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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 Chemical Indicator is intended by Nanosonics for use by health care providers for confirming that the disinfectant delivered into the Chamber of the Nanosonics Trophon EPR disinfector device is above the minimum effective concentration (MEC) required to achieve the stated performance of the Trophon EPR.

The Trophon Chemical Indicator is used exclusively for monitoring the High Level Disinfection process when placed within the Trophon EPR chamber.

The color of the Trophon Chemical Indicator changes from red to yellow when exposed to hydrogen peroxide, the active ingredient in Trophon EPR-C40 disinfectant. This occurs above the minimum effective concentration (MEC) established for this solution.

The device is a qualitative, single use, disc (26 mm in diameter) that has a hydrogen peroxide sensitive chemical indicating ink applied to a Tyvek substrate. The hydrogen peroxide sensitive chemical indicating ink has been designed to transition from an initial red color to a signal yellow color when subjected to sources of hydrogen peroxide.

Chemical indicator based on proprietary ink technology which changes color on exposure to sterilant.

The Trophon Chemical Indicator is a qualitative, single-use disc with a hydrogen peroxide-sensitive chemical indicating ink designed to transition from red to yellow when exposed to hydrogen peroxide. It is intended for use by healthcare providers to confirm that the disinfectant delivered into the Nanosonics Trophon EPR disinfector device chamber is above the minimum effective concentration (MEC).

1. Acceptance Criteria and Reported Device Performance:

The document describes the device's function: "The color of the Trophon Chemical Indicator changes from red to yellow when exposed to hydrogen peroxide, the active ingredient in Trophon EPR-C40 disinfectant. This color change occurs above the minimum effective concentration (MEC) established for this solution."

While specific numerical acceptance criteria (e.g., sensitivity, specificity percentage) are not provided in the given text, the implicit acceptance criterion is that the chemical indicator must reliably and accurately change color from red to yellow when the hydrogen peroxide concentration is at or above the MEC. The document states that the device is "substantially equivalent" to a predicate device, meaning it performs comparably.

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

The provided 510(k) summary does not explicitly state the sample size used for a test set, nor does it detail the specific data provenance (e.g., country of origin, retrospective or prospective nature of studies). Instead, it relies on a comparison to a predicate device and a general description of the device's functional design.

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

The document does not mention the use of experts to establish ground truth for a test set. The validation described is based on the chemical properties and performance comparison to a predicate device.

4. Adjudication method for the test set:

No adjudication method is described, as the evaluation is based on the chemical reaction and color change of the indicator within the specified concentration range.

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 is a chemical indicator, not an AI or imaging device that would typically involve human readers or MRMC studies. Therefore, no MRMC study was done, and no effect size for human reader improvement with AI assistance is applicable or reported.

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

The Trophon Chemical Indicator is a standalone device in the sense that it performs its function (color change) without human intervention in the chemical reaction itself. However, it's not an algorithm, and its performance is based on chemical principles, not computational ones. Its interpretation (reading the color change) does involve a human-in-the-loop, but this is a simple visual assessment.

7. The type of ground truth used:

The ground truth is established by the known chemical concentrations of hydrogen peroxide. The device is designed to visually indicate when the hydrogen peroxide concentration is at or above the Minimum Effective Concentration (MEC). The "ground truth" therefore would be the actual measured concentration of hydrogen peroxide, against which the indicator's color change is correlated.

8. The sample size for the training set:

The document does not describe a "training set" in the context of machine learning or AI. The development of this chemical indicator would involve experiments to optimize the ink formulation and its response to hydrogen peroxide. The sample size for these developmental experiments is not specified.

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

As this is a chemical indicator and not an AI/ML device, the concept of a "training set" and its "ground truth" as typically understood in AI development does not directly apply. The "ground truth" during development would be established through controlled laboratory experiments using precisely measured concentrations of hydrogen peroxide at and around the MEC. The chemical formulation would be refined until it consistently and accurately exhibits the desired color change only when the hydrogen peroxide concentration is at or above the MEC.

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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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