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The Tuttnauer 2540 EHS Series Table-top Autoclave is intended to provide sterilization of medical and dental instruments (wrapped and unwrapped) including complex lumened devices such as dental handpieces, porous, hollow loads and to sterilize liquids for non-clinical applications. Cycle parameters are as follows:

Dental and medical instruments were placed within self-sealing, disposable pouches. The pouches were placed upright in an instrument rack.

The Tuttnauer 2540 EHS Table-top Autoclave is a steam sterilizer that provides an onboard steam generation capability. It is designed for sterilization of medical and dental instruments (wrapped and unwrapped), including complex lumened devices (such as dental handpieces), porous, hollow loads and to sterilize liquids for non-clinical applications. The sterilization medium is steam, which is directly introduced into the sterilization chamber. This eliminates the need to wait for water introduced into the chamber to boil and reach sterilization parameters.

The Tuttnauer EHS Series Electronic Table-top Autoclave is a steam sterilizer that includes as its main components: a pressure vessel with steam jacket, heating elements, a dualchamber water reservoir, a water pump and a vacuum pump. The device is identical to the predicate device, with the exception of the proposed modification to the labeling that would authorize sterilization of wrapped, non-lumened devices at 273° for four (4) minutes.

The provided document describes the Tuttnauer 2540 EHS Series Table-Top Autoclave, a steam sterilizer. The acceptance criteria and the study that proves the device meets the acceptance criteria are outlined below.

1. Table of Acceptance Criteria and Reported Device Performance:

The primary acceptance criterion is successful sterilization. The device performance is reported as meeting this criterion for all tested cycles.

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

The document does not explicitly state the specific sample size (i.e., number of sterilization cycles or instruments) used for the test set. However, it indicates that "successful sterilization was accomplished in all tests performed" (Page 3), suggesting a comprehensive testing approach for the defined cycles.

The data provenance is not explicitly mentioned (e.g., country of origin, specific test sites). The studies were non-clinical validation studies described in the submission to the FDA. The nature of the studies ("Non-Clinical Testing") suggests they were conducted in a controlled laboratory environment. The document implies a prospective study design as it describes validation studies conducted to demonstrate the device's performance for specific new and existing cycles.

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

The document does not mention the use of experts to establish a "ground truth" in the traditional sense of medical image analysis or diagnostic performance. Instead, the ground truth for sterilization efficacy is established through standardized microbiological testing methods (e.g., biological indicators) as dictated by the ANSI/AAMI ST55 standard. Therefore, the "experts" would be the technicians or scientists conducting these validated sterilization efficacy tests, and their qualifications would be expertise in microbiology and sterilization validation protocols.

4. Adjudication Method for the Test Set:

Not applicable. As described above, the determination of successful sterilization is based on objective, standardized microbiological test results, not on subjective expert opinion or adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not applicable. This is a medical device for sterilization, not a diagnostic imaging or AI-assisted system that involves human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Not applicable. The device is a physical sterilizer and its performance is assessed directly, not through an algorithm's output. The "performance" is the physical sterilization process itself.

7. Type of Ground Truth Used:

The ground truth used is based on the results of sterilization efficacy tests, specifically adhering to the ANSI/AAMI ST55 standard. This standard typically involves using biological indicators (BIs) containing highly resistant bacterial spores (e.g., Geobacillus stearothermophilus). "Successful sterilization" means the complete killing of all spores on the BI, indicating a specific Sterility Assurance Level (SAL).

8. Sample Size for the Training Set:

Not applicable. This device is not an AI/ML algorithm that requires a training set. Its performance is based on the physical parameters of steam sterilization.

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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