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The TD 200® Automated TEE Probe Disinfector with TD-12® High Level Disinfectant with QwikCheck™ Chemical Indicators is designed to provide high-level disinfection of Transesophageal (TEE) ultrasound probes. The system can use TD-12® disinfectant, which is designed to be used only with the TD 200® disinfector. The disinfectant be reused in the system.

TD-12® disinfectant is intended for use as single use high-level disinfectant to be used exclusively in the TD 200® disinfector for high-level disinfection of TEE ultrasound probes.

TD-12® high level disinfectant and TD 200® disinfector is intended for use by qualified individuals trained in its use.

TD-12® disinfectant should be used with the following contact conditions in TD 200® disinfector:

High-Level Disinfectant: TD-12®
Time: 3 minutes
Temperature: 38°C
Minimum Recommended Concentration: 1750 ppm peracetic acid

QwikCheck™ Chemical Indicators are used prior to the disinfection cycle to ensure that the disinfectant used is above the minimum recommended concentration (MRC) of 1750ppm peracetic acid.

The TD 200 disinfector provides high-level disinfection of transesophageal (TEE) ultrasound probes when used according to the operating instructions and when used with TD-12 disinfectant. The TD 200 disinfector is for use only with TD-12 disinfectant. The TD-12 is for use only in the TD 200 disinfector. Thus, the TD 200 disinfector and TD-12 disinfectant represent a dedicated system. Each soiled TEE probe is bedside cleaned and manually cleaned according to the TEE probe manufacturer's instructions before insertion into the TD 200 disinfector. A fresh, unopened bottle of TD-12 disinfectant is loaded into the TD 200 disinfector. The TD 200 disinfector heats the TD-12 disinfectant to at least 38°C, soaks the TEE probe at least three (3) minutes, and then thoroughly rinses the disinfectant off the TEE probe before the cycle is complete. The TD 200 disinfector prints a verification report indicating a successful disinfection cycle, the time and the average temperature during the disinfection. The TEE probe is then removed from the TD 200 disinfector and dried according to the TEE probe manufacturer's instructions. The TD 200 disinfector is ready for a new cycle immediately after the preceding cvcle is completed. A chemical indicator is used to ensure that the solution is above the MRC.

This document describes the premarket notification (510(k)) for the TD 200® Automated TEE Probe Disinfector with TD-12® High-Level Disinfectant and QwikCheck™ Chemical Indicators. This device is intended for the high-level disinfection of Transesophageal (TEE) ultrasound probes. The submission primarily focuses on demonstrating substantial equivalence to a predicate device (TD 200/TD-12 disinfector/disinfectant system, K192228), with the main change being a new supplier for the QwikCheck Chemical Indicator.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the demonstration of "high-level disinfection" and the equivalence to the predicate device. The performance is assessed through various non-clinical tests.

| Acceptance Criteria (Implicit from Indication and Predicate) | Reported Device Performance (TD 200 with TD-12) |
| High-Level Disinfection of TEE Probes | Automated Simulated Use Studies: Measurably complete kill of microorganisms after TEE probe processing. |
| QwikCheck Chemical Indicator accuracy for MRC | The QwikCheck Chemical Indicator, with its starch and iodide agents, produces a color change within 30 seconds. A color similar to the FAIL block indicates ≤ 1750 ppm, while a color similar to the PASS block indicates > 1750 ppm peracetic acid. This indicates it properly discriminates between concentrations above and below the MRC. |
| Safety and Compatibility (Electrical, Biocompatibility, Material, TEE Probe) | Electrical Safety: Passed testing according to UL 61010-1, 3rd Edition. Biocompatibility: TD-12 is not a sensitizer, irritant, and non-cytotoxic. Residue levels on TEE probes are deemed not likely to have toxic effects. Material Compatibility: No observable effects from exposure of TD 200 materials to TD-12 disinfectant. TEE Probe Compatibility: No cosmetic or functional deterioration observed in GE, Philips, and Siemens TEE probes after processing. TD-12 probe compatibility testing was performed using a use-suspension of 3% w/v (3000ppm) PAA TD-12 at 38°C. |
| Software Validation | All qualification activities defined in the TD 200 Automated TEE Probe Disinfector with TD-12 High Level Disinfectant Verification and Validation Plan were successfully completed, and documented evidence indicates that the TD 200 consistently performs as intended. All data collected met established acceptance criteria. |

