by a panel of human experts.
• The "ground truth" for disinfection efficacy is objective microbiological results (e.g., bacterial culture, spore count reduction).

4. Adjudication method for the test set

• This information is not applicable as there is no human interpretation or subjective assessment that would require an adjudication method. The testing involves objective measurements like microbial counts, chemical residue levels, and material degradation.

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

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging AI systems where human readers interpret medical images. The EvoTech™ System is a medical device for reprocessing flexible endoscopes, not an AI for image interpretation.

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

• This question is not applicable in the context of the EvoTech™ System. While the system automates the disinfection process, it's a physical device and not a standalone algorithm in the sense of an AI performing a diagnostic task. The "performance" of the device is its ability to effectively disinfect, which is evaluated through the studies described. The device itself operates "without human-in-the-loop" once programmed for a cycle, but it doesn't involve an "algorithm only" in the AI sense.

7. The type of ground truth used

• Microbiological Ground Truth: For disinfection efficacy, the ground truth was established by demonstrating a specific reduction in a test microorganism (Mycobacterium terrae) and by showing "no growth" in sterility testing of clinically used endoscopes.
• Chemical Analysis Ground Truth: For biocompatibility, the ground truth was derived from chemical analysis to quantify OPA residuals and assess their potential toxicity.
• Material Science Ground Truth: For material compatibility, the ground truth involved assessing the physical and structural integrity of materials after exposure to the reprocessing cycles.

8. The sample size for the training set

• This concept is not applicable to a medical device like the EvoTech™ System, which is a physical washer/disinfector rather than an AI or machine learning algorithm that requires a "training set" of data.

9. How the ground truth for the training set was established

• This question is not applicable as there is no "training set" for this type of device.

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