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The trophon2 is designed to provide High-Level Disinfection (HLD) of validated ultrasound transducers. High-Level Disinfection is achieved by surface exposure to a controlled dose of hydrogen peroxide mist delivered to a disinfection chamber contain the ultrasound probe.

The trophon2 system consists of a multiple use instrument combined with a single use disinfectant "trophon Sonex-HL", delivered from a multi-dose cartridge.

The trophon2 is suitable for use in general hospital and health care facilities by trained personnel.

The trophon Sonex-HL should be used with the following contact conditions:

• Minimum Operational Cycle Time: 4 minutes
• Minimum Concentration: 31.5%
• Minimum Disinfectant Dose: 1.0 g
• Minimum Chamber Temperature: 56°C

The trophon2 is a software-controlled device which provides High- Level Disinfection of validated ultrasound probes. The device consists of a sealed disinfection chamber and operates in conjunction with a multi-dose cartridge of concentrated hydrogen peroxide disinfectant, supplied as an accessory to the device. Pre-cleaned and dried ultrasound transducers are placed within the trophon2 chamber and disinfected by means of an automated disinfection and aeration cycle.

The provided text is a 510(k) clearance letter for a medical device called "trophon2". It focuses on proving the new version of trophon2 is substantially equivalent to a previously cleared version, primarily through non-clinical testing. This document does not describe a study involving an AI model for medical image analysis, nor does it detail a multi-reader multi-case (MRMC) study or expert adjudication for ground truth related to medical imaging.

The device, trophon2, is a High-Level Disinfection (HLD) system for ultrasound transducers, a piece of equipment for cleaning medical devices, not an AI diagnostic tool. Therefore, many of the requested categories (e.g., number of experts for ground truth, MRMC study, training set ground truth) are not applicable to the information provided in this regulatory document.

However, based on the non-clinical testing section, I can extract and present the acceptance criteria and reported device performance related to its disinfection capabilities.

Analysis of Acceptance Criteria and Device Performance for trophon2 (K250434)

The trophon2 device, as described in the 510(k) submission K250434, is a High-Level Disinfection (HLD) system for ultrasound transducers. The evaluation presented in the document is primarily a demonstration of its substantial equivalence to a previously cleared version of the trophon2 (K173865) by fulfilling specified non-clinical performance and safety standards.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the trophon2 are based on its ability to perform High-Level Disinfection effectively and safely, as well as adherence to relevant industry standards.

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

The document states that "Potency tests were conducted under worst case conditions" and "Simulated use testing was conducted under worst case conditions." However, specific sample sizes (e.g., number of tested devices, number of disinfection cycles, number of contaminated probes) for these non-clinical tests are not provided in the provided 510(k) summary. The data provenance is implied to be from Nanosonics Limited's internal testing in Australia, as the company is based in Macquarie Park, NSW, Australia. The document does not specify if the data was retrospective or prospective, though it pertains to performance testing of the device itself.

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

This question is not applicable to the provided document. The trophon2 is a disinfection device, not an AI model that interprets medical images. Therefore, the concept of "ground truth" established by medical experts for a test set, as is common in AI/ML medical devices, does not apply here. The "ground truth" for this device's performance is objective measurements of microbial kill, chemical residue levels, and functional parameters, validated against established standards (e.g., AOAC, ASTM, FDA guidance).

4. Adjudication method for the test set

This question is not applicable to the provided document, as it does not describe studies involving human readers or interpretation 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

This question is not applicable to the provided document. The trophon2 is not an AI diagnostic tool, and no MRMC study or AI assistance for human readers is described.

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

This question is not applicable to the provided document. While the trophon2 is a software-controlled system, it is a physical device performing disinfection, not an algorithm providing diagnostic output. The "software verification and validation testing" mentioned refers to the functional correctness of the device's control software, not diagnostic performance.

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

The "ground truth" for the trophon2's performance is based on microbiological standards (e.g., complete kill of specific microorganisms), chemical concentration measurements, temperature parameters, and physical operational limits. This is established by well-defined laboratory testing protocols outlined in standards like AOAC and ASTM, and FDA guidance for liquid chemical sterilants/high-level disinfectants. It is a deterministic, objective ground truth based on the device's physical and chemical disinfection capabilities, not interpretive expert consensus or patient outcomes data for diagnosis.