2. Sample Size Used for the Test Set and Data Provenance

• TD 200/TD-12 Disinfection Performance:

  • Automated Simulated Use Studies: The exact sample size (number of runs or probes) is not specified, but the results state "In all cases there was a measurably complete kill of microorganisms." This implies a sufficient number of tests were conducted to support the claim.
  • Clinical In-Use Testing: The exact sample size (number of soiled TEE probes) is not specified. The results state "In all cases, there was a complete kill of microorganisms after TEE probe processing." This implies a sufficient number of tests were conducted.
  • Data Provenance: The document does not specify the country of origin for the data or whether it was retrospective or prospective. It appears to be prospective testing conducted by the manufacturer.

• QwikCheck Chemical Indicator:

  • Test Set Description: The summary describes its mechanism (starch and iodide agents, color change within 30 seconds) and how it visually indicates ppm levels (similar to FAIL block for ≤1750 ppm, similar to PASS block for >1750 ppm). No specific sample size for a test set proving its accuracy for this submission is provided, as the primary difference for this component is the change in supplier, implying the performance characteristics are already established and documented as part of that product's existing regulatory clearance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not suggest the use of human experts to establish ground truth for the disinfection or chemical indicator performance. The "ground truth" for disinfection is based on objective microbiological enumeration (complete kill of microorganisms), and for the chemical indicator, it's based on objective chemical concentration levels and colorimetric responses.

4. Adjudication Method for the Test Set

Not applicable, as there is no indication of human reader adjudication for these studies. The assessment of disinfection effectiveness and chemical indicator performance relies on objective laboratory methods.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. The device is an automated disinfectant system and a chemical indicator, not an AI diagnostic tool requiring human interpretation comparison.

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

This refers to the performance of the automated disinfection system and the chemical indicator as standalone devices.

• TD 200/TD-12 Disinfector: Yes, the performance tests (automated simulated use studies, clinical in-use testing) assess the standalone performance of the TD 200 disinfector with TD-12 disinfectant in achieving high-level disinfection.
• QwikCheck Chemical Indicator: Yes, the description of its function and visual interpretation demonstrates its standalone capability to indicate disinfectant concentration.

7. The Type of Ground Truth Used

• For Disinfection Performance (TD 200/TD-12): The ground truth used is objective microbiological enumeration (i.e., "complete kill of microorganisms").
• For QwikCheck Chemical Indicator: The ground truth is objective chemical concentration levels (1750 ppm peracetic acid) and its associated colorimetric response.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a "training set" in the conventional sense. The studies described are for verification and validation of the device's physical and chemical performance.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set for an AI/ML algorithm.

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The Ethos automated ultrasound probe cleaner disinfector is designed to provide cleaning and high-level disinfection of surface and endocavity ultrasound probes. The system uses AquaCide cleaner/disinfectant, which is designed to be used only with the Ethos automated cleaner disinfector. The disinfectant bottles cannot be reused in the system.

AquaCide cleaner/disinfectant is intended for use as a single use cleaner and high-level disinfectant, used exclusively in the Ethos automated cleaner disinfector for cleaning and high-level disinfection of surface and endocavity ultrasound probes.

AquaCide cleaner/disinfectant should be used with the following contact conditions in the Ethos automated cleaner disinfector:

High-level Disinfectant: AquaCide
Time: 3 minutes
Temperature: 47 degrees C
Minimum Recommended Concentration: 1750 ppm peracetic acid

The QwikCheck Chemical Indicator is for use in Ethos to determine whether the concentration of peracetic acid, the active ingredient in AquaCide, is above or below the Minimum Recommended Concentration (MRC) of 1750 ppm.

The Ethos cleaner disinfector with AquaCide and QwikCheck are intended for use by qualified individuals trained in its use.

