(89 days)
The M-11 UltraClave is intended to be used in medical and dental offices, hospitals, clinics, nursing homes, laboratories, and other facilities to sterilize heat- and moisturestable, reusable equipment. Dental handpieces can be sterilized in the M-11 in the Pouches cycle. This device is not recommended for sterilization of liquids intended for direct patient contact. Refer to Standard Cycle Parameters below for detailed information.
The Midmark M-11 Ultraclave Steam Sterilizer uses saturated steam at high pressures and temperatures and to kill infectious bio-organisms. This steam is generated inside the sterilization chamber by an electric heating element. The sterilizer's electronic control system is pre-programmed to complete sterilization cycles according to established time, temperature, and pressure parameters, summarized below.
The provided text describes a steam sterilizer, not an AI/ML powered device, so many of the requested fields are not applicable. However, I can extract the relevant information regarding the device's acceptance criteria and the study performed to meet those criteria.
Acceptance Criteria and Reported Device Performance
The device is a steam sterilizer, and its core function is to sterilize items according to established time, temperature, and pressure parameters. The key acceptance criterion is the ability to sterilize items to an acceptable Sterility Assurance Level (SAL).
The relevant "performance" here is defined by meeting these parameters for various cycles, and crucially, for the newly added indication for dental handpieces.
| Cycle | Temperature | Pressure | Time | Items to be Sterilized |
|---|---|---|---|---|
| Unwrapped | 132°C (270°F) | 186 kPa (27 psi) | 3 Minutes | Instruments loose on a tray. Open glass or metal canisters. Tubing not used in surgical procedures. Items manufacturers recommend for exposure at 132°C (270°F) for 3 minutes. The sterility of unwrapped items is compromised on exposure to a non-sterile environment. |
| Pouches | 132°C (270°F) | 186 kPa (27 psi) | 15 Minutes | Instruments and dental handpieces. Loosely wrapped individual instruments. Multiple layers of instruments separated by fabric. Wrapped trays of loose instruments. Tubing not used in surgical procedures. Items manufacturers recommend for exposure at 132°C (270°F) for 15 minutes. |
| Liquids | 121°C (250°F) | 104 kPa (15 psi) | 30 Minutes | Liquids or gels that could boil over with rapid depressurization. Cycle includes special vent and dry functions. Not recommended for sterilization of liquids intended for direct patient contact. |
| Packs | 121°C (250°F) | 104 kPa (15 psi) | 30 Minutes | Textiles and surgical packs wrapped for sterilization. Items, except liquids, manufacturers recommend for exposure at 121°C (250°F) for 30 minutes. |
Study Proving Device Meets Acceptance Criteria
Midmark developed a new test protocol specifically to validate sterility claims for dental handpieces.
- Sample size used for the test set and the data provenance: The document states that the protocol was designed to evaluate the M-11's ability to sterilize commercially available dental handpieces, "when presented as a worst-case challenge." It does not specify the exact number of handpieces or test runs, nor does it explicitly state the country of origin. The test was conducted by Midmark, implying internal, prospective testing.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience): Not applicable. This is a sterilizer, so "ground truth" would be established through microbiological testing (e.g., spore-kill assays), not expert review of images. The document does not specify the experts involved in the testing, but it would typically be microbiologists or sterilization validation specialists.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are relevant for subjective interpretations (like medical image diagnosis), not for objective sterility testing.
- 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 is not an AI-powered device, nor does it involve human readers.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The "study" described is a standalone performance validation of the sterilizer itself (algorithm only in the sense of the sterilizer's pre-programmed cycles).
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The ground truth for sterility is the absence of viable microorganisms to a scientifically accepted Sterility Assurance Level (SAL), typically 10^-6. This is established through microbiological testing using biological indicators (spore strips) placed in the most challenging locations and subsequent culture. The document states "The resulting testing showed that, when used in accordance with Midmark's directions for use, the M-11 can sterilize dental handpieces to an acceptable SAL."
- The sample size for the training set: Not applicable. There is no training set for a mechanical sterilizer; it operates based on pre-programmed physical parameters.
- How the ground truth for the training set was established: Not applicable.
§ 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).