8. The sample size for the training set

This question is not applicable to the provided document. The trophon2 is a hardware device with controlling software; it does not involve machine learning or a "training set" in the context of AI model development for diagnostic purposes. Its software is developed and validated through traditional software engineering principles.

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

This question is not applicable for the reasons stated in point 8.

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The trophon Wireless Ultrasound Probe Holder is an accessory to be added to the trophon EPR and trophon2 to allow wireless ultrasound probes to be disinfected.

trophon EPR:

The trophon EPR is designed to provide High-Level Disinfection of ultrasound transducers. The system uses the trophon Disinfectant which is intended to be used exclusively with the trophon EPR device.

The trophon Disinfectant is intended for use as a High-Level Disinfectant to be used exclusively with the trophon EPR for the High-Level Disinfection of ultrasound transducers.

The trophon EPR is suitable for use in general hospital and health care facilities by trained personnel.

The trophon EPR system consists of a multiple use instrument combined with a single use disinfectant, delivered from a multi-dose cartridge.

The trophon Disinfectant should be used with the following contact conditions:

Minimum Operational Cycle Time: 7 minutes Minimum Concentration: 31.5% Minimum Disinfectant Dose: 1.0 g Minimum Chamber Temperature: 56℃

trophon2:

The trophon2 is designed to provide High-Level Disinfection (HLD) of validated ultrasound transducers. High-Level Disinfection is achieved by surface exposure to a controlled dose of hydrogen peroxide mist delivered to a disinfection chamber contain the ultrasound probe.

The trophon2 system consists of a multiple use instrument combined with a single use disinfectant "trophon Sonex-HL", delivered from a multi-dose cartridge.

The trophon2 is suitable for use in general hospital and health care facilities by trained personnel.

The trophon Sonex-HL should be used with the following contact conditions: Minimum Operational Cycle Time: 7 minutes Minimum Concentration: 31.5% Minimum Disinfectant Dose: 1.0 g Minimum Chamber Temperature: 56°C

The trophon Wireless Ultrasound Probe Holder is an accessory to be added to the trophon EPR and trophon2 to allow wireless ultrasound probes to be disinfected.

The Nanosonics trophon EPR and trophon2 are software-controlled devices which provide High- Level Disinfection of ultrasound transducers. The device consists of a sealed disinfection chamber and operates in conjunction with a multi-dose cartridge of concentrated hydrogen peroxide disinfectant, supplied as an accessory to the device. Precleaned and dried ultrasound transducers are placed within the trophon EPR/trophon2 chamber and disinfected by means of an automated disinfection and aeration cycle. The disinfected ultrasound transducer is removed from the chamber and is ready for immediate use.

The provided text from the FDA 510(k) submission for the "trophon® Wireless Ultrasound Probe Holder" details the acceptance criteria and study results for non-clinical testing. However, it does not contain information about clinical studies, MRMC studies, or AI/algorithm-only performance. This device is an accessory for an existing high-level disinfection system and not a diagnostic AI device. Therefore, many of the requested categories related to AI development and clinical study methodologies are not applicable or present in this document.

Here's the breakdown of the information that is available, formatted as requested:

Device: trophon® Wireless Ultrasound Probe Holder (Accessory for trophon EPR and trophon2 High-Level Disinfection systems)
Purpose: To allow wireless ultrasound probes to be disinfected in existing trophon systems.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated as a numerical count for each test. The descriptions refer to "simulated use," "assessments," and testing "the Wireless Ultrasound Probe Holder." Given the nature of mechanical/material testing for an accessory, the sample sizes would typically be determined by engineering standards (e.g., number of units tested, number of cycles).
• Data Provenance: The document does not specify the country of origin for the test data for the non-clinical tests. The tests are described as "simulated use," "assessments," and compatibility/durability tests directly on the device accessory. It implies these were performed as part of the device's development and regulatory submission. The document is a 510(k) submission, not a clinical trial report.

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 and not provided. The "ground truth" for this device accessory's performance is based on engineering and microbiology standards (e.g., disinfection efficacy, material compatibility, dimensional accuracy), not on expert clinical interpretation or consensus.

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

• Not applicable. Adjudication methods like 2+1 or 3+1 refer to agreement among multiple readers (e.g., radiologists) for clinical ground truth establishment, which is not relevant for this type of non-clinical device testing.