The Ethos cleaner disinfector provides cleaning and high-level disinfection of surface and endocavity ultrasound probes when used according to the operating instructions and when used with AquaCide cleaner/disinfectant. The Ethos cleaner disinfector is for use only with AquaCide cleaner/disinfectant. The AquaCide cleaner/disinfectant is for use only in the Ethos cleaner disinfector. Thus, the Ethos cleaner disinfector, AquaCide cleaner/disinfectant represent a dedicated system. Each soiled ultrasound probe has the condom/cover removed and is bedside cleaned according to the ultrasound probe manufacturer's instructions before insertion into the Ethos cleaner disinfector. If a condom/cover is not used the user must manually clean the probe. A fresh, unopened bottle of granular PAA AquaCide cleaner/disinfectant is loaded into the Ethos brings in water, mixes and heats the AquaCide solution to a minimum of 47 degrees. While that is occurring, the Ethos brings in water and the ultrasound probe is pre-rinsed. After temperature is achieved and MRC is confirmed, the Ethos bring the AquaCide solution to the probe and cleans and disinfects the ultrasound probe for at least three minutes. Then the Ethos thoroughly rinses the AquaCide off the ultrasound probe before the cycle is complete. The ultrasound probe is then removed from the Ethos and dried according to the ultrasound probe manufacturer's instructions. The Ethos is ready for a new cycle immediately after the preceding cycle is completed. The Ethos cleaner disinfector incorporates a method for validating the PAA solution through an automatic chemical indicator to ensure each dose of PAA is at or above the MRC. The Ethos cleaner disinfector prints a verification report indicating a successful cleaning and disinfection cycles as well as the time and the average temperature during the cleaning/disinfection. The ultrasound probe is then removed from the Ethos cleaner disinfector and dried according to the ultrasound probe manufacturer's instructions. The Ethos cleaner disinfector is ready for a new cycle immediately after the preceding cycle is completed.

The provided document is a 510(k) Premarket Notification from the FDA for a medical device (Ethos Automated Ultrasound Probe Cleaner Disinfector). It outlines the device's indications for use, comparison to predicate devices, and a summary of non-clinical studies performed to demonstrate its safety and effectiveness.

However, the document does not describe a study involving human readers or AI assistance, but rather studies demonstrating the efficacy of a cleaning and high-level disinfection device for ultrasound probes. Therefore, many of the requested criteria related to AI/human reader studies (e.g., MRMC studies, effect size, number of experts for ground truth, adjudication methods, training/test set sample sizes for AI models) are not applicable to this document.

The document primarily focuses on chemical and microbiological testing to validate the disinfection capabilities of the device and its associated chemicals.

Here's an attempt to extract the relevant information based on the provided text, while noting the inapplicable sections:

Device Under Review: Ethos Automated Ultrasound Probe Cleaner Disinfector with AquaCide Cleaner/High-Level Disinfectant and QwikCheck Chemical Indicator (K230381)

Purpose of the Device: To provide cleaning and high-level disinfection of surface and endocavity ultrasound probes.

1. Table of Acceptance Criteria and Reported Device Performance

For this device, "performance" relates to its ability to clean and disinfect effectively, and the acceptance criteria are typically microbiological kill rates and chemical stability/concentration.

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

• Test Set Sample Size:
  • Bench Tests (Microbiological Efficacy): Not explicitly stated as numerical counts of "samples." Performance is typically demonstrated on multiple replicates of inoculated carriers/surfaces or cultures. The phrases "all lots" and "all probes" are used in some tests (e.g., Mycobacterium Terrae Simulated Use Test), suggesting multiple manufacturing lots of AquaCide and multiple types of probes were tested.
  • Biocompatibility/Toxicology: Not explicitly stated as numerical counts. These are typically performed on extracts from the device materials or reprocessed items.
  • Clinical In-Use Testing: "Soiled surface and endocavity probes" were used, but the specific number (sample size) is not provided.
• Data Provenance: The document does not specify the country of origin for the data; it focuses on adherence to FDA guidelines and recognized standards (e.g., ISO, AOAC, ASTM). The studies are generally retrospective in the sense that they are conducted in a lab setting to support a premarket submission, not in real-world clinical trials. All studies are "non-clinical" as described in the summary.

