Search Results

Not Found

The STERImaster Autoclave is a fast, efficient table-top unit for the sterilization of health care instruments. The STERImaster uses the internationally accepted standard of steam sterilization at a specific temperature for a specific time.

Here's the information about the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation of the Acceptance Criteria: The document implies that the acceptance criteria are met by demonstrating sufficiently high F0 values for each sterilization cycle, using Bacillus Stearothermophilus spores as the microbiological challenge. F0 value is a measure of the total lethal effect of a sterilization process, equivalent to the number of minutes at 121°C with saturated steam. Higher F0 values indicate a more effective sterilization process. While specific target F0 values are not explicitly listed as "acceptance criteria," the established steam sterilization process and the demonstration of a "large margin of safety" in spore destruction indicate that the reported F0 values are considered acceptable and sufficient for sterilization.

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

• Test Set Sample Size: Not explicitly stated as a number of devices or cycles. The study refers to "Extensive tests" and the use of Bacillus Stearothermophilus spores. The text does not specify the number of test runs or the quantity of spores used per test.
• Data Provenance: The study was conducted by "Sterilization Technical Services." The country of origin of this service is not specified in the provided text. The data is presented as a result of tests performed to determine "sterilization effectiveness," suggesting a prospective testing approach designed specifically for this submission.

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

• The ground truth for sterilization effectiveness was established by "Sterilization Technical Services" using Bacillus Stearothermophilus spores as the microbiological challenge. The text does not mention the number of human experts involved in establishing this ground truth or their specific qualifications. The ground truth here is biological (spore destruction), evaluated through established laboratory methods.

4. Adjudication Method for the Test Set

• Not applicable. The "ground truth" here is the biological outcome of spore destruction, measured by F0 values derived from the testing. There is no mention of human adjudication for the test results.

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 an autoclave (sterilizer), not an AI-assisted diagnostic or interpretative system. Therefore, no MRMC study involving human readers and AI assistance was conducted.

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

• Yes, in a sense. The "performance" of the device (autoclave) is its ability to sterilize. The results presented (F0 values) are a direct measure of the autoclave's standalone performance in destroying biological contaminants. There is no human interaction required for the sterilization process itself, other than loading and initiating the cycle.

7. The Type of Ground Truth Used

• Biological Ground Truth: The primary ground truth used is the destruction of Bacillus Stearothermophilus spores. This is a widely accepted biological indicator for validating steam sterilization processes. The success of sterilization is quantified by the F0 value, which reflects the lethal effect on these spores.

8. The Sample Size for the Training Set

• Not applicable. This device is a physical sterilizer, not a machine learning model. Therefore, there is no "training set" in the context of an algorithm or AI. The design and parameters were likely developed through engineering principles and iterative testing, but not in the sense of a data-driven training set for an algorithm.

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

• Not applicable, as there is no "training set" for this device. The physical and operational parameters of the STERImaster Autoclave were likely developed based on scientific principles of steam sterilization, engineering design, and general knowledge of effective sterilization cycles for various materials (e.g., historical data on various temperatures and times for different instrument types).

Ask a specific question about this device