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510(k) Data Aggregation
(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 < 3% increase in pre-sterilization test pack weight, no wet spots. | All PreVac cycles demonstrated a sterility assurance level of at least 10^-6^ through achievement of a time-at-temperature sufficient to produce an Fo of at least 12 minutes by half cycle, moisture retention of less than 3% increase in pre-sterilization test pack weight, and exhibited no wet spots. |
| Full Load Instrument Trays (Section 5.5.4): Sterility assurance level (SAL) of at least 10^-6^, Fo of at least 12 minutes by half cycle, moisture retention < 20% increase in pre-sterilization towel weight, no wet spots on outer wrapper. | All PreVac and Gravity cycles demonstrated a sterility assurance level of at least 10^-6^ through achievement of a time-at-temperature sufficient to produce an Fo of at least 12 minutes by half cycle, moisture retention of less than 20% increase in pre-sterilization weight of the towel, and exhibited no wet spots on the outer wrapper. |
| Unwrapped Instrument Trays (PreVac Immediate Use - Section 5.5.5.2): Sterility assurance level (SAL) of at least 10^-6^, Fo of at least 12 minutes by half cycle. | All PreVac Immediate Use cycles demonstrated a sterility assurance level of at least 10^-6^ through achievement of a time-at-temperature sufficient to produce an Fo of at least 12 minutes by half cycle. |
| Unwrapped Instrument Trays (Gravity Immediate Use - Section 5.5.5.1): Sterility assurance level (SAL) of at least 10^-6^, Fo of at least 12 minutes by half cycle. | All Gravity Immediate Use cycles demonstrated a sterility assurance level of at least 10^-6^ through achievement of a time at temperature sufficient to produce an Fo of at least 12 minutes by half cycle. |
| Bowie-Dick Test Pack (Section 5.6): Uniform color change throughout the test sheet, load temperature devices attain exposure temperature within 10 seconds of exposure phase. | The Bowie-Dick Test cycle demonstrated a uniform color change throughout the test sheet and the load temperature devices attained the exposure temperature within 10 seconds of progressing into the exposure phase. |
| Software Validation: Compliance with FDA's moderate level of concern recommendations (Guidance for Premarket Submissions for Software Contained in Medical Devices (May 2005)). | Software validation for cycle operation was performed according to FDA's moderate level of concern recommendations provided in the document "Guidance for the Content for Premarket Submissions for Software Contained in Medical Devices (May 2005)". |
2. Sample size used for the test set and the data provenance
The document does not specify a quantitative "sample size" in terms of number of runs for each test. Instead, it states that "Belimed validates its sterilization cycles by recommended practices, standards and guidelines developed by various independent organizations such as the Association for Advancement of Medical Instrumentation (AAMI)." It refers to "verification studies" and "qualified according to section" of ANSI/AAMI ST8.
- Sample Size: Not explicitly stated as a number of cycles/runs per test. The typical validation for sterilizers involves multiple runs (often three replicate runs) under worst-case conditions for each specified cycle and load configuration according to standards like AAMI ST8. The document implies these standard practices were followed ("All Prevac cycles verified...", "All Gravity Immediate Use cycles were verified...").
- Data Provenance: The studies were "verification studies" performed by the manufacturer, Belimed, or a contracted lab on their behalf. The country of origin for the data is not specified, but the submission is to the FDA (USA). The nature of the studies is prospective, as they are conducted specifically to validate the performance of the new device before its market release.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable as the device is a steam sterilizer, not an AI/ML device requiring expert interpretation for ground truth establishment. The "ground truth" for a sterilizer's performance is biological (kill of biological indicators) and physical (temperature, pressure, dry conditions) measurements, established through scientific laboratory testing and adherence to recognized standards.
4. Adjudication method for the test set
Not applicable. Adjudication methods (like 2+1, 3+1) are used to resolve disagreements among multiple human readers in AI/ML performance evaluation. For a sterilizer, the performance is measured objectively against defined physical and biological criteria.
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
Not applicable. This is a sterilizer, not an AI-assisted diagnostic or interpretative device. Therefore, no MRMC study involving human readers or AI assistance would have been performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a sterilizer, not an algorithm. Its performance is measured as a standalone system (the sterilizer operating independently) based on its ability to meet sterilization parameters and kill microorganisms.
7. The type of ground truth used
The ground truth used for sterilizer validation is a combination of:
- Biological Efficacy: Complete kill of biological indicators to demonstrate a sterility assurance level (SAL) of at least 10^-6^. This is the primary measure of sterilization effectiveness.
- Physical Parameters: Achievement of specified time-at-temperature (Fo value), pressure, and appropriate dry conditions (e.g., moisture retention within limits, no wet spots). These physical parameters ensure the conditions for sterilization were met.
These are objective, measurable outcomes, not subjective expert consensus or pathology in the context of an AI/ML device.
8. The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no "training set" in the machine learning sense. The device is engineered and tested against established physical and biological principles.
9. How the ground truth for the training set was established
Not applicable as there is no training set for an AI/ML model. The "ground truth" for the sterilizer's function is established by adherence to recognized sterilization standards (like ANSI/AAMI ST8) which define what constitutes effective sterilization based on decades of scientific and medical knowledge in microbiology and engineering.
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