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. This is a medical device accessory for high-level disinfection, not an AI-assisted diagnostic tool. Therefore, an MRMC study is not relevant or mentioned.

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

• Not applicable. This is a physical device accessory and does not involve AI algorithms or standalone software performance in the context of diagnostic interpretation.

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

• The "ground truth" for this device's performance is established by engineering and microbiological standards and specifications. For example:
  • Efficacy: Reduction of Mycobacterium terrae to specified log levels (as per FDA guidance for HLD devices).
  • Dimensional: Conforming to design specifications to fit existing trophon systems.
  • Material Compatibility: No degradation after a specified number of cycles.
  • Human Factors: Conformance to usability standards ensuring safe and effective use.

8. The sample size for the training set:

• Not applicable. This device does not use machine learning or AI that requires a "training set."

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

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

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The trophon2 is designed to provide High-Level Disinfection (HLD) of validated ultrasound probes. High-Level Disinfection is achieved by surface exposure to a controlled dose of hydrogen peroxide mist delivered to a disinfection chamber containing the ultrasound probe.

The trophon2 system consists of a multiple use instrument combined with a single use disinfectant "trophon Sonex-HL", delivered from a multi-dose cartridge.

The trophon2 is suitable for use in general hospital and health care facilities by trained personnel.

The trophon Sonex-HL should be used with the following contact conditions: Minimum Operational Cycle Time: 7 minutes Minimum Concentration: 31.5% Minimum Disinfectant Dose: 1.0 g Minimum Chamber Temperature: 56℃

The trophon2 is a software controlled device which provides High-Level Disinfection of ultrasound transducers. The device consists of a sealed disinfection chamber and operates in conjunction with a multi-dose cartridge of concentrated hydrogen peroxide disinfectant "trophon Sonex- HL".

Pre-cleaned and dried ultrasound transducers are placed within the trophon2 chamber and disinfected by means of an automated disinfection and aeration cycle.

The disinfected ultrasound transducer is removed from the chamber, wiped and is ready for immediate use.

The provided document is a 510(k) Pre-Market Notification for the trophon2 device, establishing its substantial equivalence to a predicate device (Trophon EPR) for High-Level Disinfection (HLD) of ultrasound transducers. It focuses on the device's technical specifications, comparisons to the predicate, and non-clinical testing performed to demonstrate its safety and effectiveness.

Based on the provided document, here's a breakdown of the requested information:

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

The document doesn't provide specific quantitative acceptance criteria or detailed reported performance values for each test. Instead, it makes a general statement:

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

The document refers to "Non-clinical Testing" but does not specify the sample sizes used for any of the tests, nor does it explicitly state the data provenance (e.g., country of origin, retrospective or prospective). The testing appears to be primarily laboratory-based to validate the device's functional and biological performance rather than clinical studies with human subjects or medical images.

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

This information is not provided in the document. The type of testing described (electromechanical, biocompatibility, microbiological, etc.) typically relies on established scientific protocols and instrumentation rather than expert human interpretation for ground truth.

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

This information is not provided in the document. Adjudication methods are typically relevant for studies involving human interpretation (e.g., image reading), which is not the primary focus of the non-clinical testing described here.

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 conducted or described in this document. This device is an automated high-level disinfection system, not an AI-assisted diagnostic tool that aids human readers.

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

The core of the device is an automated, standalone system for high-level disinfection. The "Non-clinical Testing" section describes validation of the device's automated functions: "Microbiological Efficacy Testing," "Validation testing of process parameters," and "Verification Testing of the Chemical Indicator." This implies that the device's performance in achieving HLD is evaluated independently of human intervention during the disinfection cycle.

7. The type of ground truth used:

The "ground truth" for the non-clinical tests would be established by:

• Microbiological Standards: For microbiological efficacy, ground truth would be determined by established standards for killing specified microorganisms (e.g., AOAC methods mentioned on page 6).
• Physical/Chemical Measurements: For process parameters (temperature, concentration, dose, time), ground truth would be established by precise measurements using calibrated instruments.
• Engineering Specifications: For electromechanical and material compatibility, ground truth would be established by compliance with engineering design specifications and relevant international standards (e.g., IEC, ISO standards listed).

