(106 days)
The Revolutionary Science Saniclave 200 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 wrapped and 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.
The Saniclave 200 by Revolutionary Science (model number RS-SC-200) is a 120 volt front loading 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 single heating element (permantently affixed to the bottom inside the chamber with bulkhead fittings) generates all heat for the autoclave, including preheat, sterilization and dry modes. It is immersed in the water of the chamber. When the cycle is initiated the heater turns on and boils the water.
Here's an analysis of the Revolutionary Science Saniclave 200 (RS-SC-200) based on the provided 510(k) summary, structured to address your specific points:
Since the device is a steam sterilizer (autoclave), the "acceptance criteria" and "device performance" are typically defined by demonstrating that the device effectively sterilizes according to established standards. The study mentioned is the validation testing against these standards.
Revolutionary Science Saniclave 200 (RS-SC-200) Performance Study
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from ANSI/AAMI ST55:2010) | Reported Device Performance (Saniclave 200) |
|---|---|
| Meets all requirements of ANSI/AAMI ST55:2010 for steam sterilization. | Testing showed that Saniclave 200 meets all requirements of this standard. |
| Specific Performance Parameters (for Recommended Use): | |
| Sterilization Temperature: 121°C | Operates at 121°C for sterilization (for both wrapped and unwrapped). |
| Sterilization Time: 30 minutes | Operates for 30 minutes for sterilization (for both wrapped and unwrapped). |
| Ability to sterilize wrapped instruments (up to 4.5 lbs) | Validated for wrapped instruments (single pouching) up to 4.5 lbs. |
| Ability to sterilize unwrapped instruments (up to 4.5 lbs) | Validated for unwrapped instruments up to 4.5 lbs. |
| Effective sterilization of heat and moisture stable solid instruments, mated surfaces, knurled and hinged devices (excluding lumened devices and dental hand pieces). | Intended to sterilize these types of instruments. (Implicitly met by standard compliance.) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify the exact sample size (e.g., number of cycles, number of biological indicators, number of devices) used for the physical and biological testing. It only states that "physical and biological testing were performed."
- Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. Given that it's a 510(k) submission for a new device, the testing would be prospective and conducted by Revolutionary Science or a contracted testing facility.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
For a steam sterilizer, "ground truth" related to sterilization efficacy is objectively established through physical measurements (temperature, pressure, time) and biological indicator (BI) kill-rates, which demonstrate the elimination of highly resistant microorganisms (e.g., Geobacillus stearothermophilus spores). This doesn't typically involve human expert consensus in the same way an AI diagnostic tool would.
- Number of Experts: Not applicable in the context of expert consensus for ground truth. Testing is performed under controlled laboratory conditions, often overseen by engineers and microbiologists.
- Qualifications of Experts: Not specified, but implied to be qualified personnel experienced in medical device sterilization validation according to ANSI/AAMI ST55.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. Sterilization efficacy is assessed against pre-defined, objective chemical and biological indicators, not through human consensus or adjudication of subjective interpretations.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size (AI vs. Without AI Assistance)
- MRMC Comparative Effectiveness Study: No. This type of study is relevant for AI-powered diagnostic or interpretive tools that assist human readers (e.g., radiologists interpreting images). A steam sterilizer does not involve human "readers" or "AI assistance" in its direct function of sterilizing instruments.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: Not applicable in the context of an algorithm. The device itself (the Saniclave 200) is a standalone physical product that performs sterilization. Its performance is evaluated based on its ability to meet the established physical and biological parameters for sterilization, independent of human intervention during the cycle.
7. The Type of Ground Truth Used
- Type of Ground Truth: The ground truth for sterilization efficacy is established through:
- Physical Monitoring: Verification that physical parameters (temperature, pressure, time) achieve the specified sterilization conditions within the chamber.
- Biological Indicators (BIs): Use of biological indicators containing highly resistant bacterial spores (e.g., Geobacillus stearothermophilus) to confirm that all test microorganisms are destroyed, indicating a high probability of sterility. This represents a robust, objective measure of sterilization effectiveness.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. The Saniclave 200 is a physical device, not an AI algorithm that undergoes "training" on a dataset. Its design and operational parameters are based on established scientific principles of steam sterilization, not machine learning from a training set.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set was Established: Not applicable, as there is no training set in the context of this device. The scientific and engineering principles of saturated steam sterilization (killing bacteria at 121°C for 30 minutes) are the foundational "ground truth" for the device's design, derived from decades of scientific research and validated standards like ANSI/AAMI ST55. The device is designed to execute these established principles to achieve sterility.
§ 880.6880 Steam sterilizer.
(a)
Identification. A steam sterilizer (autoclave) is a device that is intended for use by a health care provider to sterilize medical products by means of pressurized steam.(b)
Classification. Class II (performance standards).