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510(k) Data Aggregation
(116 days)
MIDMARK M3 ULTRAFAST AUTOMATIC STERILIZER
The Midmark M3 UltraFast™ Automatic Sterilizer can be used in medical, dental, and veterinary offices, hospitals, clinics, nursing homes, laboratories, and other facilities to sterilize heat and moisture stable reusable items (including dental handpieces) that are compatible with steam sterilization. Refer to Standard Cycle Parameters, in Table-1, on the following page, for detailed information:
The M3 UltraFast™ Automatic Sterilizer is a small table-top steam sterilizer that uses saturated steam at high temperature and pressure to kill infectious bio-organisms.
The device is composed of a water reservoir, an oscillatory pump, a small electric boiler, an ASME certified pressure vessel, surface heaters for drying, a removable door/tray assembly, an electric gear motor for opening and closing the door/tray, and a solenoid valve for venting. The action of all of these components is coordinated by an integral proprietary design electronic control system, which includes a PC board, an LCD display, and a user interface membrane switch. The entire device is enclosed by a plastic and steel case. External to this device is a condensation tank, which is connected to the back of the unit, via a plastic tube.
Three different fully automatic pre-programmed sterilization cycles with parameters specific to the different load characteristics provide fast and easy use for efficient instrument processing. This sterilizer provides both audible and visual notification upon cycle completion and will dry the load in accordance with the CDC guidelines. A programmable dry cycle allows the user to customize the dry times from 20-60 minutes. This sterilizer has integrated technology to let the operator know if they have low water in the reservoir, or a full external condensing tank eliminating the need to continually monitor water levels.
1. Table of Acceptance Criteria and Reported Device Performance:
The acceptance criteria for the Midmark M3 UltraFast™ Automatic Sterilizer are a Sterility Assurance Level (SAL) of 10⁻⁶ for all three sterilization cycles. The reported device performance demonstrates that the device successfully meets this criterion for each cycle.
| Acceptance Criteria (Sterility Assurance Level - SAL) | Reported Device Performance |
|---|---|
| Unwrapped Cycle: 10⁻⁶ | Validated to a SAL of 10⁻⁶ for the Unwrapped Cycle |
| Pouches Cycle: 10⁻⁶ | Validated to a SAL of 10⁻⁶ for the Pouches Cycle |
| Low Temp Cycle: 10⁻⁶ | Validated to a SAL of 10⁻⁶ for the Low Temp Cycle |
| Thermal Conditions | Achieves and maintains steady state thermal conditions |
| Total Kill Endpoint Time | Established as a starting point for cycle development |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the specific "sample size" in terms of number of sterilization runs for the test set. However, it mentions "Repetitive testing" for the validation of each cycle, implying multiple runs were conducted.
The data provenance indicates that the studies were conducted by a "third party, SPSmedical Supply Corporation," on behalf of Midmark Corp. This suggests an independent laboratory performed the testing. The country of origin of the data is not specified, but given the submission to the FDA, it is highly likely to be the United States. The studies are prospective in nature, as they involve actively testing the device's performance to establish its efficacy.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided in the document. The ground truth for sterilization efficacy (total kill endpoint and sterility assurance level) is established through standardized microbiological testing using biological indicators (Geobacillus stearothermophilus spores) rather than human expert opinion. Therefore, the concept of "experts" in the traditional sense of medical image interpretation (e.g., radiologists) is not applicable here. The experts involved would be microbiologists and validation scientists from SPSmedical Supply Corporation, but their specific number and qualifications are not detailed.
4. Adjudication Method for the Test Set:
Adjudication methods like "2+1" or "3+1" are typically used in studies involving human interpretation of data where consensus is needed (e.g., image reading). This is not relevant for the type of testing performed for a sterilizer. The "adjudication" is based on objective scientific criteria: the complete kill of a specified number of bacterial spores, as measured by microbiological techniques, to achieve a defined Sterility Assurance Level (SAL).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. MRMC studies are used to evaluate the diagnostic performance of human readers, typically in medical imaging, and are not applicable to the performance evaluation of a sterilizer. The device's effectiveness is measured against objective microbiological and thermal criteria, not against human interpretation performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Yes, the studies conducted were standalone performance evaluations of the Midmark M3 UltraFast™ Automatic Sterilizer. The tests focused solely on the device's ability to achieve sterilization without human intervention during the sterilization cycle itself. The device is an automatic sterilizer, performing its function independently once initiated.
7. The Type of Ground Truth Used:
The ground truth used for the sterilizer's performance evaluation is microbiologically established sterility, specifically a 10⁻⁶ Sterility Assurance Level (SAL), based on the complete inactivation of Geobacillus stearothermophilus spores.
This includes:
- Biological Indicators: The use of Geobacillus stearothermophilus spores as a challenge organism. The "total kill endpoint study" directly measures the time required to inactivate these spores.
- Thermal Profiles: Measurement of temperature throughout the chamber to ensure consistent thermal conditions.
- Validation of Sterilization Cycles: Confirmation that specific cycles (Unwrapped, Pouches, Low Temp) consistently achieve the desired SAL under defined load conditions.
8. The Sample Size for the Training Set:
This information is not applicable to this type of device and study. "Training set" refers to data used to train a machine learning algorithm. The Midmark M3 UltraFast™ Automatic Sterilizer is a physical device, not an AI or software algorithm. Its performance is validated through defined testing protocols, not through a training/testing split of a dataset.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable, as there is no "training set" for a physical sterilizer device. The device's operational parameters (e.g., temperature, pressure, time for each cycle) are designed and engineered by Midmark based on scientific principles of steam sterilization and validated through the performance studies described in the document.
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