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510(k) Data Aggregation
(225 days)
The Belimed Steam Sterilizer TOP 5000, Series 8, model 6-0-12 is designed for sterilization of nonporous and porous heat and moisture-stable materials used in healthcare facilities.
The Belimed Steam Sterilizer TOP 5000 Series 8, model 6-0-12, is equipped with the following factoryprogrammed Sterilization cycles and values (Tables 1-3).
The Belimed Steam Sterilizer TOP 5000 Series 8 is intended for use in hospital and health care facilities.
The provided document describes a medical device (Belimed Steam Sterilizer TOP 5000 Series 8) and its validation, rather than an AI-powered medical device. Therefore, several of the requested categories (e.g., sample size for AI test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set details) are not applicable.
However, I can extract the acceptance criteria and the study results that demonstrate the device's effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for sterilizers are based on achieving a sterility assurance level (SAL) of at least 10⁻⁶ and specific physical parameters. The reported performance indicates that the device met these criteria through various validation studies aligned with AAMI/ANSI-ST8:2001.
| Acceptance Criteria (According to AAMI/ANSI-ST8:2001) | Reported Device Performance |
|---|---|
| Sterility Assurance Level (SAL): At least 10⁻⁶ reduction (typically demonstrated by achieving an F₀ of at least 12 by ½ cycle) | Achieved: All Prevac, Flash, and Liquid cycles demonstrated a sterility assurance level of at least 10⁻⁶ through achievement of a time at temperature sufficient to produce an F₀ of at least 12 by ½ cycle. |
| Moisture Retention (Fabric Test Packs): Less than 3% increase in pre-sterilization test pack weight and no wet spots. | Met: Prevac cycles with fabric test packs demonstrated a moisture retention of less than 3% increase in pre-sterilization test pack weight, and exhibited no wet spots. |
| Moisture Retention (Full Load Instrument Trays): Less than 20% increase in pre-sterilization test pack weight and no wet spots on the outer wrapper. | Met: Prevac cycles with full load instrument trays demonstrated a moisture retention of less than 20% increase in pre-sterilization test pack weight, and exhibited no wet spots on the outer wrapper. |
| Wet Spots (Flash cycles): No wet spots. | Met: All Flash cycles exhibited no wet spots. |
| Liquid Cycles (Temperature and Duration): 121°C achieved and maintained in the center of the liquid for at least 12 minutes. | Met: Liquid cycles achieved and maintained a temperature of 121°C in the center of the liquid for at least 12 minutes. |
| Liquid Cycles (Water Loss and Sealing): Water loss not exceeding 50ml and automatic sealing of the flask closure. | Met: Liquid cycles demonstrated water loss not exceeding 50ml and an automatic sealing of the flask closure. |
| Bowie-Dick Test (BD cycle): Uniform color change throughout the test sheet. | Met: The BD cycle demonstrated a uniform color change throughout the test sheet. |
| Software Validation: Compliance with FDA's moderate level of concern recommendations. | Met: Software validation for cycle operation was performed according to the FDA's moderate level of concern recommendations provided in the document "Guidance for the Content for Premarket Submissions for Software Contained in Medical Devices (5/29/98)." |
The study that proves the device meets the acceptance criteria is detailed under the "Effectiveness" section of the 510(k) summary. Belimed Sauter AG validated its sterilization cycles by recommended practices, standards, and guidelines developed by various independent organizations, specifically the Association for the Advancement of Medical Instrumentation (AAMI).
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The document does not specify a numerical sample size for the test sets (e.g., number of fabric packs, instrument trays, or liquid flasks tested). It describes testing using "fabric test packs," "full load instrument trays," "unwrapped instrument tray," and "three 1000 ml flasks." The implication is that these tests were conducted sufficiently to meet the AAMI/ANSI-ST8:2001 requirements.
- Data Provenance: The studies were conducted by Belimed Sauter AG, the manufacturer, as part of their pre-market submission to the FDA. The country of origin for the data is not explicitly stated, but Belimed Sauter AG is identified as Belimed, Inc.'s US Agent, and the device is intended for use in "hospital and health care facilities" (presumably in the US, given the FDA filing). The studies are prospective in nature, as they are qualification/validation tests performed to demonstrate the device's effectiveness before market release.
3. 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. The ground truth for sterilizer effectiveness is established through objective physical and microbiological measurements (e.g., F₀ values, temperature logs, biological indicators, moisture retention, color change on test sheets) against predefined standards, not through expert human interpretation in the sense of image analysis or diagnostic assessment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As described above, the validation is based on objective measurements against engineering and microbiological standards, rather than human expert 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
Not applicable. This is a sterilizer, not an AI-powered diagnostic device involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not directly applicable in the context of a sterilizer. However, the entirety of the sterilization validation study can be considered "standalone" performance in that it demonstrates the device's ability to sterilize materials independently, according to its programmed cycles, without human intervention during the active sterilization process itself. The "algorithm" here refers to the pre-programmed sterilization cycles and control software.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth used for sterilizer validation is objective and based on established scientific principles and industry standards for sterilization. This includes:
- Microbiological Confirmation: Achieving a Sterility Assurance Level (SAL) of at least 10⁻⁶, often inferred from F₀ values (which relate to the equivalent time at a reference temperature required to kill a population of microorganisms).
- Physical Parameters: Verification of specific temperature, pressure, and time profiles within the sterilizer chamber and load.
- Biological Indicators: Although not explicitly detailed for every test, biological indicators are typically used to confirm the kill of highly resistant microorganisms (e.g., Geobacillus stearothermophilus spores) for SAL determination.
- Chemical Indicators: Color changes on chemical indicators (like the Bowie-Dick test) demonstrate uniform steam penetration.
- Moisture Retention: Quantitative measurement of moisture remaining on sterilized items to ensure effective drying.
These are quantitative, empirical measures derived from standard testing methodologies rather than subjective expert consensus or pathology.
8. The sample size for the training set
Not applicable. This is a physical device, not a machine learning model, so there is no "training set" in the AI sense. The device's design and factory-programmed cycles were developed through engineering and scientific principles, not by training on a dataset.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" for this type of device. The "ground truth" for the device's design and operation reflects established scientific principles of sterilization and adherence to relevant industry standards (e.g., AAMI/ANSI-ST8:2001).
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