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(242 days)
The Belimed Steam Sterilizer MST-V, model 4-4-6 is designed for sterilization of non-porous and porous heat and moisture-stable materials used in healthcare facilities.
The Belimed Steam Sterilizer MST-V, model 4-4-6 is equipped with the following factoryprogrammed Sterilization cycles and cycle values (Table 1).
The Belimed Steam Sterilizer MST-V, model 4-4-6 is available as a single door prevacuum/gravity version.
The Belimed Steam Sterilizer MST-V, model 4-4-6 is intended for use in hospital and health care facilities and is intended to be used in an identical manner as the Belimed Steam Sterilizer Series 3-3-6.
The Belimed Steam Sterilizer MST-V, model 4-4-6 is equipped with the following factoryprogrammed Sterilization cycles and cycle values (Table 1).
The Belimed Steam Sterilizer MST-V, model 4-4-6 is available with a single door, prevacuum/gravity.
The Belimed Steam Sterilizer MST-V is offered in the following configuration: Table 2: Dimensions
The Belimed Steam Sterilizer MST-V, model 4-4-6 is designed to be used for the terminal sterilization of porous and non-porous, heat and moisture stabile materials in healthcare facilities.
Depending of the chosen cycle, materials including textiles, unwrapped instrument travs with single or multiple instruments may be sterilized.
The Belimed Steam Sterilizer MST-V, model 4-4-6 is factory equipped with cycles which have been tested in accordance with ANSI/AAM1 ST8:2008 under defined load conditions. The predicate device with a chamber volume of 73 liters has been validated previously.
The provided documentation describes the Belimed Steam Sterilizer MST-V, model 4-4-6. This is a medical device intended for sterilization, not an AI/ML device, and therefore the acceptance criteria and study detailed in the document are related to the physical performance of the sterilizer, not to the performance of an algorithm.
As a result, some of the requested information regarding AI/ML device evaluation (like sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, and training set details) is not applicable or available in this document.
Here's an analysis based on the provided text for a steam sterilizer:
1. Table of Acceptance Criteria and Reported Device Performance
The device is a steam sterilizer, and its performance is evaluated against the requirements of ANSI/AAMI ST8:2008, a standard for hospital steam sterilizers. The "acceptance criteria" can be inferred from the requirements of this standard and the "reported device performance" is the statement that the device meets these requirements.
| Acceptance Criteria (from ANSI/AAMI ST8:2008) | Reported Device Performance (Belimed Steam Sterilizer MST-V, model 4-4-6) |
|---|---|
| Empty Chamber Testing (Section 5.4.2.5): Capability to provide steady state thermal conditions corresponding to predicted sterility assurance level (SAL). Meets requirements of Sections 4.4.2.2 and 4.4.2.5. | Demonstrated capability to provide steady state thermal conditions within the chamber that correspond with the predicted SAL in the load for PreVac, PreVac Immediate Use, and Gravity cycles. Meets the requirements of Section 4.4.2.2 and 4.4.2.5 of ANSI/AAMI ST8. |
| Fabric Test Pack (Section 5.5.2): Sterility assurance level (SAL) of at least 10^-6^, Fo of at least 12 minutes by half cycle, moisture retention |
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