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

• Not Applicable: This document describes device efficacy testing (microbiological kill, chemical properties, biocompatibility) rather than creating ground truth for an AI diagnostic model by human experts. The "ground truth" for the disinfection efficacy is established through standardized microbiological methods and chemical analysis, performed by trained laboratory personnel.

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

• Not Applicable: Adjudication methods like 2+1 are typically for reconciling discrepancies in expert opinion when establishing ground truth for diagnostic image sets. This is not relevant to the type of device testing described.

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: No MRMC study was performed as this is not an AI diagnostic device.

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

• Not Applicable: This is an automated cleaning and disinfection device, not an algorithm. Its "standalone performance" is its ability to disinfect as measured by the non-clinical studies.

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

• The "ground truth" for disinfection efficacy is established through:
  • Microbiological Standards: Demonstrated reduction/kill of specific microorganisms (bacteria, fungi, viruses, spores) on inoculated samples, measured by established laboratory methods (e.g., AOAC, ASTM).
  • Chemical Analysis: Verification of disinfectant concentration (e.g., 1750 ppm peracetic acid) and stability over time.
  • Biocompatibility Standards: Assessment against ISO 10993 for irritation, sensitization, and cytotoxicity.

8. The sample size for the training set

• Not Applicable: This is not an AI device that requires a "training set."

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

• Not Applicable: This is not an AI device that requires "ground truth for a training set."

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The TD 200® Automated TEE Probe Disinfector with TD-12® High Level Disinfectant is designed to provide high-level disinfection of Transesophageal (TEE) ultrasound probes. The system can use TD-12® disinfectant, which is designed to be used only with the TD 200® disinfector. The disinfectant bottles cannot be reused in the system.

TD-12® disinfectant is intended for use as single use high-level disinfectant to be used exclusively in the TD 200® disinfector for high-level disinfection of TEE ultrasound probes.

TD-12® high level disinfectant and TD 200® disinfector is intended for use by qualified individuals trained in its use.

TD-12® disinfectant should be used with the following contact conditions in TD 200® disinfector:

High-level disinfectant: TD-12®
Time: 3 minutes
Temperature: 38°C
Minimum Recommended Concentration: 1.75% peracetic acid

The TD 200® Automated TEE Probe Disinfector with TD-12® High Level Disinfectant provides high-level disinfection of transesophageal (TEE) ultrasound probes when used according to the operating instructions and when used with TD-12® disinfectant. The TD 200® disinfector is for use only with TD-12® disinfectant. The TD-12® is for use only in the TD 200® disinfector. Thus, the TD 200® disinfector and TD-12® disinfectant represent a dedicated system. Each soiled TEE probe is bedside cleaned and manually cleaned according to the TEE probe manufacturer's instructions before insertion into the TD 200® disinfector. A fresh, unopened bottle of TD-12® disinfectant is loaded into the TD 200® disinfector. The TD 200® disinfector heats the TD-12® disinfectant to at least 38 C, soaks the TEE probe at least three (3) minutes, and then thoroughly rinses the disinfectant off the TEE probe before the cycle is complete. The TD 200® disinfector prints a verification report indicating a successful disinfection cycle, the time and the average temperature during the disinfection. The TEE probe is then removed from the TD 200 disinfector and dried according to the TEE probe manufacturer's instructions. The TD 200 disinfector is ready for a new cycle immediately after the preceding cycle is completed. A chemical indicator is used to ensure that the solution is above the MRC.

The provided document describes the FDA 510(k) clearance for the TD 200® Automated TEE Probe Disinfector with TD-12® High Level Disinfectant. This device is a high-level disinfection system for transesophageal (TEE) ultrasound probes. The acceptance criteria and the study that proves the device meets them are detailed primarily through non-clinical performance testing rather than human-in-the-loop studies involving expert readers.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are demonstrated through its ability to achieve high-level disinfection, stability of the disinfectant, and safety aspects. The performance is reported as a "complete kill of microorganisms" or "measurable complete kill."

