(132 days)
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.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Achieve High-Level Disinfection | "High-Level Disinfection was achieved in all cases." |
| Effective for various materials/transducers | "A range of materials and transducers were exposed to the Trophon EPR disinfection cycle and were shown to be compatible." |
| Disinfectant stability | "Stability testing showed that the disinfectant retained effective concentration for the duration of the labeled shelf life." |
| Meets predicate device standards for high-level disinfection | "The Nanosonics Trophon EPR is substantially equivalent... in that it: - achieves validated 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.
§ 892.1570 Diagnostic ultrasonic transducer.
(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.