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The Revolutionary Science Saniclave 102 is designed to be used in medical and dental clinics, hospitals and other facilities where reusable sterile equipment is used. It is intended to sterilize unwrapped heat and moisture stable solid instruments, mated surfaces, knurled and hinged devices (excluding lumened devices and dental hand pieces) that are compatible with saturated steam sterilization at 121 degrees Celsius for 30 minutes. Unwrapped instruments that were sterilized should be used immediately after sterilization is completed (immediate use sterilization). The chamber must be manually drained and wiped dry after each cycle.

The Saniclave 102 by Revolutionary Science (model number RS-SC-102) is a 120 volt autoclave. The Saniclave works like most other table top steam sterilizers by boiling water in a pressurized vessel (or chamber). As the water boils, the chamber pressurizes and the steam sterilizes the instruments placed inside. The Saniclave technology is based on the scientific concept that prolonged saturated pressurized steam at or over a temperature of 121 degrees Celsius kills bacteria.

The Revolutionary Science Saniclave 102 is a steam sterilizer (autoclave) intended for use in medical and dental clinics, hospitals, and other facilities for sterilizing unwrapped heat and moisture-stable solid instruments.

Here's an analysis of its acceptance criteria and the study performed:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" for performance in the typical sense of quantitative measures like sensitivity, specificity, or accuracy for a diagnostic device. Instead, the "acceptance criteria" are implied through substantial equivalence to a predicate device and adherence to industry standards for sterilizers.

The core performance requirement for a sterilizer is to achieve sterilization. This is demonstrated by meeting specific thermal and time parameters.

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

The document states that "Physical and biological testing were performed in accordance with ANSI/AAMI ST55:2010." However, it does not specify the sample size used for these tests (e.g., number of cycles, number of biological indicators).

The data provenance is not explicitly stated in terms of country of origin, but the testing was conducted by Revolutionary Science, the manufacturer, in support of their 510(k) submission to the FDA (USA). The nature of the testing is prospective, as it's an evaluation of the device's performance against a standard.

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

This is not applicable in the context of device sterilization testing. The "ground truth" for a sterilizer's performance isn't established by human experts in the same way as, for example, image interpretation.

Instead, the ground truth for sterilization efficacy is established by:

• Physical measurements: Verifying that temperature, time, and pressure parameters are met throughout the cycle.
• Biological indicators: Using standardized biological indicators (e.g., spore strips) containing highly resistant bacterial spores (e.g., Geobacillus stearothermophilus) to confirm spore inactivation. A successful test (ground truth) is no growth of microorganisms after incubation.

The study refers to using "Class 5 integrators" which "confirm that pressure, temperature and time were achieved," and implies their use for each cycle. These integrators serve as a chemical indication of whether the critical sterilization parameters were met, further supporting the "ground truth" that sterilization conditions were achieved.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1, 3+1 consensus) are typically used for subjective assessments, such as expert review of medical images or clinical outcomes. This is not applicable to the objective physical and biological testing of a sterilizer. The results of biological indicator tests (growth/no growth) and physical parameter measurements are objective.

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

An MRMC study is not applicable to this device. MRMC studies are used to evaluate the diagnostic accuracy of AI systems in combination with human readers, typically for image interpretation tasks. The Saniclave 102 is a physical sterilization device, not a diagnostic tool that involves human interpretation of output.

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

While the device incorporates a microprocessor-based circuit board (software/firmware controlled), a "standalone performance" study in the context of AI algorithms is not applicable. The device's function is automated sterilization. The non-clinical testing performed (physical and biological testing per ANSI/AAMI ST55:2010) inherently assesses the "standalone" performance of the device and its control system in achieving sterilization parameters. There is no human "in the loop" required beyond operating the device.

7. Type of Ground Truth Used

The ground truth used for proving the device meets acceptance criteria is based on:

1. Objective Physical Parameters: Confirmation that the specified sterilization temperature (121°C), time (30 minutes), and pressure (15 psi) are consistently achieved and maintained within the chamber during the sterilization cycle.
2. Biological Inactivation (Biological Indicators): Absence of growth from highly resistant bacterial spores after exposure to the sterilization cycle and subsequent incubation.
3. Chemical Integration (Class 5 Integrators): Confirmation by Class 5 chemical integrators that all critical parameters (time, temperature, and steam) for sterilization have been met.

8. Sample Size for the Training Set

The concept of a "training set" is not applicable here. The Saniclave 102 is a physical device, not an AI model that learns from data. Its operational parameters (time, temperature, pressure) are pre-programmed and fixed, not learned from a training dataset.

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

As there is no "training set" in the context of this physical device, this question is not applicable.

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