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The TEEClean® automated cleaner disinfector is intended to replace manual cleaning of Transesophageal (TEE) ultrasound probes and automate high-level disinfection of TEE probes. The system uses TEEZyme® enzymatic cleaner to clean TEE probes as well as TD-5 or TD-8 disinfectant to high level disinfect TEE probes. TEE probes must undergo bedside cleaning prior to insertion into the TEEClean®.

The TD-5® or TD-8® disinfectant bottles cannot be reused in the system.

TD-5® disinfectant is intended for use as a single use high-level disinfectant used exclusively in the TEEClean® automated cleaner disinfector for high-level disinfection of TEE ultrasound probes. TD-5® disinfectant should be used with the following contact conditions in the TEEClean® automated cleaner disinfector:

High-level disinfectant TD-5®
Time - 5 minutes
Temperature - 38° - 40°C
Minimum Recommended Concentration 1.7% glutaraldehyde

TD-8® disinfectant is intended for use as a single use high-level disinfectant used exclusively in the TEEClean® automated cleaner disinfector for high-level disinfection of TEE ultrasound probes. TD-8® disinfectant should be used with the following contact conditions in TEEClean® automated cleaner disinfector:

High-level disinfectant TD-8®
Time - 5 minutes
Temperature - 38° - 40°C Minimum Recommended Concentration 0.3% ortho-phthalaldehyde

TEEZyme® enzymatic cleaner, TD-5® and TD-8® high level disinfectant, and TEEClean® automated cleaner disinfector system are intended for use by qualified individuals trained in its use.

The TEEClean® cleaner disinfector provides cleaning and high-level disinfection of transesophageal (TEE) ultrasound probes when used according to the operating instructions and when used with TEEZyme® enzymatic cleaner and TD-5® or TD-8 disinfectant. The TEEClean® cleaner disinfector iss for use only with TEEZyme® enzymatic cleaner and TD-5® or TD-8® disinfectant. Thus, the TEEClean® cleaner disinfector, TEEZyme® enzymatic cleaner, and TD-5º or TD-8º disinfectant represent a dedicated system. Each soiled TEE probe is bedside cleaned to the TEE probe manufacturer's instructions before insertion into the TEEClean® cleaner disinfector. A fresh, unopened bottle of TD-5° or TD-8° disinfectant is loaded into the TEEClean® cleaner disinfector. The TEEClean® cleaner disinfector heats the TEEZyme®, soaks the TEE probe, and thoroughly rinses the enzymatic cleaner off the TEE probe before the cleaning cycle is complete. The TEEClean® cleaner disinfector then heats TD-5® or TD-® disinfectant to 38°-40°C, soaks the TEE probe at least five (5) minutes, and then thoroughly rinses the disinfectant off the TEE probe before the disinfection cycle is complete. The TEEClean® cleaner disinfector prints a verification report indicating a successful cleaning and disinfection cycles as well as the time and the average temperature during the disinfection. The TEE probe is then removed from the TEEClean® cleaner disinfector and dried according to the TEE probe manufacturer's instructions. The TEEClean® cleaner disinfector is ready for a new cycle immediately after the preceding cycle is completed. Because a fresh bottle of TD-5% or TD-80 disinfectant is used with each cycle, no monitoring of the disinfectant's potency is required, nor is there any requirement for daily testing of the disinfectant solution.

The provided document is a 510(k) summary for a medical device (TEEClean® Automated TEE Probe Cleaner Disinfector). It describes the device, its intended use, and comparisons to predicate devices, along with summaries of non-clinical testing.

However, the document does not contain the kind of detailed information about acceptance criteria and study results typically found for AI/ML-based medical devices, specifically:

• A table of acceptance criteria and reported device performance for an AI/ML model: The acceptance criteria here are related to physical device performance (e.g., disinfectant contact time, temperature, rinsing effectiveness, microbial kill) and safety (electrical safety, biocompatibility, vapor exposure), not AI/ML performance metrics like sensitivity, specificity, or AUC.
• Sample sizes used for a "test set" and "training set": While "simulated use studies" and "routine clinical use" studies are mentioned for performance testing, the sample sizes (number of probes or cycles) are not specified in the summary. There's no separate mention of training and test sets in the context of an AI/ML model for diagnostic or other AI-driven tasks.
• Number/qualifications of experts, adjudication methods for ground truth, MRMC studies, standalone AI performance, or ground truth types (pathology, outcomes data) for an AI/ML system. These are all concepts relevant to the validation of AI/ML algorithms in diagnostic or clinical decision support, which is not the primary function of this device as described.