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: The document does not specify a precise numerical sample size for "Clinical In-Use Testing" or "Automated Simulated use studies." It states "In all cases" there was a complete kill, implying all tested units/probes/cycles met the criteria. For the specific test organisms, the results are presented for each organism type (e.g., Bacillus subtilis, Mycobacterium terrae).
• Data Provenance: The document does not explicitly state the country of origin for the data or whether the studies were retrospective or prospective. Given it's an FDA submission, the implication is that the studies were conducted under controlled conditions to support regulatory clearance, likely prospective.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

This device focuses on disinfection efficacy rather than diagnostic accuracy involving human image interpretation. Therefore, the "ground truth" is established through microbiological and chemical analysis, not expert human readers.

• Experts: Not applicable in the context of human interpretation. The "experts" would be qualified microbiologists, chemists, and engineers conducting the tests according to established standards.
• Qualifications: Not specified for individuals, but implied by the nature of regulatory testing (e.g., adherence to Good Laboratory Practices or similar standards).

4. Adjudication Method for the Test Set

Not applicable. The "ground truth" for disinfection efficacy is determined by objective laboratory measurements (e.g., microbial counts, chemical residue analysis), not subjective human judgment requiring adjudication.

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 device is a high-level disinfector, not an AI-powered diagnostic imaging tool for human readers. There are no "human readers" involved in the direct purpose of the device.

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

The entire performance evaluation of the TD 200® Disinfector is "standalone" in the sense that its primary function (disinfection) is automated and assessed directly for its output (microbial kill, residue levels). There is no "human-in-the-loop" performance component for the disinfection process itself. The "Software Validation" section details the functioning of the algorithm/software controlling the device.

7. The Type of Ground Truth Used

The ground truth used is primarily microbiological efficacy (complete kill of specified microorganisms for bactericidal, tuberculocidal, fungicidal, sporicidal, and virucidal activity), supported by chemical analysis (disinfectant residue levels, stability) and mechanical/electrical performance (software validation, electrical safety, material compatibility). No pathology reports or outcomes data on patients were used; the focus is on the device's ability to disinfect a medical instrument.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/Machine Learning device that undergoes a "training phase" with a dataset in the typical sense. Its design and performance are based on chemical, microbiological, and engineering principles rather than learning from data.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set for an AI model. The "ground truth" for the device's development would be established through scientific literature, industry standards (e.g., for disinfection efficacy), and internal research and development.

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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 TD 100® disinfector is designed to provide high-level disinfection of Transesophageal (TEE) ultrasound probes. The system can use TD-50 or TD-80 disinfectants, which are designed to be used only with the TD 100® disinfector. The disinfectant bottles cannot be reused in the system.

TD-50 disinfectant is intended for use as single use high-level disinfectant to be used exclusively in the TD 100@ disinfector for high-level disinfection of TEE ultrasound probes.

TD-50 high level disinfectant and TD 1000 disinfector system are intended for use by qualified individuals trained in its use.

TD-50 disinfectant should be used with the following contact conditions in TD 1008 disinfector:

High-Level Disinfectant: TD-5®
Time: 5 minutes
Temperature: 38°C - 40°C
Minimum Recommended Concentration: 1.7% glutaraldehyde

TD-80 disinfectant is intended for use as single use high-level disinfectant to be used exclusively in the TD 1000 disinfector for high-level disinfection of TEE ultrasound probes.

TD-8@ high level disinfectant and TD 1000 disinfector system are intended for use by qualified individuals trained in its usc.

