(276 days)
The Midmark and Ritter M9 and M11 UltraClave® Automatic Sterilizers and the Ritter M9D AutoClave® Automatic Sterilizer can be used in medical and dental offices, hospitals, clinics, nursing homes, laboratories, and other facilities to sterilize heat and moisture stable items (including dental handpieces) that are compatible with steam sterilization. Refer to Standard Cycle Parameters on the following page for detailed information.
The Midmark and Ritter M9 and M11 UltraClave and Ritter M9D AutoClave Self-Contained steam sterilizers are designed to sterilize medical, surgical, laboratory, and dental items, using pressurized steam. The M9 UltraClave models include a variation designated as the M9D Autoclave, the only difference being that the M9 UltraClave includes a motor to automatically open the door for drying and the M9D Autoclave is a manual model which requires the operator to open the door for drying. They are self-contained devices that are electrically powered with automatic controls for controlling time and temperature that are designed for safe, easy operation with minimal operator training.
The provided document describes the Midmark and Ritter M9 and M11 UltraClave Automatic Sterilizers and the Ritter M9D AutoClave Automatic Sterilizer, which are self-contained steam sterilizers used in medical and dental offices, hospitals, clinics, nursing homes, laboratories, and other facilities to sterilize heat and moisture stable items.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The device is a steam sterilizer, and its performance is evaluated based on its ability to achieve sterility For medical devices, the common performance criteria for sterilization are the achievement of a certain temperature and pressure for a specified duration, resulting in a Sterility Assurance Level (SAL) of 10^-6, meaning the probability of a single viable microorganism remaining after sterilization is one in a million.
The document implicitly defines acceptance criteria through the "Standard Cycle Parameters" and confirms the device's performance through validation studies.
| Acceptance Criterion (Standard Cycle Parameter) | Reported Device Performance (Achieved during validation) |
|---|---|
| Unwrapped Cycle: | |
| Sterilizing Temperature: 270°F (132°C) | Achieved (implicit through successful biological testing and adherence to standard) |
| Sterilizing Time: 3 min. | Achieved (implicit through successful biological testing and adherence to standard) |
| Pressure (Ref): 27.1 psi (186 kPa) | Achieved (implicit through successful biological testing and adherence to standard) |
| Drying Time: 30 min. | Achieved |
| Pouches Cycle: | |
| Sterilizing Temperature: 270°F (132°C) | Achieved (implicit through successful biological testing and adherence to standard) |
| Sterilizing Time: 4 min. | Achieved (implicit through successful biological testing and adherence to standard) |
| Pressure (Ref): 27.1 psi (186 kPa) | Achieved (implicit through successful biological testing and adherence to standard) |
| Drying Time: 30 min. | Achieved |
| Packs Cycle: | |
| Sterilizing Temperature: 250°F (121°C) | Achieved (implicit through successful biological testing and adherence to standard) |
| Sterilizing Time: 30 min. | Achieved (implicit through successful biological testing and adherence to standard) |
| Pressure (Ref): 15 psi (104 kPa) | Achieved (implicit through successful biological testing and adherence to standard) |
| Drying Time: 30 min. | Achieved |
| Handpieces Cycle: | |
| Sterilizing Temperature: 270°F (132°C) | Achieved (implicit through successful biological testing and adherence to standard) |
| Sterilizing Time: 4 min. | Achieved (implicit through successful biological testing and adherence to standard) |
| Pressure (Ref): 27.1 psi (186 kPa) | Achieved (implicit through successful biological testing and adherence to standard) |
| Drying Time: 30 min. | Achieved |
| Microbiological Performance (SAL): | |
| Sterility Assurance Level (SAL): 10⁻⁶ | Achieved (demonstrated through biological indicator overkill method) |
| Physical Performance Requirements: | All aspects of the standard met. |
The document states: "Testing showed that the M9 and M11 UltraClave and the M9D AutoClave Self-Contained Steam Sterilizers meet all aspects of the standard, including physical and microbiological performance requirements."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: For the physical performance validation, temperature sensors were used to determine the thermal profile of the empty chamber for "three (3) full chamber runs for each pre-programmed cycle parameter" (Unwrapped, Pouches, Packs, Handpieces). For microbiological testing, "biological testing was conducted on fully loaded chambers." No specific number of "fully loaded chambers" or individual biological indicators (BIs) is explicitly stated for the test set, beyond the statement that BIs were inoculated in "most difficult to sterilize locations."
- Data Provenance: The studies were conducted by "MIDMARK Corporation." The country of origin for the data is not explicitly stated, but Midmark Corporation is based in Versailles, Ohio, USA, suggesting the testing was likely conducted in the USA. The data is prospective, generated specifically for these validation studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of device (steam sterilizer) does not typically involve human experts in establishing the "ground truth" in the same way an AI diagnostic tool would. The ground truth for sterilization efficacy is established by scientific standards and laboratory methods.
- Number of Experts: Not applicable in the context of human interpretation. The "experts" are the scientific and technical personnel who designed and executed the validation protocols based on established sterilization standards.
- Qualifications of Experts: Not explicitly stated, but implied to be qualified personnel in sterilization science, microbiology, and engineering, familiar with relevant standards (e.g., ANSI/AAMI ST55).
4. Adjudication Method for the Test Set
Not applicable. Sterilization testing is based on objective, quantifiable measures (temperature, pressure, time, and biological indicator kill rates) rather than subjective expert opinion requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This device is a standalone medical device (sterilizer), not an AI algorithm intended for interpretation by human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance Study
Yes, a standalone performance study was conducted. The entire validation process, as described, evaluates the device's intrinsic mechanical and microbiological performance. The sterilizer operates autonomously through software-controlled microcontrollers (as described in the "Device Description") to achieve the specified sterilization cycles. The human operator initiates the cycle and loads/unloads the device, but the sterilization process itself is algorithmic (pre-programmed cycles and control loops) and standalone.
7. Type of Ground Truth Used
The ground truth used is based on established microbiological and physical standards for sterilization, specifically:
- Biological Indicator Overkill Method: This is a gold standard for demonstrating sterilization efficacy. Geobacillus stearothermophilus spores are highly resistant, and their complete inactivation (achieving a 10⁻⁶ SAL) confirms the sterilization process is effective.
- Physical Parameters: Measurement of temperature, pressure, and time profiles within the chamber ensure that the physical conditions required for sterilization were met.
- Reference Standards: The studies were conducted "in accordance with ANSI/AAMI ST55: 2010/(R)2014," a recognized standard for tabletop steam sterilizers, which defines the ground truth for performance requirements.
8. Sample Size for the Training Set
Not applicable. This is a physical device (sterilizer) with an embedded operating algorithm, not an AI model that undergoes "training" on a dataset in the typical machine learning sense. The device's control system is developed through engineering design and robust testing, not statistical training on large datasets.
9. How the Ground Truth for the Training Set Was Established
Not applicable for the same reasons as point 8. The "ground truth" for the device's operational parameters (e.g., control logic for heating, venting, sterilizing timing) is established through engineering principles, design specifications, and adherence to regulatory and industry standards for steam sterilization.
§ 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).