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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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