TD-80 disinfectant should be used with the following contact conditions in TD 1008 disinfector:

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

The TD 100® disinfector provides high level disinfection of transesophageal (TEE) ultrasound probes when used according to the operating instructions, and when used with TD-50 or TD-80 disinfectants. The TD 1000 disinfector is for use only with TD-50 or TD-8® disinfectants. The TD-5º and TD-8º disinfectants are for use only in the TD 100 disinfector. Thus, the TD 100® disinfector with TD-50 and TD-80 disinfectants represents a dedicated system. Each soiled TEE probe is bedside cleaned and manually cleaned according to the TEE probe manufacturer's instructions before insertion into the TD 100 disinfector. A fresh, unopened bottle of TD-50 or TD-80 disinfectant is loaded into the TD 100% disinfector. The TD 100% disinfector heats the TD-5% or TD-8% disinfectant to 38°-40°C, soaks the TEE probe for at least five minutes, and then thoroughly rinses the disinfectant off the TEE probe before the cycle is complete. The TD 100 disinfector prints a verification report indicating a successful disinfection cycle and the time and average temperature during the disinfection. The TEE probe is then removed from the TD 100® disinfector and dried according to the TEE probe manufacturer's instructions. The TD 100® disinfector is ready for a new cycle immediately after the preceding cycle is completed. Because a fresh bottle of TD-5 or TD-8 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 text is a 510(k) Summary for a medical device (TD-100 Disinfector with TD-5 and TD-88 High Level Disinfectants). It describes the device, its indications for use, and makes comparisons to predicate devices. However, the document does not contain the specific information requested in the prompt regarding an AI device, acceptance criteria tables with performance, sample sizes for test/training sets, expert ground truth, adjudication methods, or MRMC studies.

Instead, the document focuses on the disinfector's ability to achieve high-level disinfection, material compatibility, and stability in comparison to other disinfectants. The "acceptance criteria" presented are related to the effectiveness of the disinfectants against various microorganisms and operational parameters of the disinfection process (time, temperature, concentration).

Here's a breakdown of what is and is not in the provided text, in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance:

• What is present: The document includes a table (Table C.1c) comparing the TD-8 and TD-5 disinfectants' performance against various organisms (Sporicidal, Tuberculocidal, Bactericidal, Fungicidal, Virucidal, Simulated Use, Clinical In-Use) with predicate devices. The "performance" here is typically the contact time and temperature required to achieve the desired effect (e.g., kill the organism). It does not present a typical "acceptance criteria" table with a defined threshold and then the device's reported achievement against that threshold in the way an AI performance summary would.
• Missing: Specific quantitative acceptance criteria (e.g., "sensitivity must be >X%"). The table shows what the disinfectants achieve in terms of kill time/temperature.

2. Sample Size Used for the Test Set and Data Provenance:

• Missing from the text: No sample sizes are provided for any of the microbial efficacy tests (e.g., number of replicates, number of devices tested).
• Missing from the text: No data provenance (country of origin, retrospective/prospective) is mentioned for the microbial efficacy studies.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

• Not Applicable / Missing: This concept (experts establishing ground truth for a test set) is relevant for AI/diagnostic devices that interpret data (e.g., images). For a disinfectant device, the "ground truth" is established through laboratory microbiological testing (e.g., demonstrating reduction in colony-forming units). The document does not describe the laboratory personnel or their qualifications.

4. Adjudication Method for the Test Set:

• Not Applicable / Missing: Adjudication methods (like 2+1, 3+1) are for human review of data, typically in diagnostic studies. This is not mentioned for the disinfectant efficacy testing.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:

• Not Applicable: This type of study is for evaluating the impact of AI on human reader performance in diagnostic tasks. It is not relevant for a high-level disinfectant.

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

• Not Applicable: This pertains to AI algorithm performance. The device is a disinfector, not an algorithm. The "standalone" performance here would be the device's ability to disinfect, which is what the microbial efficacy tests address.

7. The Type of Ground Truth Used:

• What is present: The "ground truth" for this device's performance is microbiological efficacy (kill of specified microorganisms) demonstrated through laboratory testing (Sporicidal, Tuberculocidal, Bactericidal, Fungicidal, Virucidal, Simulated Use, Clinical In-Use). The "Clinical In-Use" section mentions "measurably complete kill of microorganisms" from "Wild-type from patients."
• Missing details: The specific methodologies for measuring kill (e.g., log reduction) are not detailed in this summary.