8. The sample size for the training set:

This information is not applicable and not provided. This device is a hardware system for disinfection and the document does not describe the use of machine learning or AI models that would require a "training set."

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

This information is not applicable and not provided for the same reason as above. There is no mention of a training set for an AI/ML model.

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The Trophon EPR is designed to provide High-Level Disinfection of ultrasound transducers. The system uses the Trophon Disinfectant which is intended to be used exclusively with the Trophon EPR device.

The Trophon Disinfectant is intended for use as a High-Level Disinfectant to be used exclusively with the Trophon EPR for the High-Level Disinfection of ultrasound transducers.

The Trophon EPR is suitable for use in general hospital and health care facilities by trained personnel.

The Trophon EPR system consists of a multiple use instrument combined with a single use disinfectant, delivered from a multi-dose cartridge.

The Trophon Disinfectant should be used with the following contact conditions:

Minimum Operational Cycle Time: 7 minutes
Minimum Concentration: 31.5%
Minimum Disinfectant Dose: 1.0 g
Minimum Chamber Temperature: 56°C

The Nanosonics Trophon EPR is a software controlled device which provides High-Level Disinfection of ultrasound transducers. The device consists of a sealed disinfection chamber and operates in conjunction with a multi-dose cartridge of concentrated hydrogen peroxide disinfectant, supplied as an accessory to the device. Pre-cleaned and dried ultrasound transducers are placed within the Trophon EPR chamber and disinfected by means of an automated disinfection and aeration cycle. The disinfected ultrasound transducer is removed from the chamber and is ready for immediate use.

This document describes the Nanosonics Trophon EPR, a device for high-level disinfection of ultrasound transducers. The information provided focuses on its performance testing and claims of equivalence to predicate devices, rather than a typical AI/ML-driven device study with specific acceptance criteria and detailed statistical analysis often seen in more recent submissions.

Here's a breakdown of the requested information based on the provided text:

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

The document does not explicitly state quantifiable "acceptance criteria" in the format of a target metric (e.g., sensitivity > X%, specificity > Y%). Instead, it describes performance through a qualitative statement of efficacy in achieving high-level disinfection.

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

• Sample size for test set: The document states "Ultrasound transducers used in a clinical setting were disinfected with the Trophon EPR." However, it does not specify the exact number of transducers or the number of disinfection cycles performed in this simulated use environment.
• Data provenance: The testing was conducted in a "simulated use environment" using "Ultrasound transducers used in a clinical setting." This suggests a retrospective or mixed prospective/retrospective approach, but the text doesn't explicitly state the country of origin. Given Nanosonics Ltd is an Australian company, it's plausible the testing was conducted there or in a region with similar clinical practices.

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

The document does not specify the number or qualifications of experts involved in establishing the ground truth. The evaluation of "High-Level Disinfection" likely relies on microbiological testing rather than expert interpretation of images or other subjective data, which would typically involve human experts.

4. Adjudication method for the test set

The document does not describe an adjudication method as would be relevant for a study involving human interpretation or subjective assessments. The "ground truth" for disinfection efficacy is determined by "Bioburden testing," which is an objective laboratory measure.

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 device is a high-level disinfection system, not an AI-driven diagnostic or interpretative tool that would involve human readers. Therefore, the concept of "human readers improving with AI vs. without AI assistance" does not apply here.

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

The device is a standalone disinfection system. The "performance testing" described ("Potency testing," "High-Level Disinfection efficacy," "materials and transducers... shown to be compatible," "Stability testing") refers to the performance of the device and its disinfectant mechanism itself, without human intervention in the disinfection cycle once initiated. The "software controlled device" operates autonomously to deliver disinfection. So, in this context, yes, a form of standalone performance was assessed as it relates to the device's functional objective.

7. The type of ground truth used

The ground truth used for evaluating disinfection efficacy was microbiological testing (Bioburden testing), which directly measures the reduction of microorganisms. This is an objective measure of "High-Level Disinfection."

8. The sample size for the training set

The document does not mention a training set. This is not an AI/ML device that requires a distinct training dataset for model development. The described testing is performance validation for a physical device.

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

As there is no training set for an AI/ML model, this question is not applicable. The device's design and operational parameters (e.g., minimum concentration, temperature, cycle time) would have been established through engineering, chemical, and microbiological research and development, not by training on a dataset with established ground truth in the AI/ML sense.

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