Therefore, based on the provided text, it is not possible to describe the acceptance criteria and study that proves an AI/ML device meets the acceptance criteria. The document pertains to a physical automated cleaning and disinfection device, not an AI/ML system.

The "Performance Testing" section describes the studies done:

• Disinfectant vapor exposure studies: Performed in a room with zero air exchanges to demonstrate filter capacity.
• Automated Simulated use studies with TEEZyme® Cleaner: Showed measurable reduction of soils.
• Automated Simulated use studies with TD-5 and TD-8: Showed measurably complete kill of microorganisms.
• Routine Clinical Use studies: Soiled TEE probes subjected to cleaning and disinfection, showing measurable complete kill of microorganisms.

The acceptance criteria for these would be qualitative (e.g., "acceptable" soil reduction, "complete kill of microorganisms," "filter has capacity for 12 months"). Specific quantitative thresholds are not provided in this summary.

In summary, the provided document does not describe an AI/ML-based device or its validation.

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The EVOTECH™ Endoscope Cleaner and Reprocessor, a washer/disinfector, is indicated for use with high- level disinfectant CIDEX® OPA Concentrate and an enzymatic detergent (CIDEZYME GI) to achieve cleaning and high level disinfection of heat sensitive (>60°C) 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 of mystical devices (endoscopes) is required when selecting the Disinfect only or Disinfect/Alcohol Flush Cycle.)

The EVOTECH™ Endoscope Cleaner and Re-processor was cleared under the Premarket Notification process (K040883) found substantially equivalent on March 15, 2005. Subsequent to that the EVOTECH ECR was granted a cleaning claim in Premarket Notification K061899 (found substantially equivalent on October 26, 2006). The system is designed to clean and disinfect endoscopes. The system performs tests to check for connection of endoscopes, for leaks in endoscopes, and for blockage of lumens. The device will clean and high-level disinfect endoscopes and provides for automated alcohol flush of the lumens. The system also has a self-disinfection cycle that can be selected (recommended to be performed every 5 days) to prevent the build up of biofilm in fluid pathways.

The provided text is a 510(k) summary for a Special 510(k) submission for the EVOTECH™ Endoscope Cleaner and Reprocessor. This type of submission is for modifications to a previously cleared device that do not affect the safety or effectiveness. As such, it does not typically include new clinical studies or detailed performance data against acceptance criteria for cleaning and high-level disinfection, but rather verification that the modifications do not negatively impact these established performances.

Therefore, many of the requested items (e.g., acceptance criteria, detailed device performance, sample sizes for test/training sets, expert qualifications, MRMC studies) are not applicable to this specific type of submission and the information provided.

However, I can extract information related to the modifications and the non-clinical tests performed to ensure they did not impact the device's original performance.

Here's a breakdown of what can be extracted and what is not provided:

1. A table of acceptance criteria and the reported device performance

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not provided. The document focuses on demonstrating that modifications did not impact existing performance, rather than re-proving the device's primary function with new detailed studies. The "non-clinical tests" mentioned are specific to verifying the modifications.

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/Not provided. This submission is not likely to involve expert ground truth for image interpretation or diagnosis. The "ground truth" for the non-clinical tests would have been the established specifications and performance parameters for each modified component.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable/Not provided. Adjudication methods are typically for clinical studies with subjective assessments. The tests described are objective engineering verifications.

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/Not provided. This is an endoscope cleaning and reprocessing device, not an AI-assisted diagnostic tool. Therefore, MRMC studies are not relevant.

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

• Not applicable/Not provided. This is a hardware device with associated software, not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• For the verification of modifications, the "ground truth" was based on:
  • Engineering specifications and compatibility testing: For material compatibility, dispensing volume, and reproducibility of the disinfectant dispenser.
  • Functional performance standards: For spray arm rotation/pattern, MEC monitor equivalence, and lid motor control safety.
  • Software validation protocols.

8. The sample size for the training set

• Not applicable/Not provided. This is not an AI/machine learning device.

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

• Not applicable/Not provided.

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