8. The Sample Size for the Training Set:

• Not Applicable / Missing: This concept is for AI/machine learning models. The device is a physical disinfector with chemical agents. There is no "training set" in this context. The development of the disinfectant formulation and system design would involve R&D and testing, but not a "training set" in the AI sense.

9. How the Ground Truth for the Training Set was Established:

• Not Applicable / Missing: As above, there is no "training set" for this type of device.

Summary of what can be extracted, interpreted, and what is missing based on the prompt's requirements:

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

• Note: The "Acceptance Criteria" column is inferred from the common requirements for high-level disinfectants and the performance of the predicate devices. The document explicitly states the "Minimum Recommended Concentration" (MRC) for TD-5 (1.7% glutaraldehyde) and TD-8 (0.3% ortho-phthalaldehyde) and the contact conditions (Time: 5 min, Temperature: 38°C - 40°C) as part of its claim.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
* Sample Size: Not specified in the provided text.
* Data Provenance: Not specified in the provided text. The studies appear to be laboratory-based efficacy tests ("Simulated Use," "Clinical In-Use").

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 as this is a disinfectant device, not an AI/diagnostic device involving expert interpretation. The "ground truth" is derived from direct microbial efficacy testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
* Not applicable for this type of device and study.

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 for this type of device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
* Not applicable in the AI sense. The microbial efficacy tests (Table C.1c) demonstrate the standalone performance of the disinfectant system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
* Microbiological efficacy (kill/inactivation of various microorganisms) determined through laboratory testing and "Clinical In-Use" studies showing "measurably complete kill of microorganisms" from probes after routine clinical use.

8. The sample size for the training set
* Not applicable for this type of device.

9. How the ground truth for the training set was established
* Not applicable for this type of device.

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The GUS ASTRA TEE™ automated reprocessor facilitates high-level disinfection and rinsing of 1 or 2 transsophageal ultrasound probes using FDA cleared and PCI Medical approved high-level liquid disinfectants.

The GUS ASTRA VR™ automated reprocessor facilitates high-level disinfection and rinsing of 1 or 2 endovaginal and/or endorectal ultrasound probes using FDA cleared and PCI Medical approved high-level liquid disinfectants.

The ASTRA Product Family of automated reprocessors are floor standing electromechanical lab equipment that facilitate high-level liquid disinfection of ultrasound probes that have been enzymatically pre-cleaned.

The GUS ASTRA TEE and GUS ASTRA VR are automated reprocessors which are identical with the exception of the disinfection chamber configuration necessary to compensate for two different types of ultrasound probes. The GUS ASTRA TEE is an automated reprocessor which enables high-level disinfection and rinsing for transesophageal (TEE) ultrasound probes. The GUS ASTRA VR is an automated reprocessor which enables high-level disinfection and rinsing for endovaginal and/or endorectal ultrasound probes.

Both ASTRA systems utilize predefined programs based upon the high-level liquid disinfectant (HLD) used during the disinfection and potable water rinsing cycles. The system controls the HLD temperature and cycle times which are fixed, no user configuration is available. The device will perform the defined automated disinfection and rinsing cycles based upon the HLD specifications. The microprocessor controlled interface monitors temperature and liquid levels of the HLD in the disinfection chamber and the reservoir. Optical sensors are used for HLD reservoir presence and probe identification. Additional user inputs include unique probe identification (for disinfection records) and the results entry of the Minimum Recommended Concentration (MRC) test using test strips and minimum concentration levels as defined by the HLD manufacturer. A sensor located on the disinfection chamber door is used to initiate the cycle after the user has input the required information. User retrievable data/information regarding reprocessing is accessible through a USB port.

This appears to be a 510(k) premarket notification for a medical device, specifically automated reprocessors for ultrasound probes. The document focuses on demonstrating substantial equivalence to a predicate device ("TD-100 Transesophageal Probe Disinfector").

The information provided does not describe an AI/ML-based device, a comparative effectiveness study with human readers, or an algorithm-only standalone study. Therefore, sections pertaining to these aspects (2, 3, 4, 5, 6, 7, 8, 9) cannot be answered from the provided text.

