(147 days)
The M4+9 EasyClave is to 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 at 270°F. Refer to Standard Cycle Parameters below for detailed information.
The Midmark M4+9 EasyClave 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.
Items to be sterilized are placed in the sterilization chamber. The operator chooses a sterilization cycle, and presses the appropriate switch. The sterilizer automatically admits a controlled volume of water to the chamber, heats the water into steam, sterilizes the items, and automatically vents the steam and dries the items after sterilization is complete.
The provided text describes the Midmark M4-9 EasyClave Steam Sterilizer and its equivalence to a predicate device, the Midmark M-11 UltraClave Steam Sterilizer. However, the document does not contain detailed information about specific acceptance criteria, study methodologies, sample sizes, ground truth establishment, or expert involvement in the way typically found in performance studies for AI/software devices.
The information provided only states that:
1. Acceptance Criteria and Device Performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Sterilization of dental handpieces to an acceptable SAL (Sterility Assurance Level) when used with specific cycle parameters. | "To validate sterility claims for dental handpieces, the M4•9 was tested to the same protocol used to validate these claims for the predicate device. The resulting testing showed that, when used in accordance with Midmark's directions for use, the M4+9 can sterilize dental handpieces to an acceptable SAL." |
Specific Cycle Parameters:
- Unwrapped: 132°C (270°F) / 186 kPa (27 psi) / 3:30 minutes
- Wrapped: 132°C (270°F) / 186 kPa (27 psi) / 9 minutes |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document states "the M4•9 was tested to the same protocol used to validate these claims for the predicate device," but the sample size of items or runs for this protocol is not mentioned.
- Data Provenance: Not specified. It's an in-house validation for a medical device manufacturer. The country of origin and whether it was retrospective or prospective is not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable. This is a validation study for a physical sterilization device, not a diagnostic or AI-powered imaging device that would typically rely on expert human interpretation for ground truth. The "ground truth" for sterilization is achieving a specific sterility assurance level (SAL), which is determined by microbiological testing, not human expert consensus on images or data.
- Qualifications of Experts: Not applicable.
4. Adjudication method for the test set:
- Adjudication method: Not applicable. This is a sterilization validation based on physical parameters and microbiological results, not a study involving human readers or interpretation requiring adjudication.
5. 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:
- MRMC Study: No. This is not an AI or software device that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Not applicable. The device is a steam sterilizer, its "performance" is its ability to sterilize. "Standalone" in this context would refer to its operation according to its pre-programmed cycles. The document confirms it "can sterilize dental handpieces to an acceptable SAL."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Ground Truth: Achieving an "acceptable SAL (Sterility Assurance Level)." This is typically established through biological indicator testing (e.g., spore strips) and monitoring physical parameters (temperature, pressure, time) to ensure the destruction of microorganisms. It is a scientific, objective measure of sterility, not expert consensus or pathology in the human diagnostic sense.
8. The sample size for the training set:
- Training Set Sample Size: Not applicable. This device is a physical sterilizer. It does not use a "training set" in the machine learning sense. Its programming is based on established sterilization principles and engineering, not data-driven learning.
9. How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable. As above, there is no "training set" for this type of device. The "ground truth" for its design and pre-programmed cycles would be based on the scientific principles of heat and moisture sterilization to achieve microbial inactivation, which has been established through extensive research and standards in microbiology and sterilization practices.
§ 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).