The acceptance criteria relate to the physical and functional performance of the device, focusing on its ability to control the high-level disinfectant (HLD) process and user safety. The "study" mentioned refers to verification and validation testing to ensure the device meets these performance specifications and is substantially equivalent to the predicate.

Here's the breakdown of the information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

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The TD-100 disinfector is designed to provide high-level disinfection of Transesophageal (TEE) ultrasound probes. The system uses the TD-5 disinfectant, which is designed to be used only with the TD-100. The disinfectant bottles cannot be reused in the system.

TD-5 is intended for use as a single use high-level disinfectant to be used exclusively in the TD-100 for the high-level disinfection of TEE ultrasound probes.

The TD-5 High Level Disinfectant and TD-100 disinfector system is intended for use by qualified individuals trained in its use.

The TD-100 disinfector provides high-level disinfection of transesophageal (TEE) ultrasound probes when used according to the operating instructions, and when used with TD-5 disinfectant. Each soiled TEE probe is pre-cleaned manually before insertion into the TD-100 disinfector. A fresh, unopened bottle of TD-5 disinfectant is loaded into the TD-100 disinfector. The TD-100 disinfector heats the TD-5 disinfectant to 38-40C, soaks the TEE probe at least fiveminutes, and then thoroughly rinses the disinfectant off the TEE probe before the cycle is complete. The TEE probe is then removed from the TD-100 disinfector and dried according to the TEE probe manufacturer's instructions. The TD-100 disinfector is ready for a new cycle immediately after the preceding cycle is completed. Because a fresh bottle of TD-5 disinfectant is used with each cycle no monitoring of the disinfectant's potency required, nor is there any requirement for daily testing of the disinfectant solution.

Here's a breakdown of the acceptance criteria and study information for the CS Medical TD-100 Transesophageal Probe Disinfector and TD-5 High-level Disinfectant, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

The document does not explicitly state a numerical sample size for either the simulated use testing or the in-use clinical testing.

• Simulated Use Testing: It states, "In all cases a 6-Log₁₀ reduction of M. terrae was achieved." This implies multiple tests were conducted, but the specific number is not provided.
• In Use Testing: It states, "TEE Probes used in a clinical setting were examined. The probes were bioburden post cleaning and a new population of probes was examined for bioburden after disinfection. In all cases, there was a complete kill of microbes after disinfection." Again, "in all cases" implies multiple probes, but no specific number is given.

Data Provenance: The document does not explicitly state the country of origin for the data. The study appears to be retrospective for the "In Use Testing" as it refers to "probes used in a clinical setting" that were then examined. The "Simulated Use Testing" likely involved prospective testing in a lab environment.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This information is not provided in the document. The efficacy testing revolves around microbial reduction and absence of growth, which would typically involve laboratory analysis by microbiologists rather than interpretation by clinical experts like radiologists.

4. Adjudication Method for the Test Set:

Not applicable. The efficacy testing involves quantitative microbial reduction (Log reductions) and qualitative assessment of microbial kill, which are objective laboratory measurements, not subjective evaluations requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

This type of study was not conducted. The device is a high-level disinfectant system, not an AI-powered diagnostic tool that assists human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

This classification doesn't directly apply because the device is a physical disinfectant system, not a software algorithm. However, the "Efficacy Testing" sections (Simulated Use and In Use Testing) demonstrate the standalone performance of the device system itself (TD-100 plus TD-5) in achieving high-level disinfection without human intervention during the disinfection cycle (after manual pre-cleaning and probe loading).

7. Type of Ground Truth Used:

• Microbiological Culture/Counts: For efficacy testing, the ground truth was established by microbiological methods measuring the reduction of specific microorganisms (M. terrae for simulated use) and the complete kill of microbes (for in-use testing). This is a direct measurement of disinfection effectiveness.
• Chemical Analysis: For biocompatibility (residue) and material compatibility, the ground truth would be chemical analysis of residue levels and visual/physical inspection for material degradation.

8. Sample Size for the Training Set:

Not applicable. This device is not an AI/ML product developed with a training set. The "development" would involve chemical formulation and engineering design, not data training.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set for this type of device.

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